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

apotex corp. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 100 mg - gabapentin is indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http:/www.aedpregnancyregistry.org/ risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and

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

apotex pty ltd - nevirapine -

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - oxytocin 10 iu/ml equivalent to 16.7 microgram/ml - solution for injection - 10 iu/ml - active: oxytocin 10 iu/ml equivalent to 16.7 microgram/ml excipient: acetic acid chlorobutanol hemihydrate water for injection - antepartum: - induction of labour for medical reasons, e.g. in cases of post-term gestation, premature rupture of the membranes, pregnancy-induced hypertension (pre-eclampsia). - enhancement of labour in selected cases of uterine inertia. - oxytocin may also be indicated in early stage of pregnancy, as adjunctive therapy for management of incomplete, inevitable or missed abortion.

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - oxytocin 5 iu/ml equivalent to 8.33 microgram/ml - solution for injection - 5 iu/ml - active: oxytocin 5 iu/ml equivalent to 8.33 microgram/ml excipient: acetic acid chlorobutanol hemihydrate water for injection - antepartum: - induction of labour for medical reasons, e.g. in cases of post-term gestation, premature rupture of the membranes, pregnancy-induced hypertension (pre-eclampsia). - enhancement of labour in selected cases of uterine inertia. - oxytocin may also be indicated in early stage of pregnancy, as adjunctive therapy for management of incomplete, inevitable or missed abortion.

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

apotex pty ltd - pioglitazone hydrochloride -

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

apotex pty ltd - midazolam -

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

apotex pty ltd - midazolam -

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

apotex pty ltd - midazolam -

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

apotex pty ltd - midazolam -

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

apotex pty ltd - capecitabine -