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- Pregnyl 5000iu Ampoule
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Pregnyl 5000 I.U.
2 Qualitative and quantitative composition
Injection containing human chorionic gonadotrophin 1500 I.U.
3 Pharmaceutical form
Freeze dried powder for injection
4 Clinical particulars
4.1 Therapeutic indications
Hypogonadotrophic hypogonadism.Delayed puberty associated with insufficient gonadotrophic pituitary function. Sterility in selected cases of deficient spermatogenesis.
In the femaleSterility due to the absence of follicle-ripening or ovulation. In conjunction with HMG, in the promotion of controlled superovulation in medically assisted reproduction programmes.
4.2 Posology and method of administrationIn the male
Hypogonadotrophic hypogonadism:500–1,000 Units 2–3 times weekly.
Delayed puberty associated with insufficient gonadotrophic pituitary function:1,500 Units twice weekly for at least 6 months.
Sterility in selected cases of deficient spermatogenesis:Usually, 3,000 Units per week in combination with an HMG preparation. In the female
Sterility due to the absence of follicle-ripening or ovulation:5,000–10,000 Units hCG to induce ovulation, following treatment with an HMG (human menopausal gonadotrophins) preparation. Up to 3 repeat injections of up to 5,000 Units hCG each, may be given within the following 9 days to prevent insufficiency of the corpus luteum.
In conjunction with HMG, in the promotion of controlled superovulation in medically assisted reproduction programmes:5,000–10,000 Units hCG 30–40 hours after the last HMGinjection. Pregnyl should not be administered if the following criteria have not been met: It is recommended that at least 3 follicles greater than 17mm in diameter are present with 17ß estradiol levels of at least 3,500 pmol/L (920 picogram/ml). Oocyte collection is carried out 32–36 hours after the hCG injection.
Method of administrationAfter addition of the solvent to the freeze-dried substance, the solution should be given immediately by intramuscular or subcutaneous injection. Any unused solution should be discarded. Subcutaneous injection may be carried out by patient or partner, provided that proper instructions are given by the physician. Self administration of Pregnyl should only be performed by patients who are wellmotivated,adequately trained and with access to expert advice.
Hypersensitivity to human gonadotropins or any of the substances of Pregnyl.Presence of uncontrolled nongonadal endocrinopathies (e.g. thyroid, adrenal or pituitary disorders)Breast, uterine, ovarian, testicular tumoursVaginal bleeding of unknown causeKnown or suspected androgendependent tumours, carcinoma of the prostate or mammary carcinoma in males.4.4 Special warnings and special precautions for use
In the female:
Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.Prior to treating patients for inadequate endogenous stimulation of the gonads, an examination should be performed to exclude anatomical abnormalities of the genital organs or nongonadal endocrinopathies (e.g. thyroid or adrenal disorders, diabetes). Primary ovarian failure should be excluded by the determination of gonadotrophin levels.In the pregnancies occurring after induction of ovulation with gonadotrophic preparations, there is an increased risk of abortion and multiplets. Multiple pregnancy, especially high order, carries an increased risk in adverse maternal and perinatal outcomes. The parents should be advised of the potential risks of multiple births before starting treatment.The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and an increased incidence of multiple gestations.Women with generally recognised risk factors for thrombosis, such as a personal or family history, severe obesity (Body Mass Index > 30 kg/m2) or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins. 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.There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment. It is not yet established whether or not treatment with gonadotrophins, increases the baseline risk of these tumours in infertile women. Unwanted Hyperstimulation During treatment of female patients, determinations of oestrogen levels and assessment of ovarian size and if possible, ultrasonography should be performed prior to treatment and at regular intervals during treatment. High dosages may cause oestrogen levels to rise excessively rapidly, e.g. more than doubling on 2 or 3 consecutive days, and possibly reaching excessively high pre-ovulatory values. The diagnosis of unwanted ovarian hyperstimulation may be confirmed by ultrasound examination. If unwanted hyperstimulation occurs (i.e. not as part of a treatment preparing for IVF/ET or GIFT or other assisted reproduction techniques), the administration of HMG should be discontinued immediately. hCG must not be given, because
INFORMATION FOR THE DOCTOR
the administration of an hLH - active gonadotrophin at this stage may induce, in addition to multiple ovulations, the ovarian hyperstimulation syndrome. This warning is particularly important with respect to patients with polycystic ovarian disease. The severe form of ovarian hyperstimulation syndrome may be life-threatening and is characterised by large ovarian cysts (prone to rupture), acute abdominal pain, ascites, very often hydrothrax and occasionally thrombo-embolic phenomena.
