Rx Item-Berinert 500(10 ml) Kit 10ml by ASD Healthcare

BERINERT- human c1-esterase inhibitor
CSL Behring GmbH

Berinert� [C1 Esterase Inhibitor (Human)]Freeze-dried powder

1 INDICATIONS AND USAGE

? Berinert is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) indicated for the treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in adult and pediatric patients.

The safety and efficacy of Berinert for prophylactic therapy have not been established.

2 DOSAGE AND ADMINISTRATION



For Intravenous Use Only.

Administer Berinert at a dose of 20 International Units (IU) per kg body weight by intravenous injection. Doses lower than 20 IU/kg body weight should not be administered.

Berinert is provided as a freeze-dried powder for reconstitution with the Sterile Water for Injection, USP provided. Store the vial in the original carton in order to protect from light. Do not freeze.

2.1 Preparation and Handling
Check the expiration date on the product vial label. Do not use beyond the expiration date.
Prepare and administer using aseptic techniques [see Dosage and Administration (2.2)].
Use a silicone-free syringe for reconstitution and administration of Berinert.
After reconstitution and prior to administration, inspect Berinert visually for particulate matter and discoloration. The reconstituted solution should be colorless, clear, and free from visible particles. Do not use if the solution is cloudy, discolored, or contains particulates.
The Berinert vial is for single use only. Berinert contains no preservative. Any product that has been reconstituted should be used promptly. The reconstituted solution must be used within 8 hours. Discard partially used vials.
Do not freeze the reconstituted solution.
2.2 Reconstitution and Administration
Each Berinert vial containing 500 IU of C1 esterase inhibitor as a lyophilized concentrate for reconstitution with 10 mL of Sterile Water for Injection, USP provided.

Use either the Mix2Vial� transfer set provided with Berinert [see How Supplied/Storage and Handling (16.1)] or a commercially available double-ended needle and vented filter spike

Berinert 500(10 ml) Kit 10ml by ASD Heal
NDC No. 63833-0825-02 UPC/GTIN No. 3-63833-82502-9 MPN 35385 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therap

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C1 ESTERASE INHIBITOR INT
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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