Nigeria - English - NAFDAC (National Agency for Food and Drugs Administration and Control)

ferrous gluconate b.p. 200mg, folic acid 5mg, vit. b1 5mg, vit. b2 2mg, vit. b12 0.005mg,

Nigeria - English - NAFDAC (National Agency for Food and Drugs Administration and Control)

ferrous gluconate b.p. 200mg, folic acid 5mg, vit. b1 5mg, vit. b2 2mg, vit. b12 0.005mg,

Bangladesh - English - DGDA (Directorate General of Drug Administration)

advanced chemical industries limited - cyanocobalamin + elemental iron + folic acid - capsule - 25 mg + 100 mg + 1 mg

Bangladesh - English - DGDA (Directorate General of Drug Administration)

advanced chemical industries limited - cyanocobalamin + elemental iron + folic acid - syrup - 25 mg + 100 mg + 1 mg/5 ml

Bangladesh - English - DGDA (Directorate General of Drug Administration)

advanced chemical industries limited - iron hydroxide polymaltose - syrup - 50 mg/5 ml

Bangladesh - English - DGDA (Directorate General of Drug Administration)

square pharmaceuticals plc, pabna - iron hydroxide polymaltose - syrup - 200 mg/5 ml

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

"kpe" zdorovye narodu" llc - amitriptyline (amitriptyline hydrochloride) - tablets - 25mg

Ireland - English - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - hyaluronidase - powder for solution for injection/infusion - 1500 international unit(s) - enzymes; hyaluronidase

Ireland - English - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd - hyaluronidase - powder for solution for injection/infusion - 1500 international unit(s) - enzymes; hyaluronidase

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

antares pharma, inc. - hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - hyaluronidase (human recombinant) 150 [usp'u] in 1 ml - hylenex recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. hylenex recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. hylenex recombinant is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. hylenex recombinant is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in hylenex recombinant. discontinue hylenex recombinant if sensitization occurs. risk summary there are no adequate and well-controlled studies of hylenex recombinant administration in pregnant women to inform a drug-associated risk. subcutaneous administration of hylenex recombinant to pregnant mice throughout organogenesis did not produce teratogenic effects at clinically relevant doses. administration of hylenex recombinant to mice in a pre-/postnatal study did not produce adverse effects on offspring at clinically relevant doses. human data limited available data with hylenex recombinant in pregnant women have not identified any potential risks. animal data in an embryofetal development study, subcutaneous administration of hyaluronidase to pregnant mice throughout organogenesis produced reduced fetal weight and increased numbers of fetal resorptions at daily doses greater or equal to 3 mg/kg (approximately 360,000 usp units/kg). no malformations were produced at any dose up to approximately 18 mg/kg (approximately 2,200,000 usp units/kg). these doses are several orders of magnitude greater than the maximum recommended human dose (5 usp units/kg). in a pre- and postnatal development study, mice were dosed daily by subcutaneous injection with hyaluronidase at dose levels up to 9 mg/kg (approximately 1,100,000 usp units/kg). the study found no adverse effects on sexual maturation, learning and memory of offspring, or their ability to produce another generation of offspring. risk summary there is no information regarding the presence of hylenex recombinant in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of hylenex recombinant to an infant during lactation. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hylenex recombinant. clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with hylenex recombinant. the dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. the potential for chemical or physical incompatibilities should be kept in mind [see drug interactions (7)]. the rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. for premature infants or during the neonatal period, the daily dosage should not exceed 25 ml/kg of body weight, and the rate of administration should not be greater than 2 ml per minute. during subcutaneous fluid administration, special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion [see dosage and administration (2.1)]. no overall differences in safety or effectiveness have been observed between elderly and younger adult patients.