Consumer medicine information

Pregnyl Vial

Chorionic gonadotrophin, human

BRAND INFORMATION

Brand name

Pregnyl Vial

Active ingredient

Chorionic gonadotrophin, human

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Pregnyl Vial.

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.

In females:
Pregnyl is used with other medicines to ripen an egg cell in the ovaries and to release the egg (ovulation).

In 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 mail
  • 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 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:

For men and women:

  • Uncontrolled pituitary gland or hypothalamic problems
  • An underactive thyroid gland (hypothyroidism)
  • Adrenal glands that are not working properly (adrenocortical insufficiency)
  • High prolactin levels in the blood (hyperprolactinemia)
  • Any other medical conditions (for example, diabetes, heart disease, or any other long-term disease).

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.

Allergic reactions

Allergic reactions, both generalised and local, including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (angioedema and anaphylaxis) have been reported. If you have an allergic reaction, stop taking Pregnyl and seek immediate medical assistance (see also Side Effects).

Misuse for weight control

Pregnyl should not be used for body weight reduction. HCG has no effect on fat metabolism, fat distribution or appetite.

If you are a woman:

Chance of having ovarian hyperstimulation syndrome (OHSS)

Treatment with gonadotrophic hormones like Pregnyl may cause ovarian hyperstimulation syndrome (OHSS). This is a serious medical condition where the ovaries are overly stimulated and the growing follicles become larger than normal. In rare cases, severe OHSS may be life-threatening. Therefore, close supervision by your doctor is very important. To check the effects of treatment, your doctor will do ultrasound scans of your ovaries. Your doctor may also check blood hormone levels. (See Side Effects).

OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to form. Call your doctor right away if you have:

  • severe abdominal swelling and pain in the stomach area (abdomen)
  • feeling sick (nausea)
  • vomiting
  • sudden weight gain due to fluid build up
  • diarrhoea
  • decreased urine output
  • trouble breathing

Ovarian torsion
Ovarian torsion is the twisting of an ovary. Twisting of the ovary could cause the blood flow to the ovary to be cut off.

Before you start to use this medicine, it is important to inform your doctor if you:

  • have ever had ovarian hyperstimulation syndrome OHSS
  • are pregnant or think you may be pregnant
  • have ever had stomach (abdominal) surgery
  • have ever had a twisting of an ovary
  • have past or current cysts in your ovary or ovaries.

Chance of having multiple births or birth defects
In pregnancies occurring after treatment with gonadotrophic preparations, there is an increased risk of having twins or multiple pregnancies. Multiple pregnancies carry an increased health risk for both the mother and her babies during pregnancy and around the time of birth.

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.

Chance of having pregnancy complications
In women undergoing fertility treatment there is a slightly increased risk of a pregnancy outside of the uterus (an ectopic pregnancy). Therefore, your doctor should perform an early ultrasound examination to exclude the possibility of pregnancy outside the uterus.

Miscarriage
In women undergoing fertility treatment there may be a slightly higher risk of miscarriage.

Chance of having a blood clot (thrombosis)
Treatment with Pregnyl (like pregnancy itself) may increase the risk of the formation of a blood clot in a blood vessel (thrombosis), most often in the veins of the legs or the lungs.

Blood clots can lead to serious medical conditions, such as:

  • blockage in your lungs (pulmonary embolus)
  • stroke
  • heart attack
  • blood vessel problems (thrombophlebitis)
  • reduced blood flow to the vital organs that may result in organ damage
  • reduced blood flow to your arm or leg that may result in a loss of your arm or leg.

Tell your doctor, before starting treatment, especially if:

  • you already know that you have an increased risk of blood clots
  • you, or anyone in your immediate family, have ever had a blood clot
  • you are severely overweight

If you are a man:

Antibody formation
If the treatment with Pregnyl is not working, consult your doctor who may perform additional tests.

Treatment with Pregnyl (hCG) can cause the body to produce substances that act against hCG (antibodies to hCG). In rare cases this could result in ineffective treatment.

Androgen production
Treatment with hCG lead to increased androgen (male sexual hormone) production. Therefore extra supervision by your doctor is necessary

  • in the treatment of boys who have not reached puberty. This is because Pregnyl can cause early sexual development and delay growth.
  • if you have or have ever had:
    - heart or blood vessel disease
    - kidney disease
    - epilepsy
    - migraine headaches
    because worsening or recurrence may occasionally be induced as a result of increased production of androgens (male sexual hormones).

