USA - engelsk - NLM (National Library of Medicine)

akorn, inc. - hyaluronidase (unii: 8kog53z5em) (hyaluronidase - unii:8kog53z5em) - hydase™ (hyaluronidase injection) is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs. hydase™ is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. hydase™ is indicated as an adjuvant in subcutaneous urography for improving resorption of radiopaque. hydase™ contraindicated in patients with known hypersensitivity to hyaluronidase or any other ingredient in the formulation. a preliminary skin test for hypersensitivity to hydase™ 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 [see dosage and administration (2) ]. a positive reaction consists of a wheal with pseudopods appearing within five 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 hydase™ if sensitization occurs. no adequate and well controlled animal studi

USA - engelsk - NLM (National Library of Medicine)

amphastar pharmaceuticals, inc. - hyaluronidase (unii: 8kog53z5em) (hyaluronidase - unii:8kog53z5em) - amphadase® is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. amphadase® is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. amphadase® is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. hypersensitivity to hyaluronidase or any other ingredient in the formulation is a contraindication to the use of this product. a preliminary skin test for hypersensitivity to amphadase® 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 amphadase® if sensitization occurs. pregnancy category c. no adequate and well controlled studies have been conducted with a

USA - engelsk - NLM (National Library of Medicine)

bausch & lomb incorporated - hyaluronidase (ovine) (unii: 64r4ohp8t0) (hyaluronidase, ovine - unii:64r4ohp8t0) - vitrase ® (hyaluronidase injection) is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. vitrase is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. vitrase is indicated as an adjuvant in subcutaneous urography for improving resorption of radiopaque agents. vitrase is contraindicated in patients with known hypersensitivity to hyaluronidase or any other ingredient in the formulation. discontinue vitrase if sensitization occurs. risk summary human studies of hyaluronidase as an aid to conception and as an aid to delivery have been conducted without reports of maternal or fetal harm. non-human animal reproduction studies have not been conducted with vitrase. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. clinical considerations hyaluronidase has been used as a component to aid the in vitro fertilization of human eggs. administration of hyaluronidase during labor was reported to cause no complications; no increase in blood loss or differences in cervical trauma were observed. risk summary there is no information regarding the presence of vitrase in human milk, the effects on breastfed infants, or the effects on milk production to inform risk of vitrase to an infant during lactation. the developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for vitrase, and any potential adverse effects on the breastfed infant from vitrase. the safety and effectiveness of vitrase have been established in pediatric patients. use of vitrase in these patients is supported by evidence from adequate and well-controlled studies. clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with vitrase. 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 overhydration by controlling the rate and total volume of the infusion [see dosage and administration (2.2)] . no overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - hyaluronidase - powder for solution for injection - 1500unit

USA - engelsk - NLM (National Library of Medicine)

janssen biotech, inc. - daratumumab (unii: 4z63yk6e0e) (daratumumab - unii:4z63yk6e0e), hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - darzalex faspro is indicated for the treatment of adult patients with multiple myeloma: - in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. - in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. - in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. - in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. - in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. - in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have receive

Malta - engelsk - Medicines Authority

wockhardt uk limited - hyaluronidase - powder for solution for infusion or injection - hyaluronidase 1500 international unit(s)/millilitre - other hematological agents

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - rituximab (unii: 4f4x42syq6) (rituximab - unii:4f4x42syq6), hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - rituximab 120 mg in 1 ml - rituxan hycela is indicated for the treatment of adult patients with: - relapsed or refractory, follicular lymphoma as a single agent. - previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy. - non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (cvp) chemotherapy. rituxan hycela is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (chop) or other anthracycline-based chemotherapy regimens. rituxan hycela is indicated, in combination with fludarabine and cyclophosphamide (fc), for the treatment of adult patients with previously untreated and previously treated cll. - initiate treatment with rituxan hycela only after patients

Malta - engelsk - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - hyaluronidase - powder for solution for injection/infusion - hyaluronidase 1500 iu - other hematological agents

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - hyaluronidase - powder for solution for injection - 1500unit

Israel - engelsk - Ministry of Health

propharm ltd - hyaluronidase - powder for solution for injection - hyaluronidase 1500 iu/ampoule - hyaluronidase - hyaluronidase - to enhance permeation of subcutaneous or intramuscular injections, local anesthetics and subcutaneous infusions to promote resorption of excess fluids and blood in the tissues .