|
Ana sayfa | Betaferon | |
|
|
This package insert for Betaferon® has been approved for use in material that is distributed within the European Community (EU). The text may not correspond exactly to the insert in other countries. Betaferon Composition Annex:
Betaferon medication record
BetaferonImportant information, please read carefully. Betaferon
contains the following substances Active substance: 1 ml of the prepared solution for injection contains 0.25 mg (8 million IU) of Interferon beta-1b. Betaferon is formulated as a sterile white to off-white powder and contains 0.3 mg (9.6 million IU) of Interferon beta-1b per vial at a calculated overfill of 20%. Inactive ingredients: Human albumin, dextrose. What presentations of Betaferon are available? Each pack of Betaferon contains either 5 or 15 vials of Interferon beta-1b and either 5 or 15 vials of 0.54% sodium chloride solution. How does Betaferon
work? Multiple sclerosis (MS) is a disease of the central nervous system (CNS) (i. e. brain and spinal cord) and its exact cause is unknown. An abnormal response by the body's immune system is thought to play an important part in the process which damages the CNS. Interferon beta-1b has been shown to modify the immune system response. Interferons belong to the family of cytokines, which are naturally occurring proteins. Who
is responsible for Betaferon? Schering AG For
what purpose is Betaferon used? Betaferon is indicated for use in ambulatory patients (patients who can walk) with relapsing-remitting multiple sclerosis (MS) characterised by at least two attacks of neurologic dysfunction over a two year period followed by complete or incomplete recovery. In this patient population Betaferon was shown to reduce the frequency and severity of clinical relapses, to reduce the number of MS related hospitalisations and to prolong the relapse-free time. There is no evidence of an effect of Betaferon on the length of attacks, symptoms in between attacks, or the progression of the disease. The effect of Betaferon on performance of daily activities or in the social field is not known. Betaferon has not yet been investigated in patients with the primary progressive form of multiple sclerosis. There is no evidence of an effect on disability in relapsing-remitting multiple sclerosis. For patients suffering from secondary progressive multiple sclerosis Betaferon is used to slow the progression of disease and to reduce the frequency of attacks. Time to progression of disability and time to become wheelchair dependent is delayed by Betaferon. Clinical studies show that not all patients respond to treatment with Betaferon. Despite treatment worsening of the symptoms during attacks has been observed in some patients. It is not possible to foresee which patients will not respond or whose symptoms will worsen despite treatment. When
should Betaferon not be used? You should not use Betaferon if you are pregnant or if you have a history of hypersensitivity to natural or recombinant interferon beta or human albumin. You should not use Betaferon if you are under 18 years of age, because it has not been investigated in this age group. You should also not use Betaferon if you have a history of severe depressive illness and/or suicidal thoughts, liver failure or inadequately treated epilepsy. If a serious hypersensitivity reaction occurs, treatment with Betaferon should be discontinued. What precautions must be observed during the use of Betaferon? Depression and suicidal thoughts have been reported by patients. In rare cases this may lead to suicidal attempts. If you experience such symptoms, contact your doctor promptly. If you have a history of seizures or of depression or if you suffer from pre-existing heart disorders, Betaferon should be administered with caution. Caution should also be exercised if you are taking anti-epileptic drugs. Betaferon should also be administered with caution, if you have a bone marrow disorder, anaemia or a low platelet level. If your white blood cell count decreases, your doctor should monitor you closely for the development of fever or infection. It is not known if Betaferon has a negative effect on human fertility but based on the experience with other interferons, a decrease in male or female fertility cannot be ruled out. There is no information on the use of Betaferon in patients with kidney problems. Therefore, if you have such problems, your kidney function should be monitored during treatment. During the treatment with Betaferon your body may produce substances which may reduce the effectiveness of the treatment. This is called neutralising etkinligini and only occurs in some patients. However, it is not possible to foresee whether you belong to this group of patients with reduced efficacy or not. Injection site necrosis (skin breakdown and tissue destruction) has been reported in patients using Betaferon (see section „Are there any side effects during the use of Betaferon?"). It can be extensive and may involve muscle fascia as well as fat and can therefore result in scar formation. Occasionally debridement and, less often, skin grafting are required and healing may take up to 6 months. If you have multiple lesions Betaferon should be discontinued until healing has taken place. Patients with single lesions may continue on Betaferon provided the necrosis is not too extensive, as some patients have experienced healing of injection site necrosis whilst on Betaferon. To minimise the risk of injection site necrosis you should:
