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

novartis pharmaceuticals australia pty ltd - ergotamine tartrate; caffeine -

Israel - inglés - Ministry of Health

sanofi - aventis israel ltd - roxithromycin - film coated tablets - roxithromycin 150 mg - roxithromycin - for the treatment of infections caused by microorganisms sensitive to roxithromycin e.g: ent bronchopulmonary, genital and skin manifestations.

Israel - inglés - Ministry of Health

cts chemical industries ltd, israel - amiodarone hydrochloride - tablets - amiodarone hydrochloride 200 mg - amiodarone - amiodarone - coronary insufficiency arrhythmias resistant to other treatments.

Unión Europea - inglés - EMA (European Medicines Agency)

pfizer europe ma eeig - voriconazole - candidiasis; mycoses; aspergillosis - antimycotics for systemic use - voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:treatment of invasive aspergillosis;treatment of in candidaemianon-neutropenic patients;treatment of fluconazole-resistant serious invasive candida infections (including c. krusei);treatment of serious fungal infections caused by scedosporium spp. and fusarium spp.vfend should be administered primarily to patients with progressive, possibly life-threatening infections.prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients.

Estados Unidos - inglés - NLM (National Library of Medicine)

corcept therapeutics incorporated - mifepristone (unii: 320t6rnw1f) (mifepristone - unii:320t6rnw1f) - mifepristone 300 mg - korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. limitations of use: - korlym should not be used in the treatment of patients with type 2 diabetes unless it is secondary to cushing's syndrome. korlym is contraindicated in: - pregnancy [see dosage and administration (2.1), use in specific populations (8.1,8.3)] - patients taking drugs metabolized by cyp3a such as simvastatin, lovastatin, and cyp3a substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, due to an increased risk of adverse events. [see drug interactions (7.1) and clinical pharmacology (12.3)] - patients receiving systemic corticosteroids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because korlym antagonizes the effect of glucocorticoids. - women with a history of unexplained vaginal bleeding or with endometrial hyperplasia with atypia or endometrial carcinoma. - patients with known hypersensitivity to mifepristone or to any of the product components. risk summary korlym is contraindicated in pregnancy because the use of korlym results in pregnancy loss. there are no data that assess the risk of birth defects in women exposed to korlym during pregnancy. available data limited to exposure following a single dose of mifepristone during pregnancy showed a higher rate of major birth defects compared to the general population comparator (see data) . mifepristone administered to pregnant mice, rats, and rabbits during organogenesis caused pregnancy loss in all species at clinically relevant doses based on body surface area comparisons (see data) . the inhibition of both endogenous and exogenous progesterone by mifepristone at the progesterone receptor results in pregnancy loss. if korlym is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. [see contraindications (4)] the estimated risk of fetal loss is elevated in patients with active cushing's syndrome (24-30%), and the risk of major birth defects is unknown. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. data human data there are no data on long term exposure to mifepristone in pregnancy. available data are limited to exposure to a single dose of mifepristone for pregnancy termination. in a prospective study in france of 46 pregnancies exposed to a single dose of mifepristone alone and 59 pregnancies exposed to a single dose of mifepristone and misoprostol, the overall major birth defect rate (4%) was greater than the general population background rate of 2 to 3% (2 birth defects in each group). there was no pattern of birth defects identified. animal data reproductive studies were performed in mice, rats and rabbits at doses of 0.25 to 4.0 mg/kg (less than human exposure at the maximum clinical dose, based on body surface area). because of the anti-progestational activity of mifepristone, fetal losses were much higher than in control animals. skull deformities were detected in rabbit studies at less than human exposure, although mifepristone did not cause any adverse developmental effects in rats or mice during organogenesis. these deformities were most likely due to the mechanical effects of uterine contractions resulting from antagonism of the progesterone receptor. risk summary mifepristone is present in human milk, however, there are no data on the amount of mifepristone in human milk, the effects on the breastfed infant, or the effects on milk production during long term use of mifepristone (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for korlym and any potential adverse effects on the breastfed child from korlym or from the underlying maternal condition. clinical considerations to minimize exposure to a breastfed infant, women who discontinue or interrupt korlym treatment may consider pumping and discarding milk during treatment and for 18-21 days (5-6 half-lives) after the last dose, before breastfeeding. data available published data based on intake of a single dose of 600 mg of mifepristone in 10 breastfeeding women who were 6-12 months postpartum showed a small amount in breast milk (the estimated relative infant dose was 0.5%). the half-life of mifepristone is longer with repeat dosing compared to a single dose; therefore, there may be greater exposure with long term use. pregnancy testing due to its anti-progestational activity, korlym causes pregnancy loss. perform pregnancy testing before the initiation of treatment with korlym or if treatment is interrupted for more than 14 days in females of reproductive potential. contraception recommend non-hormonal contraception for the duration of treatment and for one month after stopping treatment . korlym interferes with the effectiveness of hormonal contraceptives. [see drug interactions (7.6)] safety and effectiveness of korlym in pediatric patients have not been established. clinical studies with korlym did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger people. the maximum dose should not exceed 600 mg per day in renally impaired patients. [see clinical pharmacology (12.3)] in patients with mild to moderate hepatic impairment, the maximum dose should not exceed 600 mg per day. the pharmacokinetics of mifepristone in patients with severe hepatic impairment has not been studied, and korlym should not be used in these patients. [see clinical pharmacology (12.3)]

