http___www.krenizdravo.net_korisno_upute_copaxone-otopina-za-injekciju-uputa-o-lijeku_1.xml
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Fuzeon 90 mg/ml powder and solvent for solution for injection Enfuvirtide - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What Fuzeon is and what it is used for What you need to know before you use Fuzeon How to use Fuzeon Possible side effects How to store Fuzeon Contents of the pack and other information Step-by-step guide to injecting Fuzeon Fuzeon contains the active substance enfuvirtide and belongs to a group of medicines called ‘antiretrovirals’. Fuzeon is used for the treatment of Human Immune deficiency Virus (HIV) - in combination with other antiretroviral medicines in patients infected with HIV. - Your doctor has prescribed Fuzeon to help control your HIV infection. - Fuzeon is not a cure for HIV infection. HIV attacks cells in your blood called CD4 or T-cells. The virus needs to make contact with, and get inside these cells in order for the virus to multiply. Fuzeon helps by preventing this. - you are allergic to enfuvirtide or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor, pharmacist or nurse before using Fuzeon. Talk to your doctor, pharmacist or nurse before using Fuzeon if: - you have ever had any lung problems - you have ever had any kidney problems - you have chronic hepatitis B or C or another liver disease - you are more likely to get serious liver problems while using this medicine In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to a recovery of the body’s immune system. This improvement enables the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately. In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. Patients with chronic hepatitis B or C and treated with anti-HIV therapy are at an increased risk for serious liver problems. Speak with your doctor if you have a history of liver disease. Some patients taking combination anti-HIV medicines may develop a bone disease called osteonecrosis. This is where the bone tissue dies because the blood supply has been lost (death of bone tissue caused by loss of blood supply to the bone). - Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these signs please inform your doctor. - Risk factors for developing this disease include: how long you have been taking anti-HIV medicines, whether you take corticosteroids, how much alcohol you drink, how well your immune system works and being overweight. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your physician the precautions needed to avoid infecting other people. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. Fuzeon has been shown not to interact with your other anti-HIV medicines or rifampicin (an antibiotic). You can use Fuzeon with or without food. However, you still need to follow the instructions given in the package leaflets for the other medicines you are taking. - If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not use Fuzeon unless specifically told to by your doctor. - Do not breast-feed if you have HIV because HIV may be passed on to the baby. Fuzeon has not been tested for its effect on your ability to drive a car or use tools or machines. If you feel dizzy while using Fuzeon do not drive or use any tools or machines. Fuzeon contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Fuzeon must be given as an injection just below the skin – called a ‘subcutaneous’ injection. Section 7 tells you how to prepare Fuzeon and how to give yourself an injection. - The recommended dose is 90 mg twice a day for adults and adolescents (16 years and older). - This is given as a 1 ml injection just below the skin. - It is best to use Fuzeon at the same time each day. - Try and space the doses evenly apart at times which are good for you – for example, first thing in the morning and then in the early evening. See further instructions on how to use Fuzeon at the end of this leaflet (see Section 7). There you will find instructions on how to prepare Fuzeon and how to give yourself an injection. If you use more Fuzeon than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. - If you forget to use a dose, use it as soon as you remember it. However if it is less than 6 hours before you are going to take your next regular dose, skip the missed dose. - Do not take a double dose to make up for a forgotten dose. - Keep using your medicine until your doctor tells you to stop. If you stop and there is a gap in your treatment this may speed up the chances of the HIV in your blood becoming resistant to Fuzeon. This is less likely if you use it regularly and without gaps in treatment. - The HIV virus in your blood may eventually become resistant to Fuzeon. If this happens, your blood levels of virus may begin to rise. This is when your doctor may decide to no longer keep treating you with Fuzeon. Your doctor should discuss this with you at that time. