1,500 IU and 5,000 IU powder and solvent for solution for injection human
chorionic gonadotropin

What Pregnyl is and what it is used for

Pregnyl contains a hormone called human chorionic gonadotropin ( hCG ) which belongs to a group of medicines called gonadotropins.

hCG has the same effect in the body as luteinizing hormone ( LH ) which is produced in the pituitary gland in both men and women and is needed for the production and maturation of sperm and egg cells and sex hormones.

Pregnyl is used to treat women who have reduced fertility to stimulate ovulation, prepare the follicles for assisted reproduction, and aid in the luteal phase (first 2 weeks after ovulation).

Pregnyl is used to treat men whose:

  • sperm production does not work properly
  • puberty is delayed
  • the testicles (one or both) have not migrated into the scrotum.

What you need to know before using Pregnyl

Do not use Pregnyl

  • if you are allergic to human chorionic gonadotropin or any of the other ingredients of this medicine (listed in section 6).
  • if you have a known or suspected tumor that is dependent on sex hormones. Examples of such tumors are ovarian, breast, or uterine tumors in women and prostate and breast tumors in men.
  • if you have any malformations of the reproductive organs that make it impossible to get pregnant.
  • if you have lumps in the uterus (fibroids ) that make it impossible to get pregnant.


If any of the conditions described above apply to you, tell your doctor before starting treatment with Pregnyl.

Warnings and cautions

Talk to your doctor or pharmacist before using Pregnyl.

For men and women:

Tell your doctor if you:

  • have untreated problems with the part of the brain called the pituitary gland or the hypothalamus
  • has an underproduction in the thyroid gland ( hypothyroidism )
  • have adrenal glands that do not function properly (adrenal cortex insufficiency)
  • have high levels of prolactin in the blood ( hyperprolactinemia )
  • have any other illnesses (eg diabetes, heart disease, or any other long-term illness).

Allergic reactions

Allergic reactions, both general 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 get an allergic reaction, stop taking Pregnyl and seek immediate medical attention. (See also section 4).

If you are a woman:

Risk of ovarian hyperstimulation syndrome (OHSS)
Treatment with gonadotropins such as Pregnyl may cause ovarian hyperstimulation syndrome (OHSS). This is a serious medical condition where the ovaries are over-stimulated and the growing follicles (small round sacs in your ovaries that contain eggs) become larger than normal. In rare cases, severe OHSS can be life-threatening. It is therefore very important that you are monitored by your doctor. To monitor the effects of the treatment, your doctor will perform ultrasound examinations of your ovaries. Your doctor can also check your hormone levels in the blood. (See also section 4).

OHSS causes sudden accumulation of fluid in the stomach (abdomen) and the chest which can lead to the formation of blood clots. Contact your doctor immediately if you experience any of the following symptoms:

  • severe swelling in the abdomen and abdominal pain
  • nausea
  • vomiting
  • sudden weight gain due to fluid retention
  • diarrhea
  • decreased urine flow
  • breathing difficulties

Ovarian torsion

Ovarian torsion is a twisting of an ovary. Twisting of the ovary can cause the blood flow to the ovary to stop.

Before using this medicine, you must tell your doctor if you:

  • have ever had ovarian hyperstimulation syndrome (OHSS)
  • is pregnant or thinks you may be pregnant
  • have ever had surgery on the stomach (abdomen)
  • have ever had a twist of an ovary
  • have had or have cysts in one or both ovaries.

Risk of multiple births (more than one fetus) or malformations

If you become pregnant after treatment with gonadotropins, there is an increased risk of having twins or multiple births (more than one fetus).

The risk of congenital malformations may be slightly higher after assisted reproduction, which is assumed to be due to characteristics of the couple (eg the woman’s age or sperm quality) and the risk of a pregnancy with several fetuses.

Risk of pregnancy complications

Women undergoing fertility treatment have a slightly increased risk of ectopic pregnancy (ectopic pregnancy). Your doctor should therefore perform an early ultrasound examination to rule out ectopic pregnancy.

Miscarriage

Women undergoing fertility treatment may have a slightly increased risk of miscarriage.

Risk of blood clots ( thrombosis )

Treatment with Pregnyl may increase the risk of blood clots, as well as a pregnancy in itself.

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

  • blockage of the lungs ( pulmonary embolism )
  • stroke
  • myocardial infarction
  • decreased blood flow to vital organs can lead to organ damage
  • decreased blood flow to the arm or leg (deep vein thrombosis ) which can lead to loss of an arm or leg

Tell your doctor if you have:

  • increased risk of getting a blood clot, for example, if you or someone in your immediate family has ever had a blood clot or you are severely overweight.

Medical examinations (pregnancy tests)

Up to 10 days after administration of Pregnyl, a pregnancy test may show false-positive results. In case of a positive pregnancy test, contact your doctor.

If you are a man:

Formation of antibodies

If treatment with Pregnyl does not work, talk to your doctor who may perform further tests.

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

Androgen production

When treated with hCG, you get an increased production of male sex hormones ( androgens ).

