Filippini - Ingliż - FDA (Food And Drug Administration)

biotech research labs inc - ascorbic acid - tablet - 500mg

Filippini - Ingliż - FDA (Food And Drug Administration)

brymar pharmaceutical - ascorbic acid - tablet - 500mg

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - ascorbic acid 100 mg/ml - solution for injection - 500 mg/5ml - active: ascorbic acid 100 mg/ml excipient: benzyl alcohol sodium bicarbonate sodium chloride thiourea water for injection

Namibja - Ingliż - Namibia Medicines Regulatory Council

fresenius kabi manufacturing sa (pty) ltd - each 5ml ampoule contains ascorbic acid 500mg - injection - each 5ml ampoule contains ascorbic acid 500mg

Kenja - Ingliż - Pharmacy and Poisons Board

asence pharma private limited sarabhai campus dr. vikram sarabhai marg wadi - ascorbic acid 500mg - tablet - ascorbic acid 500mg - plain ascorbic acid (vitamin c)

Filippini - Ingliż - FDA (Food And Drug Administration)

vital c health products, inc. - ascorbic acid (as sodium ascorbate) - capsule - 568.18 mg (equivalent to ascorbic acid 500 mg)

Filippini - Ingliż - FDA (Food And Drug Administration)

westfield pharmaceuticals, inc. - ascorbic acid (as sodium ascorbate) - capsule - 562.43mg (equivalent to ascorbic acid 500mg)

Stati Uniti - Ingliż - NLM (National Library of Medicine)

merit pharmaceutical - ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r) - ascorbic acid 500 mg in 1 ml

Stati Uniti - Ingliż - NLM (National Library of Medicine)

mcguff pharmaceuticals, inc. - ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r) - ascorbic acid 500 mg in 1 ml - ascor is vitamin c indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated. limitations of use ascor is not indicated for treatment of vitamin c deficiency that is not associated with signs and symptoms of scurvy. none. use in specific populations 8.1 pregnancy 8.2 lactation 8.4 pediatric use 8.5 geriatric use 8.6 renal impairment 8.1 pregnancy risk summary there are no available data on use of ascor in pregnant women to inform a drug-associated risk of adverse developmental outcomes; however, use of ascorbic acid (vitamin c) has been used during pregnancy for several decades and no adverse developmental outcomes are reported in the published literature [see data]. there are dose adjustments for ascorbic acid (vitamin c) use during pregnancy [ see clinical considerations ]. animal reproduction studies have not been conducted with ascor. 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 2-4% and 15-20%, respectively. clinical considerations dose adjustments during pregnancy and post-partum period follow the u.s. recommended dietary allowances (rda) for pregnant women when considering use of ascor for treatment of scurvy [ see dosage and administration (2.3 )]. data human data there are no available data on use of ascor or another ascorbic acid injection in pregnant women. however, a published meta–analysis of randomized studies evaluating a large number of pregnant women who took oral ascorbic acid (vitamin c) (through diet and supplementation) at doses ranging from 500 to1000 mg/day (2.5 to 5 times the recommended daily intravenous dose, respectively) [ see dosage and administration (2.3) ] between the 9th and 16th weeks of pregnancy showed no increased risk of adverse pregnancy outcomes such as miscarriage, preterm premature rupture of membranes, preterm delivery or pregnancy induced hypertension when compared to placebo. these data cannot definitely establish or exclude the absence of a risk with ascorbic acid (vitamin c) during pregnancy. 8.2 lactation risk summary there are no data on the presence of ascorbic acid (vitamin c) in human milk following intravenous dosing in lactating women. ascorbic acid (vitamin c) is present in human milk after maternal oral intake. maternal oral intake of ascorbic acid (vitamin c) exceeding the u.s. recommended dietary allowances (rda) for lactation does not influence the ascorbic acid (vitamin c) content in breast milk or the estimated daily amount received by breastfed infants. there are no data on the effect of ascorbic acid (vitamin c) on milk production or the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ascor and any potential adverse effects on the breastfed child from ascor or from the underlying maternal condition. follow the u.s. recommended dietary allowances (rda) for lactating women when considering use of ascor for treatment of scurvy [see dosage and administration (2.3) ]. 8.4 pediatric use ascor is indicated for the short term (up to 1 week) treatment of scurvy in pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated. the safety profile of ascorbic acid in pediatric patients is similar to adults; however, pediatric patients less than 2 years of age may be at higher risk of oxalate nephropathy following ascorbic acid administration due to age-related decreased glomerular filtration [ see warnings and precautions (5.1 )]. ascor is not indicated for use in pediatric patients less than 5 months of age. 8.5 geriatric use glomerular filtration rate is known to decrease with age and as such may increase risk for oxalate nephropathy following ascorbic acid administration in elderly population [ see warnings and precautions (5.1 ) ]. 8.6 renal impairment ascor should be used with caution in scorbutic patients with a history of or risk of developing renal oxalate stones or evidence of renal impairment or other issues (e.g., patients on dialysis, patients with diabetic nephropathy, and renal transplant recipients). these patients may be at increased risk of developing acute or chronic oxalate nephropathy following high dose ascorbic acid administration [ see warning and precaution (5.1 ].

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - ascorbic acid, quantity: 100 mg/ml - injection, solution - excipient ingredients: sodium bicarbonate; sodium chloride; thiourea; benzyl alcohol; water for injections - this product accepted for registration/listing as 'currently supplied' at the time of commencement of the act. indications held in artg paper records. (old code) prevention and treatment of ascorbic acid deficiency (i.e. scurvy) when oral therapy is contraindicated. as a supplement during periods of increases requirements, only if needs cannot be met from normal dietary sources and oral supplemental therapy is contraindicated, e.g. wound healing, burns, infections, trauma, post-operatively and in thyrotoxicosis. as an adjunct in the treatment of idiopathic methaemoglobinaemia. the use ascorbic acid with desferrioxamine therapy to increase iron excretion remains unsubstantiated. injectable ascorbic acid is administrated for the above indications where oral administration is not possible, or in which medication given by the oral route will not be sufficiently absorbed. indications as at 8 january 2004: prevention and treatment of ascorbic acid deficiency (i.e. scurvy) when oral therapy is contraindicated. as a