GAMMANORM 165 MG/ML SOLUTION FOR INJECTION
Active substance: IMMUNOGLOBULIN NORMAL
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PACKAGE LEAFLET: INFORMATION FOR THE USER
165 mg/ml
solution for injection
Human Normal Immunoglobulin
This also applies to any unknown or emerging viruses or other types of infections. The measures taken are considered effective for enveloped viruses such as human immunodeciency virus (HIV), hepatitis B virus and hepatitis C virus. The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective. Note: Every time you receive a dose of Gammanorm you should record the name and batch number of the product in order to maintain a record of the batch used. Using other medicines
B.860.001.UK
Read all of this leaet carefully before you start using this medicine. - Keep this leaet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Gammanorm is and what it is used for 2. Before you use Gammanorm 3. How to use Gammanorm 4. Possible side effects 5. How to store Gammanorm 6. Further information 1. WHAT GAMMANORM IS AND WHAT IT IS USED FOR Gammanorm is an immunoglobulin and contains antibodies against bacteria and viruses. Antibodies protect the body and increase its resistance to infections. The purpose of this treatment is to attain normal antibody levels. Gammanorm is used as replacement therapy in adults and children to treat primary immunodeciency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia common variable immunodeciency (CVID) severe combined immunodeciency IgG subclass deciencies with recurrent infections myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
- Inform your doctor or pharmacist if you are taking, or have recently taken any other medicines, even over-the-counter ones, or if you have received a vaccination in the last three months. - Gammanorm may weaken the effect of all vaccines containing live viruses such as measles, rubella, mumps, and chicken pox. Following treatment with Gammanorm, three months should have elapsed before you are vaccinated with any of these vaccines. Where measles vaccine is concerned, you may need to wait up to a year following treatment with Gammanorm. It is therefore important that the doctor carrying out the vaccination is aware that you are having, or have had treatment with Gammanorm. - Inform your doctor that you are taking immunoglobulin when you give a blood sample, as this treatment may affect the results. Pregnancy and breast-feeding There is limited experience of usage of Gammanorm during pregnancy and breast-feeding. You should therefore consult your doctor before use of Gammanorm when you are pregnant or breast-feeding. Driving and using machines No effect has been observed upon the ability to drive or operate machinery. Important information about some of the ingredients of Gammanorm This medicinal product contains 4.35 mmol (or 100 mg) sodium per dose (40 ml). Please take this into consideration if you are on a controlled sodium diet.
3. HOW TO USE GAMMANORM The treatment will be started off by your doctor who will ensure that you receive training and precise information on using the pump, injection technique, keeping a treatment diary, and what action to take in the event of serious side effects. As soon as you are able to treat yourself, and if no side effects have arisen during treatment, your doctor may allow you to continue treatment at home. The dosage and infusion speed will be determined by your doctor, who will adapt the dose especially for you. Always follow your doctors instructions. This product should be administered subcutaneously (under the skin). In special cases where Gammanorm cannot be given subcutaneously, it may be administered intramuscularly (into muscle). An intramuscular injection must be given by a doctor or nurse. Instructions Always use Gammanorm exactly as your doctor has told you. You should check with your doctor if you are not sure. The product should be at room or body temperature prior to use. The solution should be clear or semi-translucent. Do not use solution that is cloudy, contains particles, or has deposits. Handling instructions: Remove the protective cap from the vial and wipe the rubber stopper with alcohol. To withdraw Gammanorm, use a sterile syringe and needle or transfer device (e.g. Minispike or Medimop vial adapter).
2. BEFORE YOU USE GAMMANORM Do not use Gammanorm - if you are hypersensitive to human normal immunoglobulin or any of the other ingredients of Gammanorm. - intravenously (Gammanorm must not be administered into a vein). - intramuscularly (into a muscle) by yourself. Gammanorm must not be given into a muscle if you have any bleeding disorders. Take special care with Gammanorm - Tell your doctor if you have any other illnesses. - If Gammanorm is accidentally administered into a blood vessel you could develop shock. - True hypersensitivity reactions are rare. They can particularly occur in the very rare cases of IgA deciency with anti-IgA antibodies and these patients should be treated with caution. Virus safety: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of the blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove the viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
B.860.001.UK_BPT_03.indd 1
06.03.12 05:30
Fig 1
Inject air into the vial that is equivalent to the amount of Gammanorm to be withdrawn. Then withdraw Gammanorm from the vial. If multiple vials are required to achieve the desired dose, repeat this step (Fig. 1).
