Eiropas Savienība - angļu - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed ditromethamine - carcinoma, non-small-cell lung; mesothelioma - folic acid analogues, antimetabolites - malignant pleural mesotheliomapemetrexed hospira uk limited in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed hospira uk limited in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see smpc section 5.1).pemetrexed hospira uk limited is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see smpc section 5.1).pemetrexed hospira uk limited is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see smpc section 5.1).

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline 0.5 mg - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix.             risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by approximately 30% in infants of women who smoke during pregnancy, compared to pregnant women who do not smoke. the background risk of other major birth defects and miscarriage for the indicated population are unknown. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk smoking during pregnancy causes increased risks of orofacial clefts, premature rupture of membranes, placenta previa, placental abruption, ectopic pregnancy, fetal growth restriction and low birth weight, stillbirth, preterm delivery and shortened gestation, neonatal death, sudden infant death syndrome and reduction of lung function in infants. it is not known whether quitting smoking with chantix during pregnancy reduces these risks. data human data a population-based observational cohort study using the national registers of denmark and sweden compared pregnancy and birth outcomes among women exposed to varenicline (n=335, includes 317 first trimester exposed) with women who smoked during pregnancy (n=78,412) and with non-smoking pregnant women (n=806,438). the prevalence of major malformations, the primary outcome, was similar in all groups, including between smoking and non-smoking groups. the prevalence of adverse perinatal outcomes in the varenicline-exposed cohort was not greater than in the cohort of women who smoked, and differed somewhat between the three cohorts. the prevalences of the primary and secondary outcomes are shown in table 6. major congenital malformation* 12 / 334 (3.6%) 3,382 / 78,028 (4.3%) 33,950 /804,020 (4.2%) stillbirth 1 (0.3%) 384 (0.5%) 2,418 (0.3%) small for gestational age 42 (12.5%) 13,433 (17.1%) 73,135 (9.1%) preterm birth 25 (7.5%) 6,173 (7.9%) 46,732 (5.8%) premature rupture of membranes 12 (3.6%) 4,246 (5.4%) 30,641 (3.8%) sudden infant death syndrome† 0/307 (0.0%) 51/71,720 (0.1%) 58/755,939 (<0.1%) the study limitations include the inability to capture malformations in pregnancies that do not result in a live birth, and possible misclassification of outcome and of exposure to varenicline or to smoking. other small epidemiological studies of pregnant women exposed to varenicline did not identify an association with major malformations, consistent with the danish and swedish observational cohort study. methodological limitations of these studies include small samples and lack of adequate controls. overall, available studies cannot definitely establish or exclude any varenicline-associated risk during pregnancy. animal data pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. while no fetal structural abnormalities occurred in either species, maternal toxicity, characterized by reduced body weight gain, and reduced fetal weights occurred in rabbits at the highest dose (exposures 50 times the human exposure at the mrhd of 1 mg twice daily based on auc). fetal weight reduction did not occur in rabbits at exposures 23 times the human exposure at the mrhd based on auc. in a pre- and postnatal development study, pregnant rats received up to 15 mg/kg/day of oral varenicline succinate from organogenesis through lactation. maternal toxicity, characterized by a decrease in body weight gain was observed at 15 mg/kg/day (36 times the human exposure at the mrhd based on auc). however, decreased fertility and increased auditory startle response occurred in offspring at the highest maternal dose of 15 mg/kg/day.       risk summary there are no data on the presence of varenicline in human milk, the effects on the breastfed infant, or the effects on milk production. in animal studies varenicline was present in milk of lactating rats [see data] . however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk. the lack of clinical data during lactation precludes a clear determination of the risk of chantix to an infant during lactation; however the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for chantix and any potential adverse effects on the breastfed child from chantix or from the underlying maternal condition. clinical considerations because there are no data on the presence of varenicline in human milk and the effects on the breastfed infant, breastfeeding women should monitor their infant for seizures and excessive vomiting, which are adverse reactions that have occurred in adults that may be clinically relevant in breastfeeding