Berinert - Model SC - Human C1 Esterase Inhibitor

PHARMACEUTICAL FORM
Berinert   SC is produced as a sterile, pyrogen-free. freeze-dried white powder for subcutaneous injection and supplied with Water for Injections (clear, colourless) for reconstitution.

CLINICAL PARTICULARS

Therapeutic indications
Berinert8 SC for subcutaneous injection is indicated for prevention of recurrent Hereditary Angioedema (HAE) attacks in patients aged 8 years and older with CI esterase inhibitor deficiency.

Dose and method of administration

It is recommended that prescribed doses of Berinerts SC should be expressed as International Units written in full.
Berinert* SC is intended for self-administration by subcutaneous injection. The patient or carer should be trained on how to administer Berinerts SC. Refer to the Self administration and home treatment section under Administration.

Dosage

The recommended dose is 60 IU per kg body weight twice weekly (every 3-4 days).

Reconstitution

Reconstitution and withdrawal must be carried out under aseptic conditions. Reconstitution is achieved generally within 5 minutes, but may take as long as 10 minutes. Use the syringe provided with the product or a silicone-free syringe. Bring the product and diluent (Water for Injections (WFI)) vials 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 SC only.