Yhdysvallat - englanti - NLM (National Library of Medicine)

piramal critical care inc. - zinc sulfate (unii: 89ds0h96tb) (zinc cation - unii:13s1s8sf37) - zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. zinc sulfate injection is contraindicated in patients with known hypersensitivity to zinc [ see warnings and precautions ( 5.6) ]. risk summary administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with intravenous zinc sulfate. the estimated background risk of major birth defects and miscarriage for the indicated populations 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. clinical considerations disease-associated maternal and/or embryo-fetal risk deficiency of trace elements, including zinc, is associated with adverse pregnancy and fetal outcomes. pregnant women have an increased metabolic demand for trace elements, including zinc. parenteral nutrition with zinc should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. risk summary zinc is present in human milk. administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause harm to a breastfed infant. there is no information on the effects of zinc sulfate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for zinc sulfate injection and any potential adverse effects on the breastfed infant from zinc sulfate injection or from the underlying maternal condition. zinc sulfate injection is approved for use in the pediatric population, including neonates, as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. safety and dosing recommendations in pediatric patients are based on published literature describing controlled studies of zinc-containing products in pediatric patients [see dosage and administration ( 2.2)] . because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with zinc sulfate injection may be at higher risk of aluminum toxicity [see warnings and precautions ( 5.3)] . reported clinical experience with intravenous zinc sulfate has not identified a difference in zinc requirements between elderly and younger patients. in general, dose selection should be individualized based on the patient’s clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.

Yhdysvallat - englanti - NLM (National Library of Medicine)

piramal critical care, inc. - isoflurane (unii: cys9akd70p) (isoflurane - unii:cys9akd70p) - isoflurane 1 ml in 1 ml - isoflurane may be used for induction and maintenance of general anesthesia. adequate data have not been developed to establish its application in obstetrical anesthesia. isoflurane is contraindicated in patients: • in whom general anesthesia is contraindicated. • with known sensitivity to isoflurane or to other halogenated agents. • with known or suspected genetic susceptibility to malignant hyperthermia (see warnings /malignant hyperthermia, clinical pharmacology / pharmacogenomics). • with a history of confirmed hepatitis due to a halogenated inhalational anesthetic or a history of unexplained moderate to severe hepatic dysfunction (e.g., jaundice associated with fever and/or eosinophilia) after anesthesia with isoflurane or other halogenated inhalational anesthetics.

Yhdysvallat - englanti - NLM (National Library of Medicine)

piramal critical care inc - isoflurane (unii: cys9akd70p) (isoflurane - unii:cys9akd70p) - isoflurane 1 ml in 1 ml - isoflurane may be used for induction and maintenance of general anesthesia. adequate data have not been developed to establish its application in obstetrical anesthesia. isoflurane is contraindicated in patients: • in whom general anesthesia is contraindicated. • with known sensitivity to isoflurane or to other halogenated agents. • with known or suspected genetic susceptibility to malignant hyperthermia (see warnings /malignant hyperthermia, clinical pharmacology / pharmacogenomics). • with a history of confirmed hepatitis due to a halogenated inhalational anesthetic or a history of unexplained moderate to severe hepatic dysfunction (e.g., jaundice associated with fever and/or eosinophilia) after anesthesia with isoflurane or other halogenated inhalational anesthetics.

Yhdysvallat - englanti - NLM (National Library of Medicine)

piramal critical care inc - isoflurane (unii: cys9akd70p) (isoflurane - unii:cys9akd70p) - isoflurane may be used for induction and maintenance of general anesthesia. adequate data have not been developed to establish its application in obstetrical anesthesia. isoflurane is contraindicated in patients: • in whom general anesthesia is contraindicated. • with known sensitivity to isoflurane or to other halogenated agents. • with known or suspected genetic susceptibility to malignant hyperthermia (see warnings /malignant hyperthermia, clinical pharmacology / pharmacogenomics). • with a history of confirmed hepatitis due to a halogenated inhalational anesthetic or a history of unexplained moderate to severe hepatic dysfunction (e.g., jaundice associated with fever and/or eosinophilia) after anesthesia with isoflurane or other halogenated inhalational anesthetics.