infants. data in a pre- and postnatal development study, pregnant rats received up to 15 mg/kg/day of oral varenicline succinate through gestation and lactation mean serum concentrations of varenicline in the nursing pups were 5–22% of maternal serum concentrations. chantix is not recommended for use in pediatric patients 16 years of age or younger because its efficacy in this population was not demonstrated. single and multiple-dose pharmacokinetics of varenicline have been investigated in pediatric patients aged 12 to 17 years old (inclusive) and were approximately dose-proportional over the 0.5 mg to 2 mg daily dose range studied. steady-state systemic exposure in adolescent patients of bodyweight >55 kg, as assessed by auc (0-24), was comparable to that noted for the same doses in the adult population. when 0.5 mg bid was given, steady-state daily exposure of varenicline was, on average, higher (by approximately 40%) in adolescent patients with bodyweight ≤55 kg compared to that noted in the adult population. the efficacy and safety of varenicline was evaluated in a randomized, double-blind, placebo-controlled study of 312 patients aged 12 to 19 years, who smoked an average of at least 5 cigarettes per day during the 30 days prior to recruitment, had a score of at least 4 on the fagerstrom test for nicotine dependence scale, and at least one previous failed quit attempt. patients were stratified by age (12 to 16 years of age, n=216 and 17 to 19 years of age, n=96) and by body weight (≤55 kg and >55 kg). patients were randomized to one of two doses of varenicline, adjusted by weight to provide plasma levels in the efficacious range (based on adult studies) and placebo. patients received treatment for 12 weeks, followed by a non-treatment period of 40 weeks, along with age-appropriate counseling throughout the study. results from this study showed that varenicline, at either dose studied, did not improve continuous abstinence rates at weeks 9 through 12 of treatment compared with placebo in subjects 12 to 19 years of age. the varenicline safety profile in this study was consistent with that observed in adult studies. a combined single- and multiple-dose pharmacokinetic study demonstrated that the pharmacokinetics of 1 mg varenicline given once daily or twice daily to 16 healthy elderly male and female smokers (aged 65–75 years) for 7 consecutive days was similar to that of younger subjects. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. varenicline is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug 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, and it may be useful to monitor renal function [see dosage and administration (2.2)] . no dosage adjustment is recommended for elderly patients. varenicline is substantially eliminated by renal glomerular filtration along with active tubular secretion. dose reduction is not required in patients with mild to moderate renal impairment. for patients with severe renal impairment (estimated creatinine clearance <30 ml/min), and for patients with end-stage renal disease undergoing hemodialysis, dosage adjustment is needed [see dosage and administration (2.2), clinical pharmacology (12.3)].       varenicline is not a controlled substance.       humans fewer than 1 out of 1,000 patients reported euphoria in clinical trials with chantix. at higher doses (greater than 2 mg), chantix produced more frequent reports of gastrointestinal disturbances such as nausea and vomiting. there is no evidence of dose-escalation to maintain therapeutic effects in clinical studies, which suggests that tolerance does not develop. abrupt discontinuation of chantix was associated with an increase in irritability and sleep disturbances in up to 3% of patients. this suggests that, in some patients, varenicline may produce mild physical dependence which is not associated with addiction. in a human laboratory abuse liability study, a single oral dose of 1 mg varenicline did not produce any significant positive or negative subjective responses in smokers. in non-smokers, 1 mg varenicline produced an increase in some positive subjective effects, but this was accompanied by an increase in negative adverse effects, especially nausea. a single oral dose of 3 mg varenicline uniformly produced unpleasant subjective responses in both smokers and non-smokers. animals studies in rodents have shown that varenicline produces behavioral responses similar to those produced by nicotine. in rats trained to discriminate nicotine from saline, varenicline produced full generalization to the nicotine cue. in self-administration studies, the degree to which varenicline substitutes for nicotine is dependent upon the requirement of the task. rats trained to self-administer nicotine under easy conditions continued to self-administer varenicline to a degree comparable to that of nicotine; however in a more demanding task, rats self-administered varenicline to a lesser extent than nicotine. varenicline pretreatment also reduced nicotine self-administration.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - latanoprost -