Therefore, close medical supervision is important:

  • for young boys who have not reached puberty, as Pregnyl may cause premature sexual maturation and affect height growth.
  • if you have or have had heart failure, high blood pressure, kidney disease, epilepsy, or migraines these conditions may worsen or recur as the production of male sex hormones ( androgens ) increases.

Children under 18 years

Extra supervision by a doctor is important when treating boys who have not reached puberty. This is necessary as Pregnyl can cause premature sexual development and can slow down length growth.

Other medicines and Pregnyl

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It has not been studied how Pregnyl works with other medicines. Therefore, it is not known whether other medicines affect or are affected by Pregnyl.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnyl can be used to strengthen the luteal phase (the first two weeks after ovulation), but Pregnyl should not be used later in pregnancy.

You should not use Pregnyl if you are breastfeeding.

Driving and using machines

Pregnyl does not affect the ability to drive and use machines.

Pregnyl contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per injection, ie essentially ‘sodium-free’.

How to use Pregnyl

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will decide what dose you need.

Usual dose:

Women

Ovulation and assisted reproduction: 5,000-10,000 IU as a single dose to end FSH treatment.

To strengthen the luteal phase (the first two weeks after ovulation): 2-3 doses of 1,000‑3,000 IU each within 9 days after ovulation.

Men:

Decreased sperm production: 1,000-2,000 IU 2-3 times a week.

Delayed puberty: 1,500 IU twice a week for at least 6 months. Men are injected several times a week for a few weeks up to several months, depending on the problem.

Boys whose testicles (one or both) have not migrated into the scrotum:

– under 2 years of age: 250 IU twice a week for six weeks
– under 6 years of age: 500-1 000 IU twice a week for six weeks
– over 6 years of age: 1,500 IU 2 times a week for six weeks.
The treatment can be repeated if necessary.

How the injections are given

The very first injection of Pregnyl should be given under medical supervision. Injection can be given slowly in a muscle (eg in the buttocks, thigh or upper arm) or under the skin (eg in the lower abdomen).

When an injection is given into a muscle, it should be given by a doctor or nurse. The best place to inject Pregnyl is the muscle in the buttocks. The shaded area below in Figure 1 contains a large amount of muscle with few blood vessels or larger nerves.

Picture 1


When an injection is given under the skin (see pictures 2 and 3) , it can in some cases be given by yourself or your partner. Your doctor will show you how and when to do this. If you are injecting yourself with Pregnyl, carefully follow the instructions for use below to give Pregnyl correctly and with the least possible discomfort.

Picture 2
Picture 3

User instructions

Step 1 – Preparation

  • Take a vial of powder or diluent out of the refrigerator
  • Before injection , you will need a clean and dry surface, alcohol, cotton swabs and a puncture-proof container (container for sharp objects) to dispose of the used syringe and needles.
  • Wash your hands and dry them.


Step 2 – Syringe completion

  • Remove the protective cap on the vial containing powder or diluent. Do not remove the rubber stopper.
  • Wipe the top of the rubber stoppers with an alcohol swab.
  • Use a syringe and a needle that has been recommended by your healthcare professional.
  • Attach the needle to the syringe.
  • Carefully remove the needle cover from the needle (see Figure 4 ).
Picture 4

Step 3 – Preparation of Pregnyl

  • Pregnyl is supplied in two glass vials whose contents must be mixed and used immediately. The dry powder in one vial must be dissolved in the diluent from the other vial.
  • Push the needle through the rubber stopper of the diluent vial (see Figure 5 ).
Picture 5
  • With the needle, suck up all the liquid in the syringe (see picture 6 ).
Figure 6
  • Add all the liquid to the vial containing the powder (see picture 7 ).
Figure 7
  • Remove the syringe and needle from the vial.
  • Avoid shaking or inverting the bottle, but swirl gently until the solution is clear. Pregnyl usually resolves immediately.
  • Do not use the solution if it is not free of particles or is not ready
  • The solution should be used immediately after reconstitution.
  • Make sure that everything is done during preparation so that sterile conditions are maintained (eg never put the syringe down without first putting the needle cover on the needle). Withdraw all Pregnyl solution in the same empty syringe (see picture 8 ).
Figure 8
  • Then replace the longer needle used to pull up the solution with a shorter sterile injection needle (see Figure 9 )
Figure 9
  • Finally, hold the syringe with the needle pointing upwards and tap gently on the side to make any air bubbles rise to the surface (see Fig. 10 ).
Picture 10
  • Then press the plunger so that all air disappears (is squeezed out) and only Pregnyl solution remains in the syringe and needle (see picture 11 ).
Figure 11


Step 4 – The injection site

The best place to give an injection under the skin is in the lower abdomen around the navel (see picture 2 ), where there is a lot of loose skin and layers of subcutaneous fat. The injection site should be varied slightly between each injection. The injections can be given elsewhere. Your doctor or nurse will tell you where to inject.

