ELOCTATE

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Efmoroctocog alfa 2000 [iU];  

Disponible desde:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Designación común internacional (DCI):

Efmoroctocog alfa 2000 IU

Dosis:

2000 IU

formulario farmacéutico:

Powder for infusion

Composición:

Active: Efmoroctocog alfa 2000 [iU]   Excipient: Calcium chloride dihydrate Histidine Polysorbate 20 Sodium chloride Sucrose Water for injection

tipo de receta:

General sale

Fabricado por:

Biogen Inc

indicaciones terapéuticas:

ELOCTATE is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia A (congenital factor VIII deficiency) for: · Control and prevention of bleeding episodes · Routine prophylaxis to prevent or reduce the frequency of bleeding episodes · Perioperative management (surgical prophylaxis). ELOCTATE does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand's disease.

Resumen del producto:

Package - Contents - Shelf Life: Combination pack, 1 vial + 1 syringe + 1 vial adapter, with or without ancillary pack (infusion set etc) - 2000 IU - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 hours reconstituted stored at or below 30°C protect from light 6 months from date of manufacture stored at or below 30°C protect from light. single period, no return to refrigeration - Syringe, glass, diluent - 3 mL - 60 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 months from date of manufacture stored at or below 30°C - Vial, glass, active component - 2000 IU - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 months from date of manufacture stored at or below 30°C protect from light. single period, no return to refrigeration

Fecha de autorización:

2014-12-12

Información para el usuario

ELOCTATE®
1
ELOCTATE
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ELOCTATE?
ELOCTATE contains the active ingredient efmoroctocog alfa.
Efmoroctocog alfa is a factor VIII protein necessary for forming clots
in the blood and helps to control or prevent bleeding. ELOCTATE is
used for the management of haemophilia A (congenital factor
VIII deficiency).
For more information, see Section 1. Why am I using ELOCTATE?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ELOCTATE?
Do not use if you have ever had an allergic reaction to ELOCTATE,
efmoroctocog alfa or other factor VIII replacement factors, or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ELOCTATE?
in the full CMI.
3.
WHAT IF I AM TAKING OR USING OTHER MEDICINES?
Tell your doctor or Haemophilia Treatment Centre if you are taking or
using any other medicines including any that you get
without a prescription from your pharmacy, supermarket, or health food
shop. For more information see Section 3. What if I am
taking or using other medicines? in the full CMI.
4.
HOW DO I USE ELOCTATE?
•
Your doctor will decide what dose you will receive. Do not use more
than the recommended dose.
•
ELOCTATE is administered by slow injection directly into your vein.
•
ELOCATE comes in a vial of sterile powder to cake and a pre-filled
syringe containing solvent. These need to be mixed before
use.
MORE INSTRUCTIONS AND HOW TO USE ELOCTATE CAN BE FOUND IN SECTION 4.
How do I use ELOCTATE? IN THE FULL CMI.
5.
WHAT SHOULD I KNOW WHILE USING ELOCTATE?
THINGS YOU
SHOULD DO
•
Tell your doctor immediately if bleeding is not controlled after using
ELOCTATE.
•
Tell your doctor immediately if you become pregna

Ficha técnica

ELOCTATE New Zealand Data Sheet eloctate-ccdsv12-dsv9-30oct23
Page 1 of 35
NEW ZEALAND DATA SHEET
1 ELOCTATE (POWDER FOR INFUSION)
Eloctate 250 International Units (IU) powder for infusion
Eloctate 500 IU powder for infusion
Eloctate 1000 IU powder for infusion
Eloctate 2000 IU powder for infusion
Eloctate 3000 IU powder for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-use vial contains nominally 250, 500, 1000, 2000, or 3000
International Units (IU) of
efmoroctocog alfa (rhu).
Each pre-filled syringe contains 3 mL of solvent.
Efmoroctocog alfa is produced by recombinant DNA technology in a human
embryonic kidney (HEK) cell
line, which has been extensively characterised. The HEK cell line
expresses efmoroctocog alfa into a
defined cell culture medium that does not contain any proteins derived
from animal or human sources.
The purification process utilises a series of chromatography and
multiple viral clearance steps. The viral
clearance steps include affinity chromatography, 15nm virus-retaining
nano-filtration step, and
detergent viral inactivation. No human or animal derived additives are
used in the purification and
formulation processes.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder for infusion.
ELOCTATE is formulated as a sterile, non-pyrogenic, preservative-free,
lyophilised, white to off-white
powder to cake for intravenous (IV) administration in a single-use
vial.
The liquid diluent, sterilised water for injections (sWFI) is in a
pre-filled syringe.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ELOCTATE is a long-acting antihaemophilic factor (recombinant)
indicated in adults and children with
haemophilia A (congenital factor VIII deficiency) for:
•
Control and prevention of bleeding episodes.
•
Routine prophylaxis to prevent or reduce the frequency of bleeding
episodes.
ELOCTATE New Zealand Data Sheet eloctate-ccdsv12-dsv9-30oct23
Page 2 of 35
•
Perioperative management (surgical prophylaxis).
ELOCTATE does not contain von