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. Like all medicines, this medicine can cause side effects, although not everybody gets them. - Allergic reaction (hypersensitivity) – signs may include: rash, a high temperature or chills, feeling or being sick, sweating or shaking. This side effect is rare (affects less than 1 in 1,000 people). These signs do not definitely mean you are allergic to this medicine. The most common side effects (affect more than 1 in 10 people), are problems at the place on your body where you have the injection. You will probably have one or more of the following mild to moderate reactions: - redness - swelling - feeling itchy - bruises - hardened skin or bumps - pain, feeling sore or tender These reactions can appear in the first week of treatment and usually only last for up to 7 days. They generally do not get worse after this time. If you have any of these reactions do not stop using Fuzeon, but talk to your doctor about any concerns you have. Reactions may be worse when injections are repeated in the same place on the body. They may also be worse when the injection is given deeper than intended (for example, into a muscle). Rarely, you may get an infection at a place where an individual injection was given. To reduce the risk of infection, it is important that you follow the instructions provided in Section 7. Fuzeon can cause a build-up of a type of protein, called amyloid, under the skin at the injection site. This may feel like lumps under the skin. Please contact your doctor if this occurs. Very common(affects more than 1 in 10 people) - diarrhoea - feeling sick - weight loss - pain and feeling numb in hands, feet or legs. Common(affects less than 1 in 10 people) - pneumonia - ear infection - swollen glands (lymph nodes) - inflamed eye (conjunctivitis) - flu or ‘flu-like’ symptoms - inflamed sinuses - nasal congestion - anorexia - heart burn - inflamed pancreas - decreased appetite - diabetes, - nightmares - feeling dizzy - shaking (tremor) - feeling anxious or irritated - not being able to concentrate - decreased sensation - acne - redness of the skin - eczema - dry skin - warts - muscle pain - kidney stones - feeling weak - blood in the urine - changes shown in blood tests (increased blood fat) If you get anyside effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. 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 Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label of either the Fuzeon or the Water for Injections Vials after EXP. The expiry date refers to the last day of that month. Keep the vial in the outer carton in order to protect from light. Once the solution has been prepared for your injection it should be used immediately. If it is not used straight away it must be stored in a refrigerator (2°C – 8°C) and used within 24 hours. Do not use this medicine if you notice any particles in the powder or the solution once the water for injection has been added. Also do not use the Water for Injections if you see any particles in the vial or if the water is cloudy. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. - The active substance is enfuvirtide. Each vial contains 108 mg enfuvirtide. After reconstitution with the solvent provided 1 ml of reconstituted solution contains 90 mg enfuvirtide. - The other ingredients are: Powder Sodium Carbonate, anhydrous Mannitol Sodium Hydroxide Hydrochloric Acid Solvent Water for Injections Fuzeon powder and solvent for solution for injection comes in a carton containing: 60 vials of Fuzeon 60 vials of Water for Injections that is used to reconstitute the Fuzeon powder 60 3 ml syringes 60 1 ml syringes 180 alcohol swabs. This pack provides you with everything you need to prepare and take your Fuzeon for 30 days of injections. Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany Roche Pharma AG Emil-Barell-Str. D-79639 Grenzach-Wyhlen Germany For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: United Kingdom Roche Products Ltd. This leaflet was last revised in August 2018 Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu This leaflet is available in all EU/EEA languages on the European Medicines Agency website. Always use this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor, pharmacist or nurse if you are not sure. The pictures in this leaflet show people who are right-handed. If you are left-handed, do what comes naturally to you. You will probably find it most comfortable to: - hold the syringe in your left hand and - hold the vial between the thumb and forefinger of your right hand. It may be difficult at first to inject in some places, such as the upper arms. If you need help, ask your partner, a friend, or a family member. You may like to ask someone to come with you to an injection training session with your doctor or nurse. The syringes supplied with this medicine have a coloured needle protector. This is attached to the needle and covers it after use to lower the risk of the needle accidently pricking another person. Although these syringes have this safety feature, it is still important that you dispose of used syringes properly. Follow the instructions given to you by your doctor, pharmacist or nurse. - Wash your hands well. This will reduce the risk of bacterial infections. - Once you have washed your hands, do not touch anything except the medicine and supplies. - When handling the syringe, do not touch the needle. - Do not touch the tops of the vials once they have been cleaned with alcohol swabs. - Do not use opened materials. Make sure none of the items in your kit have been opened before use. - Never use or share used needles. - Never use a syringe with a bent or damaged needle. - Never mix your medicine with tap water. - Never inject your medicine with other injectable medicines. - Only inject Fuzeon under the skin (‘subcutaneous’). - Do not inject Fuzeon into your veins (‘intravenously’) or into your muscles (‘intramuscularly’). - Dispose of all used materials into your special waste container with a lid. Do this even if the vials contain unused amounts of medicine or Water for Injections as these are for single use only. Talk to your doctor, pharmacist or nurse if you have any questions about safe disposal of these items. The following is a basic, step-by-step guide to injecting your medicine. Get the following things together: - One vial of Fuzeon (glass container with white powder inside) - One vial of Water for Injections (glass container with clear and colourless liquid inside) - One 3 ml syringe (larger syringe) with a 25 mm needle - One 1 ml syringe (smaller syringe) with a 13 mm needle - Three alcohol swabs - Special waste container with a lid for the safe disposal of the waste materials. Open syringe packs and take off vial caps. - Dispose of packaging and vial caps into your special waste container with a lid. - Place syringes and vials onto a clean surface. Wash hands thoroughly. - After washing your hands, do not touch anything except the injection supplies and where the injection will be given. Clean the tops of the vials. - Wipe each vial top with a fresh alcohol pad. Let the tops dry in the air. - Make sure you do not touch the rubber tops after cleaning them. If you touch them, make sure you clean them again. Draw Up Water for Injections Pick up the 3 ml large syringe. Using your index finger, move the coloured needle protector away from the needle. To make sure that the needle is firmly on the syringe: - hold the plastic cap under the needle protector - tighten the needle and cap with a gentle clockwise twist. Do not use too much force as the needle may loosen. To remove the clear plastic cap: - push towards the syringe and then pull the cap off. Draw back 1.1 ml of air. Push the syringe needle into the rubber top of the vial of Water for Injections and press the plunger. This injects the air. Gently turn the vial upside down. Make sure the tip