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Berinert - Model IV -Human C1 Esterase Inhibitor
Berinert IV is a highly purified, freeze-dried CI esterase inhibitor concentrate derived from human plasma. Berinerts IV is available in two presentations with different concentrations (strengths) as detailed in Table 1. When reconstituted, the 500 IU presentation contains 500 IU of CI esterase inhibitor per vial at 50 IU/mL and the 1500 IU presentation contains 1500 IU of CI esterase inhibitor per vial at 500 IU/mL.
The potency of CI esterase inhibitor is expressed in International Units (IU), which are related to the current WHO Standard for CI esterase inhibitor products.
Berinerts IV contains up to 486 mg sodium per 100 mL of solution. For the full list of excipients, see Section 6.1 List of excipients.
PHARMACEUTICAL FORM
Berinerts IV is produced as a sterile, pyrogen-free, freeze-dried white powder for intravenous injection and supplied with Water for Injections (clear, colourless) for reconstitution.
CLINICAL PARTICULARS
Therapeutic indications
Berinerts IV is indicated for the treatment of acute attacks in patients with hereditary angioedema (HAE).
Dose and method of administration
Treatment should be initiated under the supervision of a physician experienced in the treatment of C1 esterase inhibitor deficiency.
It is recommended that prescribed doses of Bennett* IV should be expressed as International Units written in full.
Berinerts IV is administered intravenously by a doctor or nurse. If self administration and home treatment is considered appropriate, refer to the Self administration and home treatment section under Administration.
Dosage
The recommended dose is 20 IU per kg body weight for adult and paediatric patients.
Reconstitution
Reconstitution and withdrawal must be carried out under aseptic conditions. Use the syringe provided with the product or a silicone-free syringe. Bring the diluent to room temperature. Ensure product and diluent vial flip caps are removed and the stoppers are treated with a disinfectant and allowed to dry prior to opening the Mix2Vial` package.
Open the carton and remove the Mix2Vial filter transfer set. The Mix2Vial filter transfer set is intended to filter the contents of a single vial of Berinerts IV only.