Malasia - inglés - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

imeks pharma sdn. bhd. - caffeine; ergotamine tartrate -

Estados Unidos - inglés - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - lopinavir (unii: 2494g1jf75) (lopinavir - unii:2494g1jf75), ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 14 days and older. limitations of use: - genotypic or phenotypic testing and/or treatment history should guide the use of kaletra. the number of baseline lopinavir resistance-associated substitutions affects the virologic response to kaletra [see microbiology ( 12.4)] . - kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, stevens-johnson syndrome, erythema multiforme, urticaria, angioedema) to any of its ingredients, including ritonavir. - kaletra is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see drug interactions ( 7.1) and clinical pharmacology ( 12.3)] . alpha 1- adrenoreceptor antagonist: alfuzosin antianginal: ranolazine antiarrhythmic: dronedarone anti-gout: colchicine antipsychotics: lurasidone, pimozide ergot derivatives: dihydroergotamine, ergotamine, methylergonovine gi motility agent: cisapride hepatitis c direct acting antiviral: elbasvir/grazoprevir hmg-coa reductase inhibitors: lovastatin, simvastatin microsomal triglyceride transfer protein (mttp) inhibitor: lomitapidemicrosomal triglyceride transfer protein (mttp) inhibitor: lomitapide pde5 inhibitor: sildenafil (revatio ® ) when used for the treatment of pulmonary arterial hypertension sedative/hypnotics: triazolam, orally administered midazolam - alpha 1- adrenoreceptor antagonist: alfuzosin - antianginal: ranolazine - antiarrhythmic: dronedarone - anti-gout: colchicine - antipsychotics: lurasidone, pimozide - ergot derivatives: dihydroergotamine, ergotamine, methylergonovine - gi motility agent: cisapride - hepatitis c direct acting antiviral: elbasvir/grazoprevir - hmg-coa reductase inhibitors: lovastatin, simvastatin - microsomal triglyceride transfer protein (mttp) inhibitor: lomitapidemicrosomal triglyceride transfer protein (mttp) inhibitor: lomitapide - pde5 inhibitor: sildenafil (revatio ® ) when used for the treatment of pulmonary arterial hypertension - sedative/hypnotics: triazolam, orally administered midazolam - kaletra is contraindicated with drugs that are potent cyp3a inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross-resistance [see drug interactions ( 7.2) and clinical pharmacology ( 12.3)] . anticancer agents: apalutamide antimycobacterial: rifampin herbal products: st. john's wort (hypericum perforatum) - anticancer agents: apalutamide - antimycobacterial: rifampin - herbal products: st. john's wort (hypericum perforatum) pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to kaletra during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry at 1-800-258-4263. risk summary available data from the antiretroviral pregnancy registry show no difference in the risk of overall major birth defects compared to the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp) (see data) . the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15-20%. the background risk for major birth defects and miscarriage for the indicated population is unknown. methodological limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at <20 weeks gestation (see data) . no treatment-related malformations were observed when lopinavir in combination with ritonavir was administered to pregnant rats or rabbits; however embryonic and fetal developmental toxicities occurred in rats administered maternally toxic doses. clinical considerations dose adjustments during pregnancy and the postpartum period administer 400/100 mg of kaletra twice daily in pregnant patients with no documented lopinavir-associated resistance substitutions [see dosage and administration ( 2.5) and clinical pharmacology ( 12.3)] . there are insufficient data to recommend kaletra dosing for pregnant patients with any documented lopinavir-associated resistance substitutions. no dose adjustment of kaletra is required for patients during the postpartum period. once daily kaletra dosing is not recommended in pregnancy. avoid use of kaletra oral solution during pregnancy due to the ethanol content. kaletra oral solution contains the excipients ethanol, approximately 42% (v/v and propylene glycol, approximately 15%. data human data kaletra was evaluated in 12 hiv-infected pregnant women in an open-label pharmacokinetic trial [see clinical pharmacology ( 12.3)] . no new trends in the safety profile were identified in pregnant women dosed with kaletra compared to the safety described in non-pregnant adults, based on the review of these limited data. antiretroviral pregnancy registry data: based on prospective reports from the antiretroviral pregnancy registry (apr) of over 3,000 exposures to lopinavir containing regimens (including over 1,000 exposed in the first trimester), there was no difference between lopinavir and overall birth defects compared with the background birth defect rate of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program. the prevalence of birth defects in live births was 2.1% (95% ci: 1.4%-3.0%) following first-trimester exposure to lopinavir-containing regimens and 3.0% (95% ci: 2.4%-3.8%) following second and third trimester exposure to lopinavir-containing regimens. based on prospective reports from the apr of over 5,000 exposures to ritonavir containing regimens (including over 2,000 exposures in the first trimester) there was no difference between ritonavir and overall birth defects compared with the u.s. background rate (macdp). the prevalence of birth defects in live births was 2.2% (95% ci: 1.7%-2.8%) following first-trimester exposure to ritonavir-containing regimens and 2.9% (95% ci: 2.4%-3.6%) following second and third trimester exposure to ritonavir-containing regimens. for both lopinavir and ritonavir, sufficient numbers of first trimester exposures have been monitored to detect at least a 1.5 fold increase in risk of overall birth defects and a 2 fold increase in risk of birth defects in the cardiovascular and genitourinary systems. animal data embryonic and fetal developmental toxicities (early resorption, decreased fetal viability, decreased fetal body weight, increased incidence of skeletal variations and skeletal ossification delays) occurred in rats administered lopinavir in combination with ritonavir (on gestation days 6-17) at a maternally toxic dosage. based on auc measurements, the drug exposures in rats at the toxic doses were approximately 0.7 times (for lopinavir) and 1.8 times (for ritonavir) the exposures in humans at the recommended therapeutic dose (400/100 mg twice daily). in a pre- and post-natal study in rats, a developmental toxicity (a decrease in survival in pups between birth and postnatal day 21) occurred. no embryonic and fetal developmental toxicities were observed in rabbits administered lopinavir in combination with ritonavir (on gestation days 6-18) at a maternally toxic dosage. based on auc measurements, the drug exposures in rabbits at the toxic doses were approximately 0.6 times (for lopinavir) and similar to (for ritonavir) the exposures in humans at the recommended therapeutic dose (400/100 mg twice daily). risk summary the centers for disease control and prevention recommend that hiv-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv-1. because of the potential for: 1) hiv transmission (in hiv-negative infants), 2) developing viral resistance (in hiv- positive infants), and 3) adverse reactions in the breastfed infant, instruct mothers not to breastfeed if they are receiving kaletra. contraception use of kaletra may reduce the efficacy of combined hormonal contraceptives. advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception [see drug interactions ( 7.3)] . the safety, efficacy, and pharmacokinetic profiles of kaletra in pediatric patients below the age of 14 days have not been established. kaletra should not be administered once daily in pediatric patients. an open-label, multi-center, dose-finding trial was performed to evaluate the pharmacokinetic profile, tolerability, safety and efficacy of kaletra oral solution containing lopinavir 80 mg/ml and ritonavir 20 mg/ml at a dose of 300/75 mg/m 2 twice daily plus two nrtis in hiv-infected infants ≥14 days and < 6 months of age. results revealed