4. POSSIBLE SIDE EFFECTS Like all medicines, Gammanorm can cause side effects, although not everybody gets them. Certain side effects may occur more often in people who are receiving Gammanorm for the rst time or, in rare cases, when changing human normal immunoglobulin products, or when treatment is suspended for more than eight weeks. In rare cases, Gammanorm may cause a fall in blood pressure and a severe hypersensitivity reaction (anaphylactic reaction), even in people who previously tolerated treatment with human normal immunoglobulin. In case of a suspected allergy or anaphylactic reaction, which may cause such things as dizziness, pounding heart, falling blood pressure, breathlessness, itching, and rash, seek medical attention immediately and follow your doctors instructions. Common side effects (affect 1 to 10 patients of 100): local reactions at the injection site such as swelling, tenderness, pain, redness, hardening, a sensation of heat, itching, bruising, or rashes Rare side effects (affect 1 to 10 patients of 10,000): low blood pressure, allergic reactions Very rare side effects (affect less than 1 of 10,000 patients): headache, dizziness, nausea, vomiting, back pain, joint pains, fever, shaking, tiredness, anaphylactic shock (severe allergic reaction) If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist.
Follow the manufacturers instructions for preparing the syringe driver. Prime the administration tubing to ensure that no air is left in the tubing by lling the tubing/needle with Gammanorm.
Fig 2
Clean the injection site(s) with antiseptic solution (Fig. 2).
Fig 3
Grasp the skin between two ngers (Fig. 3).
Fig 4
Insert the needle under the skin (Fig. 4).
Fig 5
Gammanorm must not be injected into a blood vessel. To test that no blood vessel has been accidentally hit, gently pull back on the syringe plunger and look to see if any blood is owing back into the tubing (Fig. 5). If you see any blood, remove and discard the needle and tubing, gently applying pressure with cotton wool or gauze to where the needle was inserted. Repeat priming and needle insertion steps using a new needle, tubing and a new injection site.
5. HOW TO STORE GAMMANORM Keep out of the reach and sight of children. Do not use Gammanorm after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C 8 C). Keep the vial in the outer carton. Within its shelf-life, the product may be stored below 25 C for up to 2 months. The date of transfer from the refrigerator and the end of the 2 month period should be recorded on the outer carton. The product must not be returned to the refrigerator and must be discarded if not used after the 2-month period. After rst opening, the product should be used immediately. Do not use Gammanorm if the solution is cloudy or contains particles. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Never discard used syringes with ordinary household waste.
Fig 6
Secure the needle in place by applying sterile gauze or a transparent dressing (Fig. 6).
Fig 7
Inject Gammanorm following the manufacturers instructions for the syringe driver (Fig. 7). 6. FURTHER INFORMATION What Gammanorm contains The active substance is: human normal immunoglobulin 165 mg/ml (at least 95% is immunoglobulin G) The other ingredients are: glycine, sodium chloride, and sodium acetate equivalent to 2.5 mg of sodium per ml, polysorbate 80, water for injections. What Gammanorm looks like and contents of the pack Gammanorm is a clear or slightly opalescent and pale-yellow to lightbrown solution for injection and is available as: 10 ml or 20 ml of solution in a vial (Type I glass) - pack size of 1, 10 or 20. Marketing Authorisation Holder Octapharma Limited The Zenith Building 26 Spring Gardens Manchester M2 1AB United Kingdom. Manufacturer Octapharma AB SE-112 75 Stockholm Sweden This leaet was last approved in 02/2012.
The injection site should be changed after 5 15 ml. Multiple injection sites can be used at the same time. Injection sites should be at least 5 cm apart. Remove the peel-off label from the Gammanorm vial and use this to complete the patient diary. If you use more Gammanorm than you should The risks of overdosing with Gammanorm are not known. Contact your doctor or Poison Information Centre if you have taken more Gammanorm than prescribed. If you forget to use Gammanorm If you forget to inject one dose of Gammanorm do not use a double dose or multiple doses at the same time to make up for the forgotten dose. Instead inject one dose as soon as possible, then go on injecting Gammanorm as prescribed by your doctor. If you stop using Gammanorm If you stop injecting Gammanorm the success of your treatment may be at risk. Do not stop your treatment without consulting your doctor before. If you have any further questions on the use of this product, ask your doctor or pharmacist.
