Uingereza - Kiingereza - MHRA (Medicines & Healthcare Products Regulatory Agency)

potassium 20mmol/500ml) / sodium chloride 0.9% infusion 500ml viaflo bags (baxter healthcare ltd - potassium chloride; sodium chloride - infusion - 3mg/1ml ; 9mg/1ml

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

baxter healthcare pty ltd - potassium chloride, quantity: 400 mg/l; sodium lactate, quantity: 3.22 g/l; calcium chloride dihydrate, quantity: 270 mg/l; sodium chloride, quantity: 6 g/l - injection, solution - excipient ingredients: sodium hydroxide; lactic acid; water for injections - is indicated as a source of water and electrolytes. it is also used in patients as a source of bicarbonate in the treatment of mild to moderate metabolic acidosis associated with dehydration or associated with potassium deficiency. these solutions are indicated as methods of intravenous drug delivery, if the drugs are comparable with the solutions. this product accepted for registration/listing as 'currently supplied' at the time of commencement of the act. indications held in artg paper records. (old code)

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - potassium chloride; sodium chloride - solution for infusion - 0.3 % w/v + 0.9 percent weight/volume - electrolyte solutions; potassium chloride

Marekani - Kiingereza - NLM (National Library of Medicine)

icu medical inc. - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), calcium chloride (unii: m4i0d6vv5m) (calcium cation - unii:2m83c4r6zb, chloride ion - unii:q32zn48698), sodium lactate (unii: tu7hw0w0qt) (sodium cation - unii:lyr4m0nh37, lactic acid, unspecified form - unii:33x04xa5at), dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - this solution is indicated in patients requiring parenteral administration of potassium chloride and the replacement of extracellular losses of fluids and electrolytes with minimal carbohydrate calories. solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. solutions containing lactate are not for use in the treatment of lactic acidosis. to open tear outer wrap at notch and remove solution container. if supplemental medication is desired, follow directions below before preparing for administration. some opacity of the plastic due to moisture absorption during the sterilization process may be observed. this is normal and does not affect the solution quality or safety. the opacity will diminish gradually. to add medication - prepare additive port. prepare additive port. - using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. withdraw needle after injecting medication. using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. withdraw needle after injecting medication. - the additive port may be protected by covering with an additive cap. the additive port may be protected by covering with an additive cap. - mix container contents thoroughly. mix container contents thoroughly. preparation for administration (use aseptic technique) - close flow control clamp of administration set. close flow control clamp of administration set. - remove cover from outlet port at bottom of container. remove cover from outlet port at bottom of container. - insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. note: see full directions on administration set carton. insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. note: see full directions on administration set carton. - suspend container from hanger. suspend container from hanger. - squeeze and release drip chamber to establish proper fluid level in chamber. squeeze and release drip chamber to establish proper fluid level in chamber. - open flow control clamp and clear air from set. close clamp. open flow control clamp and clear air from set. close clamp. - attach set to venipuncture device. if device is not indwelling, prime and make venipuncture. attach set to venipuncture device. if device is not indwelling, prime and make venipuncture. - regulate rate of administration with flow control clamp. regulate rate of administration with flow control clamp. warning: do not use flexible container in series connections.

Marekani - Kiingereza - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (sodium cation - unii:lyr4m0nh37), sodium phosphate, dibasic, anhydrous (unii: 22ado53m6f) (sodium cation - unii:lyr4m0nh37) - monobasic sodium phosphate and dibasic sodium phosphate tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults. monobasic sodium phosphate and dibasic sodium phosphate tablets are contraindicated in the following conditions: -   history of acute phosphate nephropathy [see warnings and precautions (5.1)] -   gastrointestinal (gi) obstruction [see warnings and precautions (5.7)] -   gastric bypass or stapling surgery -   bowel perforation -   toxic colitis -   toxic megacolon -   hypersensitivity to sodium phosphate salts or any component of monobasic sodium phosphate and dibasic sodium phosphate tablets[see warnings and precautions (5.7)]. risk summary there are no available data on sodium phosphate use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. animal reproduction studies have not been conducted with sodium phosphate. 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. risk summary there are no data available to assess the presence of sodium phosphate in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of monobasic sodium phosphate and dibasic sodium phosphate tablets to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for monobasic sodium phosphate and dibasic sodium phosphate tablets and any potential adverse effects on the breastfed child from monobasic sodium phosphate and dibasic sodium phosphate tablets or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the 599 patients in clinical trials receiving at least 48 grams of monobasic sodium phosphate and dibasic sodium phosphate tablets, 134 (22%) were 65 years of age or older, while 27 (5%) were 75 years of age or older. no overall differences in safety or effectiveness were observed between geriatric patients and younger patients. however, the mean phosphate levels in geriatric patients were greater than the phosphate levels in younger patients after monobasic sodium phosphate and dibasic sodium phosphate tablets administration. the mean colonoscopy-day phosphate levels in patients 18-64, 65-74, and ≥ 75 years old who received the recommended monobasic sodium phosphate and dibasic sodium phosphate tablets dosage regimen in study 1were 7.0, 7.3, and 8.0 mg/dl, respectively. after monobasic sodium phosphate and dibasic sodium phosphate tablets administration, the mean phosphate levels in patients 18-64, 65-74, and ≥ 75 years old were 7.4, 7.9, and 8.0 mg/dl, respectively. greater sensitivity of some older individuals cannot be ruled out; therefore, use monobasic sodium phosphate and dibasic sodium phosphate tablets with caution in geriatric patients. advise geriatric patients to adequately hydrate before, during, and after the use of monobasic sodium phosphate and dibasic sodium phosphate tablets. sodium phosphate is known to be substantially excreted by the kidney, and the risk of adverse reactions with sodium phosphate may be greater in patients with impaired renal function. since geriatric patients are more likely to have impaired renal function, consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and bun) in these patients [see warnings and precautions (5.1)]. sodium phosphate is substantially excreted by the kidney. use monobasic sodium phosphate and dibasic sodium phosphate tablets with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or patients taking concomitant medications that may affect renal function. these patients may be at risk for renal injury. advise these patients of the importance of adequate hydration before, during and after the use of monobasic sodium phosphate and dibasic sodium phosphate tablets, and consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and bun) in these patients [see warnings and precautions (5.1), drug interactions (7.1)] .

