Israel - English - Ministry of Health

tzamal bio-pharma ltd - clonazepam - drops - clonazepam 2.5 mg/ml - clonazepam - clonazepam - anti-epileptic. panic disorder.

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

roche products pty ltd - clonazepam -

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

roche products pty ltd - clonazepam -

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - clonazepam 1 mg/ml - injection with diluent - 1 mg - active: clonazepam 1 mg/ml excipient: benzyl alcohol ethanol glacial acetic acid propylene glycol water for injection - most clinical forms of epilepsy in infants and children, in particular typical and atypical absences (lennox-gastaut syndrome), nodding spasms, primary or secondary generalised tonic-clonic seizures. in adults, rivotril may be used in all varieties of generalised epilepsy (including absence, myoclonic, akinetic, tonic and tonic-clonic seizures), and in partial (focal) epilepsy (including psychomotor seizures).

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - clonazepam 2.5 mg/ml; clonazepam 2.5 mg/ml - oral solution - 2.5 mg/ml - active: clonazepam 2.5 mg/ml excipient: acetic acid peach flavour phl-014725 propylene glycol saccharin sodium active: clonazepam 2.5 mg/ml excipient: acetic acid brilliant blue fcf peach flavour phl-014725 propylene glycol saccharin sodium - most clinical forms of epilepsy in infants and children, in particular typical and atypical absences (lennox-gastaut syndrome), nodding spasms, primary or secondary generalised tonic-clonic seizures. in adults, rivotril may be used in all varieties of generalised epilepsy (including absence, myoclonic, akinetic, tonic and tonic-clonic seizures), and in partial (focal) epilepsy (including psychomotor seizures).

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

recordati rare diseases, inc. - cysteamine hydrochloride (unii: if1b771svb) (cysteamine - unii:5ux2sd1ke2) - cystadrops is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis. none. risk summary there are no adequate and well-controlled studies of ophthalmic cysteamine in pregnant women to inform any drug associated risks. oral administration of cysteamine to pregnant rats throughout the period of organogenesis was teratogenic at doses 240 to 960 times the recommended human ophthalmic dose (based on body surface area) [ see data] . cystadrops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data teratology studies have been performed in rats at oral doses in the range of 37.5 mg/kg/day to 150 mg/kg/day (240 to 960 times the recommended human ophthalmic dose based on body surface area) and have shown cysteamine bitartrate to be teratogenic. observed teratogenic findings were intrauterine death, cleft palate, kyphosis, heart ventricular septal defects, microcephaly, exencephaly, and growth deficits. risk summary there is no information regarding the presence of cysteamine in human milk, the effects on the breastfed infants, or the effects on milk production. cysteamine administered orally is present in milk of lactating rats. it is not known whether measurable levels of cysteamine would be present in maternal milk following topical ocular administration of cystadrops. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cystadrops and any potential adverse effects on the breastfed child from cystadrops or from the underlying maternal conditions. the safety and effectiveness of cystadrops has been established in pediatric patients. use of cystadrops is supported by adequate and well controlled trials in pediatric patients and additional experience supporting the safety of cystadrops. clinical studies of cystadrops did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.  the effect of renal impairment on the pharmacokinetics of cysteamine following ophthalmic administration of cysteamine ophthalmic solution has not been evaluated. clearance of cysteamine from the conjunctival sac of the eye is not dependent on renal function and the total systemic dose is negligible, so impaired renal function is unlikely to affect total body clearance. the total daily ophthalmic dose is less than 4% of the recommended oral daily dose of cysteamine; thus, the systemic exposure following ophthalmic administration is expected to be negligible compared to oral administration.

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

pharmaco australia ltd - clonazepam, quantity: 2.5 mg/ml - oral liquid, solution - excipient ingredients: saccharin sodium; propylene glycol; brilliant blue fcf; glacial acetic acid; flavour - tablets. most types of epilepsy in infants and children, especially absences (petit mal), myoclonic seizures and tonic-clonic fits, whether due to primary generalised epilepsy, or to secondary generalisation of partial epilepsy. in adults all varieties of generalised epilepsy, (including myoclonic, akinetic, tonic and tonic-clonic seizures), and in partial epilepsy (including psychomotor seizures). injection. intravenous use for status epilepticus only. note. efficacy by the intramuscular route has not need demonstrated.

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

pharmaco australia ltd - clonazepam, quantity: 0.5 mg - tablet, uncoated - excipient ingredients: iron oxide red; magnesium stearate; pregelatinised potato starch; purified talc; maize starch; iron oxide yellow; lactose monohydrate - tablets: most types epilepsy in infants and children, especially absences (petit mal), myoclonic seizures and tonic-clonic fits, whether due to primary generalised epilepsy, or to secondary generalisation of partial epilepsy. in adults all varieties of generalised epilepsy (including myoclonic, akinetic, tonic and tonic-clonic seizures), and in partial epilepsy (including psychomotor seizures).

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

pharmaco australia ltd - clonazepam, quantity: 1 mg - diluent, not applicable - excipient ingredients: water for injections - injection: intravenous use, for status epilepticus.

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

aspen pharma pty ltd - atropine sulfate monohydrate, quantity: 9.9737 mg/ml - eye drops, solution - excipient ingredients: boric acid; disodium edetate; benzalkonium chloride; hypromellose; water for injections - indications as at 06 august 1999: atropt eye drops are indicated where it is necessary to dilate the pupil and paralyse accomodation.