Ástralía - enska - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - rifabutin, quantity: 150 mg - capsule, hard - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; magnesium stearate; silicon dioxide; iron oxide red; titanium dioxide; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid; povidone; tert-butyl alcohol; sodium hydroxide - mycobutin is indicated for: the prophylaxis of m.avium-intracellulare complex (mac) infections in patients with advanced hiv infection (cd4 counts lower than 200/ul); the treatment of infections caused by mac and other atypical mycobacteria, including in immunocompromised patients; the treatment of chronic multi-drug resistant pulmonary tuberculosis in the presence of rifampicin resistant, rifabutin-sensitive m.tuberculosis strains; the treatment of newly diagnosed pulmonary tuberculosis in the presence of rifampicin resistant, rifabutin sensitive m.tuberculosis strains. in accordance with the commonly accepted criteria for the treatment of mycobacterial infections, mycobutin should always be given in combination with other anti-mycobacterial drugs not belonging to the family of rifamycins.

Malasía - enska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sm pharmaceuticals sdn. bhd. - diazepam -

Bandaríkin - enska - 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)] .

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - rifampicin, quantity: 20 mg/ml - oral liquid - excipient ingredients: agar; sucrose; methyl hydroxybenzoate; propyl hydroxybenzoate; potassium sorbate; saccharin; polysorbate 80; diethanolamine; purified water; sodium metabisulfite; fragrance (perfume) - tuberculosis. in the initial treatment and in re-treatment of patients with tuberculosis, rifadin must be used in conjunction with at least one other antituberculosis drug. leprosy. in the management of lepromatous leprosy and dimorphous leprosy to effect speedy conversion of the infectious state to the noninfectious state, which may be expected to occur in 3 to 4 months of treatment. as an alterantive drug in lepromatous, dimorphous, indeterminate and tuberculoid leprosy resistant to sulfones and other antileprosy drugs. as an alternative drug in all those patients having true drug allergy to the more commonly used antileprosy drugs. meningococcal disease. prophylaxis of meningococcal disease in close contacts of known cases and in carriers. (rifadin is not indicated for the treatment of meningococcal infections). haemophilus influenzae. prophylaxis of household contacts of patients with h. influenzae type b.

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - efavirenz 600mg;  ;  ;  ; emtricitabine 200mg;  ;  ;  ; tenofovir disoproxil fumarate 300mg;  ;  ;   - film coated tablet - active: efavirenz 600mg       emtricitabine 200mg       tenofovir disoproxil fumarate 300mg       excipient: croscarmellose sodium hyprolose magnesium stearate microcrystalline cellulose opadry pink 85f94172 purified water sodium laurilsulfate - atripla is indicated for the treatment of hiv infected adults over the age of 18 years, alone or in combination with other antiretroviral agents.

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - rifabutin 150mg - capsule - 150 mg - active: rifabutin 150mg - mycobutin is indicated for infections caused by mycobacteria, such as m. tuberculosis, m. avium intracellulare complex (mac) and other atypical mycobacteria. in infections caused by mac and other atypical mycobacteria such as m. xenopi, mycobutin has been shown to be effective for the treatment of both disseminated and localised disease, also in immunocompromised hiv positive patients. mycobutin is also indicated for the prophylaxis of m. avium intracellulare complex (mac) infections in immunodepressed patients with cd4 counts lower than or equal to 100/ml. in the treatment of tubercular disease, mycobutin has been shown to be effective for the treatment of patients with chronic pulmonary tuberculosis, even if caused by multidrug-resistant m. tuberculosis strains. in accordance with the commonly accepted criteria for the treatment of mycobacterial infections, mycobutin therapy should always be given in combination with other antimycobacterial drugs not belonging to the family of rifamycins.

