Malta - Kiingereza - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - atovaquone, proguanil hydrochloride - film-coated tablet - atovaquone 250 mg proguanil hydrochloride 100 mg - antiprotozoals

Malta - Kiingereza - Medicines Authority

glenmark pharmaceuticals europe limited - atovaquone; proguanil hydrochloride - film-coated tablet - atovaquone 250 mg; proguanil hydrochloride 100 mg - antiprotozoals

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

pfizer australia pty ltd - tofacitinib citrate, quantity: 8.078 mg (equivalent: tofacitinib, qty 5 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; triacetin; macrogol 3350 - rheumatoid arthritis (ra),xeljanz is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to methotrexate. xeljanz can be used alone or in combination with conventional synthetic disease-modifying antirheumatic drugs (dmards), including methotrexate. psoriatic arthritis (psa),xeljanz in combination with conventional synthetic dmards is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response to a prior dmard therapy. ulcerative colitis (uc),xeljanz is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy.,ankylosing spondylitis (as),xeljanz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.,juvenile idiopathic arthritis (jia),xeljanz is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis, extended oligoarthritis and systemic juvenile arthritis without systemic features for six months) and juvenile psoriatic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with dmards.

Marekani - Kiingereza - NLM (National Library of Medicine)

golden state medical supply, inc. - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated p. falciparum malaria. atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance. - atovaquone and proguanil hydrochloride tablets are contraindicated in individuals with known hypersensitivity reactions (e.g., anaphylaxis, erythema multiforme or stevens-johnson syndrome, angioedema, vasculitis) to atovaquone or proguanil hydrochloride or any component of the formulation. - atovaquone and proguanil hydrochloride tablets are contraindicated for prophylaxis of p. falciparum malaria in patients with severe renal impairment (creatinine clearance < 30 ml/min) because of pancytopenia in patients with severe renal impairment treated with proguanil [see use in specific populations (8.6), clinical pharmacology (12.3)] . available data from published literature and postmarketing experience with use of atovaquone and proguanil hydrochloride tablets in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. the proguanil component of atovaquone and proguanil hydrochloride tablets acts to inhibit parasitic dihydrofolate reductase; however, pregnant women and females of reproductive potential should continue folate supplementation to prevent neural tube defects [see clinical pharmacology (12.4)] . pregnant women with malaria are at increased risk for adverse pregnancy outcomes (see clinical considerations) . atovaquone administered by oral gavage to pregnant rats and rabbits during the period of organogenesis was not associated with fetal malformations at plasma exposures approximately 7 times and equal to, respectively, the estimated human exposure for the treatment of malaria based on auc. proguanil administered to pregnant rats and rabbits during the period of organogenesis was not associated with embryo-fetal toxicity at maternally toxic plasma exposures approximately 0.07 and 0.8 times, respectively, the estimated human exposure for treatment of malaria based on auc (see data) . the combination of atovaquone and proguanil hydrochloride given orally by gavage during the period of organogenesis was not associated with embryo-fetal developmental effects in pregnant rats or rabbits at atovaquone:proguanil hydrochloride doses of 50:20 mg/kg/day and 100:40 mg/kg/day, respectively (1.7 and 0.1 times and 0.3 and 0.5 times, respectively, the estimated human exposure for treatment of malaria). in a pre- and post-natal study with atovaquone and another pre- and post-natal study with proguanil, neither compound impaired the growth, development, or reproductive ability of first generation offspring at maternal auc exposures of approximately 7.3 and 0.04 times, respectively, the estimated human auc exposure for treatment of malaria (see data) . 