Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - letermovir 240mg - concentrate for infusion - active: letermovir 240mg excipient: hydroxypropyl-beta-cyclodextrin sodium chloride sodium hydroxide water for injection - prevymis is indicated for the prophylaxis of cytomegalovirus (cmv) infection or disease in adult cmv-seropositive recipients [r+] of an allogeneic hematopoietic stem cell transplant (hsct).

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - letermovir 480mg - concentrate for infusion - active: letermovir 480mg excipient: hydroxypropyl-beta-cyclodextrin sodium chloride sodium hydroxide water for injection - prevymis is indicated for the prophylaxis of cytomegalovirus (cmv) infection or disease in adult cmv-seropositive recipients [r+] of an allogeneic hematopoietic stem cell transplant (hsct).

Australien - engelska - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - alphaxalone - parenteral liquid/solution/suspension - alphaxalone anaesthetic active 10.0 mg/ml - anaesthetics/analgesics - cat | dog | bitch | castrate | cat - queen | cat - tom | kitten | puppy - anaesthetic - local/general | general anaesthetic | immobiliser | local anaesthetic | premedication | sedative | tranquilliser | travel sickness

USA - engelska - NLM (National Library of Medicine)

us pharmaceutical corporation - folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), ferrous fumarate (unii: r5l488ry0q) (ferrous cation - unii:gw89581owr) - folic acid 1 mg

USA - engelska - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hcl tablets, usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hcl, usp is contraindicated in patients with: 1. renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions). 2. known hypersensitivity to metformin hcl, usp. 3. acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin hcl, usp should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (see also precautions.)

Israel - engelska - Ministry of Health

taro international ltd, israel - piroxicam as beta-cyclodextrin - tablets - piroxicam as beta-cyclodextrin 20 mg - piroxicam - piroxicam - piroxicam is indicated for symptomatic relief of osteoarthritis rheumatoid arthritis or ankylosing spondylitis. when an nsaid is indicated piroxicam should be considered as a second line option. the desicion to prescribe piroxocam should be based on an assesment of the individual's patient overall risk.

Filippinerna - engelska - FDA (Food And Drug Administration)

baxter healthcare philippines, inc.; distributor: baxter healthcare philippines, inc. - peritoneal dialysis solution with 7.5% icodextrin - solution for intraperitoneal administration - formulation each 100 ml contains: icodextrin sodium chloride sodium lactate calcium chloride magnesium chloride 7.5 g 538 mg 448 mg 25.7 mg 5.08 mg per 1 liter contains: sodium calcium magnesium chloride lactate 132 mmol 1.75 mmol 0.25 mmol 96 mmol 40 mmol

Nya Zeeland - engelska - Ministry for Primary Industries

agrihealth nz limited - beta-cyclodextrin - beta-cyclodextrin 800 g/kg - antiprotozoal

USA - engelska - NLM (National Library of Medicine)

