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

baxter healthcare pty ltd - cyclophosphamide monohydrate, quantity: 2.138 g (equivalent: cyclophosphamide monohydrate, qty 2 g) - injection, powder for - excipient ingredients: - frequently responsive myeloproliferative and lymphoproliferative disorders: malignant lymphomas including hodgkins (stages iii and iv, peter's staging system*) and non-hodgkins lymphomas; multiple myeloma; leukaemias; mycosis fungoides (advanced disease). *modified as the international staging classification for hodgkin's disease in 'report of the committee on the staging of hodgkin's disease'. cancer res 26: 1310, 1966. stage i. disease limited to one anatomic region (stage i) or two contiguous anatomic regions (stage i2) on the same side of the diaphragm. stage ii. disease in more than two anatomic regions or two contiguous regions on the same side of the diaphragm. stage iii. disease on both sides of the diaphragm but not extending beyond the involvement of lymph nodes, spleen and/or waldeyer's ring. stage iv. involvement of the bone marrow, lung parenchyma, pleura, liver, bone, skin, kidneys, gastrointestinal tract, or in any tissue or organ in addition to lymph nodes, spleen or waldeyer's ring. all stages are subclassified as a or b to indicate the absence or presence, respectively, of systemic symptoms. frequently responsive solid malignancies: neuroblastoma (patients with disseminated disease); adenocarcinoma of the ovary, retinoblastoma. infrequently responsive malignancies: carcinoma of the breast; malignant neoplasms of the lung. immunosuppressive properties: cyclophosphamide has also been used in the treatment of autoimmune diseases and immunopathies of unspecified type (i.e. wegener's granulomatosis) when these diseases have been resistant to conventional first and second line of treatment, and for the prevention of transplant rejection. cyclophosphamide can be recommended for use in treatment of nonmalignancies only when in the opinion of the physician the benefits to the patient outweigh the risk of treatment with cyclophosphamide.

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

juno pharmaceuticals pty ltd - cefalotin sodium, quantity: 1.058 g (equivalent: cefalotin, qty 1 g) - injection, powder for - excipient ingredients: sodium bicarbonate - indications: cephalothin sodium for injection is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. culture and susceptibility studies should be performed. however, therapy may be instituted before results of susceptibility studies are obtained (see pharmacology: microbiology). respiratory tract: infections caused by s. pneumoniae, staphylococci (penicillinase and nonpenicillinase producing), group a beta-haemolytic streptococci, klebsiella, and h. influenzae. skin and soft tissue: infections, including peritonitis, caused by staphylococci (penicillinase and nonpenicillinase producing), group a beta-haemolytic streptococci, e.coli, pr. mirabilis and klebsiella. genitourinary tract: infections caused by e. coli, pr. mirabilis and klebsiella. septicaemia, including endocarditis: infections caused by s. pneumoniae, staphylococci (penicillinase and nonpenicillinase producing), group a beta-haemolytic streptococci, s. viridans, e. coli, pr. mirabilis and klebsiella. bone and joint: infection caused by staphylococci (penicillinase and non-penicillinase producing). prophylactically in vaginal hysterectomy, head and neck surgery, insertion of prosthetic heart valves, and prosthetic arthroplasty. cephalothin is not recommended for gastrointestinal procedures or other sites where anaerobic organisms such as bacteriodes tend to prevail. dosage is required pre-, intra-and postoperatively (i.e perioperatively, see dosage and administration). if signs of postoperative infection develop, specimens should be cultured to identify the causative organism so that appropriate therapy can be instituted. note: if the susceptibility tests show that the causative organism is resistant to cephalothin, other appropriate antibiotic therapy should be instituted.

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

pfizer australia pty ltd - medroxyprogesterone acetate, quantity: 150 mg/ml - injection, suspension - excipient ingredients: macrogol 3350; water for injections; propyl hydroxybenzoate; polysorbate 80; methyl hydroxybenzoate; sodium chloride - 1. carcinoma: palliative treatment of recurrent and/or metastatic breast or renal cell cancer and of inoperable recurrent or metastatic endometrial carcinoma. 2. endometriosis: for use in the treatment of visually proven (laparoscopy) endometriosis where the required end-point of treament is pregnancy, or for the control of symptoms when surgery is contra-indicated or has been unsuccessful. 3. contraception (ovulation supression) : for long-term prevention of pregnancy in women when administered at 3-month intervals. since loss of bone mineral density (bmd) may occur in pre-menopausal women who use depo-ralovera long-term (greater than 2 years), women should be assessed, before starting treatment for contraception or endosmetriosis, regarding the risk of osteoporosis. women under the age of 18 years may be at risk of failing to achive their predicted peak bone mineral density (see warnings).

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

baxter healthcare pty ltd - ifosfamide, quantity: 2 g - injection, powder for - excipient ingredients: - use in the treatment of tumours sensitive to ifosfamide either as a single agent or in combination with other chemotherapeutic agents. tumour types that have been demonstrated to respond to ifosfamide single agent or in combination are germ cell tumours, sarcomas, lymphomas. anti-tumour activity has been shown in ovarian and cervical cancers. some activity has also been seen in lung and breast cancer.

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

baxter healthcare pty ltd - ifosfamide, quantity: 1 g - injection, powder for - excipient ingredients: - use in the treatment of tumours sensitive to ifosfamide either as a single agent or in combination with other chemotherapeutic agents. tumour types that have been demonstrated to respond to ifosfamide single agent or in combination are germ cell tumours, sarcomas, lymphomas. anti-tumour activity has been shown in ovarian and cervical cancers. some activity has also been seen in lung and breast cancer.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

bsv bioscience malaysia sdn. bhd. - chorionic gonadotrophin -

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

aft pharmaceuticals pty ltd - voriconazole, quantity: 200 mg - injection, powder for - excipient ingredients: nitrogen; water for injections; sulfobutyl betadex sodium - voriconazole ? aft is indicated for treatment of the following fungal infections:,invasive aspergillosis.,serious candida infections (including c. krusei), including systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,serious fungal infections caused by scedosporium spp and fusarium spp.,other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

United Kingdom - English - VMD (Veterinary Medicines Directorate)

biogénesis global, s.l. - chorionic gonadotrophin, serum gonadotrophin - lyophilisate and solvent for solution for injection - hormone sex - pigs

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

syntex s.a. - gonadotrophin-serum - parenteral liquid/solution/suspension - gonadotrophin-serum hormone-gonadotrophin active 20000.0 iu/ml - endocrine system

Ireland - English - HPRA (Health Products Regulatory Authority)

ceva santé animale - gonadotrophin equine serum (ecg) - lyophilisate and solvent for solution for injection - 500 international unit - chorionic gonadotrophin - bovine, ovine - hormone