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth. atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day during organogenesis (gestation day [gd] 6 to gd15) in pregnant rats did not cause maternal or embryo-fetal toxicity at doses up to 1,000 mg/kg/day corresponding to maternal plasma exposures up to 7.3 times the estimated human exposure for the treatment of malaria based on auc. in pregnant rabbits, atovaquone administered in oral doses of 300, 600, and 1,200 mg/kg/day by gavage during organogenesis (gd6 to gd18) was associated with decreased fetal body length at a maternally toxic dose of 1,200 mg/kg/day corresponding to plasma exposures that were approximately 1.3 times the estimated human exposure during treatment of malaria based on auc. in a pre- and post-natal study in rats, atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day from gd15 until lactation day (ld) 20 did not impair the growth or developmental effects in first generation offspring at doses up to 1,000 mg/kg/day corresponding to auc exposures of approximately 7.3 times the estimated human exposure during treatment of malaria. atovaquone crossed the placenta and was present in fetal rat and rabbit tissue. proguanil administered orally to pregnant rats during organogenesis (gd6 to gd17) was not associated with fetal malformations, but increased ureter variations at a maternally toxic dose of 20 mg/kg/day corresponding to a plasma concentration approximately equal to 0.07 times the estimated human exposure for the treatment of malaria based on auc. proguanil given orally by gavage at a maternally toxic dose of 40 mg/kg/day to pregnant rabbits during organogenesis (gd6 to gd20) did not produce adverse embryo-fetal effects at a plasma concentration up to 0.8 times the estimated human exposure for the treatment of malaria based on auc. in a pre- and post-natal study in female rats, proguanil hydrochloride administered in oral doses of 4, 8, or 16 mg/kg/day from gd6 until ld20 did not impair the growth, development, or reproductive ability of first generation offspring or the survivability of second generation offspring at doses up to 16 mg/kg/day (0.04 times the average human exposure based on auc). pre- and post-natal studies of proguanil in animals at exposures similar to or greater than those observed in humans have not been conducted. the combination of atovaquone and proguanil hydrochloride administered orally to pregnant rats in atovaquone:proguanil hydrochloride doses of 12.5:5, 25:10, and 50:20 mg/kg/day during organogenesis (gd6 to gd17) did not produce maternal toxicity or adverse embryo-fetal developmental effects with doses up to 50:20 mg/kg/day corresponding to plasma concentrations up to 1.7 and 0.1 times, respectively, the estimated human exposure during treatment of malaria based on auc. in pregnant rabbits, the combination of atovaquone and proguanil hydrochloride administered orally in atovaquone:proguanil hydrochloride doses of 25:10, 50:20, or 100:40 mg/kg/day during organogenesis (gd6 to gd20) did not produce adverse embryo-fetal developmental effects at a maternally toxic dose of 100:40 mg/kg/day corresponding to plasma concentrations of approximately 0.3 and 0.5 times, respectively, the estimated human exposure during treatment of malaria based on auc. there are no data on the presence of atovaquone in human milk; however, proguanil is present in human milk. atovaquone is present in rat milk (see data) . when a drug is present in animal milk, it is likely the drug will be present in human milk. there are no data on the effects of atovaquone and proguanil on the breastfed child or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for atovaquone and proguanil hydrochloride tablets and any potential adverse effect on the breastfed child from atovaquone and proguanil or from the underlying maternal condition. in a rat study with doses of 10 and 250 mg/kg, given orally by gavage on postpartum day 11, atovaquone concentrations in the milk were 30% of the concurrent atovaquone concentrations in the maternal plasma at both doses. the concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk. safety and effectiveness have not been established in pediatric patients who weigh less than 11 kg. the efficacy and safety of atovaquone and proguanil hydrochloride tablets have been established for the prophylaxis of malaria in controlled trials involving pediatric patients weighing 11 kg or more [see clinical studies (14.1)] . safety and effectiveness have not been established in pediatric patients who weigh less than 5 kg. the efficacy and safety of atovaquone and proguanil hydrochloride tablets for the treatment of malaria have been established in controlled trials involving pediatric patients weighing 5 kg or more [see clinical studies (14.2)] . clinical trials of atovaquone and proguanil hydrochloride tablets did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, the higher systemic exposure to cycloguanil, and the greater frequency of concomitant disease or other drug therapy [see clinical pharmacology (12.3)]. do not use atovaquone and proguanil hydrochloride tablets for malaria prophylaxis in patients with severe renal impairment (creatinine clearance < 30 ml/min). use with caution for the treatment of malaria in patients with severe renal impairment only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure. no dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 ml/min) or moderate (creatinine clearance 30 to 50 ml/min) renal impairment [see clinical pharmacology (12.3)]. no dosage adjustments are needed in patients with mild or moderate hepatic impairment [see clinical pharmacology (12.3)] . no trials have been conducted in patients with severe hepatic impairment.

