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ABASAGLAR 100 units/mL KwikPen solution for injection in a pre-filled pen - Name: ABASAGLAR 100 units/mL KwikPen solution for injection in a pre-filled pen - Company: Eli Lilly and Company (Ireland) Limited - Active Ingredients: - Legal Category: Product subject to medical prescription which may be renewed (B) Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/08/20(Click to Download) Click on this link to Download PDF directly Eli Lilly and Company (Ireland) Limited Company Products When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change. Updated on 27 August 2020 Ed-HCP Reasons for updating - Replace document Free text change information supplied by the pharmaceutical company Changes Added (underline) deleted ( strikethrough) INSTRUCTIONS FOR USE Change to format of the product name: Instructions for use KwikPen ® ABASAGLAR® 100 units/mL KwikPen® solution for injection in a pre-filled pen Insulin glargine This leaflet was last revised in April July 2020 Updated on 27 August 2020 PIL Reasons for updating - Change to section 2 - what you need to know - warnings and precautions - Change to section 3 - overdose, missed or forgotten doses - Change to section 6 - what the product contains - Change to name of medicinal product Free text change information supplied by the pharmaceutical company Changes Added (underline) deleted ( strikethrough) ABASAGLAR® 100 units/mL KwikPen® solution for injection in a pre-filled pen insulin glargine What you need to know before you use ABASAGLAR Warnings and precautions Insulin mix-ups You must always check the pack and insulin label before each injection to avoid mix-ups between ABASAGLAR and other insulins. ……… Important information about some of the ingredients of ABASAGLAR contains sodium This medicine contains less than 1 mmol (23 mg) sodium per dose, which means it is essentially ‘sodium-free’. How to use ABASAGLAR How to handle ABASAGLAR KwikPen ………. Insulin Mix-ups You must always check the insulin label before each injection to avoid mix-ups between ABASAGLAR and other insulins. If you use more ABASAGLAR than you should - If you have injected too much ABASAGLAR or are unsure how much you have injected, your blood sugar level may become too low (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, see box at the end of this leaflet. If you forget to use ABASAGLAR - If you have missed a dose of ABASAGLAR or if you have not injected enough insulin or are unsure how much you have injected, your blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see box at the end of this leaflet. - Do not take a double dose to make up for a forgotten dose. After injecting If you are unsure how much you have injected then check your blood sugar levels before deciding if you need another injection. Contents of the pack and other information What ABASAGLAR contains ………. The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide (see section 2 “ Important information about some of the ingredients of ABASAGLAR contains sodium”), hydrochloric acid and water for injections. Updated on 25 August 2020 Reasons for updating - New individual SmPC (was previously included in combined SmPC) - Change to section 1 - Name of medicinal product - Change to section 2 - Qualitative and quantitative composition - Change to section 3 - Pharmaceutical form - Change to section 4.2 - Posology and method of administration - Change to section 4.4 - Special warnings and precautions for use - Change to section 6.5 - Nature and contents of container - Change to section 6.6 - Special precautions for disposal and other handling - Change to section 8 - Marketing authorisation number(s) - Change to section 10 - Date of revision of the text - Improved presentation of SmPC Free text change information supplied by the pharmaceutical company The format of the SmPC has changed from a combined Abasaglar cartridge & pre-filled pen SmPC to that of a separate SmPC for Abasaglar pre-filled pens (i.e- KwikPen). The SmPC for Abasaglar pre-filled pens also includes new text relating to the non-marketed Tempo pen. In addition, other minor formatting changes (sub-headings) have been made in sections 4.2, 4.8, 5.1 and 5.2 Added (underline) deleted ( strikethrough) NAME OF THE MEDICINAL PRODUCT ABASAGLAR 100 units/mL KwikPen solution for injection in a pre-filled pen ABASAGLAR 100 units/mL Tempo Pen solution for injection in a pre-filled pen QUALITATIVE AND QUANTITATIVE COMPOSITION ……… Insulin glargine is ……… PHARMACEUTICAL FORM Solution for injection (injection) in pre‑filled pen (KwikPen). ……… CLINICAL PARTICULARS 4.2 Posology and method of administration ……… KwikPen The KwikPen is registered in two presentations. One delivers 1 –60 units in steps of 1 unit in a single injection and the other delivers 1 – 80 units in steps of 1 unit in a single injection. The needed dose is dialled in units. The number of units is shown in the dose window of the pen. Tempo Pen The Tempo Pen delivers 1 – 80 units in steps of 1 unit in a single injection. The needed dose is dialled in units. The number of units is shown in the dose window of the pen. The Tempo Pen can be used with the optional transfer module Tempo Smart Button (see section 6.6). As with any insulin injection, when using the Tempo Pen, Smart Button and the mobile application, the patient should be instructed to check their blood sugar levels when considering or making decisions about another injection if they are unsure how much they have injected. 