САЩ - английски - NLM (National Library of Medicine)

allergan, inc. - ceftaroline fosamil (unii: 7p6fqa5d21) (ceftaroline - unii:h36z0fhr8k) - ceftaroline fosamil 400 mg in 20 ml - teflaro is indicated in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) for the treatment of acute bacterial skin and skin structure infections (absssi) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: staphylococcus aureus (including methicillin-susceptible and -resistant isolates), streptococcus pyogenes , streptococcus agalactiae , escherichia coli , klebsiella pneumoniae , and klebsiella oxytoca [see dosage and administration ( 2.2 ) and use in specific populations ( 8.4 )] . teflaro is indicated in adult and pediatric patients 2 months of age and older for the treatment of community-acquired bacterial pneumonia (cabp) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: streptococcus pneumoniae (including cases with concurrent bacteremia), staphylococcus aureus (methicillin-susceptible isolates only), haemophilus influenzae, klebsiella pneumoniae, klebsiella oxytoca, and escherichia coli. to reduce the development of drug-resistant bacteria and maintain the effectiveness of teflaro and other antibacterial drugs, teflaro should be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. 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. teflaro is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. anaphylaxis has been reported with ceftaroline. risk summary there are no adequate studies with teflaro in pregnant women that informed any drug associated risks. the background risk of major birth defects and miscarriage for the indicated population is unknown. the background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies within the general population. in developmental toxicity studies conducted in animals, no malformations or other adverse developmental effects were observed in offspring of rats exposed to teflaro at up to 4 times the maximum recommended human dose (mrhd) during the period of organogenesis through lactation. in rabbits exposed to teflaro during organogenesis at levels approximately equal to the mrhd, no drug-induced fetal malformations were observed despite maternal toxicity. data animal data developmental toxicity studies performed with ceftaroline fosamil in rats at iv doses up to 300 mg/kg demonstrated no maternal toxicity and no effects on the fetus. a separate toxicokinetic study showed that ceftaroline exposure in rats (based on auc) at this dose level was approximately 4 times the exposure in humans given 600 mg every 12 hours. there were no drug-induced malformations in the offspring of rabbits given iv doses of 25, 50, and 100 mg/kg, despite maternal toxicity. signs of maternal toxicity appeared secondary to the sensitivity of the rabbit gastrointestinal system to broad-spectrum antibacterials and included changes in fecal output in all groups and dose-related reductions in body weight gain and food consumption at > 50 mg/kg; these were associated with an increase in spontaneous abortion at 50 and 100 mg/kg. the highest dose was also associated with maternal moribundity and mortality. an increased incidence of a common rabbit skeletal variation, angulated hyoid alae, was also observed at the maternally toxic doses of 50 and 100 mg/kg. a separate toxicokinetic study showed that ceftaroline exposure in rabbits (based on auc) was approximately 0.4 times the exposure in humans given 600 mg every 12 hours at 25 mg/kg and 0.7 times the human exposure at 50 mg/kg. ceftaroline fosamil did not affect the postnatal development or reproductive performance of the offspring of rats given iv doses up to 450 mg/kg/day. results from a toxicokinetic study conducted in pregnant rats with doses up to 300 mg/kg suggest that exposure was ≥ 4 times the exposure in humans given 600 mg every 12 hours. risk summary no data is available regarding the presence of ceftaroline in human milk, the effects of ceftaroline on breastfed infants, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for teflaro and any potential adverse effects on the breastfed child from teflaro or from the underlying maternal condition. the safety and effectiveness of teflaro in the treatment of absssi have been established in pediatric patients (at least 34 weeks gestational age and 12 days postnatal age). the safety and effectiveness of teflaro in the treatment of cabp have been established in the age groups 2 months to less than 18 years old. use of teflaro in these age groups is supported by evidence from adequate and well-controlled studies of teflaro in adults with additional pharmacokinetic and safety data in pediatric patients 2 months of age and older with absssi or cabp [see clinical studies ( 14.1 and 14.2 )] . use of teflaro in pediatric patients less than 2 months of age was supported by pharmacokinetic and safety data in 11 infants at least 34 weeks gestational age and 12 days postnatal age. in these infants, concentrations of teflaro in the cerebrospinal fluid were not evaluated [see adverse reactions ( 6.1 ) , clinical pharmacology ( 12.3 ) and clinical studies ( 14.2 ) ] . results from the clinical studies in pediatric patients show that teflaro demonstrated a safety profile that was comparable with treatment of absssi and cabp in adults at the clinical dosages studied. safety and effectiveness of teflaro in pediatric patients less than 34 weeks gestational age and less than 12 days postnatal age for the treatment of absssi have not been established. safety and effectiveness of teflaro in pediatric patients below the age of 2 months for the treatment of cabp have not been established as no data are available.   of the 1300 adult patients treated with teflaro in the phase 3 absssi and cabp trials, 397 (30.5%) were ≥ 65 years of age. the clinical cure rates in the teflaro group (clinically evaluable [ce] population) were similar in patients ≥ 65 years of age compared with patients < 65 years of age in both the absssi and cabp trials. the adverse reaction profiles in patients ≥ 65 years of age and in patients < 65 years of age were similar. the percentage of patients in the teflaro group who had at least one adverse reaction was 52.4% in patients ≥ 65 years of age and 42.8% in patients < 65 years of age for the two indications combined. ceftaroline is excreted primarily 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 and it may be useful to monitor renal function. elderly subjects had greater ceftaroline exposure relative to non-elderly subjects when administered the same single dose of teflaro. however, higher exposure in elderly subjects was mainly attributed to age-related changes in renal function. dosage adjustment for elderly patients should be based on renal function [see dosage and administration ( 2.2 ) and clinical pharmacology ( 12.3 )].   dosage adjustment is required in adult patients with moderate (crcl > 30 to ≤ 50 ml/min) or severe (crcl ≥ 15 to ≤ 30 ml/min) renal impairment and in patients with end-stage renal disease (esrd – defined as crcl < 15 ml/min), including patients on hemodialysis (hd). there is insufficient information to recommend a dosage regimen for pediatric patients with crcl < 50 ml/min [see dosage and administration ( 2.2 )   and clinical pharmacology ( 12.3 ) ] .

