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Pregnyl

Human chorionic gonadotrophin (hCG)
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Pregnyl. It does not contain all the information that is known about Pregnyl. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need 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) can not 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 cancer or tumour of the ovary, breast, prostate, hypothalamus, uterus, or pituitary gland
you have malformations of the sexual organs which make a normal pregnancy not possible
you have fibroids in the uterus which make a normal pregnancy not possible
Do not use Pregnyl if you are breast-feeding.
It is not known whether hCG passes into breast milk.
Do not use Pregnyl after the expiry date printed on the pack.
Do not use Pregnyl if the packaging is torn or shows signs of tampering.
If you are not sure whether you should start using this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
a thyroid, adrenal or pituitary gland disorder
an ovarian cyst
cancer or a tumour of the breast, ovary, uterus, prostate, hypothalamus or pituitary gland
polycystic ovarian disease (irregular or no periods, acne, obesity, excess hair growth)
unexplained vaginal bleeding
menopause
premature puberty
high blood pressure
epilepsy
migraine
kidney disease
heart or blood vessel disease
blood clots
If you have any of the conditions listed above, you may not be able to use Pregnyl or you may need a dosage adjustment or special tests during treatment.
Tell your doctor if you have or have had any other medical conditions.
PREGNANCY:
When women become pregnant after treatment with gonadotrophic preparations, there is an increased risk of having twins or triplets and even higher order multiple births. Such pregnancies often have obstetric problems and may deliver very prematurely.
Multiple pregnancies and characteristics of the patients undergoing fertility treatment (e.g age of the female, sperm characteristics) may be associated with an increased risk of congenital abnormalities.
Generally in women undergoing fertility treatment there may be a slightly higher risk of miscarriage. Women with damaged fallopian tubes have a slightly increased risk of the fetus growing outside the womb (ectopic pregnancy).

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Ability to drive or operate machinery

As far as is known, Pregnyl has no effect on alertness or concentration.

How Pregnyl is given

Your doctor will decide the dose of Pregnyl.
Pregnyl will be injected into a muscle.
Females may require only one injection.
Males may receive a series of injections 2 to 3 times a week for several weeks or months.
Keep all doctors' appointments so your therapy can be monitored.

If you are given too much

As your treatment will be closely monitored it is unlikely you will be prescribed too large a dose of Pregnyl. However Pregnyl can be associated with the rare condition called Ovarian Hyperstimulation Syndrome (see Side Effects).

While you are given Pregnyl

Things you must do

Tell your doctor immediately if you think you are pregnant or become pregnant while using this medicine.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Pregnyl.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
Females:
Close supervision of your treatment by a doctor is very important. Usually ultrasound scans of the ovaries are performed, and blood and urine samples are taken regularly. The results of these tests allow the doctor to choose the correct dose. This is very important since too high a dose may lead to the rare but unwanted overstimulation of the ovaries.
Since overstimulation can occur rapidly you must contact your doctor if you experience any of the following: pain in the abdomen or pelvis, nausea, vomiting, weight gain, shortness of breath, reduced amounts of urine, diarrhoea and painful breasts.
Regular monitoring of your response to gonadotrophin treatment helps the doctor to prevent excessive ovarian stimulation.
Males:
In young boys, Pregnyl can cause early puberty. Call your doctor if a boy using this medicine shows early signs of puberty, such as a deepened voice, pubic hair growth and increased acne or sweating.

Things you must not do

Do not use this medicine to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.

Side Effects

Tell your doctor as soon as possible if you do not feel well while you are using Pregnyl.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
Severe Ovarian Hyperstimulation Syndrome (OHHS). Symptoms include severe stomach pain and swelling, nausea or vomiting, diarrhoea, weight gain, shortness of breath or urinating less than normal. This condition is rare.
Signs of an allergic reaction such as 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. These allergic reactions are mostly reported as pain and rash at the injection site.
Signs of a blood clot such as pain, warmth, redness, numbness, or tingling in your arm or leg; confusion, extreme dizziness or severe headache. This condition is rare.
Tell your doctor as soon as possible if you notice any of the following:
Signs of early puberty in young boys, such as a deepened voice, pubic hair growth, and increased acne, or sweating.
Tell your doctor if you notice any of the following and they worry you:
Injection site soreness, bruising and redness
Skin rash or fever
Breast tenderness or swelling in women
Fluid retention e.g. swelling of the ankles or feet
Breast enlargement in men
Tell your doctor if you notice any other side effects.
Other side effects not listed in this leaflet also occur in some people.

After using Pregnyl

Storage

Keep Pregnyl in the original box in a safe place out of reach of children.
Pregnyl must be stored at 2°C to 8°C (Refrigerate. Do not freeze). Protect from light.

Disposal

The product is for use in one patient only because it contains no antimicrobial preservative. Discard any residue.
Do not use Pregnyl after the expiry date stated on the label.
Return any unused medicine to your pharmacist.

Product Description

What it looks like.

The pack contains clear glass ampoules with 1500 or 5000 IU of human chorionic gonadotrophin as a dry white powder.
The pack also contains a corresponding number of clear glass ampoules of clear colourless liquid (solvent) which is used to dissolve the white powder.
Do not use this medicine if the glass ampoules are broken or damaged or if the powder or liquid is discoloured or not clear.

Ingredients

Active ingredient:
Human chorionic gonadotrophin
Powder also contains:
Carmellose sodium
Sodium phosphate monobasic anhydrous
Sodium phosphate dibasic anhydrous
Mannitol
The liquid used to dissolve the powder contains sodium chloride and water for injections.

Supplier

Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A,
26 Talavera Road
Macquarie Park NSW 2113
Australia
This leaflet was updated December 2014.
Australian Registration Numbers:
Pregnyl 1500IU: AUST R 14518
Pregnyl 5000 IU: AUST R 14519