that infants younger than 6 months of age generally had lower lopinavir auc 12 than older children (6 months to 12 years of age), however, despite the lower lopinavir drug exposure observed, antiviral activity was demonstrated as reflected in the proportion of subjects who achieved hiv-1 rna <400 copies/ml at week 24 [see adverse reactions ( 6.2), clinical pharmacology ( 12.3), clinical studies ( 14.4)] . safety and efficacy in pediatric patients > 6 months of age was demonstrated in a clinical trial in 100 patients. the clinical trial was an open-label, multicenter trial evaluating the pharmacokinetic profile, tolerability, safety, and efficacy of kaletra oral solution containing lopinavir 80 mg/ml and ritonavir 20 mg/ml in 100 antiretroviral naïve and experienced pediatric patients ages 6 months to 12 years. dose selection for patients 6 months to 12 years of age was based on the following results. the 230/57.5 mg/m 2 oral solution twice daily regimen without nevirapine and the 300/75 mg/m 2 oral solution twice daily regimen with nevirapine provided lopinavir plasma concentrations similar to those obtained in adult patients receiving the 400/100 mg twice daily regimen (without nevirapine) [see adverse reactions ( 6.2), clinical pharmacology ( 12.3), clinical studies ( 14.4)] . a prospective multicenter, open-label trial evaluated the pharmacokinetic profile, tolerability, safety and efficacy of high-dose kaletra with or without concurrent nnrti therapy (group 1: 400/100 mg/m 2 twice daily + ≥ 2 nrtis; group 2: 480/120 mg/m 2 twice daily + ≥ 1 nrti + 1 nnrti) in 26 children and adolescents ≥ 2 years to < 18 years of age who had failed prior therapy. patients also had saquinavir mesylate added to their regimen. this strategy was intended to assess whether higher than approved doses of kaletra could overcome protease inhibitor cross-resistance. high doses of kaletra exhibited a safety profile similar to those observed in previous trials; changes in hiv-1 rna were less than anticipated; three patients had hiv-1 rna <400 copies/ml at week 48. cd4+ cell count increases were noted in the eight patients who remained on treatment for 48 weeks [see adverse reactions ( 6.2), clinical pharmacology ( 12.3)] . a prospective multicenter, randomized, open-label study evaluated the efficacy and safety of twice-daily versus once-daily dosing of kaletra tablets dosed by weight as part of combination antiretroviral therapy (cart) in virologically suppressed hiv-1 infected children (n=173). children were eligible when they were aged < 18 years, ≥ 15 kg in weight, receiving cart that included kaletra, hiv-1 ribonucleic acid (rna) < 50 copies/ml for at least 24 weeks and able to swallow tablets. at week 24, efficacy (defined as the proportion of subjects with plasma hiv-1 rna less than 50 copies per ml) was significantly higher in subjects receiving twice daily dosing compared to subjects receiving once daily dosing. the safety profile was similar between the two treatment arms although there was a greater incidence of diarrhea in the once daily treated subjects. clinical studies of kaletra did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, appropriate caution should be exercised in the administration and monitoring of kaletra in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. kaletra is principally metabolized by the liver; therefore, caution should be exercised when administering this drug to patients with hepatic impairment, because lopinavir concentrations may be increased [see warnings and precautions ( 5.4) and clinical pharmacology ( 12.3)] .

Namibia - inglés - Namibia Medicines Regulatory Council

inova pharmaceuticals (pty) ltd - ergotamine tartrate; cyclizine hydrochloride; caffeine hydrate - tablet - each tablet contains ergotamine ; tartrate ep 2.0mg, cyclizine hydrochloride; bp 50,0mg and caffeine bp equivalent to ; caf

Irlanda - inglés - HPRA (Health Products Regulatory Authority)

polichem s.a. - dihydroergotamine mesilate - tablets - 20 milligram

Baréin - inglés - الهيئة الوطنية لتنظيم المهن والخدمات الصحية، مملكة البحرين

yousif mahmood hussain & bahrain pharmacy co - dihydroergotamine mesylate - nasal spray - 4