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New Merional 75 IU Vial ingredient Menopausal Gonadotrophin View larger

Merional 75 IU Vial ingredient Menopausal Gonadotrophin


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Merional 75 IU Vial ingredient  Menopausal Gonadotrophin

MERIONAL® 75 IU vial containing lyophilized powder for IM / SC injection

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For the stimulation of spermatogenesis in male patients with hypogonadotropic hypogonadism:

Spermatogenesis treatment is started with 1000 twice or three times a week via the im or sc route

IU-2000 IU hCG administration. This treatment is then administered two to three times a week im

continued with the addition of 75 IU-150 IU MERIONAL®or sc. This treatment

should be continued for at least three months without any improvement in spermatogenesis. Clinical

experience that spermatogenesis should be continued for at least 18 months


Application form

MERIONAL® is for subcutaneous or intramuscular administration. Itb Intravenously

should not administered.

The solution for injection means of the solvent bulb in the carton box

is obtained by dissolving the powder in the vial by(see 6.6).to 5 vials with a 1 ml solvent vial

It is possible to dissolve the MERIONAL® product up. Powder is usually soluble immediately.

In the case of more than one vial, 1 ml of solvent is added to the mixture and if necessary, it is

mixed slowly. The prepared solution is clear and colorless.

The prepared solution should be used immediately without waiting.

Additional information on specific populations

Renal / liver insufficiency

MERIONAL® is not known for its use in patients with renal / liver insufficiency


Pediatric population

MERIONAL® does not have an indication for children. Therefore This age

, the reliability and effectiveness of group has not been evaluated.


Clinical studies on menotrophin patients over the age of 65 do not contain.

4.3- Contraindications,

MERIONAL® is contraindicated in the following cases.

•in the active substance, menotropin or powder or solvent ampoule composition.

hypersensitivity to any of the excipients

• Pituitary or hypothalamus tumors,

• In women,

• Cysts not caused by ovarian enlargement or polycystic ovary syndrome,

• Gynecological hemorrhages that are unknown,

• Ovarian, uterine and breast carcinoma,

• Pregnancy,

• Primary ovarian failure,

• Malignant malformation of the reproductive organs,

• Fibroid tumors which are not suitable for pregnancy in the uterus,

• In males,

• In primary testicular insufficiency

4.4 - Special use warnings and precautions

Gonadotropin treatment, In terms of follow-up at appropriate times, it's physicians and

that should be reserved by assistants of healthcare professionals


The first application should be done in centers with appropriate supporting equipment. Inovarian

to ultrasound scanning order to prevent hyperstimulation syndrome and the risk of multiple pregnancies

addition, it is recommended that serum estrogen levels should be measured regularly in.

The response of patients to hMG varies among patients, and in some

cases the response to treatment may be less than expected. It should treatment in male and female patients

be aimed to use the lowest effective dose to respond to.

Before starting the treatment, the conditions of infertility and the have a negative effect on pregnancy should

conditions that may be determined. Patients should be evaluated especially in terms of hypothyroidism, adrenocortical

insufficiency, hyperprolactinemia, pituitary and hypothalamic tumors and

patients should start appropriate treatment if such conditions are determined.

Treatment in women

Ovarian hyperstimulation

OHSS (ovarian hyperstimulation syndrome) is medical different from uncontrolled ovarian growth

aevent. It is a symptom that manifests itself as the degree of seriousness increases. Significant ovarian

growth, increased plasma sex steroids, vascular permeability, pleural and rarely increases in

pericardial spaces.

In severe OHSS abdominal pain, abdominal distension, severe ovarian enlargement, weight gain,

, gastrointestinal symptoms such as dyspnea, oliguria and nausea, vomiting and diarrhea may occur. In clinical

evaluation, hypovolemia, hemoconcentration, electrolyte imbalance, acid,

hemoperitoneum, pleural effusion, hydrothorax, acute pulmonary distress and thromboembolic

events may occur.

gonadotropin treatment bCG is administered to induce ovulation

Overgrowth i rarely causes OHSS, as long as not. Therefore, hCG should not be performed in the case of OHSS.

In such a case, the treated couplesexual intercourse orfor at least 4 days

should be informed about not having using condoms. The OHSS can progress rapidly (from 24 hours to

a few days) and become a serious event. Therefore,after hCG administration

patients should be followed up for at least two weeks.

In order to minimize the risk of OHSS and multiple pregnancies,level estradiol in the serum

it is recommended to measure the and perform ultrasound screening. In the case of anovulation, the OHSS

risk of and multiple pregnancies increases when serum estradiol is> 900 pg / ml (3300 pmol / L) and more 14 mm or greater

than three follicles with a diameter of are present. When assisted reproductive techniques are

used, the risk of OHSS increases when serum oestradiol> 3000 pg / ml (11000 pmol / L) and12 mm or

20 or more follicles with a diameter of greater are present. When estradiol levels are

> 5500 pg / ml (20200 pmol / L) and a total of 40 or more follicles are

present, it may be necessary to discontinue hCG therapy.

The recommended dose of MERIONAL® and adherence to the application sequence, careful patient during treatment

follow-up of the will reduce the incidence of ovarian hyperstimulation and also the occurrence of multiple pregnancies.

In assisted reproductive techniques, aspiration of all follicles prior to ovulation

will reduce the occurrence of hyperstimulation.

OHSS can be more serious and prolonged if pregnancy occurs. OHSS often hormonal therapy

occurs after t

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