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

roche products pty ltd - rituximab, quantity: 1600 mg - injection - excipient ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride; trehalose dihydrate; methionine; polysorbate 80; water for injections - mabthera sc 1600 mg is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.

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

roche products pty ltd - rituximab, quantity: 1400 mg - injection - excipient ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride; trehalose dihydrate; methionine; polysorbate 80; water for injections - mabthera sc is indicated for treatment of patients with: - cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin's lymphoma, - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma, - cd 20 positive, diffuse large b-cell non-hodgkin's lymphoma, in combination with chemotherapy.

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

janssen-cilag pty ltd - daratumumab, quantity: 1800 mg - injection, solution - excipient ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride monohydrate; sorbitol; methionine; polysorbate 20; water for injections - darzalex sc is indicated for the treatment of patients:,? with newly diagnosed multiple myeloma:,- who are eligible for autologous stem cell transplant. for use in combination with:-bortezomib, thalidomide, and dexamethasone.,- who are ineligible for autologous stem cell transplant. for use in combination with: - bortezomib, melphalan and prednisone, or - lenalidomide and dexamethasone.,? with multiple myeloma who have received: - at least one prior therapy. for use in combination with: - bortezomib and dexamethasone, or - lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent. for use as: - monotherapy.,darzalex sc in combination with bortezomib, cyclophosphamide and dexamethasone, is indicated for the treatment of patients with light chain al amyloidosis.

Estados Unidos - inglés - 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.

Estados Unidos - inglés - 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

Estados Unidos - inglés - 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

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

bayer australia ltd - iotroxate meglumine, quantity: 105.46 mg/ml - injection, solution - excipient ingredients: sodium calcium edetate; sodium bicarbonate; sodium chloride; water for injections - biliscopin for infusion is indicated for radiological examination of hepatic and biliary ducts and gallbladder when examination by oral technique is unsuccessful or inappropriate.

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

pfizer australia pty ltd - sodium bicarbonate, quantity: 8.4 g - injection, intravenous infusion - excipient ingredients: disodium edetate; water for injections - 1. metabolic acidosis in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis where a rapid increase in plasma total co2 content is crucial. treatment of metabolic acidosis should be concurrent with measures designed to control the cause of the acidosis. 2.urinary alkalinisation in the treatment of certain drug intoxications (ie barbiturates, salicylates, lithium, methyl alcohol) and in the haemolytic reactions requiring alkalinisation of the urine to diminish nephrotoxicity of blood pigments. urinary alkalinisation is also used in methotrexate therapy to prevent nephrotoxicity. 3.severe diarrhoea which is often accompanied by a significant loss of bicarbonate.

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

pfizer australia pty ltd - vincristine sulfate, quantity: 1 mg/ml - injection, solution - excipient ingredients: mannitol; water for injections; sodium hydroxide; sulfuric acid - vincristine is used primarily in the treatment of acute leukaemia, usually as a component of various chemotherapeutic regimens. it has also been used as part of combination therapy in the treatment of hodgkin's disease, non-hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, wilm's tumour, osteogenic sarcoma, mycosis fungoides, ewing's sarcoma, carcinoma of the uterine cervix, breast cancer, malignant melanoma, oat-cell carcinoma of the lung and gynaecological tumours of childhood. vincristine may be useful in patients with true idiopathic thrombocytopenic purpura resistant to the usual treatment, but not recommended as primary treatment for this disorder

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

juno pharmaceuticals pty ltd - adrenaline (epinephrine) acid tartrate, quantity: 1.819 mg (equivalent: adrenaline (epinephrine), qty 1 mg) - injection, solution - excipient ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide - adrenaline aguettant 1:10,000 is used as an adjunct in the management of cardiac arrest.