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

almirall, llc - retapamulin (unii: 4mg6o8991r) (retapamulin - unii:4mg6o8991r) - retapamulin 10 mg - altabax® is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to staphylococcus aureus (methicillin-susceptible isolates only) or streptococcus pyogenes [see clinical studies (14)] . safety in patients younger than 9 months has not been established. to reduce the development of drug-resistant bacteria and maintain the effectiveness of altabax and other antibacterial drugs, altabax should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. none. risk summary there are no available data on altabax use in pregnant women to inform any drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. retapamulin is negligibly absorbed systemically following topical administration and maternal use is not expected to result in fetal exp

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

physicians total care, inc. - retapamulin (unii: 4mg6o8991r) (retapamulin - unii:4mg6o8991r) - retapamulin 10 mg in 1 g - altabax is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to staphylococcus aureus (methicillin-susceptible isolates only) or streptococcus pyogenes [see clinical studies (14)] . to reduce the development of drug-resistant bacteria and maintain the effectiveness of altabax and other antibacterial drugs, altabax should none. pregnancy category b . effects on embryo-fetal development were assessed in pregnant rats given 50, 150, or 450 mg/kg/day by oral gavage on days 6 to 17 postcoitus. maternal toxicity (decreased body weight gain and food consumption) and developmental toxicity (decreased fetal body weight and delayed skeletal ossification) were evident at doses ≥150 mg/kg/day. there were no treatment-related malformations observed in fetal rats. retapamulin was given as a continuous intravenous infusion to pregnan

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

rebel distributors corp. - retapamulin (unii: 4mg6o8991r) (retapamulin - unii:4mg6o8991r) - retapamulin 10 mg in 1 g - altabax is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to staphylococcus aureus (methicillin-susceptible isolates only) or streptococcus pyogenes [see clinical studies (14)] . to reduce the development of drug-resistant bacteria and maintain the effectiveness of altabax and other antibacterial drugs, altabax should none. 8.1 pregnancy pregnancy category b . effects on embryo-fetal development were assessed in pregnant rats given 50, 150, or 450 mg/kg/day by oral gavage on days 6 to 17 postcoitus. maternal toxicity (decreased body weight gain and food consumption) and developmental toxicity (decreased fetal body weight and delayed skeletal ossification) were evident at doses ≥150 mg/kg/day. there were no treatment-related malformations observed in fetal rats. retapamulin was given as a continuous intravenous infusion to pre

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

pfizer laboratories div pfizer inc - epoetin (unii: 64fs3bfh5w) (erythropoietin - unii:64fs3bfh5w) - retacrit is indicated for the treatment of anemia due to chronic kidney disease (ckd), including patients on dialysis and not on dialysis to decrease the need for red blood cell (rbc) transfusion. retacrit is indicated for the treatment of anemia due to zidovudine administered at ≤ 4,200 mg/week in patients with hiv-infection with endogenous serum erythropoietin levels of ≤ 500 munits/ml. retacrit is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. retacrit is indicated to reduce the need for allogeneic rbc transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dl who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. retacrit is not indicated for patients who are willing to donate autologous blood pre-operatively. retacrit has not been shown to improv

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

vifor (international) inc. - epoetin (unii: 64fs3bfh5w) (epoetin - unii:64fs3bfh5w) - retacrit is indicated for the treatment of anemia due to chronic kidney disease (ckd), including patients on dialysis and not on dialysis to decrease the need for red blood cell (rbc) transfusion. retacrit is indicated for the treatment of anemia due to zidovudine administered at ≤ 4,200 mg/week in patients with hiv-infection with endogenous serum erythropoietin levels of ≤ 500 munits/ml. retacrit is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. retacrit is indicated to reduce the need for allogeneic rbc transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dl who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. retacrit is not indicated for patients who are willing to donate autologous blood pre-operatively. retacrit has not been shown to improv

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - hydromorphone hydrochloride 16mg (+ 9% overage to account for residual drug retained in capsule shell) - modified release tablet - 16 mg - active: hydromorphone hydrochloride 16mg (+ 9% overage to account for residual drug retained in capsule shell) excipient: butylated hydroxytoluene cellulose acetate hypromellose iron oxide black macrogol 3350 magnesium stearate opacode black ns-78-17821 opadry clear ys-1-19025-a opadry yellow y-30-12863-a polyethylene oxide povidone sodium chloride - jurnista is indicated in the treatment of moderate to severe chronic pain.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - hydromorphone hydrochloride 8mg (+ 9% overage to account for residual drug retained in capsule shell) - modified release tablet - 8 mg - active: hydromorphone hydrochloride 8mg (+ 9% overage to account for residual drug retained in capsule shell) excipient: butylated hydroxytoluene cellulose acetate hypromellose iron oxide black macrogol 3350 magnesium stearate opacode black ns-78-17821 opadry clear ys-1-19025-a opadry red y-30-15595-a polyethylene oxide povidone sodium chloride - jurnista is indicated in the treatment of moderate to severe chronic pain.

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

glaxosmithkline australia pty ltd - retapamulin -

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

novartis pharmaceuticals australia pty ltd - rivastigmine, quantity: 27 mg - drug delivery system, transdermal - excipient ingredients: acrylates copolymer; dl-alpha-tocopherol; dimeticone 12500; ethyl acetate; methylated trimethylated silica; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - exelon / prometax is indicated for the treatment of patients with mild, moderate and severe dementia of the alzheimer's type.

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

novartis pharmaceuticals australia pty ltd - rivastigmine, quantity: 18 mg - drug delivery system, transdermal - excipient ingredients: dimeticone 12500; acrylates copolymer; dl-alpha-tocopherol; ethyl acetate; hexane; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; methylated trimethylated silica - exelon / prometax is indicated for the treatment of patients with mild, moderate and severe dementia of the alzheimer's type.