ABBREVIATED PRESCRIBING INFORMATION
MENOGON
Menotropin (human menopausal gonadotropin) for intramuscular administration.
Presentation:
Menogon is presented as a sterile freeze-dried powder in an ampoule, containing 75 i.u menotropin BP.The freeze-dried powder also contains lactose and sodium hydroxide. Each ampoule is supplied with a diluent ampoule of sodium chloride solution for injections 0.9% w/v.
Indications:
Menogon is used: In the treatment of female infertility in the following groups of patients: •Infertility in women with hypo- or normogonadotropic ovarian insufficiency: stimulation of follicle growth.
Dosage and administration:
Female infertility: The dosage of HMG to induce follicle growth in normo- or hypogonadotropic women differs individually. The quantity required depends on ovarian reaction and should be monitored by ultrasonography of the ovaries and by measuring estradiol levels. If the HMG dosage is too high for the treatment individual, multiple, uni- or bilateral follicle growth can occur.
Generally, HMG
treatment is started with a daily dosage of 75-150 i u. FSH plus 75-150 i.u LH applied i.m. If the ovaries do not respond, the dosage can be gradually increased until either an increase of the estradiol secretion or follicle growth can be ascertained. The HMG dosage is maintained until the preovulatory estradiol serum level is reached. To induce ovulation, 5000 or 10000 i.u. HCG are injected one or two days after the last HMG application. Apart from large fluctuations during various treatment cycles of the same patient, a marked variation also exists between different petients in regard to the ovarian response to gonadotropins. In order to achieve a high pregnancy rate and to avoid hyperstimulation of the ovaries, a thorough monitoring of the treatment is necessary.
Parameters for the control
of the ovarian reaction can be: the cervical score according to Insler, the estradiol measurement of the serum or the urine as well as ultrasonographical examinations of the follicle size.
Contraindications:
Pregnancy, enlargement of the ovaries or cysts not due to polycystic ovarian syndrome, gynaecological bleeding of unknown cause, tumors in the uterus, ovaries, breasts, or testes, carcinoma of the prostate, sturctural abnormalities in which a satisfactory outcome cannot be expected, for example, tubal occlusion (unless superovularion is to be induced for IVF), ovarian dysgenesis, absent uterus or premature menopause.
Precuations:
The following conditions should be properly treated and excluded as the cause of infertility before menotropin therapy is initiated: dysfunction of the thyroid gland and cortex of the suprarenal gland, hvperprolactinaemia, primary ovarian failure and tumors in the pituitary or hypothalamic glands. Ovarian hyperstimulation syndrome may develop in some cases.
Female patients
should be informed before therapy that treatment with a HMG dosage too high for the individual may lead hyperstimulation of the ovaries. In case of a moderate hyperstimulation (Grade I) with slight enlargement of the ovaries (size: 5-7 cm), excessive steroid secretion, and abdominal pain, no therapy is required, but the patient should be informed and monitored thoroughly.
In case of hyperstimulation
(Grade IT) with ovarian cysts (size of ovary: 8-10 cm), abdominal pain, nausea and vomiting, clinical supervision and symptomatic treatment, if necessary and intravenous volume replacement is indicated should an increased haemo concentration prevail. In case of severe hyperstimulation (Grade III) with large ovarian cysts (ovary size more than 10 cm) accompanied by ascites, hydrothorax, distended abdomen, abdominal pain, dyspnoea, salt retention, increased haemo concentration and blood viscosity, and increased thrombocyte aggregation with the danger of thromboembolism, hospitalization is imperative.
Side effects:
Treatment with menotropin can often lead to ovarian hyperstimulation. This, however, mostly becomes clinically relevant only after hCG has been administered to induce ovulation. Treatment with HMG can often lead to a hyperstimulation of the ovaries which, however, mostly becomes clinically releavant only after application of HCG to trigger ovulation. This can lead to the occurrence of large ovarian cysts, which tend to rupture, and can cause intra abdominal bleeding.
Furthermore ascities,
hydrothorax, oliguria, hypotension and trhomboembolic phenomena can occur. As soon as first symptoms of hyperstimulation, such as abdominal pain and palpable enlargement in the lower abdomen, appear and are sonographically detectable, the treatment should immediately be discountinued. When a woman bacomes pregnant, these side effects can intensify, be longlasting and life threatening. Unintentional multiple pregnancies occur more often during treatment with HMG. Occasionally, treatment with HMG is accompained by Nausea and vomiting.
In single cases,
patients may show hypersensitivity to HMG like a rash, fever or pain at the injection site. In very rare cases, long term application can cause the formation of antibodies so that no success is achieved by the therapy.
Pharmaceutical precautions;
Store at a temperature not exceeding 25°C, protected from light. Package quantities: 10 colorless glass ampoules of Menogon packaged toghether with 10 ampoules of sodium chloride solution for injections 0.9% w/v. Date: June 1998.
