I B2.4. Design of the patient information leaflet for VariQuin

Transcription

1 (English translation of official Dutch version) I B2.4. Design of the patient information leaflet for VariQuin Information for the Patient: Read this package leaflet carefully when you have some time to yourself, even if this medicinal product has been given to you before. The text may have been amended. General characteristics The product is marketed under the name of VariQuin. The commercial packing of VariQuin consists of a box containing: * A vial with 2 ml VariQuin. The product is delivered as a solution for injection for intramuscular use (for injection into muscles). The product contains 100 to 180 grams of protein per litre. The active substance of this protein is human varicella zoster immunoglobulin (human varicella zoster antibodies). This product contains immunoglobulin G (= IgG), an antibody that works against the varicella zoster virus, which causes chicken pox (varicella), among other things. The varicella zoster antibody content is at least 100 IU per ml (IU = International Units, units that are used to report the strength of substances). Along with the active immunoglobulin G, the protein contains very small quantities of immunoglobulin A, M and a few other plasma proteins. The product also contains the following other ingredients: glycine and water for injections. VariQuin is a protein purified from donor blood. This donor blood is obtained from healthy, voluntary, nonremunerated donors. These individuals satisfy the requirements imposed on blood donors in the Netherlands. All blood donors are tested for several pathogens such as: * the AIDS virus; * the hepatitis B and C viruses (which cause jaundice); * Treponema pallidum (the causative agent of syphilis). These pathogens could not be detected in the donors. Furthermore, this product has undergone a virus reducing treatment. This virus reducing treatment kills or eliminates as many as possible of the viruses still present, thus making the risk of virus transfer exceptionally small. Varicella zoster immunoglobulin is an antibody effective against the varicella zoster virus. VariQuin can be used to prevent chicken pox or to reduce the symptoms of the chicken pox disease. For more detailed information, see the end of this patient information leaflet under General information. The antibodies that are present in VariQuin and directed against the varicella zoster virus counteract the harmful effects of the virus. This prevents chicken pox or reduces its symptoms (so-called passive immunisation). VariQuin is manufactured and marketed by Sanquin, Plesmanlaan 125, 1066 CX Amsterdam, tel.: ; The marketing authorisation number is RVG

2 To be used with VariQuin should be used: 1. - with new-borns, where the mother experienced chicken pox (varicella) in the period from 5 days before up to and including 2 days after the delivery with people that have an ineffective or insufficiently effective immune system (reduced immunity) that have not yet had chicken pox and who show no antibodies against the varicella zoster virus, and that have been exposed to a patient with chicken pox. This applies especially to people with leukaemia, Hodgkin s disease or other forms of cancer, that are being treated with cytostatica (medicines against cancer), corticosteroids (medicines that inhibit inflammation), or radiotherapy (treatment of, in particular, malignant tumours with radiation) and thus have an insufficiently effective immune system. This also applies to patients with a congenital or acquired immune disorder. 3. a. - with premature babies younger than 28 weeks or weighing less than 1000 g at birth, that have been exposed to a patient with chicken pox. Whether the mother of the baby had, or did not have, antibodies against the varicella zoster virus present in the blood is not relevant for this. b. - with the remaining premature babies that have been exposed to a patient with chicken pox and whose mother has not experienced chicken pox or has no antibodies against the varicella zoster virus. This applies only for the duration of the hospital admission after the delivery. 4. administration of the VariQuin can be considered with: - pregnant women that have not experienced chicken pox and have been exposed to a patient with chicken pox - adults and the elderly with poor health that have not experienced varicella and that have been exposed to a patient with chicken pox. Important advance information VariQuin must not be administered to patients that are hypersensitive to the varicella zoster immunoglobulin, the remaining ingredients of the product or other comparable blood products. This applies also for persons who are missing another type of antibody, namely immunoglobulin A (IgA-deficiency) and who have antibodies against immunoglobulin A. However, in this last case your physician may yet decide to administer VariQuin (see under Note ).