In the male:Treatment with hCG leads to increased androgen production. Therefore:
Patients with latent or overt cardiac failure, renal dysfunction, 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.HCG should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly.4.5 Interaction with other medicaments and other forms of interactionNone known.
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
Oedema, headache, tiredness, mood changes, gynaecomastia and local site reactions. Skin rashes have occasionally been reported. In rare cases generalized rash or fever may occur.
In the female:
Unwanted ovarian hyperstimulation, ovarian hyperstimulation syndrome (OHSS). Characteristic symptoms of unwanted ovarian hyperstimulation and OHSS are included under ‘Special Warnings and Special Precautions for Use’ in Section 4.4.In rare instances, thromboembolism has been associated with FSH/hCG therapy (see Section 4.4).
In the male:
Water and sodium retention is occasionally seen after administration of high dosages; this is regarded as a result of excessive androgen production.HCG treatment may sporadically cause gynaecomastia.Acne may occur occasionally during hCG therapy.4.9 OverdoseThe toxicity of human chorionic gonadotrophic hormone is very low. However, too high a dose may lead to hyperstimulation of the ovaries. (See ‘Unwanted Hyperstimulation’).
5 Pharmacological properties
5.1 Pharmacodynamic propertiesPregnyl is a preparation of human chorionic gonadotrophin obtained from the urine of pregnant women. It stimulates the steroidogenesis in the gonads by virtue of a biological effect similar to that of LH (Luteinizing hormone, which is the same as interstitial cell stimulating hormone). In the male it promotesthe 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 human menopausal gonadotrophin (HMG). Because hCG is of human origin, no antibody formation is to be expected.
5.2 Pharmacokinetic propertiesMaximal hCG plasma levels will be reached in males after a single IM or SC injection of hCG at approximately six and sixteen hours respectively, and in females after approximately 20 hours.HCG is approximately 80 per cent metabolized, predominantly in the kidneys. IM and SC administrationof hCG were found to be bioequivalent regarding the extent of absorption and the apparent elimination half-lives of approximately 33 hours. On the basis of the recommended dose regimens and elimination half-life, cumulation is not expected to occur.
5.3 Preclinical safety dataThere are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 Pharmaceutical particulars
6.1 List of excipientsSodium carboxymethylcellulose 0.05 mg Mannitol 5.0 mg Disodium hydrogen phosphate, calculated as anhydrous 0.25 mg Sodium dihydrogen phosphate, calculated as anhydrous 0.25 mg
6.2 IncompatibilitiesNone stated
6.3 Shelf life36 months
6.4 Special precautions forstorage Store at 2 to 8 °C. Do not freeze. Keep the ampoules in the outer container to protect from light.
6.5 Nature and contents of container2 ml ampoule containing freezedried powder with 1ml ampoule of solvent sodium chloride 9 mg/ml.
6.6 Instructions for use/handlingPregnyl should be reconstituted with the solvent provided. Do not use if the solution contains particles or if the solution is not clear. Since an opened ampoule cannot be resealed in such a way to further guarantee the sterility of the contents, the solution should be used immediately after reconstitution. Discard any remaining solution after single use.
INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What Pregnyl is and what it is used for
Pregnyl 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.
WomenIn 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),
MenIn 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. Before you use Pregnyl
Do not use Pregnyl if you:
Are allergic (hypersensitive) to Human Chorionic Gonadotrophin (HCG) or any of the other ingredients in PregnylHave a thyroid, adrenal or pituitary illness which is not being treatedHave cancer, (especially a hormone-dependent cancer of the breast, ovaries, womb, or the testes)Have recently had unexpected vaginal bleedingAre a man and have, or suspect you have a hormone related tumour, such as prostate or breast cancer.Take special care with PregnylMedicines are not always suitable for everyone.
Tell your doctor before you use Pregnyl if you suffer from or have suffered in the past from any of the following conditions:
Men withHeart problemsKidney problemsHigh blood pressureEpilepsy, orMigraineAbnormalities of the sexual organs. Before treatment with Pregnyl your doctor should have checked that your sexual organs are normalIn women patients your doctor should have checked how your ovaries are working before starting treatment with Pregnyl.Extra supervision may be necessary in some cases. Pregnyl 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. 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 may be increasedduring IVF treatment. Being pregnant increases the chance of having a blood clot.
