GONAL-F follitropin alfa (rch) 450IU /0.75mL (32.76microgram) solution for injection cartridge, pre-assembled in a pen

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

Follitropin alfa, Quantity: 600 IU/mL

Disponível em:

Merck Healthcare Pty Ltd

DCI (Denominação Comum Internacional):

Follitropin alfa

Forma farmacêutica:

Injection, solution

Composição:

Excipient Ingredients: methionine; phosphoric acid; dibasic sodium phosphate dihydrate; sodium hydroxide; poloxamer; sucrose; metacresol; water for injections; monobasic sodium phosphate monohydrate

Via de administração:

Subcutaneous

Unidades em pacote:

1 cartridge & 12 needles

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

The treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated. For controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies. GONAL-f is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

Resumo do produto:

Visual Identification: Clear colourless solution.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Status de autorização:

Registered

Data de autorização:

2003-12-01

Folheto informativo - Bula

GONAL-F
®
_(follitropin alfa [rch]) solution for injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GONAL-f.
It does not contain all the available
information.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using GONAL-f
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS INFORMATION WITH YOUR
MEDICINE.
You may need to read it again later.
WHAT IS GONAL-F USED
FOR
GONAL-f contains follitropin alfa,
which is similar to follicle
stimulating hormone (FSH) found
naturally in humans.
GONAL-f belongs to a class of
hormones called gonadotrophins.
FSH is necessary for the growth and
development of egg cells (follicles)
in women, and sperm production in
men.
IN WOMEN
GONAL-f can be used to bring about
the development of follicles in
women who are not ovulating and
who have not responded to treatment
with clomiphene citrate.
GONAL-f is also used to stimulate
the development of several follicles
in women undergoing assisted
reproductive technologies (ART)
such as in vitro fertilisation (IVF).
IN MEN
GONAL-f is used in combination
with human chorionic gonadotrophin
(hCG) to stimulate the production of
sperm.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY GONAL-F HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
GONAL-f is available only on a
doctor's prescription.
GONAL-f is not habit-forming.
BEFORE YOU ARE GIVEN
GONAL-F
_WHEN YOU MUST NOT USE_
_GONAL-F_
DO NOT USE GONAL-F IF YOU HAVE A
HISTORY OF ALLERGY TO ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT USE GONAL-F IF YOU HAVE
TUMOURS OF TH

Características técnicas

Version: A015-1219 1 Supersedes: A014-0219
AUSTRALIAN PRODUCT INFORMATION – GONAL-F
® (FOLLITROPIN ALFA
(RCH)) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Follitropin alfa (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
GONAL-f is produced by a Chinese Hamster Ovary cell line transfected
with the human FSH
subunit genes (i.e. by recombinant DNA technology). Each cartridge
contains the active
ingredient follitropin alfa (rch) (recombinant human follicle
stimulating hormone) 300 IU/0.5
mL, 450 IU/0.75 mL or 900 IU/1.5 mL.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection in a cartridge pre-assembled in a pen.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
1.
The treatment of anovulatory infertility in women who have been
unresponsive to
clomiphene citrate or where clomiphene citrate is contraindicated.
2.
For controlled ovarian hyperstimulation in women undergoing assisted
reproductive
technologies.
3.
GONAL-f is indicated with concomitant human chorionic gonadotrophin
(hCG) therapy for
the stimulation of spermatogenesis in gonadotrophin-deficient men in
whom hCG alone is
ineffective.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment with GONAL-f should be initiated under the supervision of a
physician experienced
in the treatment of fertility disorders.
GONAL-f should be administered subcutaneously. The injection site
should be alternated daily
to prevent lipoatrophy. Self-administration of GONAL-f should only be
performed by patients
who are well motivated, adequately trained and who have access to
expert advice. Each GONAL-
f pen is for individual patient use only.
WOMEN WITH ANOVULATORY INFERTILITY (WHO GROUP II)
The objective of GONAL-f therapy is to develop a single mature
Graafian follicle from which the
ovum will be liberated after the administration of hCG.
GONAL-f may be given as a course of daily injections. In menstruating
patients, treatment
should commence within the first 7 days of the menstrual cycle.
Treatment should be tailo