Yhdysvallat - englanti - NLM (National Library of Medicine)

piramal critical care inc - isoflurane (unii: cys9akd70p) (isoflurane - unii:cys9akd70p) - isoflurane may be used for induction and maintenance of general anesthesia. adequate data have not been developed to establish its application in obstetrical anesthesia. isoflurane is contraindicated in patients: • in whom general anesthesia is contraindicated. • with known sensitivity to isoflurane or to other halogenated agents. • with known or suspected genetic susceptibility to malignant hyperthermia (see warnings /malignant hyperthermia, clinical pharmacology / pharmacogenomics). • with a history of confirmed hepatitis due to a halogenated inhalational anesthetic or a history of unexplained moderate to severe hepatic dysfunction (e.g., jaundice associated with fever and/or eosinophilia) after anesthesia with isoflurane or other halogenated inhalational anesthetics

Yhdysvallat - englanti - NLM (National Library of Medicine)

piramal critical care - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole sodium for injection is a proton pump inhibitor (ppi) indicated in adults for the following: short-term treatment (7 to 10 days) of gastroesophageal reflux disease (gerd) associated with a history of erosive esophagitis (ee). ( 1.1) pathological hypersecretion conditions including zollinger-ellison (ze) syndrome. ( 1.2) pantoprazole sodium for injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (gerd) and a history of erosive esophagitis (ee). safety and efficacy of pantoprazole sodium for injection as a treatment of patients with gerd and a history of ee for more than 10 days have not been demonstrated. pantoprazole sodium for injection is indicated for the treatment of pathological hypersecretory conditions including zollinger-ellison (ze) syndrome in adults. • pantoprazole sodium for injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see warnings and precautions (5.2, 5.4), adverse reactions (6)] . • proton pump inhibitors (ppis), including pantoprazole sodium for injection, are contraindicated in patients receiving rilpivirine-containing products [see drug interactions (7)] . risk summary available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. in animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole. reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study (see data) . a pre-and post-natal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day) were administered to pregnant females from gestation day (gd) 6 through lactation day (ld) 21. changes in bone morphology were observed in pups exposed to pantoprazole in utero and through milk during the period of lactation as well as by oral dosing from postnatal day (pnd) 4 through pnd 21 [see use in specific populations (8.4)] . there were no drug-related findings in maternal animals . advise pregnant women of the potential risk of fetal harm. 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 the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and pantoprazole use. methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. in a prospective study by the european network of teratology information services, outcomes from a group of 53 pregnant women administered median daily doses of 40 mg pantoprazole were compared to a control group of 868 pregnant women who did not take any proton pump inhibitors (ppis). there was no difference in the rate of major malformations between women exposed to ppis and the control group, corresponding to a relative risk (rr)=0.55, [95% confidence interval (ci) 0.08–3.95]. in a population-based retrospective cohort study covering all live births in denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to pantoprazole in 549 live births. a meta-analysis that compared 1,530 pregnant women exposed to ppis in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to ppis (for major malformations or=1.12 ([95% ci 0.86–1.45] and for spontaneous abortions or=1.29 [95% ci 0.84–1.97]). animal data reproduction studies have been performed in rats at intravenous pantoprazole doses up to 20 mg/kg/day (4 times the recommended human dose based on body surface area) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. a pre- and post-natal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day on a body surface area basis) were administered to pregnant females from gestation day (gd) 6 through lactation day (ld) 21. on postnatal day (pnd 4) through pnd 21, the pups were administered oral doses at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (auc) in humans at a dose of 40 mg). there were no drug-related findings in maternal animals. during the preweaning dosing phase (pnd 4 to 21) of the pups, there were increased mortality and/or moribundity and decreased body weight and body weight gain at 5 mg/kg/day (approximately equal exposures (auc) in humans receiving the 40 mg dose) and higher doses. on pnd 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day (approximately equal exposures (auc) in humans at the 40 mg dose) and higher doses. the femur findings included lower total area, bone mineral content and density, periosteal and endosteal circumference, and cross-sectional moment of inertia. there were no microscopic changes in the distal femur, proximal tibia, or stifle joints. changes in bone parameters were partially reversible following a recovery period, with findings on pnd 70 limited to lower femur metaphysis cortical/subcortical bone mineral density in female pups at 5 mg/kg/day (approximately equal exposures (auc) in humans at the 40 mg dose) and higher doses. risk summary pantoprazole has been detected in breast milk of a nursing mother after a single 40 mg oral dose of pantoprazole. there were no effects on the breastfed infant (see data) . there are no data on pantoprazole effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for pantoprazole sodium for injection and any potential adverse effects on the breastfed child from pantoprazole or from the underlying maternal condition. data the breast milk of a 42-year-old woman receiving 40 mg of oral pantoprazole, at 10 months postpartum, was studied for 24 hours, to demonstrate low levels of pantoprazole present in the breast milk. pantoprazole was detectable in milk only 2 and 4 hours after the dose with milk levels of approximately 36 mcg/l and 24 mcg/l, respectively. a milk-to-plasma ratio of 0.022 was observed at 2 hours after drug administration. pantoprazole was not detectable (<10 mcg/l) in milk at 6, 8 and 24 hours after the dose. the relative dose to the infant was estimated to be 7.3 mcg of pantoprazole, which is equivalent to 0.14% of the weight-adjusted maternal dose. no adverse events in the infant were reported by the mother. the safety and effectiveness of pantoprazole sodium for injection have not been established in pediatric patients. animal toxicity data in a pre- and post-natal development toxicity study in rats, the pups were administered oral doses of pantoprazole at 5, 15, and 30 mg/kg/day on postnatal day (pnd 4) through pnd 21, in addition to lactational exposure through milk. on pnd 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day and higher doses. changes in bone parameters were partially reversible following a recovery period [see use in specific populations (8.1)] . in neonatal/juvenile animals (rats and dogs) toxicities were similar to those observed in adult animals, including gastric alterations, decreases in red cell mass, increases in lipids, enzyme induction and hepatocellular hypertrophy. an increased incidence of eosinophilic chief cells in adult and neonatal/juvenile rats, and atrophy of chief cells in adult rats and in neonatal/juvenile dogs, was observed in the fundic mucosa of stomachs in repeated-dose studies. full to partial recovery of these effects were noted in animals of both age groups following a recovery period. of 286 patients in clinical studies of intravenous pantoprazole sodium in patients with gerd and a history of ee, 86 (43%) were 65 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience with oral pantoprazole sodium has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Yhdistynyt kuningaskunta - englanti - VMD (Veterinary Medicines Directorate)

