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

pierre fabre pharmaceuticals, inc. - propranolol hydrochloride (unii: f8a3652h1v) (propranolol - unii:9y8nxq24vq) - propranolol hydrochloride 4.28 mg in 1 ml - hemangeol oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. hemangeol is contraindicated in the following conditions: - premature infants with corrected age < 5 weeks - infants weighing less than 2 kg - known hypersensitivity to propranolol or any of the excipients [see description (11)] - asthma or history of bronchospasm - heart rate <80 beats per minute, greater than first degree heart block, or decompensated heart failure - blood pressure <50/30 mmhg - pheochromocytoma of 460 infants with proliferating infantile hemangioma requiring systemic therapy who were treated with hemangeol starting at 5 weeks to 5 months of age, 60% had complete or nearly complete resolution of their hemangioma at week 24 [see  clinical studies (14)]. safety and effectiveness for infantile hemangioma have not been established in pediatric

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

pierre fabre pharmaceuticals, inc. - vinorelbine tartrate (unii: 253gqw851q) (vinorelbine - unii:q6c979r91y) - vinorelbine 10 mg in 1 ml - navelbine is a vinca alkaloid indicated: - in combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) - as a single agent, for the treatment of patients with metastatic nsclc none risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1))] , navelbine can cause fetal harm when administered to a pregnant woman. available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively ( see data ). advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies ar

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

pierre fabre australia pty ltd - propranolol hydrochloride -

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

pierre fabre australia pty ltd - vinflunine ditartrate -

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

pierre fabre australia pty ltd - vinflunine ditartrate -

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

pierre fabre australia pty ltd - vinflunine ditartrate -

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

pierre fabre pharmaceuticals, inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 40 mg in 1 g - tolak (fluorouracil) cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp. tolak cream is contraindicated: - during pregnancy [see warnings and precautions (5.5, 8.1)] - in patients with dihydropyrimidine dehydrogenase (dpd) deficiency [see warnings and precautions (5.6)] tolak cream may cause fetal harm when administered during pregnancy and is contraindicated in women who are pregnant. if this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus. tolak cream is contraindicated in patients with dihydropyrimidine dehydrogenase (dpd) deficiency. teratogenic effects: pregnancy category x [see contraindications (4.1)] . cases of miscarriage and birth defects (including cleft lip and cleft palate) have been reported wh

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

pierre fabre australia pty ltd - milnacipran hydrochloride -

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

pierre fabre australia pty ltd - milnacipran hydrochloride -

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

pierre fabre australia pty ltd - milnacipran hydrochloride -