HUMAN CHORIONIC GONADOTROPHIN POWDER FOR SOLUTION FOR INJECTION (HCG)

NAME OF THE MEDICINAL PRODUCT

Chorionic Gonadotrophin Injection IP (HCG) 5000 IU

Chorionic Gonadotrophin Injection BP (HCG) 5000 IU

Chorionic Gonadotrophin For Injection USP 5000 IU,

Chorionic Gonadotrophin For Injection USP 10000 IU

 

Package leaflet:

Information for the patient

Read all of this leaflet carefully before you start taking 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, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. 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

Your medicine is called HUMAN CHORIONIC GONADOTROPHIN Injection depending on what your doctor has prescribed  will be known as HCG Injection for ease hereafter.

What is in this leaflet
1. What HCG Injection are and what they are used for
2. When should you not use this medicine or when should you be extra careful with this medicine?
3. How to use this medicine
4. Possible side effects
5. How to store HCG Injection
6. Contents of the pack and other information

WHAT HCG INJECTION ARE AND WHAT THEY ARE USED FOR

HCG Injection belongs to a group of medicines called gonadotrophins (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). HCG Injection 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 HCG Injection

WHEN SHOULD YOU NOT USE THISMEDICINE OR WHEN SHOULD YOU BE EXTRA CAREFUL WITH THIS MEDICINE??

When should you not use this medicine?
• If you are allergic (hypersensitive) to human chorionic gonadotrophin (hCG) or any of the other ingredients of this medicine .
• If you have a thyroid, adrenal or pituitary illness which is not being treated.
• If you have cancer, (especially a hormone-dependent cancer of the breast, ovaries or womb).
• If you have recently had unexplained vaginal bleeding which is not related to your menstrual period.
• If you have fibroids in the womb or abnormalities of the reproductive organs which make a normal pregnancy impossible.
• If you are a man and have, or suspect you have a hormone-related tumour, such as testicular, prostate or breast cancer.

When should you be extra careful with this medicine?
Medicines are not always suitable for everyone. Talk to your doctor before using HCG Injection if you suffer from or have suffered in the past from any of the following conditions:
• abnormalities of the reproductive organs. Before treatment with HCG Injection your doctor should have checked that your reproductive organs are normal
• in women patients your doctor should have checked how your ovaries are working before starting treatment with HCG Injection. Extra supervision may be necessary in some cases. • uncontrolled pituitary gland or hypothalamic problems.
• underactive thyroid gland (hypothyroidism).
• adrenal glands that are not working properly (adrenocortical insufficiency).
• high prolactin levels in the blood (hyperprolactinaemia).
• any other medical conditions (for example, diabetes, heart disease, or any other long-term disease).

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 HCG Injection and seek immediate medical assistance.

Misuse for weight control
HCG Injection must not be used for weight loss. HCG has no effect on fat metabolism (burning fat), distribution of fat or appetite.

For women:

Chance of having ovarian hyperstimulation syndrome (OHSS)
Treatment with gonadotropic hormones like HCG Injection 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 lifethreatening. 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.
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 starting to use this medicine, it is important to inform your doctor if you:
• have ever had ovarian hyperstimulation syndrome OHSS
• are pregnant or think that 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 a blood clot (thrombosis) Being pregnant increases the chance of having a blood clot.
If you have risks factors for having a blood clot (for example being overweight, or if blood clots run in your family), the chance of having a blood clot in a blood vessel (thrombosis) may be increased during IVF treatment.
Blood clots can lead to serious medical conditions, such as:
• blockage in your lungs (pulmonary embolus) • stroke
• heart attack
• reduced blood flow to the vital organs that may result in organ damage
• reduced blood flow (deep vein thrombosis) to your arm or leg that may result in a loss of your arm or leg.
Please discuss this with your doctor, before starting treatment, especially if:
• you already know 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.

