Replagal

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Agalsidase alfa 1 mg/mL (from human cell line);  

Fáanlegur frá:

Takeda New Zealand Limited

INN (Alþjóðlegt nafn):

Agalsidase alfa 1 mg/mL (from human cell line)

Skammtar:

1 mg/mL

Lyfjaform:

Concentrate for infusion

Samsetning:

Active: Agalsidase alfa 1 mg/mL (from human cell line)   Excipient: Monobasic sodium phosphate monohydrate Polysorbate 20 Sodium chloride Sodium hydroxide

Einingar í pakka:

Vial, glass, Type 1, 5 mL

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Shire Human Genetic Therapies Inc

Ábendingar:

REPLAGAL (agalsidase alfa ghu) is indicated for long-term enzyme replacement therapy of patients with Fabry Disease (alpha galactosidase A deficiency).

Vörulýsing:

Package - Contents - Shelf Life: Vial, glass, Type 1 - 5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 hours diluted stored at or below 25°C

Leyfisdagur:

2000-11-09

Vara einkenni

NEW ZEALAND DATA SHEET
REPLAGAL V3 (CCDS V20) 1
1 PRODUCT NAME
REPLAGAL 3.5 mg/3.5 mL concentrate for infusion vial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3.5 mL vial of REPLAGAL contains 3.5 mg of agalsidase alfa ghu.
Agalsidase alfa ghu is a human

‐galactosidase A produced by genetic engineering technology.
Agalsidase alfa ghu is a homodimer comprised of 2 approximately 50,000
dalton subunits, with each
subunit containing 398 amino acid residues. The product is synthesised
by a human cell line and has the
identical amino acid sequence as that of

‐galactosidase A produced in human tissues. REPLAGAL is
now manufactured using a serum‐free bioreactor process.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
REPLAGAL is provided as a sterile, clear and colourless solution
intended for intravenous (IV)
administration. A minute amount of fine particulate matter, causing
the solution to appear slightly hazy,
may be present.
REPLAGAL contains no antimicrobial agent. It is supplied in a
single‐dose vial.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
REPLAGAL (agalsidase alfa ghu) is indicated for long‐term enzyme
replacement therapy of patients with
Fabry Disease (

‐galactosidase A deficiency).
4.2
Dose and method of administration
In adults and children 6.5 years of age and older, REPLAGAL is
administered at a dose of 0.2 mg/kg body
weight every 2 weeks by intravenous infusion over a period of 40
minutes. Therapy with REPLAGAL
should only be initiated or continued by a physician with expertise in
the treatment of Fabry Disease
(see Section 4.4 Special warnings and precautions for use). Infusion
of REPLAGAL at home may be
considered for patients who have been stabilised in a controlled
hospital setting and are tolerating their
infusions well. REPLAGAL is not recommended in children below 6.5
years of age.
Instruction for use/handling
REPLAGAL for patient administration should be prepared by slowly
mixing the appropriate amount of
REPLAGAL int