United States - English - NLM (National Library of Medicine)

allergan, inc. - triptorelin pamoate (unii: 08an7wa2g0) (triptorelin - unii:9081y98w2v) - triptorelin 3.75 mg in 2 ml - trelstar is indicated for the palliative treatment of advanced prostate cancer [see  clinical studies (14) ]. trelstar is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other gnrh agonists or gnrh [see warnings and precautions (5.1) ]. risk summary based on findings in animal studies and mechanism of action, trelstar can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ] . expected hormonal changes that occur with trelstar treatment increase the risk for pregnancy loss. in animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. advise pregnant patients and females of reproductive potential of the potential risk to the fetus. dat

United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - triptorelin pamoate (unii: 08an7wa2g0) (triptorelin - unii:9081y98w2v) - triptorelin 3.75 mg in 2 ml

United States - English - NLM (National Library of Medicine)

verity pharmaceuticals inc. - triptorelin pamoate (unii: 08an7wa2g0) (triptorelin - unii:9081y98w2v) - trelstar is indicated for the treatment of advanced prostate cancer [see  clinical studies (14) ]. trelstar is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other gnrh agonists or gnrh [see warnings and precautions (5.1) ]. risk summary based on findings in animal studies and mechanism of action, trelstar can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ] . expected hormonal changes that occur with trelstar treatment increase the risk for pregnancy loss. in animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. advise pregnant patients and females of reproductive potential of the potential risk to the fetus. data animal data studies in pregnant rats administered triptorelin at doses of 2, 10, and 100 mcg/kg/day (approximately equivalent to 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area) during the period of organogenesis demonstrated maternal toxicity and embryo-fetal toxicities.  embryo-fetal toxicities consisted of pre-implantation loss, increased resorption, and reduced mean number of viable fetuses at the high dose.  teratogenic effects were not observed in viable fetuses in rats or mice.  doses administered to mice were 2, 20, and 200 mcg/kg/day (approximately equivalent to 0.1, 0.7, and 7 times the estimated human daily dose based on body surface area).     the safety and efficacy of trelstar have not been established in females.  there are no data on the presence of triptorelin in human milk, the effects of the drug on milk production, or the effects of the drug on the breastfed child.  because of the potential for serious adverse reactions in a breastfed child from trelstar, a decision should be made to either discontinue breastfeeding, or discontinue the drug taking into account the importance of the drug to the mother. infertility males based on mechanism of action, trelstar may impair fertility in males of reproductive potential [see clinical pharmacology (12.1)] . safety and effectiveness in pediatric patients have not been established. prostate cancer occurs primarily in an older population.  clinical studies with trelstar have been conducted primarily in patients ≥ 65 years [see  clinical pharmacology (12.3) and clinical studies (14) ]. subjects with renal impairment had higher exposure than young healthy males [see  clinical pharmacology (12.3) ]. subjects with hepatic impairment had higher exposure than young healthy males [see  clinical pharmacology (12.3) ].

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ipsen sa-nv - triptorelin pamoate 31 mg - eq. triptorelin 22,5 mg - powder and solvent for prolonged-release suspension for injection - 22,5 mg - triptorelin pamoate 31 mg - triptorelin

Ireland - English - HPRA (Health Products Regulatory Authority)

ipsen pharmaceuticals limited - triptorelin pamoate - powder and solvent for prolonged-release suspension for injection - 22.5 milligram(s) - gonadotropin releasing hormone analogues; triptorelin

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - triptorelin - powder and solvent for suspension for injection - 11.25 milligram(s) - triptorelin

Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - triptorelin - powder and solvent for suspension for injection - 11.25 milligram(s) - triptorelin

Singapore - English - HSA (Health Sciences Authority)

ipsen pharma singapore pte. ltd. - triptorelin pamoate eqv. triptorelin - injection, powder, for suspension, extended release - 11.25 mg/vial - triptorelin pamoate eqv. triptorelin 11.25 mg/vial

Ireland - English - HPRA (Health Products Regulatory Authority)

ipsen pharmaceuticals limited - triptorelin - powder and solvent for suspension for injection - 11.25 milligram(s) - gonadotropin releasing hormone analogues; triptorelin

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ipsen sa-nv - triptorelin pamoate - eq. triptorelin 11,25 mg - powder and solvent for suspension for injection - 11,25 mg - triptorelin pamoate - triptorelin