HELIXATE FS- antihemophilic factor, recombinant

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (UNII: P89DR4NY54) (Antihemophilic Factor, Human Recombinant - UNII:P89DR4NY54)

Dostopno od:

CSL Behring LLC

INN (mednarodno ime):

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT

Sestava:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 250 [iU] in 2.5 mL

Terapevtske indikacije:

Helixate® FS is a recombinant antihemophilic factor indicated for: Helixate FS is not indicated for the treatment of von Willebrand disease. Helixate FS is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). Pregnancy Category C Animal reproduction studies have not been conducted with Helixate FS. It is also not known whether Helixate FS can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Helixate FS should be given to a pregnant woman only if clearly needed. There is no information available on the effect of factor VIII replacement therapy on labor and delivery. Helixate FS should be used only if clinically needed. It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, caution sho

Povzetek izdelek:

How Supplied Helixate FS is available as a kit in the following single-use glass vial sizes. A suitable volume of Sterile Water for Injection, USP and Mix2Vial® filter transfer device are provided in the kit. 0053-8131-02 250 2.5 0053-8132-02 500 2.5 0053-8133-02 1000 2.5 0053-8134-02 2000 5.0 0053-8135-02 3000 5.0 Actual factor VIII activity in IU is stated on the label of each Helixate FS vial. Use the actual potency as indicated on the vial label to calculate the dose. Storage and Handling The product vial and diluent vial are not made with natural rubber latex. Product as Packaged for Sale Product After Reconstitution

Status dovoljenje:

Biologic Licensing Application

Lastnosti izdelka

HELIXATE FS- ANTIHEMOPHILIC FACTOR, RECOMBINANT
CSL BEHRING LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HELIXATE FS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR HELIXATE FS.
HELIXATE FS
[ANTIHEMOPHILIC FACTOR (RECOMBINANT), FORMULATED WITH SUCROSE]
FOR INTRAVENOUS USE, LYOPHILIZED POWDER FOR RECONSTITUTION
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Helixate FS is an Antihemophilic Factor (Recombinant) indicated for:
(1)
•
•
•
•
Helixate FS is not indicated for the treatment of von Willebrand
disease. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY.
Each vial of Helixate FS contains the labeled amount of recombinant
factor VIII in international units (IU, unit).
CONTROL OF BLEEDING EPISODES AND PERIOPERATIVE MANAGEMENT (2.1):
•
•
•
FOR ROUTINE PROPHYLAXIS IN ADULTS: 25 units per kg three times a week
(2.1).
FOR ROUTINE PROPHYLAXIS IN CHILDREN: 25 units per kg every other day
(2.1).
DOSAGE FORMS AND STRENGTHS
Available as lyophilized powder in single use vials containing
nominally 250, 500, 1000, 2000, and 3000 IU (3).
CONTRAINDICATIONS
Do not use in patients who have life-threatening hypersensitivity
reactions, including anaphylaxis to mouse or hamster
protein or other constituents of the product (4).
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (≥4%) in clinical trials are
inhibitor formation (neutralizing antibodies) in previously
untreated and minimally treated patients (PUPs and MTPs),
skin-associated hypersensitivity reactions (e.g., rash, pruritus,
urticaria), infusion site reactions (e.g., inflammation, pain), and
central venous access device (CVAD) associated infections.
(6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CSL BEHRING
PHARMACOVIGILANCE DEPARTMENT AT 1-866-
915-6958 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
USE IN SPECIFIC POPULATIONS
On-demand treatment and control of bleeding episodes in adults and
children with