of the needle is always below the surface of the Water for Injections to help keep any air bubbles from entering the syringe. Slowly pull back the plunger until the water reaches the 1.1 ml mark. Please be aware that the vial contains more liquid than you need (2 ml); you only have to pull out 1.1 ml to prepare your injection properly. Tap the syringe gently to make any air bubbles rise to the top. - If too much air gets into the syringe, gently press the plunger to force any air back into the vial. - Then pull out the water again. - Make sure you have 1.1 ml of Water for Injections in the syringe. - This step may be repeated until the correct amount of Water for Injections is in the syringe. Take out the needle from the vial. Make sure you never touch the needle with your fingers or anything else. Dispose of the vial and the Water for Injections into your special waste container with a lid - this vial is for single use only. Gently tap the vial of Fuzeon to loosen the powder. Hold the main part of the water-filled syringe and push the needle through the rubber top of the vial at a slight angle. Press the syringe plunger in slowly. - Let the water flow slowly down the inside of the vial. - Be careful not to forcefully shoot water into the powder, since this can cause foaming. - If foaming happens, it may take longer for the powder to dissolve completely. After all of the Water for Injections has been added to the vial of Fuzeon, take out the syringe from the vial. Hold the main part of the syringe with one hand and gently press the coloured needle protector down on a flat surface until it covers the needle. - You will hear a click. Do not use your free hand to press the device over the needle. Throw away the syringe into the special waste container with a lid. Gently tap the vial with your fingertip until the powder begins to dissolve. Never shake the vial or turn it upside down to mix—this will cause too much foaming. When the powder begins to dissolve you can put the vial aside to allow it to completely dissolve. - The powder may take up to 45 minutes to dissolve into solution. - The vial can also be gently rolled between your hands after adding the Water for Injections until it is fully dissolved. - This may reduce the time it takes for the powder to dissolve. After the powder has dissolved completely - Let any bubbles that may have formed settle. - If the bubbles are still there, gently tap the side of the vial to help settle them. 4 It is important to check the liquid for bits (particles). - If you see any bits in the liquid, do not use it. - Dispose of the vial into the special waste container with a lid or return it to the pharmacy. Then start again with a new vial of Fuzeon powder. If you accidentally touch the rubber stopper, make sure to clean it again with a new alcohol swab Once a dose is mixed with Water for Injections, it must be used straight away. If not, store in a refrigerator and use within 24 hours. - Let the liquid get back to room temperature before using. If you are preparing both of your daily doses at one time, make sure to use new syringes, Water for Injections, and Fuzeon for each dose. Drawing up Fuzeon into the 1 ml syringe Wipe the top of the Fuzeon vial again with a new alcohol swab. Pick up the 1 ml small syringe. Using your index finger, move back the coloured needle protector away from the needle. To make sure that the needle is firmly on the syringe: - hold the plastic cap under the needle protector - tighten the needle and cap by slightly turning and pushing it towards the syringe. To remove the clear plastic cap: - push towards the syringe and then pull the cap off. Draw back 1 ml of air. - Be careful not to pull the plunger too fast - it may go past the 1 ml marker or out of the syringe. Push the syringe needle into the rubber top of the Fuzeon vial and press the plunger. This injects the air. Gently turn the vial upside down. Make sure the tip of the needle is always below the surface of the solution to help keep air bubbles from entering the syringe. Slowly pull back the plunger until the solution reaches the 1.0 ml mark. - Be careful not to pull the plunger too fast - it may go past the 1 ml marker or out of the syringe. Tap the syringe gently to make any air bubbles rise