Close supervision of female patients undergoing fertility treatment is extremely important to avoid the rare complication of hyperstimulation of the ovaries. This side effect may be felt as pain in the stomach.If you are troubled with stomach pains, contact your doctor straight away. No one is sure if IVF treatment causes congenital malformations, or some cancers of the sex organs.
Taking other medicinesSome medicines can affect the way Pregnyl works, or Pregnyl may affect how other medicines work.
Tell your doctor or pharmacistif you are taking or have recently taken any other medicines, including medicines obtained without aprescription.
PregnancyIf treatment with Pregnyl 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 aroundthe time of birth. There is also an increased chance of a miscarriage, or a pregnancy outside of the womb (an ectopic pregnancy).
3. How to use Pregnyl
Your doctor will choose the most suitable starting dose for you. The usual starting doses for men and women are as follows:
WomenPatients undergoing ovulation induction: 5,000–10,000 I.U. Pregnyl following treatment with other fertility drugs. Up to 3 repeat injections of up to 5,000 I.U. each may be given within the following 9 days. Patients undergoing IVF treatment: 5,000–10,000 I.U. Pregnyl 30–40 hours after the last injection of other fertility drugs.
MenIn 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 Pregnyl 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 octor or nurse. The best site for injection of Pregnyl 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 andhow to do this. If you inject yourself with Pregnyl, follow the instructions on this leaflet carefully to give Pregnyl properly and with minimal discomfort.
Step 1 - Preparing PregnylPregnyl 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 (a). Draw up the liquid through the larger needle into the syringe (b). Break open the second ampoule containing the dry whitepowder (c) and add the sodium chloride solution from the syringe
INFORMATION FOR THE USER
The Pregnyl usually dissolves immediately. If the solution contains particles or does not become clear, do not use it. Draw the Pregnyl solution up into the empty syringe (e), and now replace the needle with a smaller sterile injection needle (f). 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 beenexpelled, and only Pregnyl solution is left in the syringe (g).
Step 2 - The injection siteThe best site for injection is in the stomach around the middle of the tummy (h) 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 areaA 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 (forexample 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 needleThe 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 positionIf 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 thesyringe, 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 butflush it away. Start again with Step 1 using a new needle and new ampoules of Pregnyl and sodium chloride solution.
Step 6 - Injecting the solutionDepress the syringe plunger slowly and steadily, so the solution is correctly injected and the muscleor skin tissues are not damaged.
Step 7 - Removing the syringePull 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 Pregnyl solution and relieve any discomfort. Any remaining solution should be discarded. Do not mix Pregnyl solution with any other medicines.
Step 8 - Disposing of needlesReplace 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 Pregnyl exactly as your doctor has told you. Checkwith your doctor or pharmacist if you are still not sure.
If you take more Pregnyl than you shouldAs 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 Pregnyl 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 Pregnyl 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 Pregnylleft or not. If you forget to take Pregnyl 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 Pregnyl Do not stop taking Pregnyl unless your doctor tells you to. Your doctor will advise you if you need to stop using Pregnyl for any reason. If you have any further questions on how to take Pregnyl, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Pregnyl can cause side effects, although not everybody gets them. The following side effects have been reported:
Ovarian hyperstimulation syndrome (see Fertility treatment in section 2)RashFluid retentionHeadacheTirednessMood changesPainful breastsAcne
5. How to store Pregnyl
Keep out of the reach and sight of children. Pregnyl should be stored at 2 to 8 °C. Do not freeze. Keep the ampoules in the outer container to protect from light. Do not use Pregnyl after the expiry date which is stamped on the pack. 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 dispose of medicines no longer required. These measures will help to protect the environment.
6. Further Information
What Pregnyl containsEach ampoule contains
1500 I.U. of the active ingredient HumanChorionic Gonadotrophin. The other ingredients are sodium carboxymethylcellulose, mannitol, disodium hydrogen phosphate (anhydrous), sodium dihydrogen phosphate (anhydrous). Thesolvent contains sodium chloride (9 mg) and water for injections.
What Pregnyl looks like and contents of the pack
Pregnyl comes as 2 ml ampoules of dry white powder with 1 ml ampoule of solvent (sodium chloride solution). Pregnyl 1500 I.U. is available in packs of 1, 3 or 10 ampoules of powder and solvent. Not all pack sizes may be marketed.