JIVI damoctocog alfa pegol 1000 IU powder for injection vial with diluent syringe

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

damoctocog alfa pegol, Quantity: 1000 IU

Tilgjengelig fra:

Bayer Australia Ltd

Legemiddelform:

Injection, powder for

Sammensetning:

Excipient Ingredients: polysorbate 80; calcium chloride dihydrate; glycine; sodium chloride; sucrose; histidine

Administreringsrute:

Intravenous

Enheter i pakken:

10 mL Vial

Resept typen:

Not scheduled. Not considered by committee

Indikasjoner:

Jivi, damoctocog alfa pegol, is a long-acting recombinant Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia A for:,? Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? On-demand treatment and control of bleeding episodes,? Per-operative management of bleeding (surgical prophylaxis),Jivi does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand?s disease.

Produkt oppsummering:

Visual Identification: Glass vial containing drug product powder; Container Type: Multiple containers; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

2023-03-27

Informasjon til brukeren

JIVI® CMI V1.0
1
JIVI
®
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.
This medicine is new. Please report side effects. See the full CMI for
further details.
1.
WHY AM I USING JIVI®?
JIVI® contains the active ingredient PEGylated B-domain deleted
recombinant human Factor VIII ( damoctocog alfa pegol),
produced by recombinant DNA technology. JIVI® is used for treatment
and prevention of bleeding in previously treated adults
and adolescents (from 12 years of age) with haemophilia A (congenital
Factor VIII deficiency).
For more information, see Section 1. Why am I using JIVI®?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE JIVI®?
Do not use if you have ever had an allergic reaction to damoctocog
alfa pegol, any other proteins that are of mouse or hamster
origin, 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
JIVI®?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with JIVI® and affect how it works. Tell
your doctor If you are taking any other medicines,
including vitamins or supplements that you buy without 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 JIVI®?
•
The dose of JIVI® is based on the severity of your clinical
condition, your body weight, and the extent of bleeding. Your
doctor or nurse will decide how much to inject.
•
JIVI® will be given directly into your vein (intravenously) under the
supervision of a doctor or a nurse. Once you have been
trained, you should be able to inject this medicine at home, by
yourself or with the help of a caregiver.
More instructions can be f

Preparatomtale

This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.
Jivi PI V1.0; CCDS 2.0
▼
AUSTRALIAN PRODUCT INFORMATION
JIVI
® (DAMOCTOCOG ALFA PEGOL) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Damoctocog alfa pegol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250, 500, 1000, 2000 or 3000 IU pegylated B-domain
deleted recombinant human
coagulation factor VIII (PEG-BDD-rFVIII) (INN: damoctocog alfa pegol),
presented as sterile, stable,
purified dried concentrate.
Each pre-filled syringe contains 2.5 mL of sterile water for
injections for reconstitution.
The active substance, damoctocog alfa pegol, is a site specifically
PEGylated B-domain deleted
recombinant human coagulation factor VIII, produced in baby hamster
kidney cells (BHK), with a 60 kDa
branched polyethylene-glycol (two 30 kDa PEG) moiety. The molecular
weight of the protein is
approximately 234 kDa.
Jivi is produced without the addition of any human or animal derived
protein in the cell culture process,
purification, PEGylation or final formulation.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: solid, white to slightly yellow.
Solvent: clear solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Jivi, damoctocog alfa pegol, is a long-acting recombinant Factor VIII
concentrate indicated for use in
previously treated adults and adolescents (12 years of age and older)
with haemophilia A for:
•
Routine prophylactic treatment to prevent or reduce the frequency of
bleeding episodes
•
On-demand treatment and control of bleeding episodes
•
Per-operative management of bleeding (surgical prophylaxis)
Jivi does not contain von Willebrand factor, and therefore is not
indicated in patients with von
Willebrand’s disease.
4.2
D
OSE AND METHOD OF ADMINIS