to the top. - If too much air enters the syringe, gently press the plunger to force the air back into the vial. - Then pull out the liquid again. - Make sure you have 1.0 ml of liquid in the syringe (or whatever amount your doctor prescribed, if it is different). - This step may be repeated until the correct amount of solution is in the syringe. Take out the syringe from the vial. Tip: Your doctor or nurse may suggest different injection techniques that will work best for you. - Fuzeon is given as a 1 ml injection just below the skin – called a ‘subcutaneous’ injection. - You can inject into your upper arm, upper thigh or stomach area (abdomen). - Choose a different area from where you last injected yourself. - Do not inject to a place where there is still a reaction from an earlier dose. Check for any places where you may have a reaction by pressing the skin to see if there are any hard bumps. - Do not inject into areas that could become irritated by your belt or the waistline of your clothes. - Do not inject into moles, scar tissue, bruises or your belly button (navel). Clean the area for injection well with an alcohol swab. Do this in a circular motion, starting in the middle and working outward. Allow it to dry in the air completely. Pinch as much of a skin fold as possible - without making yourself uncomfortable. Push the needle into the skin at a 45-degree angle. When the needle is in: - release the skin - use this free hand to hold on to the main part of the syringe – this will help steady it and stop it from moving. Using the thumb of your other hand, press the plunger to inject the liquid. - After the dose is fully delivered, remove the needle from the skin. Hold the main part of the syringe with one hand - then gently press the coloured needle protector down on a flat surface until it covers the needle. - you will hear a click. Do not use your free hand to press the protector over the needle. Dispose of the syringe into a special waste container with a lid. If there is any blood where you have given the injection, cover the skin with a sticking plaster. - Dispose of all used items straight into the special waste container with a lid. Do this even if the vials contain unused amounts of medicine or Water for Injections as these are for single use only. - Keep the cover of this container tight and keep it out of the reach of children. - Check with your doctor, pharmacist or nurse about proper disposal of the container. If you have any questions or concerns about the safe disposal of these materials, please talk to your doctor, pharmacist or nurse. uk-mt-pil-Fuzeon-clean-180809-90mg-ml-inj
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Copaxone otopina za injekciju – Uputa o lijeku - Budite prvi i komentirajte! - 10 min čitanja Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati lijek. - Sačuvajte ovu uputu. Možda ćete ju trebati ponovno pročitati. - Ukoliko imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku. - 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 Copaxone i za što se koristi - Prije nego počnete primjenjivati Copaxone - Kako primjenjivati Copaxone - Moguće nuspojave - Kako čuvati Copaxone - Dodatne informacije Što je Copaxone i za što se koristi Copaxone je imunomodulator odnosno lijek koji mijenja način na koji radi imunološki sustav Vašeg tijela. Smatra se da simptome multiple skleroze izazivaju upravo nedostaci tjelesnog imunološkog sustava, pa tako nastaju upalna područja u mozgu i leđnoj moždini. Copaxone se koristi za smanjenje učestalosti napada (relapsa) multiple skleroze. Neće Vam pomoći ukoliko imate oblik multiple skleroze koji nije praćen ponovnom pojavom napada (relapsa) ili s jedva nešto relapsa. Copaxone možda neće imati učinak na duljinu trajanja napada multiple skleroze niti na njegovu težinu. Koristi se za liječenje bolesnika koji mogu hodati bez tuđe pomoći. Copaxone se tako đer može koristiti i za liječenje bolesnika koji su po prvi puta imali simptome koji ukazuju na visok rizik za razvoj multiple skleroze. U tom slučaju, prije nego počnete primjenjivati Copaxone, Vaš će liječnik isključiti neke druge bolesti koje bi mogle biti uzrok tim simptomima. Prije nego počnete primjenjivati Copaxone Nemojte primjenjivati Copaxone: - ako ste alergični (preosjetljivi) na djelatnu tvar glatirameracetat ili na bilo koji drugi sastojak lijeka Copaxone - ako ste trudni Budite posebno oprezni s lijekom Copaxone: - Savjetujte se s Vašim liječnikom ako imate bilo kakvih srčanih ili bubrežnih problema jer ćete u tom slučaju trebati redovito obavljati pretrage i ići na liječničke preglede. Djeca: Copaxone se ne smije koristiti kod djece mlađe od 12 godina. Starije osobe: Copaxone nije posebno ispitivan u populaciji starijih bolesnika pa se stoga, ako ste starija osoba, savjetujte s Vašim liječnikom prije primjene lijeka Copaxone. Uzimanje drugih lijekova Obavijestite svog liječnika ili ljekarnika ukoliko uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta. Trudnoća i dojenje Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek. Copaxone ne smijete primjenjivati u trudnoći. Odmah obavijestite liječnika ukoliko planirate ostati trudni ili zatrudnite tijekom primjene lijeka Copaxone. Tijekom liječenja lijekom Copaxone morate koristiti učinkovite načine kontracepcije (npr. ‘pilule’ tj. oralne kontraceptive ili kondome) kako bi se izbjegla trudnoća. Ako biste željeli dojiti tijekom primjene lijeka Copaxone,, o tome prvo razgovarajte s Vašim liječnikom. Upravljanje vozilima i strojevima. Nije poznat utjecaj lijeka Copaxone na sposobnost upravljanja vozilima ili rada na strojevima. Kako primjenjivati Copaxone Uvijek primijenite Copaxone točno onako kako Vam je rekao liječnik. Ukoliko niste sigurni, provjerite s Vašim liječnikom ili ljekarnikom. Dnevna doza za odrasle i adolescente s navršenih 12 godina i starije je jedna napunjena štrcaljka (doza od 20 mg glatirameracetata) koja se primjenjuje potkožnom injekcijom (supkutano) jedanput dnevno. Vrlo je važno da ispravno primjenjujete injekciju lijeka Copaxone: Injekciju smijete primijeniti samo u potkožno tkivo (supkutano tkivo) (vidjeti dio “Upute za primjenu” niže) U dozi koju Vam je odredio Vaš liječnik. Smijete uzeti samo dozu koju Vam je propisao Vaš liječnik. Istu štrcaljku smijete koristiti samo jedanput. Sav neiskorišteni lijek ili otpadni materijal mora se ukloniti. Ne smijete miješati niti istodobno primjenjivati sadržaj napunjene štrcaljke lijeka Copaxone 20 mg/ml s bilo kojim drugim lijekom. Ako otopina sadrži bilo kakve vidljive čestice, nemojte je primijeniti. Uzmite novu štrcaljku. Kada prvi puta budete primjenjivali Copaxone, dobit ćete sve upute i postupak će nadzirati liječnik ili medicinska sestra. Oni će biti s Vama dok si budete davali injekciju i pola sata nakon toga, kako bi bili sigurni da je sve proteklo bez problema. Upute za primjenu Pročitajte pažljivo ove upute prije nego primijenite lijek Copaxone. Prije davanja injekcije provjerite imate li sve što vam treba: - jedan blister s jednom napunjenom štrcaljkom lijeka Copaxone - spremnik za odlaganje upotrijebljene igle i štrcaljke. Za svaku injekciju, iz pakovanja uzmite samo jednu napunjenu štrcaljku u blisteru. Sve preostale štrcaljke čuvajte u kutiji. Ako ste štrcaljku čuvali u hladnjaku, blister sa štrcaljkom izvadite i ostavite na sobnoj temperaturi najmanje 20 minuta prije nego što ćete injicirati lijek tako da se otopina zagrije do sobne temperature. Temeljito operite ruke sapunom i vodom. Izaberite mjesto za davanje injekcije. Sedam je mogućih mjesta na tijelu gdje se može dati injekcija i to na rukama, bedrima, bokovima i trbuhu. Unutar svakog područja na kojem se može dati injekcija nekoliko je mjesta za ubod. Svaki dan odaberite drugo mjesto za davanje injekcije jer ćete tako smanjiti vjerojatnost bilo kakve iritacije ili boli na mjestu primjene injekcije. Mijenjajte mjesta davanja injekcija unutar svakog područja. Nemojte davati injekciju svaki put u isto mjesto. Napomena: nemojte davati injekciju na bolno mjesto, na mjesto koje je promijenilo boju ili na mjesta gdje pod kožom osjećate čvrste čvorove ili kvržice. Preporuča se izraditi plan mjesta na koja će se davati injekcije i to zabilježiti u neku vrstu dnevnika. Postoje neka mjesta na tijelu na koja će biti teže samostalno dati injekciju (primjerice stražnji dio nadlaktice), pa će Vam za to trebati pomoć. Upotrijebljene štrcaljke nemojte odlagati u kućni otpad već ih pažljivo odložite u za to predviđene spremnike, kako Vam je preporučio liječnik ili medicinska sestra. Ako imate dojam da