HISTRELIN ACETATE - Zoekresultaten

Verenigde Staten - Engels - NLM (National Library of Medicine)

supprelin la- histrelin acetate implant

endo usa, inc. - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) - histrelin acetate 50 mg - supprelin la (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (cpp). children with cpp (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). they also show a significantly advanced bone age that can result in diminished adult height attainment. prior to initiation of treatment a clinical diagnosis of cpp should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (lh) and follicle stimulating hormone (fsh) following stimulation with a gnrh analog, and assessment of bone age versus chronological age. baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia. supprelin la is contraindicated in: - patients who are hypersensitive to gonadotropin releasing hormone (gnrh) or gnrh agonist analogs - pregnancy [see use in specific populations (8.1) ]. risk summary supprelin la is contraindicated during pregnancy [see contraindications (4)] since expected hormonal changes that occur with supprelin la treatment increase the risk for pregnancy loss. the limited data with histrelin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or adverse developmental outcomes. consistent with mechanism of action for supprelin la [see clinical pharmacology (12.1)], animal reproduction studies showed an increase in fetal loss at clinically relevant exposures. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data histrelin acetate administered to pregnant rats during the period of organogenesis increased fetal mortality and post-implantation loss at doses of 1, 3, 5 or 15 mcg/kg/day, approximating clinical exposure based on body surface area. these dosages also reduced maternal body weight gain, stimulated ovarian follicular development, increased placental weight and caused abnormal morphology and an increase in fetal size. histrelin acetate administered to pregnant rabbits during the period of organogenesis increased fetal mortality and abortion/early termination at the two highest doses and caused total litter loss at all doses of 20, 50 or 80 mcg/kg/day (approximately 3- to 12-times clinical exposures based on body surface area). risk summary there are no data on the presence of supprelin la in human or animal milk, the effects on the breastfed infant, or the effects on milk production. absorption and systemic activity are not expected from potential exposure to the peptide, histrelin, in the breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for supprelin la and any potential adverse effects on the breastfed child from supprelin la or from the underlying maternal condition. safety and effectiveness in pediatric patients below the age of 2 years have not been established. the use of supprelin la in children under 2 years is not recommended.

Verenigde Staten - Engels - NLM (National Library of Medicine)

vantas- histrelin acetate implant

endo pharmaceuticals inc. - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) - histrelin acetate 50 mg - vantas is indicated for the palliative treatment of advanced prostate cancer. vantas is contraindicated in patients who are hypersensitive to gonadotropin releasing hormone (gnrh) or gnrh agonist analogs. risk summary the safety and efficacy of vantas have not been established in females. based on findings in animal studies and its mechanism of action, vantas can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . expected hormonal changes that occur with vantas treatment increase the risk for pregnancy loss. the limited data with histrelin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or adverse developmental outcomes. in animal reproduction studies, administration of histrelin to pregnant rats and rabbits during the period of organogenesis caused an increase in fetal loss at clinically relevant exposures (see data) . advise pregnant patients and females of reproductive potential of the potential risk to the fetus. d

Verenigde Staten - Engels - NLM (National Library of Medicine)

histrelin acetate powder

attix pharmaceuticals - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) -

Verenigde Staten - Engels - NLM (National Library of Medicine)

histrelin acetate powder

zhejiang peptites biotech co., ltd - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) -

Verenigde Staten - Engels - NLM (National Library of Medicine)

ax pharmaceutical histrelin acetate powder

ax pharmaceutical corp - histrelin acetate (unii: qmg7hld1ze) (histrelin acetate - unii:qmg7hld1ze) - histrelin acetate .99 g in 1 g

Frankrijk - Frans - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

vantas 50 mg, implant

orion corporation - histréline (acétate d') - implant - 50 mg - composition pour un implant > histréline (acétate d') : 50 mg - hormones libérant la gonadotropine