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

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

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

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.

Malta - English - Medicines Authority

generics uk limited - tigecycline - powder for solution for infusion - tigecycline 50 mg - antibacterials for systemic use

Malta - English - Medicines Authority

solinea sp. z o.o. sp.k. - tigecycline - powder for solution for infusion - tigecycline 10 milligram(s)/millilitre - antibacterials for systemic use