Rx Item-Alphanate 250 (100) Vial By ASD Healthcare

ALPHANATE- antihemophilic factor/von willebrand factor complex (human)
Grifols Biologicals Inc.
Alphanate? Antihemophilic Factor/von Willebrand Factor Complex (Human), is indicated for the control and prevention of bleeding in patients with Factor VIII (FVIII) deficiency due to hemophilia A.1
1.2 von Willebrand Disease
Alphanate is indicated for surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP?) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery.
DESCRIPTION
Alphanate is sterile, lyophilized concentrate of FVIII (AHF) and von Willebrand Factor (VWF).
Alphanate is prepared from pooled human plasma by cryoprecipitation of FVIII, fractional solubilization, and further purification employing heparin-coupled, cross-linked agarose which has an affinity to the heparin binding domain of VWF/FVIII:C complex.20 The product is treated with mixture of tri-n-butyl phosphate (TNBP) and polysorbate 80 to inactivate enveloped viruses. The product is also subjected to an 80 ?C heat treatment step for 72 hours to inactivate enveloped and non-enveloped viruses. However, no procedure has been shown to be totally effective in removing viral infectivity from coagulation factor products.

2 DOSAGE AND ADMINISTRATION
For Intravenous Use Only
Antihemophilic Factor (AHF) potency (FVIII:C activity) is expressed in International Units (IU) FVIII/vial on the product label. Additionally, Alphanate contains von Willebrand Factor:Ristocetin Cofactor (VWF:RCo), which is expressed in IU VWF:RCo/vial for the treatment of VWD
Administration
Instruction for Use:
Alphanate is for intravenous use only after reconstitution. Use plastic disposable syringes. Do not refrigerate after reconstitution. Reconstituted Alphanate may be stored at room temperature (not to exceed 30 ?C) prior to administration, but administer intravenously within three hours.
Discard any unused contents into the appropriate safety container.
Do not administer Alphanate at rate exceeding 10 mL/minute.
3 DOSAGE FORMS AND STRENGTHS
Alphanate is sterile, lyophilized powder for intravenous injection after reconstitution. It is available in the following potencies:
250 IU FVIII/5 mL single dose vial
500 IU FVIII/5 mL single dose vial
1000 IU FVIII/10 mL single dose vial1500 IU FVIII/10 mL single dose vial
4 CONTRAINDICATIONS
Alphanate is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.
5 WARNINGS AND PRECAUTIONS
5.1 Anaphylaxis and Severe Hypersensitivity Reactions
Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with Alphanate should be discontinued, and emergency treatment should be administered.
Pregnancy
Pregnancy Category C.

Rx Item-Alphanate 250 (100) Vial By ASD
NDC No.68516-4601-01 UPC/GTIN No. MPN No. 43980 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Physical Thera

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ANTIHEMOPHILIC FACTOR/VWF
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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