4.4 Special warnings and precautions for use Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Diabetic ketoacidosis ABASAGLAR is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered intravenously is recommended in such cases. Insulin requirements and dose adjustments In case of insufficient glucose control or a tendency to hyperglycaemic or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. ………. Medication errors Medication errors have been reported in which other insulins, particularly short‑acting insulins, have been accidentally administered instead of insulin glargine. Insulin label must always be checked before each injection to avoid medication errors between ABASAGLAR pre-filled pen as well as and other insulins. ………. Tempo Pen The Tempo Pen contains a magnet (see section 6.5) that may interfere with the functions of an implantable electronic medical device, such as a pacemaker. The magnetic field extends to approximately 1.5 cm. ………. 6.5 Nature and contents of container KwikPen 3 mL solution in a cartridge (type 1 colourless glass) with a plunger (halobutyl rubber) and a disc seal (laminate of polyisoprene and halobutyl rubber) with aluminium seal. The cartridge is sealed in a disposable pen injector. Packs of 5 pre-filled pens and multipacks containing 10 (2 packs of 5) pre-filled pens. Tempo Pen 3 mL solution in a cartridge (type 1 colourless glass) with a plunger (halobutyl rubber) and a disc seal (laminate of polyisoprene and halobutyl rubber) with aluminium seal. The cartridge is sealed in a disposable pen injector. The Tempo Pen contains a magnet (see section 4.4). Packs of 5 pre-filled pens and multipacks containing 10 (2 packs of 5) pre-filled pens. Not all pack sizes may be marketed. Needles are not included in the pack. 6.6 Special precautions for disposal and other handling ………. Tempo Pen The Tempo Pen is designed to work with the Tempo Smart Button. The Tempo Smart Button is an optional product that can be attached to the Tempo Pen dose knob and aids in transmitting Abasaglar dose information from the Tempo Pen to a compatible mobile application. The Tempo Pen injects insulin with or without the Tempo Smart Button attached. To transmit data to the mobile application, follow the instructions provided with the Tempo Smart Button and the instructions with the mobile application. MARKETING AUTHORISATION NUMBER(S) ………. DATE OF REVISION OF THE TEXT 13 January 2019 23 July 2020 Updated on 30 July 2020 PIL Reasons for updating - Change to section 2 - what you need to know - warnings and precautions - Change to section 4 - possible side effects - Change to section 6 - date of revision Updated on 29 July 2020 Reasons for updating - Change to section 4.2 - Posology and method of administration - Change to section 4.4 - Special warnings and precautions for use - Change to section 4.8 - Undesirable effects - Change to section 8 - Marketing authorisation number(s) - Change to section 10 - Date of revision of the text Free text change information supplied by the pharmaceutical company Changes Added (underline) deleted ( strikethrough) CLINICAL PARTICULARS 4.2 Posology and method of administration ………. Method of administration ……… Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8). Injection sites must be rotated within a given injection area from one injection to the next. ……… 4.4 Special warnings and precautions for use ……… Injection technique Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered. ………. 4.8 Undesirable effects ……… Description of selected adverse reactions ……… Skin and subcutaneous tissue disorders Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see section 4.4). MARKETING AUTHORISATION NUMBER(S) Cartridges Pack of 5 cartridges Pack of 10 cartridges Pre‑filled pens (60 Units) Pack of 5 pre-filled pens Pack of 10 (2 x 5) pre-filled pens Pre‑filled pens (80 Units) Pack of 5 pre-filled pens Pack of 10 (2 x 5) pre-filled pens DATE OF REVISION OF THE TEXT 13 January 2019 23 July 2020 Updated on 28 April 2020 Ed-HCP Reasons for updating - Replace document Updated on 28 April 2020 PIL Reasons for updating - Change to section 6 - date of revision - Change to other sources of information section - Change in co-marketing arrangement Updated on 28 January 2020 PIL Reasons for updating - Change to section 4 - possible side effects - Change to section 6 - date of revision Free text change information supplied by the pharmaceutical company Possible side effects Common side effects (may affect up to 1 in 10 people) Skin changes at the injection site Skin changes at the injection site If you inject your insulin too often at the same skin site, fatty tissue underplace the skin at this site may either shrink (lipoatrophy, may affect up to 1 in 100 people) or thicken (lipohypertrophy, may affect up to 1 in 10 people). Also lumps under