MENOGON
Menotropin (human menopausal gonadotropin) for intramuscular administration.
Presentation:
Menogon is presented as a sterile freeze-dried powder in an ampoule, containing 75 i.u menotropin BP.The freeze-dried powder also contains lactose and sodium hydroxide. Each ampoule is supplied with a diluent ampoule of sodium chloride solution for injections 0.9% w/v.
Indications:
Menogon is used: In the treatment of female infertility in the following groups of patients: •Infertility in women with hypo- or normogonadotropic ovarian insufficiency: stimulation of follicle growth.
Dosage and administration:
Female infertility: The dosage of HMG to induce follicle growth in normo- or hypogonadotropic women differs individually. The quantity required depends on ovarian reaction and should be monitored by ultrasonography of the ovaries and by measuring estradiol levels. If the HMG dosage is too high for the treatment individual, multiple, uni- or bilateral follicle growth can occur.
Generally, HMG
treatment is started with a daily dosage of 75-150 i u. FSH plus 75-150 i.u LH applied i.m. If the ovaries do not respond, the dosage can be gradually increased until either an increase of the estradiol secretion or follicle growth can be ascertained. The HMG dosage is maintained until the preovulatory estradiol serum level is reached. To induce ovulation, 5000 or 10000 i.u. HCG are injected one or two days after the last HMG application. Apart from large fluctuations during various treatment cycles of the same patient, a marked variation also exists between different petients in regard to the ovarian response to gonadotropins. In order to achieve a high pregnancy rate and to avoid hyperstimulation of the ovaries, a thorough monitoring of the treatment is necessary.
Parameters for the control
of the ovarian reaction can be: the cervical score according to Insler, the estradiol measurement of the serum or the urine as well as ultrasonographical examinations of the follicle size.
Contraindications:
Pregnancy, enlargement of the ovaries or cysts not due to polycystic ovarian syndrome, gynaecological bleeding of unknown cause, tumors in the uterus, ovaries, breasts, or testes, carcinoma of the prostate, sturctural abnormalities in which a satisfactory outcome cannot be expected, for example, tubal occlusion (unless superovularion is to be induced for IVF), ovarian dysgenesis, absent uterus or premature menopause.
Precuations:
The following conditions should be properly treated and excluded as the cause of infertility before menotropin therapy is initiated: dysfunction of the thyroid gland and cortex of the suprarenal gland, hvperprolactinaemia, primary ovarian failure and tumors in the pituitary or hypothalamic glands. Ovarian hyperstimulation syndrome may develop in some cases.
Female patients
should be informed before therapy that treatment with a HMG dosage too high for the individual may lead hyperstimulation of the ovaries. In case of a moderate hyperstimulation (Grade I) with slight enlargement of the ovaries (size: 5-7 cm), excessive steroid secretion, and abdominal pain, no therapy is required, but the patient should be informed and monitored thoroughly.
In case of hyperstimulation
(Grade IT) with ovarian cysts (size of ovary: 8-10 cm), abdominal pain, nausea and vomiting, clinical supervision and symptomatic treatment, if necessary and intravenous volume replacement is indicated should an increased haemo concentration prevail. In case of severe hyperstimulation (Grade III) with large ovarian cysts (ovary size more than 10 cm) accompanied by ascites, hydrothorax, distended abdomen, abdominal pain, dyspnoea, salt retention, increased haemo concentration and blood viscosity, and increased thrombocyte aggregation with the danger of thromboembolism, hospitalization is imperative.
Side effects:
Treatment with menotropin can often lead to ovarian hyperstimulation. This, however, mostly becomes clinically relevant only after hCG has been administered to induce ovulation. Treatment with HMG can often lead to a hyperstimulation of the ovaries which, however, mostly becomes clinically releavant only after application of HCG to trigger ovulation. This can lead to the occurrence of large ovarian cysts, which tend to rupture, and can cause intra abdominal bleeding.
Furthermore ascities,
hydrothorax, oliguria, hypotension and trhomboembolic phenomena can occur. As soon as first symptoms of hyperstimulation, such as abdominal pain and palpable enlargement in the lower abdomen, appear and are sonographically detectable, the treatment should immediately be discountinued. When a woman bacomes pregnant, these side effects can intensify, be longlasting and life threatening. Unintentional multiple pregnancies occur more often during treatment with HMG. Occasionally, treatment with HMG is accompained by Nausea and vomiting.
In single cases,
patients may show hypersensitivity to HMG like a rash, fever or pain at the injection site. In very rare cases, long term application can cause the formation of antibodies so that no success is achieved by the therapy.
Pharmaceutical precautions;
Store at a temperature not exceeding 25°C, protected from light. Package quantities: 10 colorless glass ampoules of Menogon packaged toghether with 10 ampoules of sodium chloride solution for injections 0.9% w/v. Date: June 1998.
0 comments