je učinak lijeka Copaxone prejak ili preslab, savjetujte se s liječnikom. Ako primijenite više lijeka Copaxone nego što ste trebali (više od jedne štrcaljke) Odmah obavijestite svog liječnika. Ako ste zaboravili primijeniti Copaxone Primijenite ga čim se sjetite, ali nemojte primijeniti dvostruku dozu kako biste nadoknadili zaboravljenu pojedinačnu dozu. Sljedeću dozu primijenite nakon 24 h. Ako prestanete primjenjivati Copaxone Copaxone ne smijete prestati primjenjivati bez prethodnog savjetovanja s Vašim liječnikom. U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom lijeka Copaxone, obratite se svom liječniku ili ljekarniku. Moguće nuspojave Kao i svi drugi lijekovi, Copaxone može izazvati nuspojave. - Alergijske reakcije (preosjetljivost) Rijetko se mogu razviti ozbiljne alergijske reakcije na lijek Copaxone. Prekinite primjenjivati Copaxone i odmah obavijestite svog liječnika ili otiđite u hitnu službu najbliže bolnice ukoliko primijetite bilo koji znak od sljedećih nuspojava: - osip (crvene točkice ili koprivnjača), oticanja vjeđa, lica ili usana - iznenadni nedostatak zraka, konvulzije (napadaji) - nesvjestica Ostale reakcije nakon primjene injekcije (neposredno nakon injiciranja) Unutar nekoliko minuta nakon injekcije lijekom Copaxone, kod nekih osoba mogu se pojaviti jedan ili više sljedećih simptoma. Uobičajeno ti simptomi ne uzrokuju probleme i obično nestaju unutar pola sata. No, ako navedeni simptomi kod Vas traju dulje od 30 minuta, odmah obavijestite svog liječnika ili otiđite u hitnu službu najbliže bolnice: - crvenilo prsa ili lica praćeno osjećajem vrućine osjećaj stezanja u prsima - nedostatak zraka - osjećaj brzog i jakog lupanja srca (palpitacije) Sljedeće nuspojave su zabilježene uz primjenu lijeka Copaxone: Vrlo često (javljaju se u više od 1 na 10 bolesnika: Kožne reakcije na mjestu davanja injekcije, a uključuju: - crvenilo kože, bol, stvaranje urtika, svrbež, oticanje tkiva (edem), upalu i preosjetljivost na mjestu primjene injekcije. Ove reakcije na mjestu primjene injekcije nisu neuobičajene i protekom vremena obično se smanjuju. Ostale vrlo česte nuspojave uključuju: Poremećaji probavnog sustava: Opći poremećaji: - osjećaj slabosti, bol u prsima, nespecifična bol Infekcije, infekcije, gripa Poremećaji mišićno-koštanog sustava: - bol u zglobovima, bol u leđima Poremećaji živčanog sustava: Psihijatrijski poremećaji: - tjeskoba, depresija Poremećaji kože: - kožni osip Često (javljaju se u manje od 1 na 10, ali više od 1 na 100 bolesnika): Poremećaji krvi: - otečeni limfni čvorovi Srčani poremećaji: - ubrzani rad srca, osjećaj brzog i jakog lupanja srca (palpitacije) Poremećaji uha: - problemi s uhom Poremećaji oka: - dvoslike, poremećaji oka Poremećaji probavnog sustava: - problemi sa završnim crijevom, zatvor, karijes, loša probava (dispepsija), teškoće s gutanjem, crijevna inkontinencija (nemogućnost zadržavanja stolice), povraćanje Opći poremećaji: - zimica, lokalne reakcije, zadržavanje tekućine, oticanje gležnjeva, oticanje (edem) lica, povišena tjelesna temperatura, gubitak potkožnog tkiva na mjestu injekcije Poremećaji imunološkog sustava: - alergijske reakcije (preosjetljivost) Infekcije: - infekcije dišnog i probavnog sustava, upala srednjeg uha, curenje iz nosa (rinitis), herpes, zubni apscesi, gljivična infekcija rodnice (vaginalna kandidijaza) Poremećaji jetre: - poremećaji vrijednosti testova jetrene funkcije Poremećaji metabolizma: - povećanje tjelesne težine, gubitak apetita Poremećaji mišićno-koštanog sustava: - bol u vratu Dobroćudne novotvorine i zloćudni poremećaji: - tumori kože i tkiva Poremećaji živčanog sustava: - promijenjen osjet okusa, abnormalni tonus arterija ili mišića, migrena, poremećaji govora, nesvjestica, nevoljno drhtanje (tremor) Psihijatrijski poremećaji: - nervoza Poremećaji bubrega: - zadržavanje mokraće, neodgodiva potreba za mokrenjem, učestalo mokrenje Poremećaji dišnog sustava: - kašalj, sezonski rinitis Poremećaji kože: - stvaranje modrica, pojačano znojenje, svrbež, koprivnjača, ostali kožni poremećaji. Manje često (javljaju se u manje od 1 na 100, ali više od 1 na 1000 bolesnika): Poremećaji krvi: - promjene u broju ili obliku bijelih krvnih stanica, smanjenje broja krvnih pločica, povećanje slezene Srčani poremećaji: - poremećaj srčanog