the skin caused by a build-up of a protein called amyloid may occur (cutaneous amyloidosis, how often they occur is not known) .). The insulin may not work very well. Change the injection site with each injection to help prevent these skin changes. Common side effects (may affect up to 1 in 10 people) Contents of the pack and other information This leaflet was last revised in July 2019January 2020 Updated on 28 January 2020 Reasons for updating - Change to section 4.8 - Undesirable effects - Change to section 10 - Date of revision of the text Free text change information supplied by the pharmaceutical company CLINICAL PARTICULARS 4.8 Undesirable effects ……… Tabulated list of adverse reactions The following related adverse reactions from clinical trials are listed below as MedDRA preferred term by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000 and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Description of selected adverse reactions ……… Skin and subcutaneous tissue disorders Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions. DATE OF REVISION OF THE TEXT 25 July 2019 13 January 2019 Updated on 6 September 2019 PIL Reasons for updating - Change to section 4 - how to report a side effect - Correction of spelling/typing errors Updated on 31 July 2019 PIL Reasons for updating - Change to section 1 - what the product is used for - Change to section 2 - what you need to know - warnings and precautions - Change to section 2 - use in children and adolescents - Change to section 2 - driving and using machines - Change to section 3 - use in children/adolescents - Change to section 4 - possible side effects - Change to section 4 - how to report a side effect - Change to section 6 - what the product looks like and pack contents - Change to section 6 - date of revision - Removal of Black Inverted Triangle Updated on 30 July 2019 Reasons for updating - Change to section 3 - Pharmaceutical form - Change to section 4.2 - Posology and method of administration - Change to section 4.4 - Special warnings and precautions for use - Change to section 4.6 - Pregnancy and lactation - Change to section 4.7 - Effects on ability to drive and use machines - Change to section 4.8 - Undesirable effects - Change to Section 4.8 – Undesirable effects - how to report a side effect - Change to section 5.1 - Pharmacodynamic properties - Change to section 6.1 - List of excipients - Change to section 6.5 - Nature and contents of container - Change to section 6.6 - Special precautions for disposal and other handling - Change to section 8 - Marketing authorisation number(s) - Change to section 9 - Date of first authorisation/renewal of the authorisation - Change to section 10 - Date of revision of the text - Removal of Black Inverted Triangle Free text change information supplied by the pharmaceutical company This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. PHARMACEUTICAL FORM Solution for injection (injection). Solution for injection (injection) in pre‑filled pen (KwikPen). Solution for injection. KwikPen. (Injection). 4.2 Posology and method of administration The ABASAGLAR dose regimen (dose and timing) should be individually adjusted. Paediatric population Adolescents and children aged 2 years and older The safety and efficacy of insulin glargine have been established in adolescents and children aged 2 years and older (see section 5.1). The dose regimen (dose and timing) should be individually adjusted. Children below 2 years of age The safety and efficacy of insulin glargine have not been established No data are available. Safety and efficacy of insulin glargine have been established in adolescents and children aged 2 years and older. Currently available data are described in sections 4.8, 5.1 and 5.2. Safety and efficacy of insulin glargine have not been established in children below the age of 2 years. No data are available. Before using ABASAGLAR solution for injection in pre‑filled pen Kwikpen, the instructions for use included in the package leaflet must be read carefully (see section 6.6). 4.4 Special warnings and precautions for use Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia (see section 4.8). Insulin antibodies Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia (see section 5.1). Sodium content Excipients 4.6 Fertility, pregnancy and lactation The use of ABASAGLAR may be considered during pregnancy, if clinically needed necessary. 4.7 Effects on ability to drive and use machines This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating using machines). 4.8 Undesirable effects Summary of safety profile Hypoglycaemia (very common), in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement (see section 4.4). Insulin administration may cause insulin antibodies to form. In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia. Skin and subcutaneous tissue disorders As with any insulin therapy, lLipodystrophy may occur at the injection site and delay local insulin absorption. Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, website: www.hpra.ie, e-mail: medsafety@hpra.ie , 5.1 Pharmacodynamic properties Clinical safety and efficacy In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups. The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, randomi zsed, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12% of participants) or type 2 diabetes mellitus treated with ≤1 antidiabetic oral agent (88% of participants). Participants were randomi zsed (1:1) to receive insulin glargine (n=6,264), titrated to reach FPG ≤95 mg/dL (5.3 mM), or standard care (n=6,273). 6.1 List of excipients glycerol hydrochloric acid (for pH adjustment) sodium hydroxide (for pH adjustment) water for injections 6.5 Nature and contents of container Cartridges Packs of 5 and 10 1, 2, 5, 10 and multipacks containing 10 (2 packs of 5) cartridges. Not all pack sizes may be marketed. Pre-filled pens Packs of 1, 2, 5 pens and multipacks containing 10 (2 packs of 5) pens. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling ABASAGLAR Pre- filled pen (KwikPen) Handling of the pen The patient should be advised to read the instructions for use included in the package leaflet carefully before using ABASAGLAR solution for injection in pre‑filled pen. Kwikpen. MARKETING AUTHORISATION NUMBER(S) Cartridges EU/1/14/944/001 Pack of 1 cartridge EU/1/14/944/002 Pack of 2 cartridges EU/1/14/944/003 Pack of 5 cartridges EU/1/14/944/004 Pack of 10 (2 x 5) cartridges EU/1/14/944/009 Pack of 10 cartridges Pre‑filled pens (60 Units) EU/1/14/944/005 Pack of 1 pre-filled pen EU/1/14/944/006 Pack of 2 pre-filled pens EU/1/14/944/007 Pack of 5 pre-filled pens EU/1/14/944/008 Pack of 10 (2 x 5) pre-filled pens Pre‑filled pens (80 Units) EU/1/14/944/010 Pack of 1 pre-filled pen EU/1/14/944/011 Pack of 2 pre-filled pens EU/1/14/944/012 Pack of 5 pre-filled pens EU/1/14/944/013 Pack of 10 (2 x 5) pre-filled pens DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 September 2014 Date of latest renewal: 25 July 2019 DATE OF REVISION OF THE TEXT 27 February 201825 July 2019 AB5MAB6M Updated on 23 April 2018 Ed-HCP Reasons for updating - Add New Doc Updated on 9 March 2018 Reasons for updating - New SmPC for new product Legal category: Product subject to medical prescription which may be renewed (B) Updated on 9 March 2018 SPC Reasons for updating - Change to section 7 - Marketing authorisation holder - Change to section 10 - Date of revision of the text Legal category: Product subject to medical prescription which may be renewed (B) Free text change information supplied by the pharmaceutical company Changes Added (underline) deleted ( strikethrough) MARKETING AUTHORISATION HOLDER Eli Lilly Regional Operations GmbH., Kölblgasse 8-10, 1030, Vienna, Austria. Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands DATE OF REVISION OF THE TEXT 1 February 201827 February 2018 Updated on 5 March 2018 PIL Reasons for updating - Change to section 4 - how to report a side effect - Change to section 6 - marketing authorisation holder - Change to section 6 - date of revision Updated on 5 March 2018 PIL Reasons for updating - New PIL for new product Updated on 21 February 2018 SPC Reasons for updating - Change to section 1 - Name of medicinal product - Change to Section 4.8 – Undesirable effects - how to report a side effect - Change to section 6.5 - Nature and contents of container - Change to section 10 - Date of revision of the text Legal category: Product subject to medical prescription which may be renewed (B) Free text change information supplied by the pharmaceutical company Added (underline) deleted ( strikethrough) ABASAGLAR ® (insulin glargine) SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE MEDICINAL PRODUCT ABASAGLAR ] 100 units/mL solution for injection in a cartridge 4.8 Undesirable effects Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, website: www.hpra.ie, e-mail: medsafety@hpra.ie, United Kingdom: Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 6.5 Nature and contents of container Cartridges 3 mL solution in a cartridge (type 1 colourless glass) with a plunger ( chlorobutylhalobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutylhalobutyl rubber) with aluminium seal. Packs of 1, 2, 5, 10 and multipacks containing 10 (2 packs of 5) cartridges. Not all pack sizes may be marketed. Pre‑filled pens 3 mL solution in a cartridge (type 1 colourless glass) with a plunger ( chlorobutylhalobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutylhalobutyl rubber) with aluminium seal. DATE OF REVISION OF THE TEXT 19 January 20171 February 2018 Updated on 28 February 2017 PIL Reasons for updating - Change to section 2 - what you need to know - warnings and precautions - Change to section 3 - how to take/use - Change to section 6 - date of revision Updated on 24 February 2017 SPC Reasons for updating - Change to section 4.2 - Posology and method of administration - Change to section 4.4 - Special warnings and precautions for use - Change to section 6.6 - Special precautions for disposal and other handling - Change to section 10 - Date of revision of the text Legal category: Product subject to medical prescription which may be renewed (B) Free text change information supplied by the pharmaceutical company New text is underlined in bold, removed text is struckthough in bold. Changes CLINICAL PARTICULARS 