3 The use of VariQuin during pregnancy or while breastfeeding has not been investigated. To date, the use of immunoglobulins, such as VariQuin, during pregnancy or while breastfeeding has never led to harmful effects. Immunoglobulins are transferred to the new-born infant through breast milk and contribute to the new-born infant s defences. You are advised to consult with your physician if you are pregnant, while breastfeeding or if you have a desire to become pregnant. VariQuin impairs the effect of certain vaccines, in particular the vaccines against measles, mumps, varicella (chicken pox) and rubella (German measles). Inform your physician if you have been vaccinated in the past 3 to 4 weeks or will shortly be vaccinated (within 3 months after administration of VariQuin ). The use of VariQuin may influence the results of certain blood tests. No information is available concerning possible interactions between VariQuin and other medicinal products in the body. NOTE: The product is not suitable for intravenous administration (administration into a vein). The product may also be administered under the skin (subcutaneous) in patients with a special tendency towards spontaneous, sometimes long lasting, haemorrhages. The effectiveness of the product cannot be guaranteed in this case. VariQuin may induce an intense hypersensitivity attack (anaphylactic reaction) in patients who have no immunoglobulin A (IgA deficiency) and have antibodies against immunoglobulin A. An anaphylactic reaction can also occur in patients who appeared to be hypersensitive with earlier use of blood or blood products. If you have an IgA deficiency and have antibodies against immunoglobulin A or appeared to be allergic with the earlier use of blood or a blood product, then this product must only be administered if strictly necessary. Furthermore, in that case the administration of VariQuin must occur under careful monitoring by a physician. Allergic reactions occur only rarely. Where necessary, mild hypersensitivity, such as hives (urticaria), can be treated with antihistamines (medicines against allergies) and corticosteroids (medicines that inhibit inflammation). Should a serious hypersensitivity attack (anaphylactic shock) occur, then the administration must be immediately stopped and appropriate measures must be taken. You must be monitored for at least 20 minutes after the administration of VariQuin. The risk of transfer of pathogens through the use of a blood product is exceptionally small. Administration of VariQuin is of no use if the symptoms of chicken pox have already appeared (to be recognised by the typical rash, that is to say blisters and scabs). VariQuin does not prevent the herpes zoster disease (shingles) from occurring in persons that have already had chicken pox or in whom antibodies against the varicella zoster virus can be demonstrated. The product has no influence upon the clinical course of the shingles.

4 Instructions for use Dosage The quantity of VariQuin that you need will be determined by your physician. * People with a body weight up to and including 20 kg: 1 dose (one vial of 2 ml) * People with a body weight of more than 20 kg: 2 doses (two vials of 2 ml) These doses apply for all applications indicated under To be used with. VariQuin must be administered as soon as possible to new-born infants where the mother experienced chicken pox in the period from 5 days before up to and including 2 days after the delivery (see 1 under To be used with ). For the remaining applications (see 2, 3 and 4 under To be used with ), the administration must occur as soon as possible, ultimately within 72 hours, after exposure to a patient with chicken pox. It is recommended to repeat the injection if there has been another instance of exposure to a patient with chicken pox later than 3 weeks after the injection with VariQuin. Instructions for use Administration of VariQuin must be performed by a physician. In general, the injection will be given in the upper arm or buttock. The solution may not be too cold when it is administered. It is recommended to bring the product to body temperature before administration. VariQuin must be injected deep into the muscle (intramuscular). A light cloudiness or a small amount of precipitation may occur during the storage period. This causes no objection to the administration of this product.

5 Side effects As with all medicinal products, VariQuin may cause undesirable effects. Pain and sensitivity are possible at the injection site. Fever and/or skin rashes (exanthema) may occur in rare cases. Side effects such as nausea, vomiting, hypotension, increased heart rate (tachycardia) and allergic reactions or a very intense hypersensitivity attack (anaphylactic shock) occur rarely. For further information see Important advance information. Inform your physician or pharmacist if a side effect occurs that was not reported in the patient information leaflet or if you experience a side effect as serious. Storage instructions and date of expiry The expiry date of the product is indicated on the box. The product may no longer be used after this date and must be handed in at the pharmacist s. The product must be stored in the box at 2-8 C. The refrigerator is an appropriate place for this. Avoid freezing the product. General information Chicken pox: Chicken pox is a very contagious, though mostly innocent, paediatric disease. However, some children or adults have a reduced resistance. Consequently, a chicken pox infection can be life threatening for children and adults with a disturbance in natural immunity. Such a disorder can occur in children or adults that are being treated for cancer (for example, leukaemia) or in premature babies. The symptoms of chicken pox are more intense in adults and in pregnant women than in children. New-born babies also have an extra risk if the mother experiences chicken pox right before or right after the delivery. Date on which this patient information leaflet was last revised September 2003