Chance of having multiple births, birth defects, miscarriage or pregnancy complications
If treatment with HCG Injection results in pregnancy, there is an increased chance having twins or multiple births. Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth. In women undergoing fertility treatment there is a slightly increased risk of a miscarriage, or 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.
It is unknown if IVF treatment causes congenital malformations, or some cancers of the sex organs.
For men:
Talk to your doctor before using HCG Injection if you suffer from or have suffered in the past from any of the following conditions:
o heart problems
o kidney problems
o high blood pressure
o epilepsy
o migraine

Antibody formation
If the treatment with HCG Injection is not working, consult with your doctor who may perform additional tests.
Treatment with HCG Injection (hCG) can cause the body to produce substances that act against hCG (antibodies to hCG). In rare cases this could result in ineffective treatment.

Children and adolescents
HCG Injection should be used carefully when treating boys who have not reached puberty. This is because it can cause early sexual development and may result in final adult height not being reached.

Other medicines and HCG Injection
Some medicines can affect the way HCG Injection works, or HCG Injection may affect how other medicines work. For up to ten days after administration, HCG Injection may result in a falsepositive pregnancy test. In case of a positive pregnancy test, contact your doctor.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

HOW TO TAKE HCG INJECTION

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Your doctor will choose the most suitable starting dose for you. The usual starting doses for men and women are as follows:

Women
Patients undergoing ovulation induction:
5,000–10,000 I.U. HCG Injection following treatment with other fertility drugs.
2 to 3 repeat injections of 1,000 to 3,000 I.U. each may be given within the following 9 days. Patients undergoing IVF treatment:
5,000–10,000 I.U. HCG Injection 30–40 hours after the last injection of other fertility drugs.

Men
 In male patients injections are given 2 to 3 times a week for some weeks or months, depending on the problem. Because the development of sperm cells takes about 74 days, treatment should be continued for at least three months before any improvement can be expected.

How are the injections given?
The very first injection of HCG Injection should only be given under medical supervision. Injections may be given slowly into a muscle (for instance in the bottom, upper leg or upper arm) or under the skin (in the stomach wall, for example).

When given into a muscle the injection should be given by the doctor or nurse. The best site for injection of HCG Injection is the muscle of your bottom. The area shown in blue in the diagram contains a large amount of muscle with few blood vessels or major nerves.

 When given under the skin the injection may, in some cases, be given by yourself or your partner. Your doctor will tell you when and how to do this. If you inject yourself with HCG Injection, follow the instructions on this leaflet carefully to give HCG Injection properly and with minimal discomfort.

Step 1 – Preparing HCG Injection
HCG Injection comes in two glass ampoules whose contents must be mixed together and used immediately.
First, break the top off the ampoule with the sodium chloride solution
Draw up the liquid through the larger needle into the syringe
Break open the second ampoule containing the dry white powder and add the sodium chloride solution from the syringe
Do not shake, but gently swirl until the solution is clear. The HCG Injection usually dissolves immediately.
If the solution contains particles or does not become clear, do not use it. Draw the HCG Injection solution up into the empty syringe, and now replace the needle with a smaller sterile injection needle. Finally hold the syringe with the needle pointing upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until all the air has been expelled, and only HCG Injection solution is left in the syringe.

Step 2 – The injection site
The best site for injection is in the stomach around the middle of the tummy  where there is a lot of loose skin and layers of fatty tissue. Pinch up a large area of skin between the finger and thumb. You should change the injection site a little each time you inject. It is possible to inject in other areas. Your doctor or nurse will advise you where to inject.

Step 3 – Preparing the area
A few taps at the injection site will stimulate tiny nerve endings and help reduce discomfort when the needle goes in. Hands should be washed and the injection site swabbed with disinfectant (for example chlorohexidine 0.5%) to remove any surface bacteria. Clean about two inches around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.

Step 4 – Inserting the needle
The needle should be inserted at the base of the pinched-up skin at an angle of 45° to the skin surface

Step 5 – Checking the correct needle position
If the needle position is correct the plunger should be quite difficult to draw back. Any blood sucked back into the syringe means that the needle tip has entered a vein or artery. If this happens pull out the syringe, cover the injection site with a swab containing disinfectant and apply pressure; the site will stop bleeding in a minute or two. Do not use this solution but flush it away.
Start again with Step 1 using a new needle and new ampoules of HCG Injection and sodium chloride solution.

