PREGNYL 1500IU powder for injection with diluent

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

human chorionic gonadotrophin

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

Authorization status:

Registered

Patient Information leaflet

PREGNYL
®
_Human chorionic gonadotrophin (hCG)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pregnyl.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Pregnyl
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION WITH YOUR
MEDICINE.
You may wish to read it again.
WHAT PREGNYL IS USED
FOR
Pregnyl belongs to a group of
hormones known as gonadotrophins
which play an important part in
human fertility and reproduction. It
only works if it is injected.
FEMALES:
Pregnyl is used with other medicines
to ripen an egg cell in the ovaries and
to release the egg (ovulation).
MALES:
Pregnyl is used to increase sperm
count. It is also used in young boys
with un-descended testicles.
Your doctor may have prescribed
Pregnyl for another reason.
Pregnyl is not addictive.
A doctor's prescription is required to
obtain this medicine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU USE
PREGNYL
THE ACTIVE INGREDIENT OF THIS
PREPARATION IS EXTRACTED OF HUMAN
URINE. THEREFORE THE RISK OF A
TRANSMISSION OF A PATHOGEN (KNOWN
OR UNKNOWN) CANNOT BE COMPLETELY
EXCLUDED.
_WHEN YOU MUST NOT USE IT_
DO NOT USE PREGNYL IF:
•
you are allergic (hypersensitive)
to human gonadotrophins or any
of the ingredients listed at the end
of the leaflet.
•
you have a known or suspected
cancer or tumour of the ovary,
breast , uterus in the female and
prostate or breast carcinoma in
the male.
•
you have malformations of the
reproductive organs which make
a normal pregnancy not possible
•
you have fibroids in the uterus
which make a normal pregnancy
not possible
•
you have heavy or irregular
vaginal bleeding, other than
menstrual bleeding, without a
diagnosed cause.
DO NOT USE PREGN

Summary of Product characteristics

PREGNYL PI A170424 v6 AMP
1
PRODUCT INFORMATION
NAME OF THE MEDICINE
PREGNYL
®
(HUMAN CHORIONIC GONADOTROPHIN)
DESCRIPTION AND PHARMACOLOGY
Pregnyl is a preparation of human chorionic gonadotrophin (hCG)
obtained from the
urine of pregnant women. It stimulates steroidogenesis in the gonads
by virtue of a
biologic effect similar to that of LH (luteinising hormone, which is
the same as
interstitial cell stimulating hormone). In the male it promotes the
production of
testosterone and in the female the production of estrogens and
particularly of
progesterone
after
ovulation.
In
certain
cases,
this
preparation
is
used
in
combination
with
a
follicle
stimulating
hormone
(FSH)
containing
preparation.
Because hCG is of human origin, no antibody formation is to be
expected.
INDICATIONS
IN THE FEMALE:

Sterility due to the absence of follicle-ripening or ovulation.
IN THE MALE:

Hypogonadotrophic hypogonadism.

Delayed puberty associated with insufficient gonadotrophic pituitary
function.

Cryptorchism, not due to an anatomic obstruction.

Sterility, in selected cases of deficient spermatogenesis.
CONTRAINDICATIONS

Hypersensitivity to human gonadotrophins or any of the ingredients in
Pregnyl
(see PRECAUTIONS).

Known or suspected sex hormone-dependent tumours, such as ovary,
breast
and
uterine
carcinoma
in
female
and
prostatic
carcinoma
or
mammary
carcinoma in the male.

Malformations of the reproductive organs incompatible with pregnancy.

Fibroid tumours of the uterus incompatible with pregnancy.

Abnormal (not menstrual) vaginal bleeding without a known/diagnosed
cause.
PRECAUTIONS
The active ingredient of this preparation is extracted from human
urine. Therefore
the risk of a transmission of a pathogen (known or unknown) cannot be
completely
excluded.
PREGNYL PI A170424 v6
2
FOR MALES AND FEMALES:
_ _
Hypersensitivity reactions:

Hypersensitivity reactions, both generalised and local; anaphylaxis;
and
angioedema have been reported. If a hypersensitivity reaction is
suspected,
discontin