PREGNYL 5000 I.U., powder and solvent for solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chorionic gonadotrophin

Available from:

NV Organon

ATC code:

G03GA; G03GA01

INN (International Name):

Chorionic gonadotrophin

Dosage:

5000 international unit(s)

Pharmaceutical form:

Powder and solvent for solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Gonadotropins; chorionic gonadotrophin

Authorization status:

Not marketed

Authorization date:

1979-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGNYL® 5000 IU, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
human chorionic gonadotropin (hCG)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their signs
of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1. WHAT PREGNYL IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PREGNYL
3.
HOW TO USE PREGNYL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PREGNYL
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT PREGNYL IS AND WHAT IT IS USED FOR
Pregnyl belongs to a group of medicines called gonadotropins (sex
hormones). It controls the release of eggs
from the ovary in women, and controls production of the male hormone,
testosterone in men.
WOMEN
In female infertility it can be used to cause women to ovulate
(OVULATION INDUCTION). Pregnyl is also used along
with other fertility drugs, to help produce eggs in medically assisted
reproduction programmes (IVF TREATMENT).
MEN
In men it is used to help treat DELAYED PUBERTY, UNDESCENDED TESTES or
oligospermia (LOW SPERM COUNT).
ASK YOUR DOCTOR if you are unsure why you have been given Pregnyl.
2. 2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PREGNYL
DO NOT USE PREGNYL:

If you are ALLERGIC to Human Chorionic Gonadotropin (HCG) or any of
the other ingredients of this
medicine (listed in section 6).

have CANCER (especially a hormone-dependent cancer of the breast,
ovaries, womb or the testes) or uterus in
the female and prostate tumor in males.

suffer from MALFORMATIONS OF THE REPRODUCTIVE ORGANS incompatible with
pregnancy

suffer from FIBROIDS IN THE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PREGNYL 5000 I.U., powder and solvent for solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregnyl consists of a freeze-dried powder for injection and a solvent
for reconstitution. The active ingredient [human
chorionic gonadotropin (hCG)] which is obtained from the urine of
pregnant women, has luteinising hormone (LH)
activity.
An ampoule contains 5,000 IU hCG
The reconstituted solution contains 5000 IU hCG per mL.
Excipient with known effect: sodium. This medicinal product contains
less than 1 mmol sodium (23 mg) per daily
dose, i.e. essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is a white, dry powder or cake. The solvent is a clear and
colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the female:
o
Ovulation induction in subfertility due to anovulation or impaired
follicle-ripening.
o
Preparation of follicles for puncture in controlled ovarian
hyperstimulation programs (for medically assisted
reproductive techniques).
o
Luteal phase support.
In the male:
o
Hypogonadotropic hypogonadism (also cases of idiopathic dysspermias
have shown a positive response to
gonadotropins).
o
Delayed puberty associated with insufficient gonadotropic pituitary
function.
o
Cryptorchidism, not due to anatomical obstruction.
o
Preoperative preparation of ectopic testes
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
Dosage in females:
o
Ovulation induction in subfertility due to anovulation or impaired
follicle-ripening
Usually, one injection of 5 000-10 000 IU Pregnyl to complete
treatment with an FSH-containing preparation.
o
Preparation of follicles for puncture in controlled ovarian
hyperstimulation programs
Usually, one injection of 5 000-10 000 IU Pregnyl to complete
treatment with an FSH-containing preparation.
o
Luteal phase support
Two to three repeat injections of 1000 to 3000 IU each may be g