The procedure for self-administration should be reviewed periodically by your doctor especially if injection site reactions have occurred. During treatment with Betaferon cardiomyopathy (disease of the heart muscle) has been reported in rare cases. If you experience symptoms like irregularity of your heart beat or fluid retention (swelling) in the lower part of your body (e.g. ankles, legs) or shortness of breath, contact your doctor immediately. Patients who have the rare condition known as monoclonal gammopathy may develop problems with their small blood vessels (capillaries) leading to shock (collapse) which can be fatal, when they use medicines like Betaferon. If you think that you might have monoclonal gammopathy (a disorder the immune systems in which abnormal proteins are found in the blood), you should check this with your doctor before you use Betaferon. May Betaferon be used during pregnancy and lactation? Betaferon should not be used during pregnancy or if you are trying to become pregnant. If you wish to become pregnant, discuss the matter with your doctor first. While using Betaferon women of childbearing age should take appropriate contraceptive measures. If you do become pregnant you should stop your treatment and contact your doctor immediately. It is not known whether Interferon beta-1b is excreted in human milk. However, since serious adverse reactions to Interferon beta-1b in breast-fed infants are theoretically possible, you should discuss the matter with your doctor and make a decision whether breast-feeding or Betaferon should be stopped. What to be aware of if you are taking any other medicine (interactions) With the exception of corticoids or ACTH, Betaferon should not be used with substances modifying the immune system response. Caution should be exercised when Interferon beta-1b is administered in combination with other drugs which need a certain liver enzyme system (known as cytochrome P450 system) for their metabolism. These drugs include some widely used antipyretics (drugs against fever and pain) and anti-epileptics. Tell your doctor about any additional medicine you are using. How is
Betaferon used? The treatment with Betaferon should be initiated under the supervision of a physician experienced in the treatment of the disease. At the present time it is not known how long treatment with Betaferon should last. Efficacy of treatment for longer than two years has not sufficiently been demonstrated for relapsing-remitting multiple sclerosis. For secondary progressive multiple sclerosis efficacy for a period of two years with limited data for a period of up to three years of treatment has been demonstrated under controlled clinical trial conditions. The duration of treatment will be decided by your doctor. Treatment is not recommended for patients with relapsing-remitting multiple sclerosis if they have had fewer than two MS attacks in the previous two years. Before administration, the Betaferon solution for injection has to be prepared from a vial of Betaferon and 1.2 ml of liquid from a vial of solvent. 1.0 ml of the prepared Betaferon solution for injection is then injected subcutaneously (under the skin) every other day. This is equal to 0.25 mg (8 million IU). This will either be done by your doctor or his/her assistant or by yourself after you have been carefully and sufficiently instructed and trained. To assist you in subcutaneous self-administration of Betaferon, detailed instructions for self-injection are provided with this leaflet. These instructions also tell you how the Betaferon solution for injection is prepared. What to do if you miss an injection If you forget to administer your injection at the correct time you should give it as soon as you remember. Your next injection should be given 48 hours later. What
effect could an overdose of Betaferon have? Administration of many times the dose of Betaferon recommended for the treatment of MS did not lead to life-threatening situations. However, in the case of accidental overdosage, please consult the doctor who has prescribed Betaferon for you. Also if by mistake you administer your injection too frequently (e.g. one injection every 24 h instead of one injection every 48 h) you should consult your doctor. Are there any side effects during the use of Betaferon? Injection site reactions including redness, swelling, discoloration, inflammation, pain, hypersensitivity, skin breakdown and tissue destruction (necrosis), and non-specific reactions occur frequently (see „What precautions must be observed during the use of Betaferon?"). The occurrence of injection site reactions usually decreases over time. Flu-like symptoms (fever, chills, muscular pain, a general feeling of being unwell, or sweating) have been seen frequently. The occurrence of the symptoms decreased over time. Menstrual disorders may occur in premenopausal women. Occasionally, nausea and vomiting may occur. Loss of scalp hair has been reported in rare cases. Central nervous system (CNS) related adverse events including depression, anxiety, emotional instabilitesini, loss of identity or reality (depersonalization), convulsions, suicide attempts, and confusion have been observed. Muscle stiffness has been reported. Serious hypersensitivity reactions are rare. If a severe reaction occurs, consult your doctor immediately. The number of white cells and red cells in your blood may fall. The number of platelets (which help the blood to clot) may also fall and in rare cases, the number of platelets in the blood has been found to be extremely small. The etkinligini of the liver may also be affected: this is shown by rises in the