cumberland pharmaceuticals inc. - telavancin hydrochloride (unii: 0701472zg0) (telavancin - unii:xk134822z0) - vibativ is indicated for the treatment of adult patients with complicated skin and skin structure infections (csssi) caused by susceptible isolates of the following gram-positive microorganisms: staphylococcus aureus (including methicillin-susceptible and -resistant isolates), streptococcus pyogenes , streptococcus agalactiae , streptococcus anginosus group (includes s. anginosus, s. intermedius, and s. constellatus) , or enterococcus faecalis (vancomycinsusceptible isolates only). vibativ is indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (habp/vabp), caused by susceptible isolates of staphylococcus aureus (both methicillin-susceptible and -resistant isolates). vibativ should be reserved for use when alternative treatments are not suitable. combination therapy may be clinically indicated if the documented or presumed pathogens include gram-negative organisms. appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. vibativ may be initiated as empiric therapy before results of these tests are known. to reduce the development of drug-resistant bacteria and maintain the effectiveness of vibativ and other antibacterial drugs, vibativ 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. use of intravenous unfractionated heparin sodium is contraindicated with vibativ administration because the activated partial thromboplastin time (aptt) test results are expected to be artificially prolonged for 0 to 18 hours after vibativ administration [see warnings and precautions (5.5) and drug interactions (7.1) ]. vibativ is contraindicated in patients with known hypersensitivity to telavancin. risk summary based on findings in animal reproduction studies, vibativ may cause fetal harm. there are no available data on vibativ use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses providing approximately 1- to 2-fold the human exposure at the maximum recommended clinical dose (see data). advise pregnant women of the potential risk to a fetus. 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 of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses up to 150, 45, or 75 mg/kg/day, respectively. these doses resulted in exposure levels approximately 1- to 2-fold the human exposure (auc) at the maximum recommended clinical dose. malformations observed at <1% (but absent or at lower rates in historical or concurrent controls), included brachymelia (rats and rabbits), syndactyly (rats, minipigs), adactyly (rabbits), and polydactyly (minipigs). additional findings in rabbits included flexed front paw and absent ulna, and in the minipigs included misshapen digits and deformed front leg. fetal body weights were decreased in rats. in a prenatal/perinatal development study, pregnant rats received intravenous telavancin at up to 150 mg/kg/day (approximately the same auc as observed at the maximum clinical dose) from the start of organogenesis through lactation. offspring showed decreases in fetal body weight and an increase in the number of stillborn pups. brachymelia was also observed. developmental milestones and fertility of the pups were unaffected. risk summary there are no data on the presence of telavancin in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vibativ and any potential adverse effects on the breastfed child from vibativ or from the underlying maternal conditions. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating vibativ. contraception females vibativ may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception during treatment and for 2 days after the final dose. infertility males based on findings in rats, vibativ may impair male fertility [see nonclinical toxicology (13.1)]. the effect on fertility was reversible in rats. the safety and effectiveness of vibativ have not been established in pediatric patients. in particular, there is a concern for poor clinical outcomes in pediatric patients less than one year of age due to immature renal function. increased mortality in adult patients with habp/vabp and renal impairment and decreased clinical response in adults with csssi and renal impairment were observed [see boxed warning and warnings and precautions (5.1, 5.2)] . of the 929 patients treated with vibativ at a dose of 10 mg/kg once daily in clinical trials of csssi, 174 (19%) were ≥65 years of age and 87 (9%) were ≥75 years of age. in the csssi trials, lower clinical cure rates were observed in patients ≥65 years of age compared with those <65 years of age. overall, treatment-emergent adverse events occurred with similar frequencies in patients ≥65 (75% of patients) and <65 years of age (83% of patients). fifteen of 174 (9%) patients ≥65 years of age treated with vibativ had adverse events indicative of renal impairment compared with 16 of 755 (2%) patients <65 years of age [see warnings and precautions (5.3), clinical trials (14.1) ]. of the 749 habp/vabp patients treated with vibativ at a dose of 10 mg/kg once daily in clinical trials of habp/vabp, 397 (53%) were ≥65 years of age and 230 (31%) were ≥75 years of age. treatment-emergent adverse events as well as deaths and other serious adverse events occurred more often in patients ≥ 65 years of age than in those <65 years of age in both treatment groups. telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group. the mean plasma auc values of telavancin were similar in healthy young and elderly subjects. dosage adjustment for elderly patients should be based on renal function [see dosage and administration (2), clinical pharmacology (12.3) ]. the habp/vabp and csssi trials included patients with normal renal function and patients with varying degrees of renal impairment. patients with underlying renal dysfunction or risk factors for renal dysfunction had a higher incidence of renal adverse events [see warnings and precautions (5.3) ]. in the habp/vabp studies higher mortality rates were observed in the vibativ-treated patients with baseline crcl ≤50 ml/min. use of vibativ in patients with pre-existing moderate/severe renal impairment should be considered only when the anticipated benefit to the patient outweighs the potential risk [see warnings and precautions (5.1, )]. vibativ-treated patients in the csssi studies with baseline creatinine clearance ≤50 ml/min had lower clinical cure rates. consider these data when selecting antibacterial therapy in patients with baseline moderate/severe renal impairment (crcl ≤50 ml/min) [see warnings and precautions (5.2 )]. dosage adjustment is required in patients with ≤50 ml/min renal impairment [see dosage and administration (2 )]. there is insufficient information to make specific dosage adjustment recommendations for patients with end-stage renal disease (crcl <10 ml/min), including patients receiving hemodialysis [see overdosage (10), clinical pharmacology (12.3) ]. hydroxypropyl-beta-cyclodextrin is excreted in urine and may accumulate in patients with renal impairment. serum creatinine should be closely monitored and, if renal toxicity is suspected, an alternative agent should be considered [see warnings and precautions (5.3), clinical pharmacology (12.3) ]. the habp/vabp and csssi trials included patients with normal hepatic function and with hepatic impairment. no dosage adjustment is recommended in patients with mild or moderate hepatic impairment [see clinical pharmacology (12.3) ].

Irland - engelska - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - icodextrin; sodium chloride; sodium (s) - lactate ; calcium chloride; magnesium chloride - solution for peritoneal dialysis - isotonic solutions