B.860.001.UK_BPT_03.indd 2
06.03.12 05:30
165 mg/ml
solution for injection
Human Normal Immunoglobulin
This also applies to any unknown or emerging viruses or other types of infections. The measures taken are considered effective for enveloped viruses such as human immunodeciency virus (HIV), hepatitis B virus and hepatitis C virus. The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective. Note: Every time you receive a dose of Gammanorm you should record the name and batch number of the product in order to maintain a record of the batch used. Using other medicines
B.860.001.UK
Read all of this leaet carefully before you start using this medicine. - Keep this leaet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Gammanorm is and what it is used for 2. Before you use Gammanorm 3. How to use Gammanorm 4. Possible side effects 5. How to store Gammanorm 6. Further information 1. WHAT GAMMANORM IS AND WHAT IT IS USED FOR Gammanorm is an immunoglobulin and contains antibodies against bacteria and viruses. Antibodies protect the body and increase its resistance to infections. The purpose of this treatment is to attain normal antibody levels. Gammanorm is used as replacement therapy in adults and children to treat primary immunodeciency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia common variable immunodeciency (CVID) severe combined immunodeciency IgG subclass deciencies with recurrent infections myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
- Inform your doctor or pharmacist if you are taking, or have recently taken any other medicines, even over-the-counter ones, or if you have received a vaccination in the last three months. - Gammanorm may weaken the effect of all vaccines containing live viruses such as measles, rubella, mumps, and chicken pox. Following treatment with Gammanorm, three months should have elapsed before you are vaccinated with any of these vaccines. Where measles vaccine is concerned, you may need to wait up to a year following treatment with Gammanorm. It is therefore important that the doctor carrying out the vaccination is aware that you are having, or have had treatment with Gammanorm. - Inform your doctor that you are taking immunoglobulin when you give a blood sample, as this treatment may affect the results. Pregnancy and breast-feeding There is limited experience of usage of Gammanorm during pregnancy and breast-feeding. You should therefore consult your doctor before use of Gammanorm when you are pregnant or breast-feeding. Driving and using machines No effect has been observed upon the ability to drive or operate machinery. Important information about some of the ingredients of Gammanorm This medicinal product contains 4.35 mmol (or 100 mg) sodium per dose (40 ml). Please take this into consideration if you are on a controlled sodium diet.
3. HOW TO USE GAMMANORM The treatment will be started off by your doctor who will ensure that you receive training and precise information on using the pump, injection technique, keeping a treatment diary, and what action to take in the event of serious side effects. As soon as you are able to treat yourself, and if no side effects have arisen during treatment, your doctor may allow you to continue treatment at home. The dosage and infusion speed will be determined by your doctor, who will adapt the dose especially for you. Always follow your doctors instructions. This product should be administered subcutaneously (under the skin). In special cases where Gammanorm cannot be given subcutaneously, it may be administered intramuscularly (into muscle). An intramuscular injection must be given by a doctor or nurse. Instructions Always use Gammanorm exactly as your doctor has told you. You should check with your doctor if you are not sure. The product should be at room or body temperature prior to use. The solution should be clear or semi-translucent. Do not use solution that is cloudy, contains particles, or has deposits. Handling instructions: Remove the protective cap from the vial and wipe the rubber stopper with alcohol. To withdraw Gammanorm, use a sterile syringe and needle or transfer device (e.g. Minispike or Medimop vial adapter).
2. BEFORE YOU USE GAMMANORM Do not use Gammanorm - if you are hypersensitive to human normal immunoglobulin or any of the other ingredients of Gammanorm. - intravenously (Gammanorm must not be administered into a vein). - intramuscularly (into a muscle) by yourself. Gammanorm must not be given into a muscle if you have any bleeding disorders. Take special care with Gammanorm - Tell your doctor if you have any other illnesses. - If Gammanorm is accidentally administered into a blood vessel you could develop shock. - True hypersensitivity reactions are rare. They can particularly occur in the very rare cases of IgA deciency with anti-IgA antibodies and these patients should be treated with caution. Virus safety: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of the blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove the viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
B.860.001.UK_BPT_03.indd 1
06.03.12 05:30
Fig 1
Inject air into the vial that is equivalent to the amount of Gammanorm to be withdrawn. Then withdraw Gammanorm from the vial. If multiple vials are required to achieve the desired dose, repeat this step (Fig. 1).