Marekani - Kiingereza - NLM (National Library of Medicine)

ascend laboratories, llc - sodium sulfate (unii: 0ypr65r21j) (sodium cation - unii:lyr4m0nh37), potassium sulfate (unii: 1k573lc5tv) (potassium cation - unii:295o53k152), magnesium sulfate, unspecified form (unii: de08037sab) (magnesium cation - unii:t6v3lhy838) - sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients. pediatric use information is approved for braintree laboratories, inc.’s suprep bowel prep kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. however, due to braintree laboratories, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. sodium sulfate, potassium sulfate and magnesium sulfate oral solution is contraindicated in the following conditions: - gastrointestinal obstruction or ileus [see warnings and precautions (5.6)] - bowel perforation [see warnings and precaution (5.6)] - toxic colitis or toxic megacolon - gastric retention - hypersensitivity to any of the ingredients in sodium sulfate, potassium sulfate and magnesium sulfate oral solution risk summary there are no available data on sodium sulfate, potassium sulfate and magnesium sulfate oral solution use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproductive studies have not been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate (sodium sulfate, potassium sulfate and magnesium sulfate oral solution). 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.  risk summary there are no data available data on the presence of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in human or animal milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sodium sulfate, potassium sulfate and magnesium sulfate oral solution and any potential adverse effects on the breastfed child from sodium sulfate, potassium sulfate and magnesium sulfate oral solution or from the underlying maternal condition.  the safety and effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in pediatric patients less than 12 years of age have not been established.   pediatric use information is approved for braintree laboratories, inc.’s suprep bowel prep kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. however, due to braintree laboratories, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. of the 375 patients who received sodium sulfate, potassium sulfate and magnesium sulfate oral solution in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. no overall differences in safety or effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution, administered as the recommended split-dose (2-day) regimen, were observed between geriatric patients and younger patients. geriatric patients reported more vomiting when sodium sulfate, potassium sulfate and magnesium sulfate oral solution was given as a one-day preparation (not a recommended regimen). elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see warnings and precautions (5.1)].  use sodium sulfate, potassium sulfate and magnesium sulfate oral solution with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function. these patients may be at risk for renal injury. advise these patients of the importance of adequate hydration before, during and after use of sodium sulfate, potassium sulfate and magnesium sulfate oral solution and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and bun) in these patients [see warnings and precautions (5.4)] .  dispense the enclosed medication guide to each patient. sodium sulfate, potassium sulfate and magnesium sulfate oral solution booklet includes: 1- patient instrutions 2- full prescribing information 3- medication guide on the day before your procedure • you may have a light breakfast or have clear liquids only; please have nothing for dinner • do not  drink milk • do not  eat or drink anything colored red or purple • do not  drink alcoholic beverages any of the following clear liquids are ok • water • strained fruit juices (without pulp) including apple, orange, white grape, or white cranberry • limeade or lemonade • coffee or tea (do not  use any dairy or non-dairy creamer) • chicken broth • gelatin desserts without added fruit or topping (no red or purple) • in the evening before the procedure complete steps 1 through 4 using one (1) 6-ounce bottle before going to bed • in the morning on the day of the procedure, repeat steps 1 through 4 using the other 6-ounce bottle

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

b. braun medical limited - sodium chloride potassium chloride sodium lactate solution calcium chloride dihydrate - solution for infusion - 500ml,1000 %v/v

Marekani - Kiingereza - NLM (National Library of Medicine)

ucsf radiopharmaceutical facility - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 200 mci in 1 ml - sodium fluoride f 18 injection is indicated for diagnostic positron emission tomography (pet) imaging of bone to define areas of altered osteogenic activity. none. pregnancy category c any radiopharmaceutical including sodium fluoride f 18 injection has a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. animal reproductive and developmental toxicity studies have not been conducted with sodium fluoride f 18 injection. prior to the administration of sodium fluoride f 18 injection to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f 18 injection should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f 18 injection is excreted into human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of sodium fl

Marekani - Kiingereza - NLM (National Library of Medicine)

precision nuclear llc - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 200 mci in 1 ml - sodium fluoride f 18 injection usp is indicated for diagnostic positron emission tomography (pet) imaging of bone to define areas of altered osteogenic activity. none pregnancy category c any radiopharmaceutical including sodium fluoride f 18 injection has a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. animal reproductive and developmental toxicity studies have not been conducted with sodium fluoride f 18 injection. prior to the administration of sodium fluoride f 18 injection to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f 18 injection should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f 18 injection is excreted into human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of sodium f

Marekani - Kiingereza - NLM (National Library of Medicine)

sofie co. - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 200 mci in 1 ml - sodium fluoride f 18 injection, usp is indicated for diagnostic positron emission tomography (pet) imaging of bone to define areas of altered osteogenic activity. none. pregnancy category c any radiopharmaceutical including sodium fluoride f18 injection has a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. animal reproduction and developmental toxicity studies have not been conducted with sodium fluoride f 18 injection. prior to the administration of sodium fluoride f 18 injection to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f 18 injection should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f 18 injection is excreted into human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administr