blood levels of the enzimler it produces. There have also been some cases of hepatitis (liver inflammation) which may have been caused by Betaferon. For these reasons, your doctor will usually order blood tests (a complete blood count, differential white cell count and measurement of liver enzimler known as SGOT, SGPT and g -GT in the blood) before you start Betaferon and regularly whilst you are on it. Rare cases of cardiomyopathy (disease of the heart muscle) have been reported. See section „What precautions must be observed during the use of Betaferon?". Rarely the thyroid gland does not work properly (too much or too little hormone is produced) during Betaferon use. If side effects are severe or if you notice any other side effects please inform your doctor. How should Betaferon be stored? Betaferon must be kept cold (2-8 °C). Store it in a refrigerator (but not in a freezer or the freezing compartment) before reconstitution (preparing the Betaferon solution for injection). If, after reconstitution, you do not inject Betaferon at once, you can store the reconstituted solution in a refrigerator (but not in a freezer or the freezing compartment) up to 3 hours. Please note the expiry date on the pack. Do not use after this date. Store all drugs properly and keep them out of the reach of children. Package insert was last updated on: 26.01.1999 Annex:The following instructions are intended to explain how to prepare Betaferon for administration and how to proceed in injecting Betaferon yourself. Please read the instructions carefully and follow them step by step. Your doctor or his/her assistant will instruct and assist you in learning the procedure and the technique of self-administration. Do not attempt self-administration until you are sure that you understand the requirements for preparing the injection solution and giving the injection to yourself. The instructions comprise the following main steps: I.Preparing for self-injection. II.Drawing up the solvent (sodium chloride solution) into the syringe. III.Injecting the required volume of solvent (1.2 ml) into the vial of Betaferon. IV.Drawing up the required volume of the solution for injection (1.0 ml) into the syringe. V.Choosing and preparing the injection site and injecting the Betaferon solution (1.0 ml) subcutaneously (under the skin). I.Preparing for self-injection 1.Collect all your equipment before you begin the process. You will need:
2.Wash your hands thoroughly with soap and water. 3.Remove the protective caps from both vials. 4.Use alcohol wipes to clean the tops of the vials – move in one direction and use one wipe per vial. NOTE: Leave an alcohol wipe on top of each vial until you are ready to use it. II. Drawing up the solvent (sodium chloride solution) into the syringe. Only the vial of solvent (liquid) that comes inside your prescription package should be used to dissolve the white powder in the Betaferon vial. 1.Resting your hands on a stable surface, remove the syringe from its wrapping. Do not touch the tip (nozzle) of the syringe. 2.Take the 21-gauge needle out of its wrapping and place it firmly onto the tip (nozzle) of the syringe. Remove the needle guard from the needle. Do not touch the needle. 3.Pull back the plunger (on the syringe) to the 1.2 ml mark. NOTE: Read the label on the vials – find the solvent vial and throw away the alcohol wipe on top of it. 4.Holding the vial of solvent on a stable surface, slowly insert the needle straight through the rubber stopper, into the top of the vial. NOTE: When inserting and removing needles from vials, be sure not to touch the needles or the rubber stoppers on the vials with your hands. If you do touch a stopper, clean it with a fresh alcohol wipe. If you touch a needle or the tip (nozzle) of the syringe, throw it away into the disposal unit and start with a new one. If the needle touches any surface, throw it away into the disposal unit and start with a new one. 5.Push in the plunger all the way to gently inject air into the vial (leave the needle in the vial of solvent). 6.Turn the vial of solvent upside down. NOTE: Keep the needle tip in the liquid. 7.Resting your hands on a stable surface, hold the vial and syringe in one hand and slowly pull back the plunger of the syringe to the 1.2 ml mark (to draw up that amount of liquid) with your other hand. 8.Keeping the vial upside down, gently tap the syringe until any air bubbles rise to the top of the barrel of the syringe. 9.Carefully push in the plunger to eject ONLY THE AIR through the needle. Make sure that the syringe contains 1.2 ml of solvent. 10.Remove the needle with the syringe from the vial of solvent. III.Injecting the required volume of solvent (1.2 ml) into the vial of Betaferon NOTE: Find the Betaferon vial and throw away the alcohol wipe on top of it. 1.Holding the Betaferon vial on a stable surface, slowly insert the needle of the syringe (containing 1.2 ml of liquid) all the way through the stopper of the vial. 2.Push the plunger down slowly, directing the needle toward the side of the vial to allow the liquid to run down the inside wall (injecting solvent directly onto the powder will cause excess foaming). 3.Make sure that the needle does not come into contact with the powder or the resulting solution. 4.After the solvent in the syringe has been completely injected into the Betaferon vial hold the vial between your thumb, forefinger and middle finger with the needle and syringe resting against your hand. 5.Gently rotate your hand to completely dissolve the white powder of Betaferon. DO NOT SHAKE! 