ארצות הברית - אנגלית - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - ritlecitinib tosylate (unii: eag4t1459k) (ritlecitinib - unii:2oye00pc25) - litfulo is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. limitations of use : not recommended for use in combination with other jak inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. litfulo is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients [see warnings and precautions (5.6)] .       if a patient becomes pregnant while receiving litfulo, healthcare providers should report litfulo exposure by calling 1-877-390-2940. risk summary available data from clinical trials with litfulo use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of ritlecitinib to pregnant rats and rabbits during organogenesis caused fetotoxicity and fetal malformations at exposures 49 and 55 times the maximum recommended human dose (mrhd) based on area under the curve (auc) comparison, respectively (see animal data) . the background risks of major birth defects and miscarriage for the indicated population are unknown. all pregnancies carry some risk of birth defects, loss, or other adverse outcomes. the estimated background risks in the u.s. general population of major birth defects and miscarriages are 2-4% and 15-20% of clinically recognized pregnancies, respectively. data animal data in an embryo-fetal development study in pregnant rats, oral administration of ritlecitinib from gestation days 6 to 17 decreased fetal body weights and caused fetal skeletal malformations (malformed vertebrae and ribs) and variations (delayed ossification) at doses ≥175 mg/kg/day (49 times the mrhd based on auc comparison). maternal toxicity (lower body weights) was noted at 325 mg/kg/day (102 times the mrhd based on auc comparison). there was no developmental toxicity at 75 mg/kg/day (16 times the mrhd based on auc comparison). in an embryo-fetal development study in pregnant rabbits, oral administration of ritlecitinib from gestation days 7 to 19 decreased mean fetal body weights and increased visceral malformations (malpositioned kidneys), skeletal malformations (supernumerary sternebrae, absent thoracic arch, and/or fused thoracic centra), and skeletal variations (delayed ossification) at 75 mg/kg/day (55 times the mrhd based on auc comparison). there was no developmental toxicity at doses up to 25 mg/kg/day (12 times the mrhd based on auc comparison). in a pre- and postnatal development study in rats, oral administration of ritlecitinib from gestation day 6 through lactation day 20 had no effects on pre- and postnatal development at doses up to 75 mg/kg/day (14 times the mrhd based on auc comparison). at 175 mg/kg/day (41 times the mrhd based on auc comparison), ritlecitinib caused adverse lower postnatal survival and lower offspring body weights, which correlated with delayed sexual maturation in both sexes. bred females in the f1 generation also exhibited lower mean numbers of corpora lutea at 175 mg/kg/day. risk summary there are no data on the presence of ritlecitinib in human milk, the effects on the breastfed infant, or the effects on milk production. ritlecitinib is present in the milk of lactating rats (see data) . when a drug is present in animal milk, it is likely that it will be present in human milk. because of the serious adverse effects in adults, including risks of serious infection and malignancy, advise women not to breastfeed during treatment with litfulo and for approximately 14 hours after the last dose (approximately 6 elimination half-lives). data after a single oral 30 mg/kg dose of ritlecitinib to lactating rats, ritlecitinib concentrations in milk over time were higher than those in plasma. the mean milk to plasma auc ratio was 2.2. the safety and effectiveness of litfulo for the treatment of alopecia areata have been established in pediatric patients ages 12 years and older. a total of 181 pediatric patients ages 12 to <18 years were enrolled in alopecia areata clinical trials, with 105 pediatric patients ages 12 to <18 years with alopecia areata randomized in a pivotal, double-blind, placebo-controlled trial (trial aa-i). efficacy was consistent between the pediatric patients and adults [see clinical studies (14)] . the adverse reaction profile in the pediatric patients was similar to adults. the safety and efficacy of litfulo have not been established in pediatric patients under 12 years of age. no dose adjustment is required for patients ≥65 years of age. a total of 28 patients enrolled in alopecia areata trials were 65 years of age and older, and none were 75 years of age and older. clinical trials of litfulo did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. as there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly. no dose adjustment is required in patients with mild (child pugh a) or moderate (child pugh b) hepatic impairment. litfulo is not recommended in patients with severe (child pugh c) hepatic impairment [see dosage and administration (2.3) and clinical pharmacology (12.3)] .

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - glucose monohydrate, quantity: 54.99 mg/ml (equivalent: glucose, qty 50 mg/ml) - injection, intravenous infusion - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - indications as at 31 july 2000: for fluid and carbohydrate depletion wherever a non-electrolyte fluid is required. in the treatment of hypoglycaemia. in the treatment of acute diarrhoeal disease. as a vehicle for the administration of other medications.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - sodium bicarbonate, quantity: 8.4 g - injection, intravenous infusion - excipient ingredients: disodium edetate; water for injections - 1. metabolic acidosis in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis where a rapid increase in plasma total co2 content is crucial. treatment of metabolic acidosis should be concurrent with measures designed to control the cause of the acidosis. 2.urinary alkalinisation in the treatment of certain drug intoxications (ie barbiturates, salicylates, lithium, methyl alcohol) and in the haemolytic reactions requiring alkalinisation of the urine to diminish nephrotoxicity of blood pigments. urinary alkalinisation is also used in methotrexate therapy to prevent nephrotoxicity. 3.severe diarrhoea which is often accompanied by a significant loss of bicarbonate.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - midazolam, quantity: 5 mg/ml - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - intravenously as an agent for: conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures such as bronchoscopy, gastroscopy, cystoscopy,coronary angiography and cardiac catheterisation, either alone or in conjunction with an opioid. induction of anaesthesia preliminary to administration of other anaesthetic agents. with the use of an opioid premedicant, induction of anaesthesia can be obtained with a narrower dose range and in a shorter period of time. intermittent intravenous administration or continuous infusion for: sedation in intensive care units. intramuscularly for: preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - midazolam, quantity: 5 mg/ml - injection, solution - excipient ingredients: sodium chloride; water for injections; sodium hydroxide; hydrochloric acid - intravenously as an agent for: conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures such as bronchoscopy, gastroscopy, cystoscopy,coronary angiography and cardiac catheterisation, either alone or in conjunction with an opioid. induction of anaesthesia preliminary to administration of other anaesthetic agents. with the use of an opioid premedicant, induction of anaesthesia can be obtained with a narrower dose range and in a shorter period of time. intermittent intravenous administration or continuous infusion for: sedation in intensive care units. intramuscularly for: preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - aciclovir -

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - aciclovir -

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - midazolam, quantity: 1 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; sodium chloride; water for injections - intravenously as an agent for: conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures such as bronchoscopy, gastroscopy, cystoscopy,coronary angiography and cardiac catheterisation, either alone or in conjunction with an opioid. induction of anaesthesia preliminary to administration of other anaesthetic agents. with the use of an opioid premedicant, induction of anaesthesia can be obtained with a narrower dose range and in a shorter period of time. intermittent intravenous administration or continuous infusion for: sedation in intensive care units. intramuscularly for: preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - calcium folinate, quantity: 10.8 mg/ml (equivalent: folinic acid, qty 10 mg/ml) - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; sodium chloride; water for injections - leucovorin calcium injection usp is indicated following high dose methotrexate therapy to reduce toxicity (leucovorin rescue). it is also indicated after inadvertent overdosage with methotrexate and in impaired methotrexate elimination.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - calcium folinate, quantity: 10.8 mg/ml (equivalent: folinic acid, qty 10 mg/ml) - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium chloride; hydrochloric acid - leucovorin calcium injection usp is indicated following high dose methotrexate therapy to reduce toxicity (leucovorin rescue). it is also indicated after inadvertent overdosage with methotrexate and in impaired methotrexate elimination.