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

astrazeneca pty ltd - acalabrutinib maleate monohydrate, quantity: 129 mg - tablet, film coated - excipient ingredients: mannitol; microcrystalline cellulose; hyprolose; sodium stearylfumarate; hypromellose; copovidone; titanium dioxide; macrogol 3350; medium chain triglycerides; iron oxide yellow; iron oxide red - calquence is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.,this indication is approved via the provisional approval pathway, based on overall response rate. full registration for this indication depends on verification and description of clinical benefit in confirmatory trials. calquence is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll)/small lymphocytic lymphoma (sll).

Canada - English - Health Canada

mint pharmaceuticals inc - trimebutine maleate - tablet - 200mg - trimebutine maleate 200mg

Canada - English - Health Canada

mint pharmaceuticals inc - trimebutine maleate - tablet - 100mg - trimebutine maleate 100mg

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

seroyal usa - tin (unii: 387gmg9fh5) (tin - unii:387gmg9fh5), english walnut (unii: 1v3shr7qb7) (english walnut - unii:1v3shr7qb7), nerium oleander leaf (unii: 7kv510r6h6) (nerium oleander leaf - unii:7kv510r6h6), bufo bufo cutaneous gland (unii: q59qu6n72q) (bufo bufo cutaneous gland - unii:q59qu6n72q), nitric acid (unii: 411vrn1tv4) (nitric acid - unii:411vrn1tv4), sulfur (unii: 70fd1kfu70) (sulfur - unii:70fd1kfu70), thuja occidentalis leafy twig (unii: 1nt28v9397) (thuja occidentalis leafy twig - unii:1nt28v93 - tin 10 [hp_x] in 20 ml - uses for the temporary relief of symptoms associated with skin warts. uses for the temporary relief of symptoms associated with skin warts. directions to be taken ten minutes away from food. invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water. hold contents for about 20 seconds and swallow. to promote drop flow, invert bottle and shake before each use. adults and adolescents (12 years and older) take 10 drops two times daily, in the morning and evening, or as recommended by your healthcare practitioner. children (under 12 years) take under the direction of your healthcare practitioner.

