United States - English - 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.

Philippines - English - FDA (Food And Drug Administration)

stada philippines inc.; importer: n/a; distributor: n/a - ascorbic acid - tablet - 1g (equivalent to 1.125g sodium ascorbate)

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

anazaohealth corporation - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide 3 ug - sincalide may be used: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; to stimulate pancreatic secretion (especially in conjunction with secretin) prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology;  to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract gallbladder stones (stimulation of gallbladder contraction in patients with small gallbladder stones may lead to the evacuation of the stones from the gallbladder resulting in their lodging in the cystic duct or in the common bile duct; however, this is unlikely with usual doses of sincalide since complete contraction of the gallbladder is not induced.)

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

teva pharmaceuticals usa, inc. - zinc acetate (unii: fm5526k07a) (zinc cation - unii:13s1s8sf37) - zinc cation 25 mg - zinc acetate therapy is indicated for maintenance treatment of patients with wilson’s disease who have been initially treated with a chelating agent (see precautions: monitoring patients). zinc acetate capsules are contraindicated in patients with known hypersensitivity to any of the components of the formulation.

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

bracco diagnostics inc. - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide 5 ug in 5 ml - kinevac is indicated in adults to: - to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. kinevac is contraindicated in patients with: - a history of hypersensitivity to sulfites or sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)] . - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide may cause preterm labor or spontaneous

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

bell laboratories, inc. - zinc phosphide; malathion - ready-to-use bait - zinc phosphide ungrouped active 20.0 g/kg; malathion organophosphorus-dithiophospha other 0.11 g /kg - vertebrate poison

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

fondel chemicals ltd. - zinc sulfate monohydrate (unii: ptx099xsf1) (zinc cation - unii:13s1s8sf37) - zinc cation 0.4 kg in 1.6 kg - purpose:zinc sulphate monohydrate powder is used as an aid in hoof rot management under veterinary guidance. warnings: - zinc can be toxic to sheep. do not allow animals to eat or drink the zinc sulphate powder or hoof bath solution. - know the volume of the hoof bath and calculate the amount of zinc sulphate carefully. - do not overdose by using more zinc sulphate than what is recommended by your veterinarian.

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

american regent, inc. - zinc sulfate anhydrous (unii: 0j6z13x3wo) (zinc cation - unii:13s1s8sf37) - concentrated zinc sulfate injection, usp is indicated for use as a supplement to intravenous solutions given for tpn. administration helps to maintain plasma levels and to prevent depletion of endogenous stores. concentrated zinc sulfate injection, usp should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential to increase renal loss of zinc from a bolus injection.

Kenya - English - Pharmacy and Poisons Board

alkem laboratories 167/mahatma gandhi udyog nagar dabhel daman 396 - zinc sulfate tablets usp 20mg - dispersible tablet - zinc sulfate usp (as monohydrate) 54.88mg… - mineral supplements: zinc

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

alkermes, inc. - aripiprazole lauroxil (unii: b786j7a343) (aripiprazole lauroxil - unii:b786j7a343) - aristada initio, in combination with oral aripiprazole, is indicated for the initiation of aristada when used for the treatment of schizophrenia in adults. aristada initio is contraindicated in patients with a known hypersensitivity reaction to aripiprazole. hypersensitivity reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aristada initio during pregnancy. for more information, contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. limited published data on aripiprazole use in pregnant women are not sufficient to inform any drug-associated risks for birth defects or miscarriage. no teratogenicity was observed in animal reproductive studies with intramuscular administration of aripiprazole lauroxil to rats and rabbits during organogenesis at doses up to 8 and 23 times, respectively, the maximum recommended human dose (mrhd) of 675 mg based on body surface area (mg/m2 ). however, aripiprazole caused developmental toxicity and possible teratogenic effects in rats and rabbits [see data]. the background risk of major birth defects and miscarriage for the indicated population are 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. advise pregnant women of the potential risk to a fetus. clinical considerations fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. these symptoms have varied in severity. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. some neonates recover within hours or days without specific treatment; others required prolonged hospitalization. data animal data for aristada (aripiprazole lauroxil) aripiprazole lauroxil did not cause adverse developmental or maternal effects in rats or rabbits when administered intramuscularly during the period of organogenesis at doses of 18, 49, or 144 mg/animal in pregnant rats which are approximately 1 to 8 times the mrhd of 675 mg based on mg/m2 , and at doses of 241, 723, and 2893 mg/animal in pregnant rabbits which are approximately 2 to 23 times the mrhd based on mg/m2 . however, aripiprazole caused developmental toxicity and possible teratogenic effects in rats and rabbits [see data below] . animal data for aripiprazole pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day which are approximately 1 to 10 times the oral mrhd of 30 mg/day based on mg/m2 of aripiprazole during the period of organogenesis. treatment at the highest dose caused a slight prolongation of gestation and delay in fetal development, as evidenced by decreased fetal weight, and undescended testes. delayed skeletal ossification was observed at 3 and 10 times the oral mrhd based on mg/m2 . at 3 and 10 times the oral mrhd based on mg/m2 , delivered offspring had decreased body weights. increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia were observed in offspring from the highest dose group (the other dose groups were not examined for these findings). a low incidence of diaphragmatic hernia was also seen in the fetuses exposed to the highest dose. postnatally, delayed vaginal opening was seen at 3 and 10 times the oral mrhd based on mg/m2 and impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) along with some maternal toxicity were seen at the highest dose; however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity. in pregnant rabbits treated with oral doses of 10, 30, and 100 mg/kg/day which are 2 to 11 times human exposure at the oral mrhd based on auc and 6 to 65 times the oral mrhd based on mg/m2 of aripiprazole during the period of organogenesis decreased maternal food consumption and increased abortions were seen at the highest dose as well as increased fetal mortality. decreased fetal weight and increased incidence of fused sternebrae were observed at 3 and 11 times the oral mrhd based on auc. in rats treated with oral doses of 3, 10, and 30 mg/kg/day which are 1 to 10 times the oral mrhd based on mg/m2 of aripiprazole perinatally and postnatally (from day 17 of gestation through day 21 postpartum), slight maternal toxicity and slightly prolonged gestation were seen at the highest dose. an increase in stillbirths and decreases in pup weight (persisting into adulthood) and survival were also seen at this dose. risk summary aripiprazole is present in human breast milk; however, there are insufficient data to assess the amount in human milk, the effects on the breastfed infant, or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for aristada initio and any potential adverse effects on the breastfed infant from aristada initio or from the underlying maternal condition. safety and effectiveness of aristada initio in pediatric patients have not been established. safety and effectiveness of aristada initio in patients >65 years of age have not been evaluated. elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. aristada initio is not approved for the treatment of patients with dementia-related psychosis [see warnings and precautions (5.1, 5.2)]. approximately 8% of caucasians and 3-8% of black/african americans cannot metabolize cyp2d6 substrates and are classified as poor metabolizers (pm). avoid use of aristada initio in these patients because dosage adjustments are not possible (it is only available in one strength in a single-dose pre-filled syringe) [see dosage and administration (2.3), clinical pharmacology (12.3)] . no dosage adjustment for aristada initio is required based on a patient's hepatic function (mild to severe hepatic impairment, child-pugh score between 5 and 15), or renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 ml/minute) [see clinical pharmacology (12.3)] . no dosage adjustment for aristada initio is required on the basis of a patient's sex, race, or smoking status [see clinical pharmacology (12.3)] .