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - rifampicin 20 mg/ml (5% overage is added.) - oral suspension - 100 mg/5ml - active: rifampicin 20 mg/ml (5% overage is added.) excipient: agar diolamine methyl hydroxybenzoate polysorbate 80 potassium sorbate propyl hydroxybenzoate purified water raspberry saccharin sodium metabisulfite sucrose - tuberculosis rifampicin is indicated in the treatment of all forms of tuberculosis, including fresh, advanced, chronic and drug resistant cases. rifampicin should be used in conjunction with at least one other antituberculosis medicine. leprosy rifampicin is indicated in the treatment of multibacillary and paucibacillary leprosy to effect a conversion of the infectious state to a non-infectious state. rifampicin should be used in conjunction with at least one other anti-leprosy drug. methicillin-resistant staphylococcal infections (mrsa) rifampicin can be used as an alternative to vancomycin in the treatment of mrsa. in such circumstances an appropriate companion antibiotic (e.g. fusidic acid) should always be employed. serious staphylococcal infections rifampicin has been used for the treatment of both life-threatening and serious staphylococcal infections. in such circumstances an appropriate companion antibiotic should be employed. brucellosis rifampicin may be used for the treatment of brucellosis. in such circumstances doxycycline should also be used. meningococcal carriers rifampicin is indicated for the treatment of asymptomatic carriers of n. meningitidis to eliminate meningococci from the nasopharynx. (rifampicin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms). haemophilus influenzae rifampicin is indicated for the treatment of asymptomatic carriers of h influenzae and as chemoprophylaxis of exposed children of 4 years of age or younger. other infections infections caused by rifampicin-sensitive microorganisms such as staphylococci, streptococci, n gonorrhoeae, proteus sp., h. influenzae, e. coli and legionella sp. to prevent emergence of resistant organisms, rifampicin should be given with another antibacterial agent to which the organism has been shown to be susceptible.

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - rifampicin 600mg - tablet - 600 mg - active: rifampicin 600mg excipient: acacia calcium stearate carmellose sodium carnauba wax colloidal silicon dioxide colophony erythrosine ethanol gelatin hard paraffin kaolin lactose monohydrate magnesium carbonate magnesium stearate maize starch microcrystalline cellulose povidone purified talc purified water sodium laurilsulfate sucrose titanium dioxide white beeswax - tuberculosis rifampicin is indicated in the treatment of all forms of tuberculosis, including fresh, advanced, chronic and drug resistant cases. rifampicin should be used in conjunction with at least one other antituberculosis medicine. leprosy rifampicin is indicated in the treatment of multibacillary and paucibacillary leprosy to effect a conversion of the infectious state to a non-infectious state. rifampicin should be used in conjunction with at least one other anti-leprosy drug. methicillin-resistant staphylococcal infections (mrsa) rifampicin can be used as an alternative to vancomycin in the treatment of mrsa. in such circumstances an appropriate companion antibiotic (e.g. fusidic acid) should always be employed. serious staphylococcal infections rifampicin has been used for the treatment of both life-threatening and serious staphylococcal infections. in such circumstances an appropriate companion antibiotic should be employed. brucellosis rifampicin may be used for the treatment of brucellosis. in such circumstances doxycycline should also be used. meningococcal carriers rifampicin is indicated for the treatment of asymptomatic carriers of n. meningitidis to eliminate meningococci from the nasopharynx. (rifampicin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms). haemophilus influenzae rifampicin is indicated for the treatment of asymptomatic carriers of h influenzae and as chemoprophylaxis of exposed children of 4 years of age or younger. other infections infections caused by rifampicin-sensitive microorganisms such as staphylococci, streptococci, n gonorrhoeae, proteus sp., h. influenzae, e. coli and legionella sp. to prevent emergence of resistant organisms, rifampicin should be given with another antibacterial agent to which the organism has been shown to be susceptible.

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - diazepam 4 mg/ml - enema - 10mg/2.5ml - active: diazepam 4 mg/ml excipient: benzoic acid benzyl alcohol ethanol propylene glycol purified water sodium benzoate - for the treatment of febrile and childhood convulsions, where rapid onset of anticonvulsant therapy is imperative.

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - diazepam 2 mg/ml - enema - 5mg/2.5ml - active: diazepam 2 mg/ml excipient: benzoic acid benzyl alcohol ethanol propylene glycol purified water sodium benzoate - for the treatment of febrile and childhood convulsions, where rapid onset of anticonvulsant therapy is imperative.