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methotrexate, quantity: 500 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide - antineoplastic chemotherapy - treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic and meningeal leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemia. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. methotrexate is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. high dose therapy - the use of very high doses is made possible by vials for injection containing 500 mg and 1000 mg (see precautions). diseases treated with these doses administered in the form of single-drug or combination therapy, include osteogenic sarcoma, acute leukaemia, bronchogenic carcinoma and epidermoid carcinoma of the head and n

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - daunorubicin, quantity: 20 mg - injection, solution - excipient ingredients: sodium chloride; water for injections; sodium hydroxide; hydrochloric acid - indications as at 22 november 2004 : daunorubicin injection is indicated for the treatment of the following: acute lymphocytic (lymphoblastic) leukaemia: daunorubicin is usually reserved for use in cases shown to be resistant to other drugs. however, combined treatment with daunorubicin, vincristine and a steroid has been used in the early stages of this disease. acute myeloblastic leukaemia: daunorubicin has been used in all stages, alone or in combination with other cytotoxic agents (e.g. cytarabine). disseminated solid tumours: daunorubicin has been investigated for use in these tumours and found to be effective in some cases of disseminated neuroblastoma and rhabdomyosarcoma.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - tobramycin, quantity: 80 mg - injection, solution - excipient ingredients: sodium hydroxide; sodium metabisulfite; phenol; water for injections; sulfuric acid; disodium edetate - for the treatment of serious infections of the following type where they are caused by susceptible organisms: skin and skin structure infections including burns, bone infections; gastrointestinal infections including peritonitis; central nervous system infections including meningitis, septicaemia and neonatal sepsis; lower respiratory tract infections including pneumonia, bronchopneumonia, and acute bronchitis; complicated and recurrent urinary tract infections such as pyelonephritis and cystitis.,aminoglycosides, including tobramycin, should not be used in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to other less toxic antibiotics.,tobramycin can be used in serious staphylococcal infections for which penicillin or other less toxic drugs are contraindicated and where susceptibility testing and clinical judgement indicate its use. if susceptibility tests show a resistance to tobramycin in the causative organisms other appropriate therapy should be instituted.,note that bacterial cultures should bo obtained before and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. if the organisms are resistant, other appropriate therapy should be instituted. in patients in whom gram-negative septicaemia, neonatal sepsis or meningitis is suspected, including those in whom concurrent therapy with a penicillin or cefalosporin and an aminoglycoside may be indicated, tobramycin therapy may be initiated before results of susceptibility studies are obtained. the decision to continue tobramycin therapy should be based upon the results of susceptibility studies, the severity of infection and the important additional concepts discussed in the product information leaflet.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - tobramycin, quantity: 80 mg - injection, solution - excipient ingredients: water for injections; disodium edetate; sodium hydroxide; sulfuric acid - for the treatment of serious infections of the following type where they are caused by susceptible organisms: skin and skin structure infections including burns, bone infections; gastrointestinal infections including peritonitis; central nervous system infections including meningitis, septicaemia and neonatal sepsis; lower respiratory tract infections including pneumonia, bronchopneumonia, and acute bronchitis; complicated and recurrent urinary tract infections such as pyelonephritis and cystitis.,aminoglycosides, including tobramycin, should not be used in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to other less toxic antibiotics.,tobramycin can be used in serious staphylococcal infections for which penicillin or other less toxic drugs are contraindicated and where susceptibility testing and clinical judgement indicate its use. if susceptibility tests show a resistance to tobramycin in the causative organisms other appropriate therapy should

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - sodium chloride, quantity: 900 mg - injection, intravenous infusion - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - for the restoration and maintenance of salt and extracellular fluid levels or as a vehicle for the administration of parenteral drugs.

Austrālija - angļu - 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.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - sodium chloride, quantity: 450 mg - injection, intravenous infusion - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - for the restoration and maintenance of salt and extracellular fluid levels or as a vehicle for the administration of parenteral drugs.