Stany Zjednoczone - angielski - NLM (National Library of Medicine)

kite pharma, inc. - brexucabtagene autoleucel (unii: 4md2j2t8sj) (brexucabtagene autoleucel - unii:4md2j2t8sj) - tecartus is a cd19-directed genetically modified autologous t cell immunotherapy indicated for the treatment of: adult patients with relapsed or refractory mantle cell lymphoma (mcl). this indication is approved under accelerated approval based on overall response rate and durability of response [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. adult patients with relapsed or refractory b-cell precursor acute lymphoblastic leukemia (all). none. risk summary there are no available data with tecartus use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with tecartus to assess whether tecartus can cause fetal harm when administered to a pregnant woman. it is not known if tecartus has the potential to be transferred to the fetus. based on the mechanism of action of tecartus, if the transduced cells cross the placenta, they may cause fetal toxicity, including b cell lymphocytopenia. therefore, tecartus is not recommended for women who are pregnant. pregnancy after tecartus infusion should be discussed with the treating physician. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively. risk summary there is no information regarding the presence of tecartus in human milk, the effect on the breastfed infant, and the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tecartus and any potential adverse effects on the breastfed infant from tecartus or from the underlying maternal condition. pregnancy testing pregnancy status of females with reproductive potential should be verified. sexually active females of reproductive potential should have a negative pregnancy test prior to starting treatment with tecartus. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with tecartus. infertility there are no data on the effect of tecartus on fertility. the safety and efficacy of tecartus have not been established in pediatric patients. of the 82 patients treated with tecartus for mcl, 42 (51%) were 65 years of age and over. of the 78 patients treated with tecartus for all, 12 (15%) were 65 years of age and over. no overall differences in safety or effectiveness were observed between these patients and younger patients.

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

aspen pharmacare australia pty ltd - hydrocortisone acetate, quantity: 10 mg/g - eye ointment - excipient ingredients: white soft paraffin; liquid paraffin; wool fat - inflammatory conditions of the eye, including allergic conjunctivitis, nonpurulent conjunctivitis and/or blepharitis, iritis, herpes zoster ophthalmicus, recurrent marginal ulceration.

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

glaxosmithkline australia pty ltd - aciclovir -

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

oceania orthopaedics pty ltd -

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

life healthcare pty ltd - 33692 - rotating hinged total knee prosthesis - composed of titanium tial6v4 alloy. connects between the modular proximal tibial component of the mutars (modular universal tumor and revision system) system and an extension piece or directly to a tibial stem. a connecting component for a proximal tibial replacement component to connect to a tibial stem, indicated for tumours in the area of the proximal tibia with a constrained femoral resurfacing knee joint replacement. primary indication for the use of the mutars systems is after bone resection because of a tumour. further indications for the use of the mutars systems are massive bone loss such as in morbus gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis

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

oceania orthopaedics pty ltd -

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

oceania orthopaedics pty ltd -

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

oceania orthopaedics pty ltd -

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

boucher & muir pty ltd - primaquine phosphate, quantity: 13.2 mg (equivalent: primaquine, qty 7.5 mg) - tablet, uncoated - excipient ingredients: wheat starch; povidone; purified water; lactose monohydrate; purified talc; gelatin; magnesium stearate; glycerol - prevention of relapses (radical cure) of malaria caused by p.vivax and p. ovale. adjunctive therapy in the treatment of gametocytemia due to p.falciparum in patients resident in areas receptive to malaria.

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

generic health pty ltd - valaciclovir hydrochloride monohydrate, quantity: 1223.4 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; povidone; magnesium stearate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. for the treatment of opthalmic zoster. for the treatment of recurrent herpes labialis (cold sores). for the treatment of clinical episodes of genital herpes simplex infections. for the prevention of recurrent genital herpes. reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. in addition to therapy with altic, it is recommended that patients use safer sex practices (see precautions). prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.