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.

For up to ten days after administration, Pregnyl may result in a false positive pregnancy test.

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.

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

  • You have pain in the stomach (abdomen) or any of the other symptoms of ovarian hyperstimulation, even if they occur some days after the administration of Pregnyl has been given.
  • A possible complication of treatment with gonadotrophic hormones like Pregnyl is unwanted overstimulation of the ovaries. The chance of this complication can be reduced by carefully monitoring the number of maturing follicles (small round sacs in your ovaries that contain the eggs). Your doctor will do ultrasound scans of your ovaries to carefully monitor the number of maturing follicles. Your doctor may also check blood hormone levels. The first symptoms of ovarian overstimulation may be noticed as pain in the stomach (abdomen), feeling sick or diarrhoea. Ovarian overstimulation may develop into a medical condition call ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem. In more severe cases this may lead to enlargement of the ovaries, collection of fluid in the abdomen and/or chest (which may cause sudden weight gain due to fluid build-up) or clots in the blood vessels.
  • 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.
  • In men, fluid may be retained in the tissues, usually marked by swelling of ankles or feet, and occasionally enlargement of the breast may occur. This can be caused by an increased androgen production by treatment with hCG.

Tell your doctor if you notice any of the following and they worry you:

  • Injection site bruising, pain, redness, swelling and itching
  • Skin rash and fever
  • Breast tenderness or swelling in women

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 in the dark at 2°C to 8°C (Refrigerate. Do not freeze). Protect from light.

The solution should be used immediately after reconstitution.

Do not use Pregnyl if you notice that the reconstituted solution contains particles or if the solution is not clear.

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 vials with 1500 or 5000 IU of human chorionic gonadotrophin as a dry white powder.

The pack also contains a corresponding number of clear glass vials of clear colourless liquid (solvent) which is used to dissolve the white powder.

Do not use this medicine if the glass vials 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
  • Monobasic sodium phosphate dihydrate
  • Dibasic sodium phosphate dihydrate
  • 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 prepared 30 June 2020

Australian Registration Numbers:

Pregnyl 1500 IU: AUST R 273873

Pregnyl 5000 IU: AUST R 273874

Published by MIMS August 2020

BRAND INFORMATION

Brand name

Pregnyl Vial

Active ingredient

Chorionic gonadotrophin, human

Schedule

S4

 

1 Name of Medicine

Human chorionic gonadotrophin.

2 Qualitative and Quantitative Composition

Pregnyl is a preparation of human chorionic gonadotrophin (hCG) obtained from the urine of pregnant women.
Each vial of Pregnyl powder for injection contains 1500 IU or 5000 IU human chorionic gonadotrophin.
Each mL of the reconstituted Pregnyl 1500 IU solution contains 1500 IU of human chorionic gonadotrophin (hCG).
Each mL of the reconstituted Pregnyl 5000 IU solution contains 5000 IU of human chorionic gonadotrophin (hCG).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection.

Powder for injection.

White to almost white amorphous powder.

Diluent.

Clear colourless aqueous solution.

4 Clinical Particulars

4.1 Therapeutic 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.

4.2 Dose and Method of Administration

Dosage.

In the female. Sterility due to the absence of follicle-ripening or ovulation: usually, 5000-10000 IU to complete treatment with a FSH containing preparation. A repeat injection of 5000 IU may be given 7 days later (or in accordance with individual patient needs) to prevent insufficiency of the corpus luteum.
In the male.

Hypogonadotrophic hypogonadism.

500-1000 IU 2-3 times per week.

Delayed puberty associated with insufficient gonadotrophic pituitary function.

1500 IU twice weekly for at least 6 months.

Cryptorchism, not due to an anatomic obstruction.

Under 6 years of age: 500 IU twice weekly for 6 weeks.
Over 6 years of age: 1000 IU twice weekly for 6 weeks.
If necessary, this treatment can be repeated.

Sterility in selected cases of deficient spermatogenesis.

Usually, 3000 IU per week in combination with a FSH containing preparation.

Method of administration.