piramal critical care limited - isoflurane - inhalation vapour, liquid - neurological agent general anaesthetic - cats, chinchilla, dogs, ferrets, gerbil, guinea pig, hamster, horses, mouse, ornamental birds, pigs, rat, reptiles

Irlanti - englanti - HPRA (Health Products Regulatory Authority)

piramal critical care b.v. - isoflurane - inhalation vapour, liquid - 1000 milligram(s)/gram - isoflurane

Yhdysvallat - englanti - NLM (National Library of Medicine)

piramal critical care inc - ceftriaxone sodium (unii: 023z5br09k) (ceftriaxone - unii:75j73v1629) - before instituting treatment with ceftriaxone for injection, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. therapy may be instituted prior to obtaining results of susceptibility testing. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection and other antibacterial drugs, ceftriaxone for injection should be used only to treat or prevent 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. ceftriaxone for injection is indicated for the treatment of the following infections when caused by susceptible organisms: lower respiratory tract infections caused by streptococcus p

Yhdysvallat - englanti - NLM (National Library of Medicine)

piramal critical care inc - ceftriaxone sodium (unii: 023z5br09k) (ceftriaxone - unii:75j73v1629) - before instituting treatment with ceftriaxone for injection appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. therapy may be instituted prior to obtaining results of susceptibility testing. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection and other antibacterial drugs, ceftriaxone for injection should be used only to treat or prevent 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. ceftriaxone for injection is indicated for the treatment of the following infections when caused by susceptible organisms: lower respiratory tract infections caused by streptococcus p