6.Look closely at the solution (it should be clear). NOTE: If the mixture contains particles or is discoloured, throw it away and start again. IV.Drawing up the required volume of the solution for injection (1.0 ml) into the syringe 1.Slightly incline the vial of Betaferon solution and keep the needle tip at the lowest point of the vial. NOTE: Keep the needle tip in the liquid. 2.Pull back the plunger to withdraw 1.0 ml of liquid into the syringe. 3.Turn the vial upside down and hold the syringe with the needle pointing upward. 4.Tap the syringe gently until any air bubbles rise to the top of the barrel of the syringe. 5.Carefully push in the plunger to eject only the air through the needle. 6.Remove the syringe from the needle. Leave the needle in the vial. 7.Place the syringe (without needle) on a surface. Make sure that the tip (nozzle) of the syringe does not touch the surface. 8.Find the 27-gauge needle, take it out of its wrapping and place it firmly onto the tip (nozzle) of the syringe. 9.Throw away unused portion of the solution remaining in the vial and the needle in it. NOTE: The injection should be administered immediately after mixing (if the injection is delayed, refrigerate the solution and inject it within 3 hours). Do not freeze. V.Choosing and preparing the injection site and injecting the Betaferon solution (1.0 ml) subcutaneously (under the skin) 1.Choose an injection site. You may want to hold the syringe like a pencil or dart. Use a different area each day you inject (see "Rotating injection sites"). The injection sites should be situated in the following areas:
NOTE: Do not use any areas in which you feel lumps, bumps, firm knots or pain. Do not use any area in which the skin is discolored, depressed, scabbed, or has broken open. Talk to your doctor or healthcare professional about these or any other unusual conditions that you find. 2.Use an alcohol wipe to clean the skin at the injection site; let it air dry. 3.Throw away the wipe. 4.Find the syringe with the 27-gauge needle on it. Remove the needle guard from the needle. Make sure not to touch the needle. 5.Gently pinch the skin together around the site (to lift it up a bit). 6.Resting your wrist on the skin near the site, stick the needle straight into the skin at a 90° angle with a quick, firm motion. 7.Inject the drug by using a slow steady push (push the plunger all the way in until the syringe is empty). 8.Hold a swab on the injection site. Remove the needle from the skin. 9.Gently massage the injection site with a dry cotton ball or gauze. 10.Throw away the syringe and the needle in the disposal unit. Betaferon (Interferon beta-1b) therapy should be injected into subcutaneous (under the skin) tissue. The best areas for injection are loose and soft (flabby), away from joints, nerves, bones, and other important structures. Each therapy day you can choose an injection site from the ones identified in the diagrams. It's a good idea to know where your injection will be given before you prepare your syringe. If there are any sites that are difficult for you to reach, you can ask your support person (or someone who has been trained to give injections) to help you. It is neccessary to choose a new site for each injection as changing sites each time gives the area time to recover and helps prevent infection. It is a good idea to know where the injection is to go before you prepare your syringe. The schedule shown in the diagram will help you to vary the sites adequately. For example, if you administer the first injection into the right side of the abdomen, choose the left side for the second injection, then move to the right thigh for the third, and so on through the diagram until as many suitable areas of the body as possible have been used. Keep a record of where and when you last gave yourself an injection. One way to do that is to note the injection site on the enclosed medication record card. By following this schedule, you will come back to your first area (e.g. the right side of the abdomen) after 8 injections (16 days). As per the diagram you should then, however, not use the same section in that area as during your first injection but the section which is most distant. If all areas become tender, talk to your doctor about choosing other injection sites. For any information please contact the local representative of the marketing authorization holder.
Medication record Filling-in instructions for injection record Fill in the dates on the calendar overleaf, starting with the date of your next injection (note the weekdays shown at the top of the columns). Beginning with your first day of therapy (or your last injection), circle every other day. On every circled day: Select an injection site (refer to diagrams below) in different areas (If you have already been using Betaferon starting with the area that has not been used during the past 2 weeks). When you are coming back to the same area that you have started with use a different section in that area (the one which is most distant from the one being used 16 days before). After your injection, write the date in the box on the diagram below corresponding to that injection site. (When the medication record is used up, start again with a new record, using the same procedure.)
|
||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||
Bu sayfadaki bilginin en son güncellendiği/doğrulandığı tarih:11/09/2001 |
Ana sayfa | Bağlantılar | Kayıt ve geri bildirim | Sözlükçe | Arama motoru ve site haritası | Yerel Bilgiler | Yardım| Bir arkadaşa söyleyin | Sorumluluk almama | Basın Bilgileri | Schering |
 |