4. POSSIBLE SIDE EFFECTS Like all medicines, Gammanorm can cause side effects, although not everybody gets them. Certain side effects may occur more often in people who are receiving Gammanorm for the rst time or, in rare cases, when changing human normal immunoglobulin products, or when treatment is suspended for more than eight weeks. In rare cases, Gammanorm may cause a fall in blood pressure and a severe hypersensitivity reaction (anaphylactic reaction), even in people who previously tolerated treatment with human normal immunoglobulin. In case of a suspected allergy or anaphylactic reaction, which may cause such things as dizziness, pounding heart, falling blood pressure, breathlessness, itching, and rash, seek medical attention immediately and follow your doctors instructions. Common side effects (affect 1 to 10 patients of 100): local reactions at the injection site such as swelling, tenderness, pain, redness, hardening, a sensation of heat, itching, bruising, or rashes Rare side effects (affect 1 to 10 patients of 10,000): low blood pressure, allergic reactions Very rare side effects (affect less than 1 of 10,000 patients): headache, dizziness, nausea, vomiting, back pain, joint pains, fever, shaking, tiredness, anaphylactic shock (severe allergic reaction) If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist.
Follow the manufacturers instructions for preparing the syringe driver. Prime the administration tubing to ensure that no air is left in the tubing by lling the tubing/needle with Gammanorm.
Fig 2
Clean the injection site(s) with antiseptic solution (Fig. 2).
Fig 3
Grasp the skin between two ngers (Fig. 3).
Fig 4
Insert the needle under the skin (Fig. 4).
Fig 5
Gammanorm must not be injected into a blood vessel. To test that no blood vessel has been accidentally hit, gently pull back on the syringe plunger and look to see if any blood is owing back into the tubing (Fig. 5). If you see any blood, remove and discard the needle and tubing, gently applying pressure with cotton wool or gauze to where the needle was inserted. Repeat priming and needle insertion steps using a new needle, tubing and a new injection site.
5. HOW TO STORE GAMMANORM Keep out of the reach and sight of children. Do not use Gammanorm after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C 8 C). Keep the vial in the outer carton. Within its shelf-life, the product may be stored below 25 C for up to 2 months. The date of transfer from the refrigerator and the end of the 2 month period should be recorded on the outer carton. The product must not be returned to the refrigerator and must be discarded if not used after the 2-month period. After rst opening, the product should be used immediately. Do not use Gammanorm if the solution is cloudy or contains particles. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Never discard used syringes with ordinary household waste.
Fig 6
Secure the needle in place by applying sterile gauze or a transparent dressing (Fig. 6).
Fig 7
Inject Gammanorm following the manufacturers instructions for the syringe driver (Fig. 7). 6. FURTHER INFORMATION What Gammanorm contains The active substance is: human normal immunoglobulin 165 mg/ml (at least 95% is immunoglobulin G) The other ingredients are: glycine, sodium chloride, and sodium acetate equivalent to 2.5 mg of sodium per ml, polysorbate 80, water for injections. What Gammanorm looks like and contents of the pack Gammanorm is a clear or slightly opalescent and pale-yellow to lightbrown solution for injection and is available as: 10 ml or 20 ml of solution in a vial (Type I glass) - pack size of 1, 10 or 20. Marketing Authorisation Holder Octapharma Limited The Zenith Building 26 Spring Gardens Manchester M2 1AB United Kingdom. Manufacturer Octapharma AB SE-112 75 Stockholm Sweden This leaet was last approved in 02/2012.
The injection site should be changed after 5 15 ml. Multiple injection sites can be used at the same time. Injection sites should be at least 5 cm apart. Remove the peel-off label from the Gammanorm vial and use this to complete the patient diary. If you use more Gammanorm than you should The risks of overdosing with Gammanorm are not known. Contact your doctor or Poison Information Centre if you have taken more Gammanorm than prescribed. If you forget to use Gammanorm If you forget to inject one dose of Gammanorm do not use a double dose or multiple doses at the same time to make up for the forgotten dose. Instead inject one dose as soon as possible, then go on injecting Gammanorm as prescribed by your doctor. If you stop using Gammanorm If you stop injecting Gammanorm the success of your treatment may be at risk. Do not stop your treatment without consulting your doctor before. If you have any further questions on the use of this product, ask your doctor or pharmacist.
B.860.001.UK_BPT_03.indd 2
06.03.12 05:30
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
