GAMUNEX 10% 100 MG/ML SOLUTION FOR INFUSION

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gamunex 1 % 0

Solution for infusion for intravenous administration Active substance: human normal immunoglobulin G
Read all of this leaflet carefully before you start using this medicine. - Keep this leaflet. 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 signs of illness are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What Gamunex 10% is and what it is used for 2.Before you use Gamunex 10% 3.How to use Gamunex 10% 4.Possible side effects 5.How to store Gamunex 10% 6.Further information Certain side effects may occur more frequently: - with a high infusion rate, - in patients with a complete lack of gammaglobulins or low gammaglobulin levels (agammaglobulinaemia or hypogammaglobulinaemia) with or without IgA deficiency, - in patients who are receiving human normal immunoglobulin for the first time or, in rare cases, when the immunoglobulin product is switched or after a prolonged interval without treatment. Potential complications can often be avoided by ensuring: - that you are not hypersensitive to human immunoglobulin by having Gamunex 10% initially infused slowly (0.1 ml/kg BW per hour) -that you are carefully monitored for any symptoms throughout the infusion period. In particular, if you are receiving human immunoglobulin for the first time, if you have been switched from a different immunoglobulin or if you have not received treatment for some time, you should be monitored for possible side effects during the first infusion and for one hour afterwards. If side effects occur, the infusion rate should be reduced or the infusion should be suspended until the symptoms have disappeared. If the symptoms persist even after suspending the infusion, suitable treatment should be commenced. In the event of a shock reaction (anaphylactic shock with a severe fall in blood pressure), treatment with the product should be stopped immediately and the current standard medical treatment for shock should be implemented. Cases of kidney function disorders and acute kidney failure have been reported in connection with administration of intravenous immunoglobulins. You are particularly at risk if you have certain risk factors such as pre-existing impairment of kidney function (renal insufficiency), diabetes (diabetes mellitus) or a reduced blood volume (hypovolaemia). Other circumstances considered to be risk factors are if you are overweight or are being treated simultaneously with medicines that have harmful effects on the kidneys and/or if you are over the age of 65. The following precautions should be taken by you in any case: - Please, drink enough to ensure adequate fluid intake prior to commencement of therapy, - Your doctor should control your urine output and measure kidney function, - Please, do not use simultaneously certain medicines that increase urine output (loop diuretics). If a kidney function disorder occurs, your doctor will consider discontinuing the immunoglobulin treatment. While the reports of kidney function disorders and acute kidney failure have been associated with use of many of the licensed immunoglobulin products, products containing cane sugar (sucrose) as a stabiliser accounted for a disproportionate share of the total number. If you are at increased risk in respect of the above-mentioned factors, you should receive an immunoglobulin product that is free of cane sugar. Gamunex 10% contains no cane sugar. Furthermore, the infusion rate in your case should be as low as possible and the immunoglobulin product should be used at the lowest feasible concentration. 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 blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of plasma starting materials for specific signs of infectivity. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.

1.WHAT Gamunex 10% IS AND WHAT IT IS USED FOR
Gamunex 10% is an unmodified human immunoglobulin G (IgG) with a broad spectrum of antibodies to various infectious agents. Gamunex 10% is used: for treatment in: - primary immunodeficiency syndromes such as congeni tal gammaglobulin deficiency and low gammaglobulin levels in the blood (congenital agammaglobulinaemia and hypogammaglobulinaemia), common variable immunodeficiency, severe combined immunodeficiency, congenital immune defect with deficiency of blood plate lets (thrombocytopenia) and increased susceptibility to infection in males (Wiskott-Aldrich syndrome), - certain cancer diseases (multiple myeloma or chronic lymphocytic leukaemia) with acquired, extremely low gammaglobulin levels in the blood (secondary hypo gammaglobulinaemia) and recurrent infections, -children with AIDS and recurrent severe bacterial infections. to modify the immune response (immunomodulation): - in cases of bruising and mucosal bleeding with no discernible cause that are associated with a low blood platelet count (idiopathic thrombocytopenic purpura; ITP); in adults and children at high risk of bleeding or to correct the platelet count prior to surgery, - Guillain-Barr syndrome, - Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and - Kawasaki disease (in this case in conjunction with acetylsalicylic acid therapy) in bone marrow transplantation

2.BEFORE YOU USE Gamunex 10%
Do not use Gamunex 10%, - if you are hypersensitive (allergic) to human immunoglobulins. This applies in particular if you have an extremely rare, selective IgA deficiency and have antibodies against IgA, - if you are hypersensitive to any of the other ingredients of the product. Special care to be taken with Gamunex 10%: Certain side effects may be related to the rate of infusion. The recommended infusion rate (see 3. How to use Gamunex 10%) should therefore be followed.

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Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. 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 immunodeficiency 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/or parvovirus B19. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, however, possibly because the antibodies against these infections, which are contained in the product, are protective. It is strongly recommended that every time you receive a dose of Gamunex 10% the name and batch number of the product are recorded using the supplied tear-off labels in order to maintain a link between the patient and the batch of the product. Using other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Please inform your doctor if you have received recently a vaccination. Using Gamunex 10% with food and drink: There are to date no known clinically relevant interactions with food and drink on simultaneous use of Gamunex 10%. Pregnancy and breast-feeding The safety of Gamunex 10 % for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given after careful benefit-risk analysis to pregnant women and breast-feeding mothers. Long clinical experience with immunoglobulins suggests that no harmful effects on the course of the pregnancy or on the foetus and the baby are to be expected, however. Immunoglobulins are, on the other hand, present in breast milk and may consequently transfer protective antibodies to the baby. Driving and using machines: There are no indications that immunoglobulins impair the ability to drive or use machines.

