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

hf acquisition co llc, dba healthfirst - hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - 1.1 subcutaneous fluid administration hylenex recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. 1.2 dispersion and absorption of injected drugs hylenex recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. 1.3 subcutaneous urography 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. a preliminary skin test for hypersensitivity to hylenex recombinant can be performed. the skin test is made by an intradermal injection of approximately 0.02 ml (3 units) of a 150 unit/ml solution. a positive reaction consists of a wheal with pseudopods appearing within 5 minutes and persisting for 20 to 30 minutes and accompanied by localized itching. transient vasodilation at the site of the test, i.e., erythema, is

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.

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)

argenx us - efgartigimod alfa (unii: 961yv2o515) (efgartigimod alfa - unii:961yv2o515), hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - vyvgart hytrulo is indicated for the treatment of generalized myasthenia gravis (gmg) in adult patients who are anti-acetylcholine receptor (achr) antibody positive. vyvgart hytrulo is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products, to hyaluronidase, or to any of the excipients of vyvgart hytrulo. reactions have included anaphylaxis and hypotension leading to syncope [see warnings and precautions (5.2)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to vyvgart hytrulo during pregnancy. healthcare providers and patients may call 1-855-272-6524 or go to https://www.vyvgartpregnancy.com to enroll in or to obtain information about the registry. risk summary there are no available data on the use of vyvgart hytrulo or efgartigimod alfa containing products during pregnancy. there was no evidence of adverse developmental outcomes following the intravenous administration of efgartigimod alfa at up to 100 mg/kg/day in rats and rabbits (see data). the background rate of major birth defects and miscarriage in the indicated population is unknown. in the u.s. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. therefore, efgartigimod alfa may be transmitted from the mother to the developing fetus. as vyvgart hytrulo is expected to reduce maternal igg antibody levels, reduction in passive protection to the newborn is anticipated. risk and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to vyvgart hytrulo in utero [see warnings and precautions (5.1)]. data animal data vyvgart hytrulo for subcutaneous injection contains efgartigimod alfa and hyaluronidase [see description (11)] . efgartigimod alfa: hyaluronidase: risk summary there is no information regarding the presence of efgartigimod alfa or hyaluronidase, from administration of vyvgart hytrulo, in human milk, the effects on the breastfed infant, or the effects on milk production. maternal igg is known to be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vyvgart hytrulo and any potential adverse effects on the breastfed infant from vyvgart hytrulo or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of vyvgart hytrulo did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger adult patients. no dose adjustment of vyvgart hytrulo is needed for patients with mild renal impairment. there are insufficient data to evaluate the impact of moderate renal impairment (egfr 30-59 ml/min/1.73 m2 ) and severe renal impairment (egfr <30 ml/min/1.73 m2 ) on pharmacokinetic parameters of vyvgart hytrulo [see clinical pharmacology (12.3)].

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

bausch & lomb incorporated - hyaluronidase, ovine (unii: 64r4ohp8t0) (hyaluronidase, ovine - unii:64r4ohp8t0) - hyaluronidase, ovine 200 [usp'u] in 1 ml

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

ista pharmaceuticals, inc. - hyaluronidase, ovine (unii: 64r4ohp8t0) (hyaluronidase, ovine - unii:64r4ohp8t0) - hyaluronidase, ovine 200 [usp'u] in 1 ml

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

baxter healthcare corporation - hyaluronidase recombinant human (unii: 743quy4vd8) (hyaluronidase recombinant human - unii:743quy4vd8) - hyaluronidase recombinant human 150 [usp'u] in 1 ml

Malta - English - Medicines Authority

pinewood laboratories ltd ballymacarbry, clonmel, co. tipperary, ireland - hyaluronidase - powder for solution for infusion or injection - hyaluronidase 1500 iu/ml - other hematological agents

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

a-s medication solutions - hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - 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. a preliminary skin test for hypersensitivity to hylenex recombinant can be performed. the skin test is made by an intradermal injection of approximately 0.02 ml (3 units) of a 150 unit/ml solution. a positive reaction consists of a wheal with pseudopods appearing within 5 minutes and persisting for 20 to 30 minutes and accompanied by localized itching. transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction. discontinue hylenex recombinant if sensitization occurs. pregnancy category c. in an em