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

juno pharmaceuticals pty ltd - tigecycline, quantity: 50 mg - injection, powder for - excipient ingredients: arginine; hydrochloric acid; sodium hydroxide - tigecycline juno is indicated for the treatment of the following infections in adults:,? complicated skin and skin structure infections, including those with methicillin resistant staphylococcus aureus (mrsa), where there is suspected or proven resistance to, intolerance of, or there are co- morbidities preventing the use of, other available agents.,? complicated intra-abdominal infections, where there is suspected or proven resistance to, intolerance of, or there are co-morbidities preventing the use of, other available agents.

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

fresenius kabi usa, llc - tigecycline (unii: 70je2n95kr) (tigecycline - unii:70je2n95kr) - tigecycline 50 mg in 5 ml - tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of escherichia coli, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus agalactiae, streptococcus anginosus grp. (includes s. anginosus, s. intermedius, and s. constellatus ), streptococcus pyogenes, enterobacter cloacae, klebsiella pneumoniae, and bacteroides fragilis.  tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections caused by susceptible isolates of citrobacter freundii, enterobacter cloacae, escherichia coli, klebsiella oxytoca, klebsiella pneumoniae, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus anginosus grp. (includes s. anginosus, s. intermedius, and s. constellatus ), bacteroides fragilis, bacteroides thetaiotaomicron, bacteroides uniformis, bacteroides vulgatus, clostridium perfringens, and peptostreptococcus micros. tigecycline for injection is indicated in patients 18 years of age and older for the treatment of community-acquired bacterial pneumonia caused by susceptible isolates of  streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, haemophilus influenzae , and legionella pneumophila . tigecycline for injection is not indicated for the treatment of diabetic foot infections.  a clinical trial failed to demonstrate non-inferiority of tigecycline for injection for treatment of diabetic foot infections. tigecycline for injection is not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia.  in a comparative clinical trial, greater mortality and decreased efficacy were reported in tigecycline-treated patients [see warnings and precautions (5.2)]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of tigecycline and other antibacterial drugs, tigecycline for injection should be used only to treat  infections that are proven or strongly suspected to be caused by susceptible bacteria.  when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.  in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to tigecycline.  tigecycline for injection may be initiated as empiric monotherapy before results of these tests are known.  tigecycline for injection is contraindicated for use in patients who have known hypersensitivity to tigecycline. reactions have included anaphylactic reactions [see  warnings and precautions (5.3) and adverse reactions (6.2)] . teratogenic effects—pregnancy category d [see warnings and precautions (5.6)] tigecycline was not teratogenic in the rat or rabbit.  in preclinical safety studies, 14 c-labeled tigecycline crossed the placenta and was found in fetal tissues, including fetal bony structures.  the administration of tigecycline was associated with reductions in fetal weights and an increased incidence of skeletal anomalies (delays in bone ossification) at exposures of 5 times and 1 times the human daily dose based on auc in rats and rabbits, respectively (28 mcg•hr/ml and 6 mcg•hr/ml at 12 and 4 mg/kg/day).  an increased incidence of fetal loss was observed at maternotoxic doses in the rabbits with exposure equivalent to human dose. there are no adequate and well-controlled studies of tigecycline in pregnant women.  tigecycline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. results from animal studies using 14 c-labeled tigecycline indicate that tigecycline is excreted readily via the milk of lactating rats.  consistent with the limited oral bioavailability of tigecycline, there is little or no systemic exposure to tigecycline in nursing pups as a result of exposure via maternal milk. it is not known whether this drug is excreted in human milk.  because many drugs are excreted in human milk, caution should be exercised when tigecycline is administered to a nursing woman [see warnings and precautions (5.7)] . use in patients under 18 years of age is not recommended.  safety and effectiveness in pediatric patients below the age of 18 years have not been established.  because of the increased mortality observed in tigecycline-treated adult patients in clinical trials, pediatric trials of tigecycline to evaluate the safety and efficacy of tigecycline were not conducted. in situations where there are no other alternative antibacterial drugs, dosing has been proposed for pediatric patients 8 to 17 years of age based on data from pediatric pharmacokinetic studies  [see dosage and administration (2.3) and clinical pharmacology (12.3)] . because of effects on tooth development, use in patients under 8 years of age is not recommended [see warnings and precautions (5.7)] . of the total number of subjects who received tigecycline in phase 3 clinical studies (n=2,514), 664 were 65 and over, while 288 were 75 and over.  no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity to adverse events of some older individuals cannot be ruled out. no significant difference in tigecycline exposure was observed between healthy elderly subjects and younger subjects following a single 100 mg dose of tigecycline [see clinical pharmacology (12.3) ]. no dosage adjustment is warranted in patients with mild to moderate hepatic impairment (child pugh a and child pugh b).  in patients with severe hepatic impairment (child pugh c), the initial dose of tigecycline should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours.  patients with severe hepatic impairment (child pugh c) should be treated with caution and monitored for treatment response [see clinical phar macology (12.3) and dosage and administration (2.2)] .

