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

viva global brands llc - 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. place enough product in your palm to thoroughly cover your hands rub hands together briskly until dry children under 6 years of age should be supervised when using this product stop use and ask a physician if skin irritation or rash develops.

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

viva products - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - hand & skin antiseptic hand & skin antiseptic to help decrease pathogens (germs) on the skin open wounds or serious burns. irritation or redness develops or persists for 72 hours.

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

viva products - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - hand & skin antiseptic hand & skin antiseptic to help decrease pathogens (germs) on the skin open wounds or serious burns. irritation or redness develops or persists for 72 hours.

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

sanofi-aventis australia pty ltd - hepatitis a virus antigen, quantity: 160 elisa unit - injection, suspension - excipient ingredients: neomycin; formaldehyde; bovine serum albumin; polysorbate 80; aluminium hydroxide hydrate; phenoxyethanol; glucose monohydrate; ascorbic acid; sodium chloride; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - vivaxim is indicated for simultaneous active immunisation against typhoid fever and hepatitis a virus infections in subject's aged 16 and older.

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

neos therapeutics brands, llc - amphetamine (unii: ck833kgx7e) (amphetamine - unii:ck833kgx7e) - amphetamine 3.1 mg - adzenys xr-odt is a central nervous system (cns) stimulant indicated for the treatment of attention deficit hyperactivity disorder (adhd) in patients 6 years and older [see clinical studies (14) ]. adzenys xr-odt is contraindicated: - in patients known to be hypersensitive to amphetamine, or other components of adzenys xr-odt. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see adverse reactions (6.2) ]. - patients taking monoamine oxidase inhibitors (maois), or within 14 days of stopping maois (including maois such a linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see warnings and precautions (5.7) , drug interactions 7.1]. the effect of adzenys xr-odt on labor and delivery in humans is unknown. amphetamine, in the enantiomer ratio present in adzenys xr-odt (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. these doses are approximately 2 and 12 times, respectively, the maximum recommended human dose (mrhd) for adolescents of 12.5 mg/day (as base), on a mg/m2 body surface area basis. fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 10 times the mrhd for adolescents on a mg/m2 basis) or greater to pregnant animals. administration of these doses was also associated with severe maternal toxicity. a study was conducted in which pregnant rats received daily oral doses of amphetamine (d- to lenantiomer ratio of 3:1, the same as in adzenys xr-odt) of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. these doses are approximately 0.8, 2, and 4 times the mrhd for adolescents of 12.5 mg/day (as base), on a mg/m2 basis. all doses caused hyperactivity and decreased weight gain in the dams. a decrease in pup survival was seen at all doses. a decrease in pup bodyweight was seen at 6 and 10 mg/kg which correlated with delays in developmental landmarks. increased pup locomotor activity was seen at 10 mg/kg on day 22 postpartum but not at 5 weeks post-weaning. when pups were tested for reproductive performance at maturation, gestational weight gain, number of implantations, and number of delivered pups were decreased in the group whose mothers had been given 10 mg/kg. a number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d, l-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function. there are no adequate and well-controlled studies in pregnant women. there are limited published data on the use of amphetamine in pregnant women. these data are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nonteratogenic effects amphetamines, such as adzenys xr-odt, may cause vasoconstriction, including vasoconstriction of placental blood vessels, and may increase the risk for intrauterine growth restriction. in addition, amphetamines can stimulate uterine contractions increasing the risk of premature delivery. premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. monitor infants born to mothers taking amphetamines for symptoms of withdrawal, such as feeding difficulties, irritability, agitation, and excessive drowsiness. based on limited case reports in published literature, amphetamine (d- or d, l-) is present in human milk at relative infant doses of 2% to 13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9 and 7.5. there are no reports of adverse effects on the breastfed infant and no effects on milk production. however, long-term neurodevelopmental effects on infants from stimulant exposure are unknown. because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with adzenys xr-odt. adzenys xr-odt has not been studied in the geriatric population. the safety and effectiveness have been established in pediatric patients with adhd ages 6 to 17 years of age in three adequate and well-controlled clinical trials of up to 4 weeks in duration [see adverse reactions (6.1), clinical pharmacology (12), clinical studies (14) ]. the safety and efficacy of adzenys xr-odt in pediatric patients less than 6 years have not been established. long-term growth suppression growth should be monitored during treatment with stimulants, including adzenys xr-odt, in pediatric patients aged 6 to 17 years who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.5) ]. juvenile animal data in a juvenile developmental study, rats received daily oral doses of amphetamine (d to l enantiomer ratio of 3:1, the same as in adzenys xr-odt) of 2, 6, or 20 mg/kg on days 7 to 13 of age; from day 14 to approximately day 60 of age these doses were given twice daily for total daily doses of 4, 12, or 40 mg/kg. the latter doses are approximately 0.6, 2, and 6 times the maximum recommended human dose for children of 18.8 mg/day (as base), on a mg/m 2 basis. post dosing hyperactivity was seen at all doses; motor activity measured prior to the daily dose was decreased during the dosing period but the decreased motor activity was largely absent after an 18 day drug-free recovery period. performance in the morris water maze test for learning and memory was impaired at the 40 mg/kg dose, and sporadically at the lower doses, when measured prior to the daily dose during the treatment period; no recovery was seen after a 19 day drug-free period. a delay in the developmental milestones of vaginal opening and preputial separation was seen at 40 mg/kg but there was no effect on fertility. adzenys xr-odt contains amphetamine, a schedule ii controlled substance. adzenys xr-odt has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions (5.1)] . adzenys xr-odt can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of amphetamine may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including adzenys xrodt, can result in overdose and death [see overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. physical dependence adzenys xr-odt may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including adzenys xr-odt include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance adzenys xr-odt may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

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

jaymac pharmaceuticals llc - folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), ferrous fumarate (unii: r5l488ry0q) (iron - unii:e1uol152h7), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol acetate (unii: 9e8x80d2l0) (.alpha.-tocopherol - unii:h4n855pnz1), thiamine mononitrate (unii: 8k0i04919x) (thiamine - unii:x66nso3n35), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), pyridoxine hydrochlorid - folic acid 1 mg - viva® ct prenatal chewable is indicated for the distinct nutritional requirements of individuals in need of prenatal/postnatal dietary supplementation as determined by a licensed medical practitioner. this product can be used fordietary management prior to conception. viva® ct prenatal chewable should be administered under the supervision of a licensed medical practitioner. viva® ct prenatal chewable is contraindicated in individuals with a known hypersensitivity to any of the ingredients.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

viva life science sdn. bhd. - wheat sprout powder; tomato powder; strawberry powder; spinach powder; pineapple powder; parsley powder; papaya powder; orange powder; carrot extract; bean sprout powder; alfalfa powder; carrot powder; cabbage powder -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

viva life science sdn. bhd. - barley -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

viva life science sdn. bhd. - ginkgo biloba extract -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

viva life science sdn. bhd. - ginkgo biloba extract -