4.2 Posology and method of administration …… Transition Switch from other insulins to ABASAGLAR When changing switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with ABASAGLAR, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products). Switch from twice daily NPH insulin to ABASAGLAR To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with ABASAGLAR should reduce their daily dose of basal insulin by 20-30 % during the first weeks of treatment. Switch from insulin glargine 300 units/ml to ABASAGLAR ABASAGLAR and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable. To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with ABASAGLAR should reduce their dose by approximately 20%. During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually. As with other insulin analogues, patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with ABASAGLAR. Close metabolic monitoring is recommended during the transition switch and in the initial weeks thereafter. With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypoglycaemia or hyperglycaemia (see section 4.4). Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with ABASAGLAR. 4.4 Special warnings and precautions for use ………. Pens to be used with ABASAGLAR cartridges The cartridges should only be used in conjunction with a Lilly reusable insulin pen recommended for the use with Lilly insulin cartridges and should not be used with any other reusable pen as the dosing accuracy has not been established with other pens. PHARMACEUTICAL PARTICULARS 6.6 Special precautions for disposal and other handling ABASAGLAR must not be mixed with any other insulin or medicinal products or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation. Insulin pen The ABASAGLAR cartridges are to be used only in conjunction with a Lilly reusable insulin pen recommended for the use with Lilly insulin cartridges (see section 4.4). The pen should be used as recommended in the information provided bywith the device manufacturer. The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection. If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used. If the pen malfunctions (see instructions for using the pen), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 units/mL) and injected. It is important to ensure that syringes do not contain traces of any other material. …………. DATE OF REVISION OF THE TEXT 19 January 2017 Updated on 3 December 2015 SPC Reasons for updating - New SPC for new product Legal category: Product subject to medical prescription which may be renewed (B) Free text change information supplied by the pharmaceutical company Updated on 1 December 2015 PIL Reasons for updating - New PIL for new product ABASAGLAR 100 units/mL pre-filled penInstructions for use(Click to Download) Educational Materials for Medicines Educational Materials for Medicines
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Lantus – Uputa o lijeku - Budite prvi i komentirajte! - 12 min čitanja Lantus 100 jedinica/ml otopina za injekciju u ulošku inzulin glargin Pažljivo pročitajte cijelu uputu prije nego što poč nete uzimati lijek, jer sadržava važne informacije za Vas. Upute za uporabu inzulinske brizgalice priložene su uz brizgalicu. Proučite ih prije uporabe lijeka. - Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati. - Ukoliko imate dodatnih pitanja obratite se svom liječniku, ljekarniku ili medicinskoj sestri. - Ovaj je lijek propisan Vama. Nemojte ga davati drugima. Može im štetiti, čak i ako imaju simptome jednake Vašima. - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. U ovoj uputi: - Što je Lantus i za što se koristi - Prije nego počnete uzimati Lantus - Kako uzimati Lantus - Moguće nuspojave - Kako čuvati Lantus - Dodatne informacije Što je Lantus i za što se koristi Lantus je otopina za injekciju koja sadržava inzulin glargin. Inzulin glargin je modificirani inzulin, vrlo sličan ljudskom inzulinu. Lantus se upotrebljava za liječenje šećerne bolesti u odraslih bolesnika, adolescenata i djece starije od 2 godine. Šećerna bolest (dijabetes) je bolest u kojoj vaše tijelo ne stvara dovoljno inzulina za regulaciju razine šećera u krvi. Inzulin glargin ima dugotrajan i kontinuiran učinak na snižavanje šećera u krvi. Prije nego počnete uzimati Lantus Nemojte uzimati Lantus Ako ste alergični (preosjetljivi) na inzulin glargin ili na bilo koji drugi sastojak Lantusa (za cjeloviti popis pomoćnih tvari vidjeti dio 6.). Budite oprezni s Lantusom Razgovarajte s Vašim liječnikom, ljekarnikom ili medicinskom sestrom prije nego počnete koristiti Lantus. Pažljivo slijedite upute o doziranju, kontroli (pretrage krvi i mokraće), prehrani i fizičkoj aktivnosti (fizički rad i tjelovježba) o kojima ste razgovarali sa svojim liječnikom. Ako vam je šećer u krvi prenizak (hipoglikemija), slijedite upute za hipoglikemiju (vidjeti uokvireni tekst na kraju upute). Putovanje Prije puta posavjetujte se sa svojim liječnikom. Porazgovarajte o: - dostupnosti inzulina u zemlji koju posjećujete, opskrbi inzulinom, štrcaljkama i dr., - ispravnom čuvanju inzulina za vrijeme putovanja, - rasporedu uzimanja obroka i inzulina za vrijeme putovanja, mogućim utjecajima promjene