Reconstitution.

Do not use if the solution contains particles or if the solution is not clear.
After addition of the solvent to the freeze-dried substance, the reconstituted Pregnyl solution should be administered intramuscularly. The solution should be used immediately after reconstitution.

4.3 Contraindications

Hypersensitivity to human gonadotrophins or any of the ingredients in Pregnyl (see Section 4.4 Special Warnings and Precautions for Use).
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.

4.4 Special Warnings and Precautions for Use

The active ingredient of this preparation is extracted from human urine. Therefore the risk of a transmission of a pathogen (known or unknown) can not be completely excluded.

For males and females.

Hypersensitivity reactions.

Hypersensitivity reactions, both generalised and local; anaphylaxis; and angioedema have been reported. If a hypersensitivity reaction is suspected, discontinue Pregnyl and assess for other potential causes for the event. (See Section 4.3 Contraindications).

General.

Patients should be evaluated for uncontrolled non-gonadal endocrinopathies (e.g. thyroid, adrenal or pituitary disorders) and appropriate specific treatment given.
Pregnyl should not be used for body weight reduction. HCG has no effect on fat metabolism, fat distribution or appetite.

In the female.

Multi-foetal gestation and birth.

In pregnancies occurring after induction of ovulation with gonadotrophic preparations, there is an increased risk of multiple pregnancies.

Ectopic pregnancy.

Infertile women undergoing Assisted Reproductive Technologies (ART) have an increased incidence of ectopic pregnancy. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.

Pregnancy loss.

Rates of pregnancy loss in women undergoing ART are higher than in normal population.

Congenital malformations.

The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g. maternal age, sperm characteristics) and to the higher incidence of multiple gestations after ART. There are no indications that the use of gonadotrophins during ART is associated with an increased risk of congenital malformations.

Ovarian hyperstimulation syndrome (OHSS).

OHSS is a medical event distinct from uncomplicated ovarian enlargement. Clinical signs and symptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhoea, mild to moderate enlargement of ovaries and ovarian cysts. Severe OHSS may be life-threatening. Clinical signs and symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, hydrothorax, dyspnoea, oliguria, haematological abnormalities and weight gain. In rare instances, venous or arterial thromboembolism may occur in association with OHSS. Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy have also been reported in association with OHSS.
Adherence to the recommended Pregnyl dose and treatment regimen is advised. Care should be taken with the administration of Pregnyl because OHSS may be triggered by administration of human Chorionic Gonadotrophin (hCG). OHSS may also be triggered by pregnancy (endogenous hCG). Early OHSS usually occurs within 10 days after hCG administration and may be associated with an excessive ovarian response to gonadotrophin stimulation. Late OHSS occurs more than 10 days after hCG administration, as a consequence of the hormonal changes with pregnancy. Because of the risk of developing OHSS, patients should be monitored for at least two weeks after hCG administration.
Women with known risk factors for a high ovarian response may be especially prone to the development of OHSS during or following treatment with Pregnyl. For women having their first cycle of ovarian stimulation, for whom risk factors are only partially known, close observation for early signs and symptoms of OHSS is recommended.
Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive Technology (ART). Careful monitoring of ovarian response is important to reduce the risk of OHSS. To monitor the risk of OHSS, ultrasonographic assessments of follicular development should be performed prior to treatment and at regular intervals during treatment; the concurrent determination of serum estradiol levels may also be useful. In ART, there is an increased risk of OHSS with 18 or more follicles of 11 mm or more in diameter. For patients at increased risk of OHSS or if OHSS develops, standard and appropriate management of OHSS should be implemented and followed.

Ovarian torsion.

Ovarian torsion has been reported after treatment with gonadotrophins, including Pregnyl. Ovarian torsion may be related to other conditions, such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, and previous or current ovarian cysts. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.

Vascular complications.

Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotrophins, including Pregnyl. Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities. Women with generally recognised risk factors for thrombosis, such as a personal or family history, severe obesity or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotrophins. In these women the benefits of IVF treatment need to be weighed against the risks. It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis.

In the male.

Antibody formation.

Administration of hCG can provoke the formation of antibodies against hCG. In rare cases, this may result in an ineffective treatment.

Treatment with hCG leads to increased androgen production.

