Recombinate

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Octocog alfa 1000 [iU]

Disponible desde:

Takeda New Zealand Limited

Designación común internacional (DCI):

Octocog alfa 1000 IU

Dosis:

1000 IU

formulario farmacéutico:

Injection with diluent

Composición:

Active: Octocog alfa 1000 [iU] Excipient: Albumin Calcium chloride dihydrate Histidine Hydrochloric acid Macrogol 3350 Sodium chloride Sodium hydroxide Water for injection

Unidades en paquete:

Combination pack, 1 x ( powder + diluent, ex-Baxter), 1000 IU

clase:

General sale

tipo de receta:

General sale

Fabricado por:

Baxalta U.S. Inc

indicaciones terapéuticas:

in haemophilia A (classical haemophilia) for the prevention and control of haemorrhagic episodes. · in the perioperative management of patients with haemophilia A (classical haemophilia).

Resumen del producto:

Package - Contents - Shelf Life: Combination pack, 1 x ( powder + diluent, ex-Baxter) - 1000 IU - 36 months from date of manufacture stored at or below 25°C. expiry date is earliest for 2 components 3 hours reconstituted stored at or below 25°C - Combination pack, 1 x ( powder + diluent, ex-Ben Venue) - 1000 IU - 24 months from date of manufacture stored at or below 25°C. expiry is earliest of 2 components 3 hours reconstituted stored at or below 25°C - Vial, glass, single dose, 1 x 10 ml, ex-Baxter - 10 mL - 48 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, 1 x 10 ml, ex-Ben Venue - 10 mL - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, 1 x 1000IU - 1000 IU - 36 months from date of manufacture stored at or below 30°C

Fecha de autorización:

1993-03-05

Ficha técnica

NEW ZEALAND DATA SHEET
RECOMBINATE Data Sheet 18 October 2017
Page 1 of 10
Shire New Zealand Ltd
1 RECOMBINATE (injection with diluent)
RECOMBINATE is available in the following strengths:
250IU
500IU
1000IU.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Octocog alfa [rAHF, Factor VIII (rch)].
_Biological origin of active substance _
The active ingredient in RECOMBINATE, octocog alfa [Antihaemophilic
Factor (Recombinant)], is a
glycoprotein synthesized using genetically engineered Chinese Hamster
Ovary Cells (CHO). The CHO
cells secrete recombinant Factor VIII (rFVIII) into a cell culture
medium, which is then purified by a
series of chromatography columns. The rFVIII is selectively isolated
in a purification matrix prepared
by immobilisation of a monoclonal antibody directed to Factor VIII.
The rFVIII produced has the same
biological effects as natural human Factor VIII. Recombinant von
Willebrand Factor (rVWF) is co‐
expressed with the rFVIII and helps to stabilize it.
RECOMBINATE is available in single dose vials containing 250, 500 and
1000IU (International Units)
octocog alfa, nominally per vial. When RECOMBINATE (dry factor
concentrate) is reconstituted with
the appropriate volume of diluent (10mL Sterile Water for Injection,
USP) prior to administration;
each vial contains 250IU/10mL, 500IU/10mL and 1000IU/10mL octocog alfa
respectively.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Injection with diluent.
RECOMBINATE is a sterile, non‐pyrogenic, off‐white to faint yellow
lyophilised powder preparation of
concentrated recombinant factor VIII (rAHF) for intravenous injection.
The reconstituted solution is colourless to faint yellow in
appearance, and substantially free from
foreign particles.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is
indicated in haemophilia A
(classical haemophilia) for the prevention and control of haemorrhagic
episodes. RECOMBINATE is
also indicated in the perioperative