vremenskih zona, - mogućim novim rizicima po zdravlje u zemljama koje namjeravate posjetiti - tome što trebate učiniti u hitnim slučajevima, ako se ne osjećate dobro ili obolite. Bolesti i ozljede Liječenje Vaše bolesti (dijabetesa) može zahtijevati posebnu pozornost (na primjer prilagodbu doze inzulina, pretrage krvi i urina) u sljedećim situacijama: - ako ste bolesni ili jako ozlijeđeni, šećer u krvi Vam može porasti (hiperglikemija), - ako ne jedete dovoljno, šećer u krvi vam može postati prenizak (hipoglikemija). U većini slučajeva trebat ćete liječ Kontaktirajte liječnika na vrijeme. Ako imate dijabetes tipa 1 (šećernu bolest koja je ovisna o inzulinu), nemojte prestati uzimati inzulin i nastavite uzimati dovoljno ugljikohidrata. Uvijek recite osobama koje skrbe o vama ili vas liječe da vam je potreban inzulin. U nekih bolesnika s dugotrajnim dijebetesom tipa 2 i bolešću srca ili prethodnim moždanim udarom koji su liječeni pioglitazonom i inzulinom došlo je do razvoja zatajenja srca. Odmah obavijestite svog liječnika ako uočite znakove srčanog zatajenja, kao što je neuobičajena zadihanost, nagli dobitak na težini ili lokalizirano oticanje (edem). Uzimanje drugih lijekova s Lantusom Neki lijekovi uzrokuju promjenu razine šećera u krvi (smanjenje, povećanje ili oboje, ovisno o situaciji). U svakom slučaju, može biti potrebno prilagoditi dozu inzulina kako biste izbjegli prenisku ili previsoku razinu šećera u krvi. Budite oprezni kad započinjete i kad prestajete uzimati drugi lijek. Obavijestite svog liječ nika ili ljekarnika ako uzimate ili ste nedavno uzimali bilo koji drugi lijek, uključujući i one koje ste kupili bez recepta. Prije uzimanja lijeka upitajte svog liječnika može li taj lijek utjecati na razinu šećera u krvi i što treba poduzeti, bude li potrebno. Lijekovi koji mogu uzrokovati pad razine šećera u krvi (hipoglikemija) uključuju: - sve ostale lijekove za liječenje dijabetesa - ACE inhibitore (koriste se za liječenje nekih bolesti srca ili visokog krvnog tlaka) - dizopiramid (koristi se za liječenje nekih bolesti srca) - fluoksetin (koristi se za liječenje depresije) - fibrate (koriste se za snižavanje visoke razine lipida u krvi) - inhibitore monoaminooksidaze (koriste se za liječenje depresije) - pentoksifilin, propoksifen, salicilate (kao što je acetilsalicilatna kiselina, koja se koristi za ublažavanje boli i snižavanje povišene temperature) - sulfonamidske antibiotike. Lijekovi koji mogu uzrokovati povišenje razine šećera u krvi (hiperglikemija) uključuju: - kortikosteroide (kao što je kortizon, koji se koristi za liječenje upala) - danazol (lijek koji djeluje na ovulaciju) - diazoksid (koristi se za liječenje visokog krvnog tlaka) - diuretike (koriste se za liječenje visokog krvnog tlaka ili prekomjerno zadržavanje tekućine) - glukagon (hormon gušterače, koji se koristi za liječenje teške hipoglikemije) - izoniazid (koristi se za liječenje tuberkuloze) - estrogene i progesterone (primjerice kontracepcijske tablete) - derivate fenotiazina (koriste se za liječenje psihijatrijskih poremećaja) - somatropin (hormon rasta) - simpatomimetike (primjerice adrenalin, salbutamol ili terbutalin za liječenje astme) - tireoidne hormone (koriste se za liječenje poremećaja funkcije štitnjače) - atipične antipsihotike (primjerice klozapin i olanzapin) - inhibitore proteaze (za liječenje infekcija HIV-om) Razina šećera u krvi može se povisiti ili sniziti ako uzimate: - beta-blokatore (koriste se za liječenje visokog krvnog tlaka) - klonidin (koristi se za liječenje visokog krvnog tlaka) - soli litija (koriste se za liječenje psihijatrijskih poremećaja) Pentamidin (koristi se za liječenje nekih infekcija uzrokovanih parazitima) može uzrokovati hipoglikemiju, nakon koje katkad može nastupiti hiperglikemija. Beta blokatori kao i drugi simpatolitici (npr. klonidin, gvanetidin i rezerpin) mogu oslabiti ili čak potpuno potisnuti upozoravajuće simptome hipoglikemije. Ako niste sigurni uzimate li koji od ovih lijekova, upitajte svog liječnika ili ljekarnika. Uzimanje hrane i pića s Lantusom Razina šećera u krvi može se povisiti ili sniziti ako pijete alkohol. Trudnoća i dojenje Prije uzimanja bilo kojeg lijeka, zatražite savjet od svog liječnika ili ljekarnika. Ako ste trudni ili planirate trudnoću, o tome obavijestite svog liječnika. Možda će trebati promijeniti dozu inzulina za vrijeme trudnoć e i nakon poroda. Za zdravlje Vašeg djeteta posebno je važna pažljiva kontrola dijabetesa i sprječavanje hipoglikemije. Ako dojite, posavjetujte se sa svojim liječnikom jer ćete možda trebati prilagoditi dozu inzulina i način prehrane. Upravljanje vozilima i strojevima Vaša sposobnost koncentracije i reagiranja može biti smanjena ako imate: - hipoglikemiju (niska razina šećera u krvi), - hiperglikemiju (visoka razina šećera u krvi), - probleme s vidom. Imajte to na umu u svim situacijama u kojima sebe i druge možete izložiti riziku (primjerice vožnja autom ili upravljanje strojevima). Morate pitati liječnika preporuča li Vam voziti: - ako imate česte epizode hipoglikemije, - ako su Vam smanjeni ili izostaju upozoravajući znakovi hipoglikemije. Važne informacije o nekim pomoćnim tvarima u