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) ].

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

united-ah ii, llc - triptorelin acetate (unii: 43ofw291r9) (triptorelin - unii:9081y98w2v) - triptorelin 100 ug in 1 ml - for the synchronization of time of insemination in weaned sows to facilitate a single fixed-time artificial insemination.  not approved for use in gilts.  safety and effectiveness have not been evaluated in these animals. use of a bottle mount multi-dose applicator is recommended to ensure accurate dosing. the use of adequate sperm numbers per insemination and proper semen storage, as recommended by the semen or artificial inseminator catheter suppliers, is recommended.

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

azurity pharmaceuticals, inc. - triptorelin (unii: 9081y98w2v) (triptorelin - unii:9081y98w2v) - triptorelin 22.5 mg in 2 ml - triptodur is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (cpp). - hypersensitivity: triptodur is contraindicated in individuals with a known hypersensitivity to triptorelin, any other component of the product, or other gnrh agonists or gnrh [see adverse reactions (6.2)] . - pregnancy: triptodur may cause fetal harm [see use in specific populations (8.1)] . risk summary triptodur is contraindicated in women who are pregnant [see contraindications (4)] since expected hormonal changes that occur with triptodur treatment increase the risk for pregnancy loss. available data with triptorelin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. based on mechanism of action in humans and findings of increased pregnancy loss in animal studies, triptodur may cause fetal harm when administered to pregnant women. advise pregnant women of the potential risk to a fetus. the estimated background risk of m

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

aurora pharmaceutical, inc. - triptorelin acetate (unii: 43ofw291r9) (triptorelin - unii:9081y98w2v) - for the synchronization of time of insemination in weaned sows to facilitate a single fixed-time artificial insemination.  not approved for use in gilts.  safety and effectiveness have not been evaluated in these animals. use of a bottle mount multi-dose applicator is recommended to ensure accurate dosing. the use of adequate sperm numbers per insemination and proper semen storage, as recommended by the semen or artificial inseminator catheter suppliers, is recommended.

Israel - English - Ministry of Health

ferring pharmaceuticals ltd - triptorelin acetate - solution for injection - triptorelin acetate 0.1 mg/ml - triptorelin - triptorelin - ivf

Israel - English - Ministry of Health

ferring pharmaceuticals ltd - triptorelin as embonate - powder and solvent for suspension for injection - triptorelin as embonate 11.25 mg - triptorelin - triptorelin - - lowering of sexual hormones and- treatment of advanced hormone-dependent prostate cancer.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

vetoquinol australia pty ltd - triptorelin acetate - unknown - triptorelin acetate anthelmintic active 0.0 - active constituent

Australia - English - Department of Health (Therapeutic Goods Administration)

ferring pharmaceuticals pty ltd - triptorelin acetate, quantity: 100 microgram (equivalent: triptorelin, qty 95.6 microgram/ml) - injection, solution - excipient ingredients: glacial acetic acid; water for injections; sodium chloride - decapeptyl 100 micrograms/1 ml is indicated for down-regulation and prevention of premature luteinising hormone (lh) surges in women undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (art).,in clinical trials decapeptyl 100 micrograms/1 ml has been used in cycles where urinary and recombinant human follicle stimulating hormone (fsh) as well as human menopausal gonadotrophin (hmg) were used for stimulation.