USA - engelsk - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg in 250 ml - avelox is indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies (14.3)] . mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. avelox is indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus or streptococcus pyogenes [see clinical studies (14.4)]. avelox is indicated in adult patients for the treatment of complicated skin and skin

USA - engelsk - NLM (National Library of Medicine)

aurobindo pharma limited - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 5 mg in 1 ml - moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: corynebacterium species* micrococcus luteus* staphylococcus aureus staphylococcus epidermidis staphylococcus haemolyticus staphylococcus hominis staphylococcus warneri* streptococcus pneumoniae streptococcus viridans group acinetobacter lwoffii* haemophilus influenza haemophilus parainfluenzae* chlamydia trachomatis *efficacy for this organism was studied in fewer than 10 infections. moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. risk summary there are no adequate and well-controlled studies with moxifloxacin in pregnant women to inform any drug-associated risks. oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabbits during the period of organogenesis did not produce adverse maternal or fetal effects at clinically relevant doses. oral administration of moxifloxacin to pregnant rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses (see data) . data animal data embryo-fetal studies were conducted in pregnant rats administered with 20, 100, or 500 mg/kg/day moxifloxacin by oral gavage on gestation days 6 to 17, to target the period of organogenesis. decreased fetal body weight and delayed skeletal development were observed at 500 mg/kg/day [277 times the human area under the curve (auc) at the recommended human ophthalmic dose]. the no-observed-adverse-effect-level (noael) for developmental toxicity was 100 mg/kg/day (30 times the human auc at the recommended human ophthalmic dose). embryo-fetal studies were conducted in pregnant rabbits administered with 2, 6.5, or 20 mg/kg/day moxifloxacin by intravenous administration on gestation days 6 to 20, to target the period of organogenesis. abortions, increased incidence of fetal malformations, delayed fetal skeletal ossification, and reduced placental and fetal body weights were observed at 20 mg/kg/day (1086 times the human auc at the recommended human ophthalmic dose), a dose that produced maternal body weight loss and death. the noael for developmental toxicity was 6.5 mg/kg/day (246 times the human auc at the recommended human ophthalmic dose). pregnant cynomolgus monkeys were administered moxifloxacin at doses of 10, 30, or 100 mg/kg/day by intragastric intubation between gestation days 20 and 50, targeting the period of organogenesis. at the maternal toxic doses of ≥ 30 mg/kg/day, increased abortion, vomiting, and diarrhea were observed. smaller fetuses/reduced fetal body weights were observed at 100 mg/kg/day (2864 times the human auc at the recommended human ophthalmic dose). the noael for fetal toxicity was 10 mg/kg/day (174 times the human auc at the recommended human ophthalmic dose). in a pre- and postnatal study, rats were administered moxifloxacin by oral gavage at doses of 20, 100, and 500 mg/kg/day from gestation day 6 until the end of lactation. maternal death occurred during gestation at 500 mg/kg/day. slight increases in the duration of pregnancy, reduced pup birth weight, and decreased prenatal and neonatal survival were observed at 500 mg/kg/day (estimated 277 times the human auc at the recommended human ophthalmic dose). the noael for pre- and postnatal development was 100 mg/kg/day (estimated 30 times the human auc at the recommended human ophthalmic dose). risk summary there is no data regarding the presence of moxifloxacin in human milk, the effects on the breastfed infants, or the effects on milk production/excretion to inform risk of moxifloxacin to an infant during lactation. a study in lactating rats has shown transfer of moxifloxacin into milk following oral administration. systemic levels of moxifloxacin following topical ocular administration are low [see clinical pharmacology (12.3)] , and it is not known whether measurable levels of moxifloxacin would be present in maternal milk following topical ocular administration. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for moxifloxacin and any potential adverse effects on the breastfed child from moxifloxacin. the safety and effectiveness of moxifloxacin have been established in all ages. use of moxifloxacin is supported by evidence from adequate and well controlled studies of moxifloxacin in adults, children, and neonates [see clinical studies (14) ]. there is no evidence that the ophthalmic administration of moxifloxacin has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals. no overall differences in safety and effectiveness have been observed between elderly and younger patients.

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

apotex pty ltd - moxifloxacin hydrochloride monohydrate -

Hellas - gresk - Εθνικός Οργανισμός Φαρμάκων

ΒΙΟΣΕΡ Α.Ε. ΒΙΟΜΗΧΑΝΙΑ ΠΑΡΕΝΤΕΡΙΚΩΝ ΔΙΑΛΥΜΑΤΩΝ Δ.Τ. ΒΙΟΣΕΡ Α.Ε. 9ο χλμ. Εθνικής Οδού Τρικάλων-Λάρισας, 421 00 Ταξιάρχες, Τρίκαλα 2431 083441-2 - moxifloxacin hydrochloride - sol.inf (ΔΙΑΛΥΜΑ ΓΙΑ ΕΓΧΥΣΗ) - 400mg/250ml - moxifloxacin hydrochloride 1,745mg - moxifloxacin

Portugal - portugisisk - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

bluepharma - indústria farmacêutica, s.a. - moxifloxacina - comprimido revestido por película - 400 mg - cloridrato de moxifloxacina 436.8 mg - moxifloxacin - genérico - duração do tratamento: curta ou média duração

Portugal - portugisisk - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

bluepharma - indústria farmacêutica, s.a. - moxifloxacina - comprimido revestido por película - 400 mg - cloridrato de moxifloxacina 436.8 mg - moxifloxacin - genérico - duração do tratamento: curta ou média duração

Portugal - portugisisk - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

hikma farmacêutica (portugal), s.a. - moxifloxacina - solução para perfusão - 400 mg/250 ml - cloridrato de moxifloxacina 437.5 mg - moxifloxacin - genérico - duração do tratamento: curta ou média duração

Portugal - portugisisk - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

aristo pharma iberia, sl - moxifloxacina - comprimido revestido por película - 400 mg - cloridrato de moxifloxacina 436.8 mg - moxifloxacin - genérico - duração do tratamento: curta ou média duração

USA - engelsk - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin tablets are indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies ( 14.3) ]. mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. moxifloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus or str

USA - engelsk - NLM (National Library of Medicine)

remedyrepack inc. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin tablets are indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies ( 14.3) ]. mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. moxifloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus or str