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

chiesi australia pty ltd - stiripentol, quantity: 500 mg - capsule - excipient ingredients: sodium starch glycollate type a; magnesium stearate; povidone; gelatin; titanium dioxide; iron oxide black; shellac - diacomit is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (smei, also known as dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

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

chiesi australia pty ltd - stiripentol, quantity: 250 mg - capsule - excipient ingredients: sodium starch glycollate type a; magnesium stearate; povidone; gelatin; titanium dioxide; erythrosine; indigo carmine; shellac; iron oxide black - diacomit is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (smei, also known as dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

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

jurox pty limited - dexmedetomidine hydrochloride - parenteral liquid/solution/suspension - dexmedetomidine hydrochloride active 0.5 mg/ml - anaesthetics/analgesics - cat | dog | bitch | castrate | cat - queen | cat - tom | kitten | puppy - analgesic | pre-anaesthetic | restraint | sedative | anaesthetic premedicant | antipyretic | colic | muscle relaxant | sedative | spasmolytic

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

biocodex, inc. - stiripentol (unii: r02xot8v8i) (stiripentol - unii:r02xot8v8i) - diacomit is indicated for the treatment of seizures associated with dravet syndrome (ds) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. there are no clinical data to support the use of diacomit as monotherapy in dravet syndrome. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as diacomit, during pregnancy. physicians are advised to recommend that pregnant patients taking diacomit enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves or their caregiver. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of diacomit in pregnant women. administration of stiripentol to pregnant animals produced evidence of development

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

actelion pharmaceuticals us, inc. - macitentan (unii: z9k9y9wmvl) (macitentan - unii:z9k9y9wmvl) - macitentan 10 mg - opsumit is an endothelin receptor antagonist (era) indicated for the treatment of pulmonary arterial hypertension (pah, who group i) to reduce the risks of disease progression and hospitalization for pah. effectiveness was established in a long-term study in pah patients with predominantly who functional class ii–iii symptoms treated for an average of 2 years. patients had idiopathic and heritable pah (57%), pah caused by connective tissue disorders (31%), and pah caused by congenital heart disease with repaired shunts (8%) [see clinical studies (14.1)] . opsumit may cause fetal harm when administered to a pregnant woman. opsumit is contraindicated in females who are pregnant. opsumit was consistently shown to have teratogenic effects when administered to animals. if opsumit is used during pregnancy, advise the patient of the potential risk to a fetus [see warnings and precautions (5.1) and use in specific popul

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

chiesi australia pty ltd - stiripentol, quantity: 500 mg - powder, oral - excipient ingredients: sodium starch glycollate type a; povidone; spray-dried liquid glucose; erythrosine; titanium dioxide; aspartame; carmellose; hyetellose; flavour - diacomit is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (smei, also known as dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

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

chiesi australia pty ltd - stiripentol, quantity: 250 mg - powder, oral - excipient ingredients: sodium starch glycollate type a; povidone; spray-dried liquid glucose; erythrosine; titanium dioxide; aspartame; carmellose; hyetellose; flavour - diacomit is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (smei, also known as dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

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

janssen-cilag pty ltd - macitentan, quantity: 10 mg - tablet, film coated - excipient ingredients: sodium starch glycollate type a; magnesium stearate; microcrystalline cellulose; polysorbate 80; povidone; lactose monohydrate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - opsumit, as monotherapy or in combination with approved pah treatments (phosphodiesterase-5 inhibitors or inhaled prostanoids), is indicated for the treatment of: ?idiopathic pulmonary arterial hypertension ?heritable pulmonary arterial hypertension ?pulmonary arterial hypertension associated with connective tissue disease ?pulmonary arterial hypertension associated with congenital heart disease with repaired shunts in patients with who functional class ii, iii or iv symptoms.

New Zealand - English - Medsafe (Medicines Safety Authority)

chiesi new zealand limited t/a emerge health - stiripentol 250mg;   - capsule - 250 mg - active: stiripentol 250mg   excipient: erythrosine   gelatin   indigo carmine   ink black 10a2 magnesium stearate povidone sodium starch glycolate titanium dioxide   - indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (smei, also known as dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

New Zealand - English - Medsafe (Medicines Safety Authority)

chiesi new zealand limited t/a emerge health - stiripentol 500mg;   - capsule - 500 mg - active: stiripentol 500mg   excipient: gelatin   ink black 10a2 magnesium stearate povidone sodium starch glycolate titanium dioxide   - indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (smei, also known as dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.