Lantusu Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija, odnosno praktički ne sadržava natrij. Kako uzimati Lantus Doziranje Uvijek uzimajte ovaj lijek točno onako kako Vam je propisao liječnik. Ako niste sigurni, trebate se savjetovati s liječnikom ili ljekarnikom. Na temelju Vašeg načina života, rezultata pretraga razine šećera u krvi (glukoze), te Vaše ranije uporabe inzulina, Vaš liječnik će: odrediti koliko Vam je Lantusa dnevno potrebno i u koje vrijeme, reći kad ćete provjeriti razinu šećera u krvi i trebate li napraviti pretrage mokraće, reći kad ćete možda trebati injicirati veću ili manju dozu Lantusa. Lantus je inzulin dugog djelovanja. Liječnik će Vam možda reći da ga uzimate u kombinaciji s kratkodjelujućim inzulinom odnosno s tabletama koje snižavaju povišeni šećer u krvi. Mnogi čimbenici mogu utjecati na razinu šećera u krvi. Morate ih poznavati da biste ispravno odgovorili na promjene razine šećera u krvi i spriječili da postane previsoka ili preniska. Za dodatne informacije pogledajte uokvireni tekst na kraju upute. Upotreba u djece i adolescenata Lantus mogu koristiti adolescenti i djeca od 2 godine naviše. Nema podataka o upotrebi Lantusa u djece mlađe od 2 godine. Učestalost primjene Potrebna Vam je jedna injekcija Lantusa svaki dan u isto vrijeme. Način primjene Lantus se daje injekcijom pod kožu. NE ubrizgavajte Lantus u venu, budući da će to promijeniti njegovo djelovanje i može uzrokovati hipoglikemiju. Liječnik će Vas uputiti u koje područje na koži trebate injicirati Lantus. Prilikom svake injekcije promijenite mjesto uboda unutar tih područja na koži. Kako rukovati s ulošcima Lantus ulošci smiju se upotrebljavati samo s brizgalicama OptiPen, ClikSTAR, Tactipen ili Autopen 24 kako bi se osigurala primjena ispravne doze. Moguće je da neke od navedenih brizgalica nisu na tržištu u vašoj zemlji. Brizgalicu treba koristiti sukladno preporukama proizvođača medicinskog proizvoda. Treba pažljivo slijediti upute proizvođa ča za uporabu brizgalice, o umetanju staklenog uloška, pričvršćivanju igle te primjeni injekcije inzulina. Prije stavljanja u brizgalicu, uložak treba držati na sobnoj temperaturi sat do dva. Pregledajte uložak prije nego li ga uporabite. Rabite ga samo ako je otopina bistra, bezbojna i vodenasta, te ako u njoj nema vidljivih čestica. Nemojte mućkati ili miješati otopinu prije uporabe. Upotrijebite novi uložak uvijek kad primijetite da Vam se neočekivano pogoršala regulacija šećera u krvi. To je zbog toga što je stari inzulin možda izgubio na učinkovitosti. Smatrate li da imate poteškoća s Lantusom, provjerite to sa svojim liječnikom ili ljekarnikom. Posebna upozorenja prije primjene lijeka Prije injekcije uklonite mjehuriće zraka (vidi upute za uporabu brizgalice). Pazite da alkohol, druga sredstva za dezinfekciju ili neke druge tvari ne kontaminiraju inzulin. Prazne uloške nemojte ponovno puniti i rabiti. Ne dodavajte u uložak drugi inzulin. Ne miješajte Lantus s drugim inzulinima ili lijekovima. Ne razrjeđujte ga. Miješanje i razrjeđivanje mogu promijeniti djelovanje Lantusa. Problemi s inzulinskom brizgalicom? Pridržavajte se uputa proizvođača za uporabu brizgalice. Ako je inzulinska brizgalica oštećena ili ne radi ispravno (zbog mehaničkih oštećenja), potrebno ju je ukloniti i upotrijebiti novu. Ako brizgalica ne radi ispravno, otopina se može iz uloška uvući u štrcaljku za injekciju. Stoga, uvijek uza se imajte i štrcaljke i igle. Međutim, smijete koristiti samo štrcaljke za injiciranje koje su namijenjene koncentraciji inzulina od 100 jedinica po mililitru.. Ako uzmete više Lantusa nego što ste trebali Ako ste ubrizgali previše Lantusa, razina šećera u krvi može vam postati preniska (hipoglikemija). Često provjeravajte razinu šećera u krvi. Općenito, da spriječite hipoglikemiju, morate više jesti i kontrolirati šećer u krvi. Za informacije o liječenju hipoglikemije pogledajte uokvireni tekst na kraju upute. Ako ste zaboravili uzeti Lantus Ako propustite dozu Lantusa ili injicirate premalu dozu, razina šećera u krvi može postati previsoka (hiperglikemija). Često provjeravajte razinu šećera u krvi. Za dodatne informacije o liječenju hiperglikemije pogledajte uokvireni tekst na kraju upute. Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu. Ako prestanete uzimati Lantus To može dovesti do teške hiperglikemije (vrlo visoka razina šećera u krvi) i ketoacidoze (nakupljanje kiseline u krvi zato što tijelo razgrađuje masti umjesto šećera). Nemojte prestati uzimati Lantus, prije nego se posavjetujete s Vašim liječnikom, koji će vam reći što trebate napraviti. Zamjene inzulina Da bi se izbjegle pogreške pri primjeni između Lantusa i ostalih inzulina, potrebno je prije svake injekcije provjeriti označavanje inzulina. U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom Lantusa obratite se svom liječniku ili ljekarniku. Moguće nuspojave Kao i svi drugi lijekovi, Lantus može izazvati nuspojave, iako se one ne javljaju u svih bolesnika. Hipoglikemija (preniska razina šećera u krvi) može biti vrlo ozbiljna. Ako Vam se razina šećera u krvi previše snizi, možete izgubiti svijest. Ozbiljna hipoglikemija može uzrokovati oštećenje mozga te može biti opasna po život. Ako imate simptome