Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi limited - sodium chloride; potassium chloride; calcium chloride dihydrate; sodium lactate solution 50% - solution for infusion - %v/v - solutions affecting the electrolyte balance; electrolytes

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

hope pharmaceuticals pty ltd - sodium nitrite, quantity: 300 mg - solution - excipient ingredients: water for injections - sodium nitrite injection is indicated as an antidote in the treatment of cyanide poisoning, in conjunction with sodium thiosulfate.

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

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 227.72 mg (equivalent: gemcitabine, qty 200 mg) - injection, concentrated - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections - gemcitabine kabi is indicated for treatment of patients with locally advance or metastatic non-small cell lung cancer. gemcitabine kabi is indicated for treatment of patients with locally advance or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. gemcitabine kabi, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. gemcitabine kabi, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. gemcitabine kabi, in combinatin with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

fresenius kabi usa, llc - lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987) - lidocaine hydrochloride anhydrous 10 mg in 1 ml - xylocaine (lidocaine hcl) injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine hcl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

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

aphena pharma solutions - tennessee, llc - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 40 mg - pantoprazole sodium delayed-release tablets, usp are indicated for: pantoprazole is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole is indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison syndrome. - pantoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. hypersensitivity reactions may include ana

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

fresenius kabi usa, llc - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - sodium chloride 9 mg in 1 ml - intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. none known. check flexible container solution composition, lot number, and expiry date. do not remove solution container from its overwrap until immediately before use. use sterile equipment and aseptic technique. to open - turn solution container over so that the text is face down. using the pre-cut corner tabs, peel open the overwrap and remove solution container. - check the solution container for leaks by squeezing firmly. if leaks are found, or if the seal is not intact, discard the solution. - do not use if the solution is cloudy or a precipitate is present. to add medication - identify white additive port with arrow pointing toward container. - immediately before injecting additives, break off white additive port cap with the arrow pointing toward container. - hold base of white additive port horizontally. - insert needle horizont

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

aphena pharma solutions - tennessee, llc - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin 10 mg - doxepin hydrochloride capsules, usp are recommended for the treatment of: the target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age. doxepin hydrochloride capsules are contraindicated in individuals who have shown hypersensitivity to the drug. possibility of cross sensitivity with other dibenzoxepines should be kept in mind. doxepin hydrochloride capsules are contraindicated in patients with glaucoma or a tendency to urinary retention. these disorders should be ruled out, particularly in older patients.

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

fresenius kabi usa, llc - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride 5 mg in 1 ml - naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. surgical anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration acute pain management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. risk summary there are no available human data on use of naropin (ropivacaine) injection in pregnant women to evaluate a drug- associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone, and cardiac function (see clinical considerations) . no teratogenicity was observed at doses up to 0.3 times the maximum recommended human dose of 770 mg/24 hours for epidural use, and equal to the mrhd of 250 mg for nerve block use, based on body surface area (bsa) comparisons and a 60 kg human weight (see animal data) . 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 clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations labor or delivery local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal, and neonatal toxicity [see clinical pharmacology (12)] . the incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration. adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. maternal adverse reactions maternal hypotension has resulted from regional anesthesia. local anesthetics produce vasodilation by blocking sympathetic nerves. therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. elevating the patient's legs will also help prevent decreases in blood pressure. the fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. data animal data no malformations were reported in embryo-fetal development toxicity studies conducted in pregnant new zealand white rabbits and sprague-dawley rats. during gestation days 6 to 18, rabbits received daily subcutaneous doses of ropivacaine at 1.3, 4.2, or 13 mg/kg/day (equivalent to 0.03, 0.10, and 0.33 times the maximum recommended human dose (mrhd) of 770 mg/24 hours, respectively, and 0.10, 0.32, and 1.0 times the mrhd of 250 mg for nerve block use, respectively based on body surface area (bsa) comparisons and a 60 kg human weight). rats received daily subcutaneous doses of 5.3, 11, and 26 mg/kg/day (equivalent to 0.07, 0.14, and 0.33 times the mrhd for epidural use, respectively, and 0.21, 0.43, and 1.0 times the mrhd for nerve block use, respectively, based on bsa comparisons) during gd 6 to 15. no treatment-related effects on late fetal development, parturition, litter size, lactation, neonatal viability, or growth of the offspring were reported in a prenatal and postnatal reproductive and development toxicity study; however functional endpoints were not evaluated. female rats were dosed daily subcutaneously from gd 15 to lactation day 20 at doses of 5.3, 11,and 26 mg/kg/day (equivalent to 0.07, 0.1, and 0.3 times the mrhd for epidural use, respectively, and 0.21, 0.43, and 1.0 times the mrhd for nerve block use, respectively), with maternal toxicity exhibited at the high dose. no adverse effects in physical developmental milestones or in behavioral tests were reported in a 2-generational reproduction study, in which rats received daily subcutaneous doses of 6.3, 12, and 23 mg/kg/day (equivalent to 0.08, 0.15, and 0.29 times the mrhd for epidural use, respectively, and 0.24, 0.45, and 0.88 times the mrhd for nerve block use, respectively, based on bsa comparisons) for 9 weeks before mating and during mating for males, and for 2 weeks before mating and during mating, pregnancy, and lactation, up to day 42 post coitus for females. significant pup loss was observed in the high dose group during the first 3 days postpartum, from a few hours up to 3 days after delivery compared to the control group, which was considered secondary to impaired maternal care due to maternal toxicity. no differences were observed in litter parameters, or fertility, mean gestation time, or number of live births were observed between the control (saline) and treatment groups [see carcinogenesis, mutagenesis, impairment of fertility (13.1)] . risk summary one publication reported that ropivacaine is present in human milk at low levels following administration of ropivacaine in women undergoing cesarean section. no adverse reactions were reported in the infants. there is no available information on the drug's effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for naropin and any potential adverse effects on the breastfed child from naropin or from the underlying maternal condition. the safety and efficacy of naropin in pediatric patients have not been established. of the 2,978 subjects that were administered naropin injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older which includes 127 patients (4%) 75 years of age and over. naropin injection was found to be safe and effective in the patients in these studies. clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. in one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (map) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age. this drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concomitant disease. therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function [see clinical pharmacology (12.3)] . because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations [see warning and precautions (5.11)]. this drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function [see clinical pharmacology (12.3)] .

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

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 2277.2 mg (equivalent: gemcitabine, qty 2000 mg) - injection, powder for - excipient ingredients: sodium hydroxide; mannitol; hydrochloric acid; sodium acetate - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 1138.6 mg (equivalent: gemcitabine, qty 1000 mg) - injection, powder for - excipient ingredients: hydrochloric acid; sodium acetate; sodium hydroxide; mannitol - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.