Rare side effects (affects 1 to 10 users in 10,000): Hypersensitivity (allergic) reactions with a sudden fall in blood pressure and dyspnoea, to the point even of a severe generalised allergic reaction (anaphylactic shock) with loss of consciousness in isolated instances, may occur Frequency not known (cannot be estimated from available data): Aseptic meningitis with severe headache, nausea, vomiting, fever, neck stiffness or diminished consciousness; blockages of blood vessels (thromboembolisms); reversible anaemia / destruction of red blood cells; low blood pressure; joint pain; weakness and reactions at the injection site What countermeasures should be taken if side effects occur? If side effects occur, the infusion rate should be reduced or the infusion should be suspended until the signs of the effects have disappeared. If the signs persist even after suspending the infusion, suitable treatment should be initiated. In the event of a severe hypersensitivity reaction with a fall in blood pressure and dyspnoea to the point even of a severe generalised allergic reaction (anaphylactic shock), use of Gamunex 10% should be ceased immediately and appropriate countermeasures should be initiated. If you notice one of the listed side effects or other undesirable effects during treatment with Gamunex 10%, please inform your doctor or pharmacist.

5.HOW TO STORE Gamunex 10%
Store in a refrigerator (+2 to +8 C ). Do not freeze. Do not use Gamunex 10 % after the expiry date which is stated on the carton and the vial. The shelf life is 3 years. The product may be stored in its outer carton for a one-off period of up to 6 months at room temperature (not above 25C). In that case, the shelf life of the product expires after 6 months, irrespective of the original expiry date. The new expiry date must be noted on the outer carton and the vial label. The new expiry date must be no later than the printed expiry date, however. Subsequent refrigeration is not possible. Once individual ampoules have been opened, the contents must be used immediately. Any remainder must be discarded. Further storage, even in a refrigerator, is not permitted on account of possible invasion of germs. Keep Gamunex 10%, like other medicines, out of the reach and sight of children.

3.HOW TO USE Gamunex 10%
Gamunex 10% is administered intravenously by your doctor as described at the end of this patient information. The dosage and the interval between infusions are dependent on the indication you are treated, your weight and your age and should be individually adjusted. Please ask your doctor for the recommended dosages. If you have the impression that the effect of Gamunex 10% triggers too strong or too weak a reaction in your body, talk to your doctor or pharmacist. If use of Gamunex 10% has been stopped: If treatment with Gamunex 10% is stopped, your clinical condition may worsen. Please talk to the doctor in charge of your treatment if you wish to end treatment with Gamunex 10% prematurely. If you have any further questions on the use of this product, ask your doctor or pharmacist.

6.Further information
What Gamunex 10% contains: 1 ml Gamunex 10% contains 100 mg protein with an IgG content of at least 98% (IgA content: mean: 0.059 mg/ml; max.: 0.084 mg/ml; n=5) in water for injection. The other ingredient is glycine. What Gamunex 10% looks like and contents of the pack: Gamunex 10% is a water-clear, ready-for-use solution available in pack sizes of 10 ml, 50 ml, 100 ml and 200 ml. The carton contains a vial made of white glass with a rubber stopper, a tear-off hanger label printed in green and blue and a package leaflet. Marketing authorisation holder: Talecris Biotherapeutics GmbH Lyoner Strasse 15 60528 Frankfurt Germany Manufacturer: Talecris Biotherapeutics GmbH Lyoner Strasse 15 60528 Frankfurt Germany This leaflet was approved on:

4.POSSIBLE SIDE EFFECTS
Like all medicines, Gamunex 10% can cause side effects, although not everybody gets them. Certain side effects, e.g. headache, may be reduced by slowing the infusion rate. Common side effects (affects 1 to 10 users in 100): Pyrexia, headache Uncommon side effects (affects 1 to 10 users in 1,000): Allergic skin reactions such as urticaria, pruritus, rash; chest pain; shoulder pain; influenza like illness; white blood cell count decreased; dizziness; abdominal pain; diarrhoea; nausea; vomiting; pharyngitis; wheezing; cough; dermatitis; nasal congestion; arthralgia; back pain; neck pain; malaise; fatigue; chills; asthenia; injection site reaction

03/2011

Marketing Authorisation Number: PL 29527/0001


The following information is intended for medical or health care professionals only Use only clear solutions for infusion do not shake. Prior to infusion, bring Gamunex 10% up to room temperature or body temperature (possibly in a water bath at a temperature no higher than 37C). The vials are supplied with a hanger label (Fig. 1). After inserting the giving set (Fig. 2), the vial is inverted and the loop section of the label is folded back (Fig. 3). Firm finger pressure is used to create a crease on each side where the loop section joins the rest of the label (Fig. 4). The vial is suspended from the infusion stand by the resulting loop (Fig. 5).

Fig. 1 Gamunex

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Fig. 5

10% should initially be administered at an infusion rate of 0.01 0.02 ml/kg body weight per minute (corresponding to approximately 0.75 1.5 ml per minute for a body weight of 75 kg). If the product is well tolerated, the rate of infusion may gradually be increased after approximately 30 minutes to a maximum of 0.08 0.14 ml/kg per minute (corresponding to 6 10.5 ml per minute for a body weight of 75 kg). In children or patients at risk of kidney failure, the maximum infusion rate should not exceed 0.08 ml/kg body weight per minute. Please, refer to the SPC for detailed dose recommendations. Gamunex 10% must not be mixed with other solutions for infusion and other medicines. If dilution is necessary prior to infusion, 5% glucose solution may be used for this purpose. Gamunex 10% is not compatible with saline solution.
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