Step 5 – Preparation of the injection site

Wash your hands and clean the injection site with alcohol to remove bacteria from the surface. Clean about 5 cm around the place where the needle should go in and let the disinfectant dry for at least one minute before continuing.

Step 6 – Insertion of the needle

Pinch between the thumb and forefinger a large area of ​​the skin. On the other hand, insert the needle at the base of the pinched skin at an angle of 45 ° to the surface of the skin (see picture 3 ).

Step 7 – Checking the position of the needle

Carefully pull back on the syringe plunger to check that the needle is in the correct position. If the position of the needle is correct, the piston should be quite difficult to retract. If blood is sucked into the syringe, it means that the tip of the needle has hit a vein or artery. If this should happen, pull out the syringe and cover the injection site with a swab containing alcohol and apply pressure to the skin. The bleeding will stop within one to two minutes. Do not use the solution mixed with blood. 

Start again from step 1 with a new needle and a new vial of Pregnyl and diluent respectively.

Step 8 – Inject the solution

Press the plunger slowly and steadily so that the solution is injected correctly and the skin is not damaged.

Step 9 – Removing the syringe

Pull out the syringe quickly and press on the injection site with a swab of alcohol. Any remaining solution should be discarded. Never mix Pregnyl with other medicines.

Step 10 – Disposal of needles

To avoid injury, do not put the needle cover back on the syringe. Discard any needles you have used. Throw the needles in a closed syringe jar with a lid. Do not share your needles or syringes.

Always take Pregnyl exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

If you use more Pregnyl than you should 

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.

If you forget to use Pregnyl

Do not take a double dose to make up for a forgotten dose.

Contact your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you are a woman:

A possible complication of treatment with gonadotropins such as Pregnyl is unwanted overstimulation of the ovaries. The risk of getting this complication can be reduced by carefully monitoring the number of mature follicles (small round sacs in your ovaries that contain eggs). Your doctor will perform ultrasound examinations of the ovaries to closely monitor the number of maturing follicles. Your doctor may also check the hormone levels in your blood. The first symptoms of overstimulation of the ovaries can be felt as pain in the stomach (abdomen), nausea or diarrhea. Overstimulation of the ovaries can develop into a medical condition called ovarian hyperstimulation syndrome (OHSS)., which can be a serious medical problem. In more severe cases, this can lead to enlargement of the ovaries, accumulation of fluid in the abdomen and / or breast (which can cause sudden weight gain due to fluid accumulation), or the formation of blood clots in vessels (see also section 2).

Contact a doctor immediately if you experience abdominal (abdominal) pain, nausea, diarrhea, or sore breasts, even if it occurs a few days after the last injection of Pregnyl, as it may be a sign of ovarian hyperstimulation (OHSS).

In rare cases, blood clots can occur even without unwanted overstimulation of the ovaries (see also section 2).

Common (may affect up to 1 in 10 people):

  • injection site reactions such as bruising, pain, redness, swelling and itching .

Rare (may affect up to 1 in 1,000 people):

  • general rash, fever.


The following side effects may be due to ovarian hyperstimulation in women:

Common (may affect up to 1 in 10 people):

  • abdominal pain
  • nausea
  • diarrhea
  • ovarian cysts
  • enlargement of the ovaries
  • multiple births.


Uncommon (may affect up to 1 in 100 people):

  • sore breasts
  • palpable cysts on the ovaries
  • water in the alveoli
  • increased amount of fluid in the abdomen.


Rare (may affect up to 1 in 1,000 people):

  • blood clot
  • ruptured cysts on the ovaries
  • weight gain.


The following side effects may be due to increased production of male sex hormones in men:

Rare (may affect up to 1 in 1,000 people):

  • The amount of fluid and sodium can increase in the body which can cause symptoms such as swollen ankles or feet
  • breast augmentation ( gynecomastia ).

How to store Pregnyl

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP and the carton after EXP. The expiration date is the last day of the specified month.

Store in a refrigerator (2ºC-8ºC). Store in the original package. Sensitive to light. Prepare with the supplied diluent and use it immediately.

Do not use this medicine if you notice that the solution contains particles or if it is not completely transparent.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is human chorionic gonadotropin , a hormone also called hCG. One vial of powder contains 1,500 IU or 5,000 IU hCG .
  • The other ingredients in the powder are mannitol (E 421), disodium hydrogen phosphate, sodium dihydrogen phosphate and carmellose sodium.
  • The diluent contains sodium chloride (9 mg) and water for injections (1 ml).

What the medicine looks like and the contents of the pack

The powder is white, dry, and like a powder or a cake. The diluent is a clear and colorless aqueous solution.

Pack sizes:

1,500 IU:

1x ( powder vial and diluent vial )

3x ( powder vial and diluent vial )

5,000 IU:

1x ( powder vial and diluent vial )

3x ( powder vial and diluent vial )

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Merck Sharp & Dohme BV

Box 581

2003 PC Haarlem

Netherlands

Manufacturer

NV Organon

PO Box 20

NL-5340 BH Oss

Netherlands

Muhammad Nadeem

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