Marekani - Kiingereza - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral solution. this section is empty. no content has been added. risk summary available data from postmarketing experience with use of atovaquone in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. pregnant women with hiv who are infected with pcp are at increased risk of adverse pregnancy outcomes (see clinical considerations). atovaquone given orally by gavage to pregnant rats and rabbits during organogenesis did not cause fetal malformations at plasma concentrations up to 3 times and 0.5 times, respectively, the estimated human exposure based on steady-state plasma concentrations ( see data ). 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk: pregnant women with hiv who are infected with pcp are at increased risk of severe illness and maternal death associated with pcp compared with non-pregnant women. data animal data: atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day to pregnant rats during organogenesis (gestation day [gd] 6 to gd15) did not cause maternal or embryo-fetal toxicity at doses up to 1,000 mg/kg/day corresponding to maternal plasma concentrations approximately 3 times the estimated human exposure during the treatment of pcp based on steady-state plasma concentrations. in pregnant rabbits, atovaquone administered in oral doses of 300, 600, and 1,200 mg/kg/day during organogenesis (gd6 to gd18) caused decreased fetal body length at a maternally toxic dose of 1,200 mg/kg/day corresponding to a plasma concentration that is approximately 0.5 times the estimated human exposure based on steady-state plasma concentrations. in a pre- and post-natal study in rats, atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day from gd15 until lactation day (ld) 20 did not impair the growth or developmental effects in first generation offspring at doses up to 1,000 mg/kg/day corresponding to approximately 3 times the estimated human exposure based on steady-state plasma concentrations during the treatment of pcp. atovaquone crossed the placenta and was present in fetal rat and rabbit tissue. 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. there are no data on the presence of atovaquone in human milk, the effects on the breastfed child, or the effects on milk production. atovaquone was detected in rat milk when lactating rats were administered oral atovaquone ( see data ). when a drug is present in animal milk, it is likely the drug will be present in human milk. because of the potential for hiv-1 transmission to hiv-negative infants, instruct mothers with hiv-1 not to breastfeed if they are taking atovaquone for the prevention or treatment of pcp. data in a rat study with doses of 10 and 250 mg/kg given orally by gavage on postpartum day 11, atovaquone concentrations in the milk were 30% of the concurrent atovaquone concentrations in the maternal plasma at both doses. the concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk evidence of safety and effectiveness in pediatric patients (aged 12 years and younger) has not been established. in a trial of atovaquone oral suspension administered once daily with food for 12 days to 27 hiv-1-infected, asymptomatic infants and children aged between 1 month and 13 years, the pharmacokinetics of atovaquone were age-dependent. the average steady-state plasma atovaquone concentrations in the 24 subjects with available concentration data are shown in table 5. table 5. average steady-state plasma atovaquone concentrations in pediatric subjects c ss  = concentration at steady state. clinical trials of atovaquone did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

Marekani - Kiingereza - NLM (National Library of Medicine)

chartwell rx, llc - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx). atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx. clinical experience with atovaquone oral suspension for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient [(a-a)do 2 ] ≤ 45mm hg). treatment of more severe episodes of pcp with atovaquone oral suspension has not been studied. the efficacy of atovaquone oral suspension in subjects who are failing therapy with tmp-smx has also not been studied. atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the comp

Marekani - Kiingereza - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated p. falciparum malaria. atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance. - atovaquone and proguanil hydrochloride is contraindicated in individuals with known hypersensitivity reactions (e.g., anaphylaxis, erythema multiforme or stevens-johnson syndrome, angioedema, vasculitis) to atovaquone or proguanil hydrochloride or any component of the formulation. - atovaquone and proguanil hydrochloride is contraindicated for prophylaxis of p. falciparum malaria in patients with severe renal impairment (creatinine clearance < 30 ml/min) because

Marekani - Kiingereza - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated p. falciparum malaria. atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance. - atovaquone and proguanil hydrochloride is contraindicated in individuals with known hypersensitivity reactions (e.g., anaphylaxis, erythema multiforme or stevens-johnson syndrome, angioedema, vasculitis) to atovaquone or proguanil hydrochloride or any component of the formulation. - atovaquone and proguanil hydrochloride is contraindicated for prophylaxis of p. falciparum malaria in patients with severe renal impairment (creatinine clearance < 30 ml/min) because

Marekani - Kiingereza - NLM (National Library of Medicine)

abon pharmaceuticals, llc - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx). atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx. clinical experience with atovaquone for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient [(a-a)do 2] ≤45 mm hg). treatment of more severe episodes of pcp with atovaquone has not been studied. the efficacy of atovaquone in subjects who are failing therapy with tmp-smx has also not been studied. atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral solution. risk summary availabl

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

generic health pty ltd - atovaquone, quantity: 62.5 mg; proguanil hydrochloride, quantity: 25 mg - tablet, film coated - excipient ingredients: poloxamer; povidone; hyprolose; purified water; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate type a; microcrystalline cellulose; titanium dioxide; macrogol 8000; hypromellose; iron oxide red; macrogol 400 - atovaquopro gh is indicated for:,? prophylaxis of plasmodium falciparum malaria in adults and children greater than or equal to 11 kg.,? treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.