Merional Vial ingredient Menopausal Gonadotrophin

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BRIEF PRODUCT DETAILS

2- QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Menotropin 75 IU

[75 IU human follicle stimulating hormone (FSH) and 75 IU luteinizing hormone ( LH) corresponding

menopausal gonadotropin (HMG)]

Excipients:

Lactose monohydrate 10 mg

Sodium chloride 0.9% For

excipients see 6.1.

3- PHARMACEUTICAL FORM

Powder and solvent for injection solution

Powder: White lyophilized powder

Solvent: Clear colorless solution

4- CLNK PROPERTIES

4.1- Therapeutic indications

MERIONAL®,untreated

• For women who areto treatment with clomiphene citrate, including or irregular

not responding women anovulation (polycystic ovary syndrome (PCOS)) is

the case,

• in women, in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI),

transfer the gametes fallopian tube (GIFT) and transfer into the fallopian tubes of zygotes (ZIFT),

in such assisted reproductive technologies, multiple In controlled ovarian follicle development,

stimulation to stimulate

male patients with congenital or acquired hypogonadotropic hypogonadism

treatment of human chorionic gonadotropin (hCG) to induce spermatogenesis in

it is indicated with the.

4.2- Posology and administration form,

Posology / frequency and duration of

administration Anovulation in women (including PCOS): In the

case of anovulation (including PCOS), the aim of MERIONAL® treatment is to which hCG administration

develop a mature single Graaf follicle, in the egg is released after. MERIONAL®

can be administered in daily injections. In the menstrual treatment should menstrual cycle

period,start within the first 7 days of.

The dose measurement of the follicle size with the level of estradiol in the ultrasound and / or serum and

should be determined individually based on the the response of the patient to the treatment. The common practice is to start

treatment with MERIONAL® at a dose of 75-150 IU and dose according to the patient response

transfer the. The maximum recommended daily dose should not be higher than 225 IU. If4

after weeks of treatment the patient does not get an adequate response, the treatment should be stopped and the

treatment should be started with a higher dose than the previous one.

When adequate response is obtained,24-48 hours following the last dose of

5000-10.000 IU hCG should be administered MERIONAL® administered. The patient hCG injection and

is advised to have sex on the day of the following day. Alternatively, intrauterine insemination

(IUI) may be performed.

When over-response to treatment is obtained, treatment should be stopped and hCG should not be administered

(see 4.5). The treatment should be started at a lower other menstrual period than in the previous cycle

dose in the.

Anovulation due to severe LH and FSH failure in women In

these women (hypogonadotropic hypogonadism), the aim of MERIONAL® treatment is to hCG

develop a single mature Graaf follicle in which the egg is released after administration. Since these

women have no menstrual and the lower endogenous estrogen secretion is lower,

cycle treatment can be initiated at any time.

The dose assessed by measurement of follicle size with ultrasound and / or estrogen level

should be individually adjusted according to the individual response. The common practice is to start treatment 75-150

with MERIONAL® at a dose of IU and increase the dose according to the patient response.

When the dose of MERIONAL® is to be increased, the dose should be performed 7-14 days apart and preferably with an150 IU

increase of. The duration of stimulation in a cure can be extended up to 5 weeks.

When adequate response is obtained,24-48 hours the last dose of MERIONAL®

a single injection of 5000-10,000 IU hCG should be performed after administered. The patient hCG

is advised to have a sexual relationship on the day of injection and on the following day.

Alternatively, intrauterine insemination (IUI) may be performed.

Luteal Deficiency of luteotrophic substances (LH / hCG) after ovulation corpus

support should be considered because they can lead to premature loss of the luteum.

3 When over-

response to treatment is obtained, treatment should be stopped and hCG should not be administered

(see 4.5). The treatment should be started at a lower other menstrual period than in the previous cycle

dose in the.

Controlled Women undergoing assisted reproductive techniques for multiple follicle development

ovarian stimulation in:

According to the common practice for superovulation, treatment daily on day 2 or 3 of the cycle

begins at a dose of 150-225 IU and provides measurement of serum estrogen levels and / or ultrasound

adequate follicular development as determined by assessment. The Until According to the patient response

treatment is continued the dose determined(usually not more than 450 IU daily)

. Adequate follicular development ison the 10th day of the treatment (5-20 days)

achieved.

To initiate follicular maturation,hours after the last MERIONAL® administration

a single 5000-10,000 IU hCG injection is performed 244848.

Into suppress the endogenous luteinizing hormone (LH) flux and control the LH tonic levels,

order pituitary down-regulation is commonly gonadotropin releasing hormone (GnRH)

achieved using the agonist. According to the common practice, treatment with MERIONAL® is started starting

approximately two weeks after agonist therapy and sufficient both treatments

continued until follicular growth is achieved in. For example;hypophysis down-with the agonist for two weeks

Following Regulation, MERIONAL® is administered at a dose of 150-225 IU for the first seven days.

The dose is then adjusted according to the development in the egg of the patient.

Experience with assisted reproductive techniques generally shows that the success in the first 4 trials

rate remains constant, but the success rate in subsequent trials is decreasing