ritma (ekstrasistole), usporeni ili ubrzani rad srca Endokrini poremećaji: - povećanje štitnjače (guša), pojačani rad štitnjače Poremećaji oka: - zamućenje leće (katarakta), oštećenje rožnice, suho oko, krvarenje u oku, spuštene vjeđe, proširenje zjenice (midrijaza), poremećaj ili gubitak vida Poremećaji probavnog sustava: - upala crijeva, polipi debelog crijeva, podrigivanje, vrijed jednjaka, upala desni, krvarenje iz rektuma, povećanje žlijezda slinovnica Opći poremećaji: - ciste, mamurnost, hipotermija (snižena tjelesna temperatura), nespecifična upala, oštećenje tkiva na mjestu primjene injekcije, poremećaji na sluznicama Infekcije: - apsces (lokalizirana gnojna upala), čirevi na koži, infekcije kože ili bubrega, herpes zoster Ozljede ili trovanja: - umor nakon cijepljenja (postvakcinacijski sindrom) Poremećaji jetre: žučni kamenci, povećanje jetre Poremećaji metabolizma: - slabo podnošenje alkohola, giht, povišene vrijednosti masnoća (lipida) u krvi, povišene vrijednosti natrija u krvi, snižene vrijednosti feritina u krvi Poremećaji mišićno-koštanog sustava: - otečeni zglobovi (artritis ili osteoartritis), smanjenje mišićne mase Dobroćudne novotvorine ili zloćudni poremećaji: - rak kože Poremećaji živčanog sustava: - bol i utrnulost u šakama, mentalne smetnje, napadaji (konvulzije), poremećaj pisanja i čitanja, mišićni grč, poremećaji tonusa mišića, upale živaca, mišićna slabost, paraliza, trzanje oka, viseće stopalo, nesvjesno stanje (stupor), defekt vidnog polja Stanja vezana uz trudnoću: - pobačaj (abortus) Psihijatrijski poremećaji: - abnormalni snovi, smetenost, prekomjeran osjećaj sreće ili prekomjerna aktivnost, halucinacije (kada osoba vidi ili čuje stvari koje ne postoje), agresivnost, poremećaji ličnosti, pokušaj suicida Poremećaji bubrega: - krv u mokraći, poremećaji mokraćnog sustava, bubrežni kamenci Poremećaji reproduktivnog sustava: - otečene dojke, stalna erekcija, poteškoće u postizanju erekcije, spuštanje (prolaps) zdjeličnih organa, poremećaji rodnice, prostate ili testisa, krvarenje iz rodnice, abnormalni nalaz brisa vrata maternice Poremećaji dišnog sustava: - plućni poremećaji, osjećaj stezanja u grlu, zastoj disanja u kratkim razmacima, abnormalno ubrzano ili duboko disanje (hiperventilacija), krvarenje iz nosa, osjećaj gušenja Poremećaji kože: - oticanje kapilara, kontaktni kožni osip, kvržice na koži, bolne crvene kvržice na koži (nodozni eritem) Krvožilni poremećaji: - proširene vene. Rijetko (javljaju se između 1 i 10 na 10 000 bolesnika) i vrlo rijetko (javljaju se u manje od 1 na 10 000 bolesnika) - Teške alergijske reakcije. Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika ili ljekarnika. Kako čuvati Copaxone Čuvati izvan dohvata i pogleda djece. Čuvati u hladnjaku (2ºC – 8ºC). Copaxone 20 mg/ml napunjene štrcaljke mogu se čuvati do najviše mjesec dana van hladnjaka na sobnoj temperaturi. To možete napraviti samo jednom. Nakon mjesec dana, Copaxone 20 mg/ml napunjene štrcaljke koje nisu uporabljene i još se nalaze u originalnom pakovanju, moraju se ponovno pohraniti u hladnjak. Ne zamrzavati. Štrcaljke čuvati u vanjskom pakovanju radi zaštite od svjetlosti. Copaxone se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakovanju. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca. Lijek Copaxone se ne smije upotrijebiti ukoliko primijetite čestice. Lijekovi se ne smiju uklanjati putem otpadnih voda ili kućnog otpada. Pitajte svog ljekarnika kako ukloniti lijekove koje više ne trebate. Ove mjere pomoći će u zaštiti okoliša. Dodatne informacije Što Copaxone sadrži Djelatna tvar je glatirameracetat. 1 ml otopine za injekciju (sadržaj jedne napunjene štrcaljke) sadrži 20 mg glatirameracetata. Drugi sastojci su manitol i voda za injekcije. Kako Copaxone izgleda i sadržaj pakiranja Copaxone je sterilna, bistra otopina bez vidljivih čestica. Pakovanje sadrži 28 napunjenih štrcaljki s 1 ml lijeka Copaxone. Ukoliko otopina sadrži čestice, štrcaljku bacite i počnite ispočetka. Upotrijebite novu štrcaljku. Napomene: Nositelj odobrenja za stavljanje gotovog lijeka u promet PLIVA Hrvatska d.o.o. Prilaz baruna Filipovića 25, 10000 Zagreb, Hrvatska Proizvođač Teva Pharmaceuticals Europe B.V. Box 43011, 3540 AA Utrecht Nizozemska Način i mjesto izdavanja lijeka Na recept, u ljekarni.