niske razine šećera u krvi, odmah poduzmite mjere da povisite razinu šećera u krvi. Ako iskusite sljedeće simptome, odmah obavijestite svog liječnika: raširene kožne reakcije (osip i svrbež po cijelom tijelu), jako oticanje kože ili mukozne membrane (angioedem), zadihanost, pad krvnog tlaka s ubrzanim otkucajima srca i znojenjem. To mogu biti simptomi teške alergije na inzulin, koja može biti opasna po život. Vrlo česte prijavljene nuspojave (pojavljuju se u više od 1 na 10 bolesnika) Hipoglikemija Kao kod svih terapija inzulinom, najčešća nuspojava je hipoglikemija. Hipoglikemija (preniska razina šećera u krvi) znači da u krvi nema dovoljno šećera. Za dodatne informacije o nuspojavama niske ili visoke razine šećera u krvi, pogledajte uokvireni tekst na kraju upute. Česte prijavljene nuspojave (pojavljuju se u najviše 1 od 10 bolesnika) Kožne promjene na mjestu injiciranja Ako prečesto injicirate inzulin u isto mjesto na koži, masno tkivo ispod kože na tom mjestu može se stanjiti (lipoatrofija) ili zadebljati (lipohipertrofija). Do zadebljanja masnog tkiva dolazi u 1-2% bolesnika, dok je stanjivanje manje često. Može se dogoditi da inzulin koji injicirate na tom mjestu ne djeluje dobro. Promjena mjesta na koži prilikom svakog injiciranja može spriječiti takve kožne reakcije. Kožne i alergijske reakcije Kod 3-4% bolesnika mogu se pojaviti reakcije na mjestu injiciranja (crvenilo, neuobičajeno jaka bol prilikom injiciranja, svrbež, koprivnjača, oticanje ili upala). Ove reakcije se mogu proširiti i oko mjesta injiciranja. Većina manjih reakcija na inzulin obično prolazi nakon par dana ili tjedana. Rijetke prijavljene nuspojave (pojavljuju se u najviše 1 od 1000 bolesnika) Teške alergijske reakcije na inzulin Povezani simptomi uključ uju raširene kožne reakcije (osip i svrbež po cijelom tijelu), jako oticanje kože ili mukozne membrane (angioedem), zadihanost, pad krvnog tlaka uz ubrzane otkucaje srca i znojenje. To mogu biti simptomi teške alergijske reakcije na inzulin i mogu biti opasni po život. Poremećaji oka Značajne promjene (poboljšanje ili pogoršanje) u razini Vašeg šećera u krvi mogu uzrokovati prolazno pogoršanje vida. Ako imate proliferativnu retinopatiju (bolest očiju povezana s dijabetesom), teški hipoglikemijski napadi mogu uzrokovati privremeni gubitak vida. Opći poremećaji U rijetkim slučajevima, liječenje inzulinom također može uzrokovati privremeno nakupljanje vode u tijelu, uz oticanje listova i zglobova. Vrlo rijetke prijavljene nuspojave (pojavljuju se u 1 od 10000 bolesnika) U vrlo rijetkim slučajevima mogu se pojaviti disgeuzija (poremećaj okusa) i mijalgija (bol u mišićma). Ostale nuspojave s nepoznatom učestalošću (učestalost se ne može odrediti iz dostupnih podataka): Liječenje inzulinom može uzrokovati nastanak protutijela na inzulin (tvari koje djeluju protiv inzulina). U rijetkim slučajevima to može zahtijevati prilagodbu doze inzulina. Primjena u djece i adolescenata Općenito uzevši, nuspojave u djece i adolescenata u dobi do 18 godina slične su onima koje se javljaju u odraslih bolesnika. Pritužbe na reakcije na mjestu injiciranja (bol i reakcije na mjestu injiciranja) i kožne reakcije (osip, urtikarija) zabilježene su češće u bolesnika mlađih od 18 godina, nego u odraslih bolesnika. Za bolesnike mlađe od 2 godina nema dostupnih kliničkih podataka o sigurnosti primjene lijeka. Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika ili ljekarnika. Kako čuvati Lantus Lantus morate čuvati izvan dohvata i pogleda djece. Nemojte upotrebljavati Lantus nakon isteka roka valjanosti navedenog na pakovanju i na ulošku. Rok valjanosti odnosi se na posljednji dan navedenoga mjeseca. Neotvoreni ulošci Čuvati u hladnjaku (2°C-8 °C). Ne zamrzavati. Nemojte stavljati Lantus blizu zamrzivača ili rashladnog uloška u prijenosnim hladnjacima. Čuvajte uložak u vanjskom pakovanju, radi zaštite od svjetlosti. Ulošci u uporabi Ulošci u uporabi (u inzulinskoj brizgalici) se mogu čuvati do najviše 4 tjedna pri temperaturi do 25°C, zaštićeno od izvora topline ili svjetlosti, ne u hladnjaku. Nemojte koristiti lijek nakon isteka tog perioda. Ne upotrebljavajte Lantus opazite li u njemu čestice. Rabite ga samo ako je otopina bistra, bezbojna i vodenasta. Lijekovi se ne smiju bacati u otpadne vode ili kućni otpad. Upitajte svog ljekarnika kako odložiti lijek koji Vam više nije potreban. Ove mjere pomoći će u zaštiti okoliša. Dodatne informacije Što Lantus sadrži Djelatna tvar je inzulin glargin. Jedan mililitar otopine sadržava 100 jedinica djelatne tvari inzulina glargina (što odgovara količini od 3,64 mg). Pomoćne tvari u Lantusu su: cinkov klorid, metakrezol, glicerol, natrijev hidroksid (vidjeti dio 2 “Važne informacije o nekim pomoćnim tvarima u Lantusu”), kloridna kiselina i voda za injekcije. Kako Lantus izgleda i sadržaj pakovanja Lantus 100 jedinica/ml otopina za injekciju u ulošku bistra je i bezbojna otopina. Lantus dolazi u posebnome ulošku koji se smije koristiti samo s brizgalicama OptiPen, ClikSTAR, Tactipen ili Autopen 24. Jedan uložak sadržava 3 ml otopine (što odgovara količini od 300 jedinica). Dostupno je pakovanje s 5 uložaka. Način i mjesto izdavanja lijeka Na recept, u ljekarni.