Step 6 – Injecting the solution
Depress the syringe plunger slowly and steadily, so the solution is correctly injected and the muscle or skin tissues are not damaged.

Step 7 – Removing the syringe
Pull the syringe out quickly and apply pressure to the injection site with a swab containing disinfectant. A gentle massage of the site – while still maintaining pressure – helps disperse the HCG Injection solution and relieve any discomfort. Any remaining solution should be discarded. Do not mix HCG Injection solution with any other medicines.

Step 8 – Disposing of needles
Replace the needle guard on the syringe to prevent injury. Carefully dispose of any needles that you use. You can dispose of needles in a ‘sharps bin’, or take them to your local pharmacy for disposal.
Do not share your needles or syringes.

Always take HCG Injection exactly as your doctor has told you. Check with your doctor or pharmacist if you are still not sure.

If you take more HCG Injection than you should
As your doctor will be keeping a close eye on you it is unlikely you will be given too much, however too high a dose of HCG Injection may cause hyperstimulation of the ovaries. This may be noticed as pain in the abdomen. If you are troubled by stomach pains, tell your doctor immediately.
If you accidentally use too much HCG Injection contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there is any HCG Injection left or not.

If you forget to take HCG Injection
If you forget to take a dose do not take a double dose to make up for a missed dose.
→ Contact your doctor.

If you stop taking HCG Injection
Do not stop taking HCG Injection unless your doctor tells you to. Your doctor will advise you if you need to stop using HCG Injection for any reason. If you have any further questions on how to take HCG Injection, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

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

Serious side effects: tell a doctor straight away If you have an allergic reaction to HCG Injection see a doctor straight away
• HCG Injection may cause reactions at the site of injection, such as bruising, pain, redness, swelling and rashes at the injection site.
• more widespread rash and fever may occur
Contact a doctor immediately if you are a woman and experience:
Severe pain in the abdomen, feeling sick (nausea), diarrhoea, painful breasts, also if it occurs a few days after you receive your last injection, since it could be a sign of unwanted overstimulation of the ovaries (OHSS).

If you are a woman:
A possible complication of treatment with gonadotropic hormones like HCG Injection is unwanted overstimulation of the ovaries. The chance of having 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 called 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 (See also Section 2 When should you be extra careful with this medicine?).

Contact your doctor without delay if you have pain in the stomach (abdomen) or any of the other symptoms of ovarian hyperstimulation, even if they occur some days after HCG Injection has been given.

If you are a man:
• 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.
→ If any of these signs appear, tell your doctor immediately.

Other possible side effects
• acne (in men)
• fluid retention
• headache
• tiredness
• mood changes

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE HCG INJECTION

Keep out of the sight and reach of children.
HCG Injection should be stored in a refrigerator (2°C to 8°C).
Do not freeze.
Keep the ampoules in the outer carton in order to protect from light. Do not use HCG Injection after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Contents of the pack and other information

What HCG Injection contains
Each ampoule contains 5000 I.U. of the active ingredient Human Chorionic Gonadotrophin. The other ingredients are carmellose sodium, mannitol (E421), disodium phosphate (anhydrous), sodium dihydrogen phosphate (anhydrous). The solvent contains sodium chloride (9 mg) and water for injections.

What HCG Injection looks like and contents of the pack
HCG Injection comes as 2 ml ampoules of dry white powder with 1 ml ampoule of solvent (sodium chloride solution). HCG Injection 5000 I.U. is available in packs of 1, 3 or 10 ampoules of powder and solvent. Not all pack sizes may be marketed.

Manufactured by:
Taj Pharmaceuticals Limited
220, Mahagujarat Ind. Estate, Moraiya, Tal. Sanand, Dist. Ahmedabad, Gujarat, INDIA

Marketing Authorization Holder:
Regal sun co., Ltd.Myanmar