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Microrelin 3.75 mg ( Triptorelin S.R.)

Microrelin : is used in the management of advanced hormone dependent prostate cancer
Microrelin : A synthetic agonist of the the Luteinizing Hormone Releasing Hormone (LHRH or GnRH) which possesses greater potency than the natural hormone.
The sustained release formulation of Microrelin allows continuous release of the drug over 30days so that 3.75mg of triptorelin peptide correspond to a maximum dose of 0.100mg/day plus a 25% excess.
Plasma DHEA (Dihydroepiandresterone) levels are not influenced which therapeutically leads to a decrease in grows of testosterone sensitive prostate tumors in men.
Microrelin is well tolerated by patients.
Microrelin can be stored in room temperature.
Microrelin is owned by Pooyesh Darou Trading Co. and manufacturing know and technology was transfer by PRIMM Co. Italy.
Microrelin is proved by GLP lab in Italy , Europe , and Ministry of Health, I.R.IRAN.

Sustained-release preparation for monthly intramuscular administration lease to an initial olasma peak during the first 3 hours and then triptorelin plasma levels decrease and remain stable at a plateau for 28 days. When the sex hormone testosterone is measured , its levels increase initially, then fall below the castration levels and remain below this level for least 4 weeks.

Abbreviated prescribing information
Microrelin 3.75mg , active ingredient: triptorelin acetate presentation and composition : One vial contains injectable amount 3.75mg triptorlin in PLGA(polymer for microcapsules) 157mg, manitol cellulose 30mg, Sterile water for injection (2mL).
Pharmacology
Microrelin is a synthetic decapeptide agonist analog of naturally occurring gonadotropin releasing hormone(GnRH). This analog possesses greater potency than the natural hormone. 1xLGnkc2 acts as potent inhibitor of gonadotropin secretion when given continuously in therapeutic doses. On administration of 1xLGnkc2 there is an initial and transient increase simulating hormone(FSH) and testosterone . chronic in an inhibition of pituitary LH and FSH secretion and level. These results are generally reversible upon discontinuation of drug therapy.

Therapeutic indications
Advanced hormone dependent prostatic cancer. Other situations where lowering of sex steroid serum levels to castrate level is desired, such as endometriosis , uterine myoma . Microrelin is combined with other uterine myoma. Microrelin is combined with other gonadotropines when used for in vitro fertilization procedures. Besides Microrelin is used in treatment of confirmed central precocious puberty (girls under 9years, boys under 10years).
Dosage and method of administration: Locally advanced non-metastatic prostate cancer
By intramuscular injection, 3.75mg every four weeks.
3.75mg every four weeks starting during first five days of menstrual five days of menstrual cycle; for uterine fibroids continue treatment for at least 3months; maximum duration of treatment 6 months (no repeated). For more information consult your doctor.

Contraindication
Proven non hormone dependent carcinoma , after surgical castration. Microrelin should not be used in patients with hypersensivity to triptorelin or any of its components. It is contraindicated in women who are or may become pregnant while receiving the drug and in nursing women.

Special warnings and precautions for use
As like other GnRH agonists cause a transient increase in serum concentration of testosterone during the first weeks of treatment, patients may experience worsening of symptoms or onset of new symptoms, including bone pain, neuropathy, hematuria, urethral or bladder outlet obstruction.

Men
The use of Microrelin has to be carefully evaluated in patients with premonitory signs of modularly compression and the medical surveillance has to be closer in the first weeks of treatment, particular in patients with spinal metastases. In order to prevent accentuation of the clinical symptoms, supplementary administration of an appropriate antiandrogen agent should be considered in the initial phase of the treatment.

Women
Pregnancy should be precluded prior to treatment. Menstruation does not occur during treatment of uterine myomas and endometriosis. A superventing metrorrhagia in the course of treatment is abnormal (apart from the first month) and should lead to verification of plasma estrogen level, During treatment of uterine myomas the size of uterus and myoma should be determined regularly, e.g. by means of ultrasonography. Treatment with Microrelin over several months can lead to a decrease of bone density so the therapy should not exceed a duration of 6 months.

Children
The chronological age at the beginning of therapy should be under 9 years in girls and under 10 years in boys. After finalizing the therapy, development of puberty characteristics will occur. Information with regards to future fertility is still limited.

Side effects
As seen with other GnRH agonists therapies, the most commonly observed adverse events during triptorelin treatment are due to the expected physiological effects related to decreased testosterone levels, these effects included hot flushes, impotence, and decreased libido. Due to a transient increase in serum cencerntration of testosterone during the first weeks of treatment, potential exacerbations of signs and symptoms of the disease during the first few weeks of treatment are of concern in patients with vertebral meta stases and/or urinary obstruction or hematuria. If these conditions are aggravated it may lead to neurological , problems such as weakness and/or paresthesia of the lower limbs or worsening of urinary symptoms. In rare cases allergic reaction or more rarely nausea, vomiting, weight gain, hypertension, mood disorders, visual disturbances, fever or pain at the injection site may occur.

Use in pregnancy and lactation
It is contraindicated in women who are or may become pregnant while receiving the drug and in nursing women.

Special precautions for storage
Microrelin should not be stored under 15°C and above 25°C. Keep out if the reach and sight of children.

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