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

seagen inc. - enfortumab vedotin (unii: dle8519rwm) (enfortumab vedotin - unii:dle8519rwm) - padcev® , in combination with pembrolizumab, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (muc). padcev, as a single agent, is indicated for the treatment of adult patients with locally advanced or muc who: none. risk summary based on the mechanism of action and findings in animals, padcev can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available human data on padcev use in pregnant women to inform a drug-associated risk. in an animal reproduction study, administration of enfortumab vedotin-ejfv to pregnant rats during organogenesis caused maternal toxicity, embryo-fetal lethality, structural malformations and skeletal anomalies at maternal exposures similar to the exposures at the recommended human dose of 1.25 mg/kg (see data) . advise patients of the potential risk to the fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. data animal data in a rat pilot embryo-fetal development study, administration of enfortumab vedotin-ejfv on gestation day 6 and 13 during the period of organogenesis resulted in a complete litter loss in all pregnant rats at the maternally toxic dose of 5 mg/kg (approximately 3 times the exposure at the recommended human dose). a dose of 2 mg/kg (similar to the exposure at the recommended human dose) resulted in maternal toxicity, embryo-fetal lethality and structural malformations that included gastroschisis, malrotated hindlimb, absent forepaw, malpositioned internal organs and fused cervical arch. additionally, skeletal anomalies (asymmetric, fused, incompletely ossified, and misshapen sternebrae, misshapen cervical arch, and unilateral ossification of the thoracic centra) and decreased fetal weight were observed. risk summary there are no data on the presence of enfortumab vedotin-ejfv in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment with padcev and for 3 weeks after the last dose. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating padcev treatment [see use in specific populations (8.1)] . contraception females padcev can 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 with padcev and for 2 months after the last dose. males advise male patients with female partners of reproductive potential to use effective contraception during treatment with padcev and for 4 months after the last dose. infertility females based on findings in animal studies with mmae-containing antibody-drug conjugates (adcs), padcev may impair female fertility. the effect on fertility is reversible [see nonclinical toxicology (13.1)] . males based on findings from animal studies, padcev may impair male fertility [see nonclinical toxicology (13.1)] . safety and effectiveness of padcev in pediatric patients have not been established. of the 564 patients treated with padcev in combination with pembrolizumab, 44% (n=247) were 65-74 years and 26% (n=144) were 75 years or older. of the 720 patients treated with padcev as a single agent in clinical trials, 39% (n=282) were 65-74 years and 24% (n=170) were 75 years or older. no overall differences in effectiveness were observed between patients 65 years of age or older and younger patients. patients 75 years of age or older treated with padcev in combination with pembrolizumab experienced a higher incidence of fatal adverse reactions than younger patients. the incidence of fatal adverse reactions was 4% in patients younger than 75 and 7% in patients 75 years or older. patients 75 years of age or older treated with padcev as a single agent experienced a higher incidence of fatal adverse reactions than younger patients. the incidence of fatal adverse reactions was 6% in patients younger than 75 years, and 11% in patients 75 years or older. no significant difference was observed in the pharmacokinetics of padcev between patients 65 years and older and younger patients [see clinical pharmacology (12.3 )]. avoid the use of padcev in patients with moderate or severe hepatic impairment (total bilirubin >1.5 x uln and ast any). padcev has only been studied in a limited number of patients with moderate hepatic impairment (n=3) and has not been evaluated in patients with severe hepatic impairment [see clinical pharmacology (12.3)] . in another adc that contains mmae, the frequency of ≥ grade 3 adverse reactions and deaths was greater in patients with moderate (child-pugh b) or severe (child-pugh c) hepatic impairment compared to patients with normal hepatic function.

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

rbk nutraceuticals pty ltd - squalene, quantity: 1 g - capsule, soft - excipient ingredients: soya oil; gelatin; glycerol; d-alpha-tocopherol; purified water - antioxidant/reduce free radicals formed in the body ; maintain/support general health and wellbeing

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

aspen pharmacare australia pty ltd - ceftazidime pentahydrate, quantity: 1.164 g (equivalent: ceftazidime, qty 1 g) - injection, powder for - excipient ingredients: sodium carbonate - fortum is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials , but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. indications include: severe infections in general: for example septicaemia, including neonatal sepsis, bacteraemia, and in patients in intensive care units with specific problems, e.g., infected burns. respiratory tract infections: for example, pneumonia, bronchopneumonia, infected pleurisy, infected bronchiectasis and bronchitis. severe ear, nose and throat infections: for example, otitis media, mastoiditis. urinary tract infections: for example, acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and infections associated with bladder and renal stones. skin and soft tissue infections: for example, erys

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

glaxosmithkline pharmaceutical sdn. bhd. - ceftazidime -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

glaxosmithkline pharmaceutical sdn. bhd. - ceftazidime -