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

sandoz inc - tigecycline (unii: 70je2n95kr) (tigecycline - unii:70je2n95kr) - tigecycline 50 mg in 10 ml - tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of escherichia coli, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus agalactiae, streptococcus anginosus grp. (includes s. anginosus, s. intermedius, and s. constellatus ), streptococcus pyogenes , enterobacter cloacae , klebsiella pneumoniae , and bacteroides fragilis. tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections caused by susceptible isolates of citrobacter freundii, enterobacter cloacae, escherichia coli, klebsiella oxytoca, klebsiella pneumoniae, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus anginosus grp. (includes s. anginosus, s. intermedius,

Malta - English - Medicines Authority

antibiotice s.a. 1 valea lupului street, 707410, iasi, romania - tigecycline - powder for solution for infusion - tigecycline 50 mg - antibacterials for systemic use

Malta - English - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - tigecycline - powder for solution for infusion - tigecycline 50 mg - antibacterials for systemic use

Malta - English - Medicines Authority

galenicum health, s.l.u calle sant gabriel, 50 esplugues de llobregat 08950 barcelona, spain - tigecycline - powder for solution for infusion - tigecycline 10 mg/ml - antibacterials for systemic use

Malta - English - Medicines Authority

1 a pharma gmbh keltenring 1+3, 82041 oberhaching, germany - tigecycline - powder for solution for infusion - tigecycline 50 mg - antibacterials for systemic use

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - tigecycline - powder for solution for infusion - tigecycline 50 mg - antibacterials for systemic use

