Human normal immunoglobulin

Composition: 1 ml solution contains: Human plasma protein 50 mg, of which immunoglobulin at least 95% IgM 6 mg, IgA 6 mg, IgG 38 mg. Further constituents: Glucose monohydrate (27.5 mg/ml), sodium chloride (78µmol/ml), water for injections (ad 1 ml).

Indications: Treatment of bacterial infections (concomitantly with antibiotics), especially in sepsis caused by gram-positive or gram-negative bacteria and their toxins. Immunoglobulin substitution in immunosuppressed patients and severe secondary antibody deficiency syndrome.

Contra-indications: Hypersensitivity to human immunoglobulin.

Special precautions for use: Certain severe drug reactions may be related to the rate of infusion. The recommended infusion rate given under “Method of administration” must be closely followed, as the incidence of adverse events tends to increase with the rate of infusion. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.

Dosage instructions and duration of application: Unless otherwise prescribed, the following guideline apply:. 1. Neonates and infants: 5 ml/kg body weight daily on three consecutive days. Further infusion may be required depending on the clinical course. 2. Children and adults: a) Therapy of severe bacterial infections: 5 ml/kg body weight daily on three consecutive days. b) Immunoglobulin substitution in immunosuppressed patients and severe secondary antibody deficiency syndrome: 3-5 ml/kg body weight. Repetition at weekly intervals if necessary. Interactions with other medicinal products: Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella. After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year . Therefore patients receiving measles vaccine should have their antibody status checked.

Method of administration: Pentaglobin® is intended for intravenous infusion. Before administration, Pentaglobin® should be warmed at least to room temperature and preferably to body temperature. Infuse only clear solutions. The opalescence is a property of the product. Infusion rate: in neonates and infants 1. 7 ml/kg/hour, by perfusor; in children and adults: 0.4 ml/kg/hour, Alternative : the first 100 ml at 0.4 ml/kg/hour; then 0.2 ml/kg/hour continouslycontinuously until 15.0 ml/kg is reached within 72 hours.

Special precautions for storage: Pentaglobin® has to be stored in the refrigerator at +2 ºC TO +8 ºC. At this temperature Pentaglobin® has a shelf-life of 2 years.

Presentations: Ampoules of 10 ml. Infusion bottles of 50 ml, 100 ml. For further information please refer to the package insert.