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.

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

chalmers dale & co pty ltd - propolis dry extract -

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

agt investments group pty ltd - propolis dry extract, quantity: 200 mg (equivalent: lead, qty 2 microgram; equivalent: propolis, qty 1000 mg) - capsule, soft - excipient ingredients: white beeswax; vegetable oil; glycerol; gelatin; carob pod; purified water; lecithin; soya oil - antioxidant/reduce free radicals formed in the body ; maintain/support general health and wellbeing

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

rbk nutraceuticals pty ltd - propolis dry extract -

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

h c l manufacturers pty ltd - propolis dry extract -

Israel - English - Ministry of Health

pharma shalom - melissa officinalis; valerian dry extract - coated tablets - valerian dry extract 120 mg; melissa officinalis 80 mg - other hypnotics and sedatives - sedative in states of tension, nervousness and insomnia.

Ireland - English - HPRA (Health Products Regulatory Authority)

kora corporation limited trading as kora healthcare - green tea dry extract - ointment - 10 percent - antivirals; sinecatechins - chemotherapeutics for topical use, antivirals - it is indicated for the cutaneous treatment of external genital and perianal warts (condylomataacuminata) in immunocompetent patients from the age of 18 years.

Ireland - English - HPRA (Health Products Regulatory Authority)

kwizda pharma gmbh - thyme herb dry extract 7-13:1, native extraction solvent: water - pastille - . - expectorants; combinations

Ireland - English - HPRA (Health Products Regulatory Authority)

chefaro ireland dac - pumpkin seed, crushed; pumpkin seed oil; dry extract of saw palmetto fruit - capsules hard - 400/340/75 milligram - urologicals

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

nature's family australia pty ltd - propolis dry extract, quantity: 500 mg (equivalent: lead, qty 5 microgram) - capsule, soft - excipient ingredients: carob pod; lecithin; grape seed oil; yellow beeswax; soya oil; hydrogenated vegetable oil; gelatin; glycerol; iron oxide black; iron oxide red; purified water - propolis is the resinous substance collected by bees from the leaf buds and bark of trees which contains amino acids, vitamins, menerals and flavonoids. nature's family mega gold propolis 2500mg contains dry extract (5:1) of fresh propolis to deliver the rich source in natural acids, bioflavonoid, minerals and nutrients. nature's family mega gold propolis 2500mgt may relieve symptoms of colds, reducing the severity and duration of symptoms. it may assist or help in the maintenance or improvement of general well-being. it may assists in the maintenance or improvement of general well-being. propolis may cause irritation and allergic reactions. if irritation or swelling of the mouth or throat occurs, discontinue use. not suitable for infants under the age of twelve months. not to be used for pregnant or lactating women, children under 2 years of age without medical advice.if symptoms persist consult your healthcare practitioner. nutritional supplements can only be of assistance where dietary intake is inadequate. always read the label. use only as directed. do not use if cap seal is broken.