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

amneal pharmaceuticals llc - tigecycline (unii: 70je2n95kr) (tigecycline - unii:70je2n95kr) - tigecycline for injectionis indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of escherichia coli, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus agalactiae, streptococcus anginosus grp. (includes s. anginosus, s. intermedius, and s. constellatus ), streptococcus pyogenes, enterobacter cloacae, klebsiella pneumoniae, and bacteroides fragilis. tigecycline for injectionis indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections caused by susceptible isolates of citrobacter freundii, enterobacter cloacae, escherichia coli, klebsiella oxytoca, klebsiella pneumoniae, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus anginosus grp. (includes s. anginosus, s. intermedius, and s. constellatus ), bacteroides fragilis, bacteroides thetaiotaomicron, bacteroides uniformis, bacteroides vulgatus, clostridium perfringens, and peptostreptococcus micros. tigecycline for injection is indicated in patients 18 years of age and older for the treatment of community-acquired bacterial pneumonia caused by susceptible isolates of streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, haemophilus influenzae , and legionella pneumophila . tigecycline for injection is not indicated for the treatment of diabetic foot infections. a clinical trial failed to demonstrate non-inferiority of tigecycline for treatment of diabetic foot infections. tigecycline for injection is not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia. in a comparative clinical trial, greater mortality and decreased efficacy were reported in tigecycline-treated patients [see warnings and precautions (5.2)]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of tigecycline for injectionand other antibacterial drugs, tigecycline for injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to tigecycline. tigecycline for injection may be initiated as empiric monotherapy before results of these tests are known. tigecycline for injection is contraindicated for use in patients who have known hypersensitivity to tigecycline. reactions have included anaphylactic reactions [see warnings and precautions (5.3)  andadverse reactions (6.2)]. risk summary tigecycline for injection, like other tetracycline class antibacterial drugs, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see warnings and precautions (5.7), (5.8), data, anduse in specific populations (8.4)]. there are no available data on the risk of major birth defects or miscarriage following the use of tigecycline for injection during pregnancy. administration of intravenous tigecycline in pregnant rats and rabbits during the period of organogenesis was associated with reduction in fetal weights and an increased incidence of skeletal anomalies (delays in bone ossification) at exposures of 5 and 1 times the human exposure at the recommended clinical dose in rats and rabbits, respectively. advise the patient of the potential risk to the fetus if tigecycline for injection is used during the second or third trimester. 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 estimated background risk in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. human data the use of tetracycline-class antibacterial drugs, that includes tigecycline for injection, during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous teeth. this adverse reaction is more common during long-term use of tetracyclines but has been observed following repeated short-term courses. tigecycline for injection may cause reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy. a decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours. animal data in embryo-fetal development studies, tigecycline was administered during the period of organogenesis at doses up to 12 mg/kg/day in rats and 4 mg/kg in rabbits or 5 and 1 times the systemic exposure at the recommended clinical dose, respectively. in the rat study, decreased fetal weight and fetal skeletal variations (reduced ossification of the pubic, ischial, and supraoccipital bones and increased incidences of rudimentary 14th rib) were observed in the presence of maternal toxicity at 12 mg/kg/day (5 times the recommended clinical dose based on systemic exposure). in rabbits, decreased fetal weights were observed in the presence of maternal toxicity at 4 mg/kg (equivalent to the human exposure at the recommended clinical dose). in preclinical safety studies, 14 c-labeled tigecycline crossed the placenta and was found in fetal tissues. risk summary   there are no data on the presence of tigecycline in human milk; however, tetracycline-class antibacterial drugs are present in breast milk. it is not known whether tigecycline has an effect on the breastfed infant or on milk production. tigecycline has low oral bioavailability; therefore, infant exposure is expected to be low. tigecycline is present in rat milk with little or no systemic exposure to tigecycline in nursing pups as a result of exposure via maternal milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tigecycline for injection and any potential adverse effects on the breastfed child from tigecycline for injection or from the underlying maternal condition (see clinical considerations) . because of the theoretical risk of dental discoloration and inhibition of bone growth, avoid breastfeeding if taking tigecycline for injection for longer than three weeks. a lactating woman may also consider interrupting breastfeeding and pumping and discarding breastmilk during administration of tigecycline for injection and for 9 days (approximately 5 half-lives) after the last dose in order to minimize drug exposure to a breastfed infant. use in patients under 18 years of age is not recommended. safety and effectiveness in pediatric patients below the age of 18 years have not been established. because of the increased mortality observed in tigecycline for injection-treated adult patients in clinical trials, pediatric trials of tigecycline for injection to evaluate the safety and efficacy of tigecycline were not conducted. in situations where there are no other alternative antibacterial drugs, dosing has been proposed for pediatric patients 8 to 17 years of age based on data from pediatric pharmacokinetic studies [see dosage and administration (2.3)  and clinical pharmacology (12.3)] . because of effects on tooth development, use in patients under 8 years of age is not recommended [see warnings and precautions (5.7)] . of the total number of subjects who received tigecycline in phase 3 clinical studies (n=2514), 664 were 65 and over, while 288 were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity to adverse events of some older individuals cannot be ruled out. no significant difference in tigecycline exposure was observed between healthy elderly subjects and younger subjects following a single 100 mg dose of tigecycline [see clinical pharmacology (12.3)]. no dosage adjustment is warranted in patients with mild to moderate hepatic impairment (child pugh a and child pugh b). in patients with severe hepatic impairment (child pugh c), the initial dose of tigecycline should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours. patients with severe hepatic impairment (child pugh c) should be treated with caution and monitored for treatment response [see clinical pharmacology (12.3)  anddosage and administration (2.2)] .

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

auromedics pharma llc - tigecycline (unii: 70je2n95kr) (tigecycline - unii:70je2n95kr) - tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of escherichia coli, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus agalactiae, streptococcus anginosus grp. (includes s. anginosus, s. intermedius, and s. constellatus ), streptococcus pyogenes, enterobacter cloacae, klebsiella pneumoniae, and bacteroides fragilis. tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections caused by susceptible isolates of citrobacter freundii, enterobacter cloacae, escherichia coli, klebsiella oxytoca, klebsiella pneumoniae, enterococcus faecalis (vancomycin-susceptible isolates), staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus anginosus grp. (includes s. anginosus, s. intermedius,