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

a-s medication solutions - rifapentine (unii: xjm390a33u) (rifapentine - unii:xjm390a33u) - priftin® (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis (tb) caused by mycobacterium tuberculosis . priftin must always be used in combination with one or more antituberculosis (anti-tb) drugs to which the isolate is susceptible [see dosage and administration (2.1) and clinical studies (14.1)] . limitations of use do not use priftin monotherapy in either the initial or the continuation phases of active antituberculous treatment. priftin should not be used once weekly in the continuation phase regimen in combination with isoniazid (inh) in hiv-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin (rif)-resistant organisms [see warnings and precautions (5.4) and clinical studies (14.1)] . priftin has not been studied as part of the initial phase treatment regimen in hiv-infected patients with active pulmonary tuberculosis. priftin is indicated in adults and children 2 years and older for the treatment of latent tuberculosis infection caused by mycobacterium tuberculosis in patients at high risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, hiv-infected patients, or those with pulmonary fibrosis on radiograph) [see clinical studies (14.2)] . limitations of use active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection. priftin must always be used in combination with isoniazid as a 12-week once-weekly regimen for the treatment of latent tuberculosis infection [see dosage and administration (2.2) and clinical studies (14.2)] . - priftin in combination with isoniazid is not recommended for individuals presumed to be exposed to rifamycin-resistant or isoniazid-resistant m. tuberculosis . priftin is contraindicated in patients with a history of hypersensitivity to rifamycins. risk summary based on animal data, priftin may cause fetal harm when administered to a pregnant woman. available data from clinical trials, case reports, epidemiology studies and postmarketing experience with priftin use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, adverse maternal or fetal outcomes. in two clinical trials, a total of 59 patients who were treated with rifapentine in combination with other anti-tuberculosis drugs became pregnant. overall, the reported rate of miscarriage following rifapentine exposure in these two clinical trials did not represent an increase over the background rate of miscarriage reported in the general population (see data) . there are risks associated with active tuberculosis during pregnancy. when administered during the last few weeks of pregnancy, priftin may be associated with maternal postpartum hemorrhage and bleeding in the exposed neonates (see clinical considerations) . in animal reproduction and developmental toxicity studies, adverse developmental outcomes (including cleft palate or mal-positioned aortic arches) were observed following administration of rifapentine to pregnant rats and rabbits at doses approximately 0.6 and 0.3 to 1.3 times, respectively, of the recommended human dose based on body surface area comparisons (see data) . based on animal data, advise pregnant women of the risk for fetal harm. as rifapentine is always used in combination with other antituberculosis drugs such as isoniazid, ethambutol, and pyrazinamide, refer to the prescribing information of the other drug(s) for more information on their associated risks of use during pregnancy. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations disease-associated maternal and/or embryo-fetal risk active tuberculosis in pregnancy is associated with adverse maternal and neonatal outcomes including maternal anemia, cesarean delivery, preterm birth, low birth weight, birth asphyxia, and perinatal infant death. labor or delivery when administered during the last few weeks of pregnancy, priftin may increase the risk for maternal postpartum hemorrhage and bleeding in the exposed neonate. monitor prothrombin time of pregnant women and neonates who are exposed to priftin during the last few weeks of pregnancy. treatment with vitamin k may be indicated. data human data fourteen patients with active tuberculosis treated with multiple antituberculosis drugs including priftin became pregnant during clinical studies. six delivered normal infants, four had first trimester spontaneous abortions (of these, one patient abused ethanol and another patient was hiv-infected), one had an elective abortion, and outcome was unknown in three patients. these data are, however, limited by the quality of reporting and confounded by comorbid medical conditions and multiple antituberculosis drug exposures. in the trial that compared the safety and effectiveness of priftin in combination with isoniazid to isoniazid alone for the treatment of latent tuberculosis infection, a total of 45 (2.5%) women in the priftin/isoniazid arm and 71 (4.1%) women in the isoniazid arm became pregnant. among the 46 total pregnancies in the priftin/isoniazid arm, there were 31 live births, 6 elective abortions, 7 spontaneous abortions, and 2 unknown outcomes. of the 31 live infants, 21 were reported healthy while in the other ten cases no further details were available. the rate of spontaneous abortion in the priftin/isoniazid arm (15%) and the rate of spontaneous abortion in the isoniazid arm (19%) did not represent an increase over the background rate of 15 to 20 percent reported in the general population. further interpretation of these results is limited by the quality of adverse event reporting. animal data animal studies in rats and rabbits revealed malformations and other adverse developmental outcomes in both species. pregnant rats given oral rifapentine during organogenesis (gestational days 5 through 15) at 40 mg/kg/day (0.6 times the human dose of 600 mg based on body surface area comparisons) produced pups with cleft palates and mal-positioned aortic arches, delayed ossification, increased number of ribs, a decrease in litter size and mean litter weight, an increase in number of stillbirths, and an increase in mortality during lactation. when rifapentine was administered orally to mated female rats late in gestation, at 20 mg/kg/day (0.3 times the human dose based on body surface area), pup weights and gestational survival (live pups born/pups born) were reduced compared to controls. increased resorptions and postimplantation loss, decreased mean fetal weights, increased numbers of stillborn pups, and slightly increased pup mortality during lactation were also noted. when pregnant rabbits received oral rifapentine at 10 mg/kg to 40 mg/kg (0.3 times to 1.3 times the human dose based on body surface area) during organogenesis (gd6 to gd18), major fetal malformations occurred including: ovarian agenesis, pes varus, arhinia, microphthalmia, and irregularities of the ossified facial tissues. at 40 mg/kg/day, there were increases in postimplantation loss and the incidence of stillborn pups. risk summary there are no data on the presence of rifapentine or its metabolite in human or animal milk, the effects on the breastfed infant, or the effects on milk production. since priftin may produce a red-orange discoloration of body fluids, there is a potential for discoloration of breast milk. monitor infants exposed to rifapentine through breast milk for signs of hepatotoxicity (see clinical considerations) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for priftin and any potential adverse effects on the breastfed infant from priftin or from the underlying maternal condition. clinical considerations monitor infants exposed to rifapentine through breast milk for signs of hepatotoxicity to include irritability, prolonged unexplained crying, yellowing of the eyes, loss of appetite, vomiting, and changes in color of the urine (darkening) or stool (lightening, pale or light brown). contraception use of priftin may reduce the efficacy of hormonal contraceptives. advise patients using hormonal contraceptives to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment with priftin [see warnings and precautions (5.5) and drug interactions (7.3)] . the safety and effectiveness of priftin in the treatment of active pulmonary tuberculosis have not been established in pediatric patients under the age of 12. the safety and effectiveness of priftin in combination with isoniazid once-weekly regimen has been evaluated in pediatric patients (2 to 17 years of age) for the treatment of latent tuberculosis infection. in clinical studies, the safety profile in children was similar to that observed in adult patients [see adverse reactions (6.1) and clinical studies (14.2)] . in a pharmacokinetic study conducted in 2 to 11-year-old pediatric patients with latent tuberculosis infection, priftin was administered once weekly based on weight (15 mg/kg to 30 mg/kg, up to a maximum of 900 mg). exposures (auc) in children 2 to 11 years old with latent tuberculosis infection were higher (average 31%) than those observed in adults receiving priftin 900 mg once weekly [see dosage and administration (2.2) and clinical pharmacology (12.3)] . clinical studies with priftin did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. in a pharmacokinetic study with priftin, no substantial differences in the pharmacokinetics of rifapentine and 25-desacetyl metabolite were observed in the elderly compared to younger adults [see clinical pharmacology (12.3)] .

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

rpk pharmaceuticals, inc. - rifapentine (unii: xjm390a33u) (rifapentine - unii:xjm390a33u) - priftin® (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis (tb) caused by mycobacterium tuberculosis . priftin must always be used in combination with one or more antituberculosis (anti-tb) drugs to which the isolate is susceptible [see dosage and administration (2.1) and clinical studies (14.1)] . limitations of use do not use priftin monotherapy in either the initial or the continuation phases of active antituberculous treatment. priftin should not be used once weekly in the continuation phase regimen in combination with isoniazid (inh) in hiv-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin (rif)-resistant organisms [see warnings and precautions (5.4) and clinical studies (14.1)] . priftin has not been studied as part of the initial phase treatment regimen in hiv-infected patients with active pulmonary tuberculosis. priftin is indicated in adults and children 2 years

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

boehringer ingelheim pty ltd - aspirin,dipyridamole -

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

apotex pty ltd - atomoxetine hydrochloride -

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

apotex pty ltd - atomoxetine hydrochloride -

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

apotex pty ltd - atomoxetine hydrochloride -