Alprolix

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Eftrenonacog alfa 500 [iU];  

Saadav alates:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Rahvusvaheline Nimetus):

Eftrenonacog alfa 500 IU

Annus:

500 IU

Ravimvorm:

Powder for infusion

Koostis:

Active: Eftrenonacog alfa 500 [iU]   Excipient: Histidine Mannitol Polysorbate 20 Sucrose Sodium chloride Water for injection

Retsepti tüüp:

General sale

Valmistatud:

Biogen Inc

Näidustused:

ALPROLIX is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia B (congenital factor IX deficiency) for: - Control and prevention of bleeding episodes - Routine prophylaxis to prevent or reduce the frequency of bleeding episodes - Perioperative management (surgical prophylaxis)

Toote kokkuvõte:

Package - Contents - Shelf Life: Combination pack, vial + syringe + plunger rod + vial adaptor, with or without ancillary pack (infusion set etc) - 1 dose units - 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 6 hours reconstituted stored at or below 30°C - Syringe, glass, Diluent - 1 dose units -   - Vial, glass, single dose, Active, Type 1 glass with teflon coated butyl rubber stopper - 1 dose units -  

Loa andmise kuupäev:

2014-11-10

Infovoldik

ALPROLIX®
1
ALPROLIX®
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 ALPROLIX?
ALPROLIX contains the active ingredient eftrenonacog alfa (recombinant
coagulation factor IX fusion protein). ALPROLIX is used
for the management of haemophilia B (congenital factor IX deficiency).
For more information, see Section
1. Why am I using
ALPROLIX? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ALPROLIX?
Do not use if you have ever had an allergic reaction to ALPROLIX or
other factor IX 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, USE 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 ALPROLIX?
in the full CMI.
3.
WHAT IF I AM TAKING 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 other medicines? in the full CMI.
4.
HOW DO I USE ALPROLIX?
•
Your doctor will decide how much ALPROLIX you use. This will depend on
your individual need for replacement factor IX
therapy. Your doctor may change the dose you use during your
treatment.
•
ALPROLIX is given by slow injection directly into your veins.
•
ALPROLIX comes in a vial of sterile powder to cake and a pre-filled
syringe containing solvent, also known as diluent. These
need to be mixed before use. More instructions can be found in Section
4. How do I use ALPROLIX? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ALPROLIX?
THINGS YOU
SHOULD DO
•
Tell your doctor immediately if bleeding is not controlled after using
ALPROLIX.
•
If you become pregnant while on treatment with ALPROLIX, immediately
tell your

Toote omadused

alp-ccdsv14-dsv9-20jun22
Page 1 of 31
NEW ZEALAND DATA SHEET
1 ALPROLIX (POWDER FOR INFUSION)
ALPROLIX 250 International Units (IU), Powder for infusion
ALPROLIX 500 IU, Powder for infusion
ALPROLIX 1000 IU, Powder for infusion
ALPROLIX, 2000 IU, Powder for infusion
ALPROLIX, 3000 IU, Powder for infusion
ALPROLIX, 4000 IU, Powder for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alprolix 250 IU: Each single-use vial contains nominally 250 IU of
eftrenonacog alfa
(rhu). After reconstitution, each mL of solution for injection
contains 50 IU of
eftrenonacog alfa (rhu
1
).
Alprolix 500 IU: Each single-use vial contains nominally 500 IU of
eftrenonacog alfa
(rhu). After reconstitution, each mL of solution for injection
contains 100 IU of
eftrenonacog alfa (rhu
1
).
Alprolix 1000 IU: Each single-use vial contains nominally 1000 IU of
eftrenonacog alfa
(rhu). After reconstitution, each mL of solution for injection
contains 200 IU of
eftrenonacog alfa (rhu
1
).
Alprolix 2000 IU: Each single-use vial contains nominally 2000 IU of
eftrenonacog alfa
(rhu). After reconstitution, each mL of solution for injection
contains 400 IU of
eftrenonacog alfa (rhu
1
).
Alprolix 3000 IU: Each single-use vial contains nominally 3000 IU of
eftrenonacog alfa
(rhu). After reconstitution, each mL of solution for injection
contains 600 IU of
eftrenonacog alfa (rhu
1
).
Alprolix 4000 IU: Each single-use vial contains nominally 4000 IU of
eftrenonacog alfa
(rhu). After reconstitution, each mL of solution for injection
contains 800 IU of
eftrenonacog alfa (rhu
1
).
For the full list of excipients, see _Section 6.1 LIST OF EXCIPIENTS_.
3 PHARMACEUTICAL FORM
Powder for infusion
1
rhu: Produced in human embryonic kidney (HEK) 293H cells by
recombinant DNA technology.
alp-ccdsv14-dsv9-20jun22
Page 2 of 31
ALPROLIX is formulated as a sterile, preservative-free, non-pyrogenic,
lyophilised,
white to off-white powder to cake, for intravenous (IV) administration
in a single-use
vial. The liquid diluent is in a pre-filled syringe.
4 CLINICAL PARTICU