Therefore, hCG should be used cautiously in prepubertal boys to avoid premature epiphysial closure or precocious sexual development. Skeletal maturation should be monitored regularly.
Patients with latent or overt cardiac failure, hypertension, epilepsy or migraine (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced as a result of increased androgen production.

Use in renal impairment.

In the male: patients with renal dysfunction (or a history of this condition) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced as a result of increased androgen production.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.2 Dose and Method of Administration, In the male.

Effects on laboratory tests.

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Interactions of Pregnyl with other medicines have not been investigated; interactions with commonly used medicinal products can therefore not be excluded.
Following administration, Pregnyl may interfere for up to 10 days with the immunological determination of serum/urinary hCG, leading to a false positive pregnancy test.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

See Section 4.1 Therapeutic Indications.
(Category A)
Pregnyl may be used for luteal phase support, but should not be used later on in pregnancy.
 Pregnyl must not be used during lactation.

4.7 Effects on Ability to Drive and Use Machines

As far as is known this medicine has no influence on alertness and concentration.

4.8 Adverse Effects (Undesirable Effects)

Immune system disorders.

In rare cases generalised rash or fever may occur.

General disorders and administrative site conditions.

Pregnyl may cause reactions at the site of injection, such as bruising, pain, redness, swelling and itching. Occasionally allergic reactions have been reported, mostly manifesting as pain and/or rash at the injection site.

In the female.

Vascular disorders.

In rare instances, thromboembolism has been associated with FSH/hCG therapy, usually associated with severe OHSS (see Section 4.4 Special Warnings and Precautions for Use).

Respiratory, thoracic and mediastinal disorders.

Hydrothorax, as a complication of severe OHSS.

Gastrointestinal disorders.

Abdominal pain and gastrointestinal symptoms such as nausea and diarrhoea, related to mild OHSS. Ascites, as a complication of severe OHSS.

Reproductive system and breast disorders.

Unwanted ovarian hyperstimulation, mild or severe ovarian hyperstimulation syndrome (OHSS) (see Section 4.4 Special Warnings and Precautions for Use).
Painful breasts, mild to moderate enlargement of ovaries and ovarian cysts related to mild OHSS. Large ovarian cysts (prone to rupture), usually associated with severe OHSS.

Investigations.

Weight gain as a characteristic of severe OHSS.

In the male.

Metabolism and nutrition disorders.

Water and sodium retention is occasionally seen after administration of high dosages; this is regarded as a result of excessive androgen production.

Reproductive system and breast disorders.

hCG treatment may sporadically cause gynaecomastia.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

The acute toxicity of urinary gonadotrophin preparations has been shown to be very low. Nevertheless there is a possibility that too high a dosage of hCG may lead to ovarian hyperstimulation syndrome (OHSS) (see Section 4.4 Special Warnings and Precautions for Use).
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Human chorionic gonadotrophin (hCG) 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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption and distribution.

Maximal hCG plasma levels will be reached in males approximately six and sixteen hours after a single IM or SC injection of hCG respectively, and in females after approximately 20 hours. Although high intersubject variability was observed, the difference related to gender after IM injection may be caused by gluteal fat thickness in women which exceeds that in men.

Metabolism.

HCG is approximately 80% metabolised, predominantly in the kidneys.

Excretion.

IM and SC administration of hCG were found to be bioequivalent regarding the extent of absorption and the apparent elimination half-lives of approximately 33 hours. On basis of the recommended dose regimens and elimination half-life, cumulation is not expected to occur.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Powder for injection.

Carmellose sodium, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dihydrate, and mannitol.

Diluent.

Sodium chloride (9 mg) and Water for Injections (1 mL).

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
The contents of the vial should be used immediately after reconstitution.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. (Refrigerate. Do not freeze). Protect from light.
Store in the original package.

6.5 Nature and Contents of Container

Both Pregnyl powder for injection and the diluent are available in glass (Type 1 clear) vials.

Pack sizes.

Pregnyl 1500 IU: 3 vials of powder for injection and 3 vials of diluent.
Pregnyl 5000 IU: 1 vial of powder for injection and 1 vial of diluent; 3 vials of powder for injection and 3 vials of diluent*.
*Pack size not currently marketed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

CAS number.

9002-61-3.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes