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

novartis pharmaceuticals corporation - tisagenlecleucel (unii: q6c9whr03o) (tisagenlecleucel - unii:q6c9whr03o) - tisagenlecleucel 2000000 - kymriah is a cd19-directed genetically modified autologous t cell immunotherapy indicated for the treatment of: patients up to 25 years of age with b-cell precursor acute lymphoblastic leukemia (all) that is refractory or in second or later relapse. adult patients with relapsed or refractory (r/r) large b-cell lymphoma after two or more lines of systemic therapy including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, high grade b-cell lymphoma and dlbcl arising from follicular lymphoma. limitation of use: kymriah is not indicated for treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory (r/r) follicular lymphoma (fl) after two or more lines of systemic therapy. this indication is approved under accelerated approval based on response rate and duration of response [see clinical studies (14.3)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary there are no available data with kymriah use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with kymriah to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known if kymriah has the potential to be transferred to the fetus. based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including b-cell lymphocytopenia. therefore, kymriah is not recommended for women who are pregnant, and pregnancy after kymriah administration should be discussed with the treating physician. report pregnancies to novartis pharmaceuticals corporation at 1-888-669-6682.  in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there is no information regarding the presence of kymriah in human milk, the effect on the breastfed infant, and the effects on milk production. a risk to the breastfed infant cannot be excluded. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kymriah and any potential adverse effects on the breastfed infant from kymriah 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 pregnancy test prior to starting treatment with kymriah. 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 kymriah. infertility there are no data on the effect of kymriah on male and female fertility. the safety and efficacy of kymriah have been established in pediatric patients with r/r b-cell all. use of kymriah is supported by a single-arm trial [see clinical studies (14.1)] that included 61 pediatric patients with r/r b-cell precursor all in the following age groups: 40 children (ages 2 years to less than 12 years) and 21 adolescents (ages 12 years to less than 17 years). no differences in efficacy or safety were observed between the different age subgroups or in comparison to the young adults in the trial. the safety and efficacy of kymriah in pediatric patients with r/r dlbcl and r/r fl have not been established. the safety and effectiveness of kymriah have not been established in geriatric patients with r/r b-cell all. clinical studies of kymriah did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Philippines - English - FDA (Food And Drug Administration)

metz pharmaceuticals, inc. - ascorbic acid , cholecalciferol , zinc - capsule classification: over-the-counter (otc) - 500 mg (equivalent to 562.43 mg sodium ascorbate) 1,000 iu/10 mg (equivalent to 70 mg zinc gluconate) dosage

Philippines - English - FDA (Food And Drug Administration)

isopropyl alcohol - topical solution classification: household remedy (hr) - 70% v/v dosage

Philippines - English - FDA (Food And Drug Administration)

methyl salicylate , menthol , eucalyptus oil - liniment oil classification: household remedy (hr) - 27 mg/ 25 mg/ 6 mg per 100 ml dosage

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

phytodyne inc. - sage (unii: 065c5d077j) (sage - unii:065c5d077j) - for temporary relief of inflammation of the mouth and throat

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

novartis pharmaceuticals australia pty ltd - tisagenlecleucel -

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

novartis pharmaceuticals australia pty ltd - tisagenlecleucel -

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bell,sons & co (druggists) ltd - capsicum tincture; benzoin tincture; cetylpyridinium chloride; ipecacuanha tincture - oral solution - 4.4microlitre/1ml ; 16.6microlitre/1ml ; 300microgram/1ml ; 20microlitre/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a.vogel uk ltd - sage leaf; echinacea root extract; echinacea - spray - 430mg/1ml ; 45.5mg/1ml ; 863.3mg/1ml

Ireland - English - HPRA (Health Products Regulatory Authority)

bioforce (uk) ltd - tincture from fresh echinacea purpurea (l) moench herb (1:12-13) extraction solvent:ethanol 65 v/v - oromucosal spray - 1 n/a - throat preparations