Ирландия - английски - HPRA (Health Products Regulatory Authority)

clinical technology centre (international) limited (ppd) - alprostadil - cream - 2 mg/g

Ирландия - английски - HPRA (Health Products Regulatory Authority)

clinical technology centre (international) limited (ppd) - alprostadil - cream - 3 mg/g

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

the simple pharma company uk ltd - alprostadil - cutaneous cream - 3mg/1gram

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

haleon uk ltd - diclofenac diethylammonium - cutaneous gel - 23.2mg/1gram

Израел - английски - Ministry of Health

taro international ltd - fluconazole 150 mg - capsules - fluconazole - cryptococcosis. systemic candidiasis. mucosal candidiasis. vaginal candidiasis. dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and candida infections where topical therapy is considered inapproppriate due to the site, severity or extent of the infection.

Израел - английски - Ministry of Health

taro international ltd, israel - anastrozole - film coated tablets - anastrozole 1.0 mg - anastrozole - anastrozole - treatment of advanced breast cancer in post menopausal women. efficay has not been demonstrated in estrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen. adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.

Израел - английски - 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.

Израел - английски - Ministry of Health

taro international ltd, israel - propofol - emulsion for injection or infusion - propofol 10 mg/ml - propofol - propofol - diprofol 1% is a short-acting intravenous general anaesthetic for:• induction and maintenance of general anaesthesia in adults and children > 1 month.• sedation of ventilated patients > 16 years of age in the intensive care unit.• sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month..

Израел - английски - Ministry of Health

taro international ltd, israel - propofol - emulsion for injection or infusion - propofol 10 mg/ml - propofol - propofol - diprofol 1% is a short-acting intravenous general anaesthetic for:• induction and maintenance of general anaesthesia in adults and children > 1 month.• sedation of ventilated patients > 16 years of age in the intensive care unit.• sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month.