Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions ( 5.3 )] . pregnancy category c there are no adequate and well-controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbits (

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . pregnancy category c there are no adequate and well-controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbi

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate tablets usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome. topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache. none pregnancy category d  [see  warnings and precautions 5.7 ] topiramate  can cause fetal harm when administered to a pregnant woman. data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts). when multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weigh

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - cyclobenzaprine hydrochloride (unii: 0ve05jys2p) (cyclobenzaprine - unii:69o5wqq5ti) - cyclobenzaprine hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. hypersensitivity to any component of this product. concomitant use of monoamine oxidase (mao) inhibitors or with

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

compass health brands corp. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - on children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

Μάλτα - Αγγλικά - Malta Medicines Authority

novartis ireland limited vista building, elm park, merrion road, ballsbridge, dublin 4,, ireland - fluorometholone acetate - eye drops, suspension - fluorometholone acetate 1 mg/ml - ophthalmologicals

Αυστραλία - Αγγλικά - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - herpes virus of turkeys (hvt) strain fc 126 - parenteral liquid/solution/suspension - herpes virus of turkeys (hvt) strain fc 126 vaccine-viral active 0.0 pfu/dose - immunotherapy - poultry | breeders | broiler | chickens | chicks | chooks | day old chicks | hatchlings | layers - marek's disease | herpes virus of turkeys (hvt)

Νέα Ζηλανδία - Αγγλικά - Ministry for Primary Industries

de sangosse sa - metaldehyde - metaldehyde 50 g/kg - molluscicide

Νέα Ζηλανδία - Αγγλικά - Ministry for Primary Industries

de sangosse sa - metaldehyde - metaldehyde 40 g/kg - molluscicide

Ιρλανδία - Αγγλικά - HPRA (Health Products Regulatory Authority)

alcon laboratories (uk) ltd - fluorometholone acetate - eye drops suspension - 0.1 %w/v