European Union - English - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - efavirenz/emtricitabine/tenofovir disoproxil zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil zentiva prior to initiation of their first antiretroviral treatment regimen., the demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavir

Ireland - English - HPRA (Health Products Regulatory Authority)

glenmark pharmaceuticals europe limited - atovaquone; proguanil hydrochloride - film-coated tablet - 250 mg/100 milligram(s) - biguanides; proguanil, combinations

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

proficient rx lp - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone 250 mg - atovaquone and proguanil hydrochloride tabletsare indicated for the prophylaxis of plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. atovaquone and proguanil hydrochloride tabletsare 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 of pancytopenia i

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

pd-rx pharmaceuticals, inc. - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone 250 mg - 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 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 sever

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

prasco laboratories - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone 250 mg - 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 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. risk summary available data from published literature and postmarketing experience with use of atovaquone and proguanil hydrochloride 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 fola

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

st. mary's medical park pharmacy - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone 250 mg - 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

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

bluepoint laboratories - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone 250 mg - 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 (creatin

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

glenmark pharmaceuticals inc.,usa - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone 250 mg - 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. risk summary available data from published literature and postmarketing experience with use of atovaquone and proguanil hydrochloride 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 cont