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

hospira, inc. - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - dextrose monohydrate 50 g in 1000 ml - these solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride. solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. 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. - 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. - mix container contents thoroughly. preparation for admin

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

icu medical inc. - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - these solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride. solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. 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. - 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. - mix container contents thoroughly. preparation for administration (use aseptic technique) - close flow control clamp of administration set. - 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. - suspend container from hanger. - squeeze and release drip chamber to establish proper fluid level in chamber. - 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. - regulate rate of administration with flow control clamp. warning: do not use flexible container in series connections.

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

hospira, inc. - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - sodium chloride 900 mg in 100 ml - each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution. not for injection by usual parenteral routes. an electrolyte solution should not be used for irrigation during electrosurgical procedures.

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

amneal pharmaceuticals llc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 18 mg - methylphenidate hydrochloride (hcl) extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children 6 years of age and older, adolescents and adults up to the age of 65 [see clinical studies (14)] . hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate hcl extended-release tablets. therefore, methylphenidate hcl extended-release tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product [see adverse reactions (6.5)] . methylphenidate hcl extended-release tablets are contraindicated during treatment with monoamine oxidase (mao) inhibitors, and also within a minimum of 14 days following discontinuation of a mao inhibitor (hypertensive crises may result) [see drug interactions (7.1)] . pregnancy category c methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively. a reproduction study in rats revealed no evidence of harm to the fetus at oral doses up to 30 mg/kg/day, approximately 15-fold and 3-fold the maximum recommended human dose of methylphenidate hcl extended-release tablets on a mg/kg and mg/m2 basis, respectively. the approximate plasma exposure to methylphenidate plus its main metabolite ppaa in pregnant rats was 1 to 2 times that seen in trials in volunteers and patients with the maximum recommended dose of methylphenidate hcl extended-release tablets based on the auc. the safety of methylphenidate for use during human pregnancy has not been established. there are no adequate and well-controlled studies in pregnant women. methylphenidate hcl extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of methylphenidate hcl extended-release tablets on labor and delivery in humans is unknown. it is not known whether methylphenidate is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised if methylphenidate hcl extended-release tablets are administered to a nursing woman. in lactating female rats treated with a single oral dose of 5 mg/kg radiolabeled methylphenidate, radioactivity (representing methylphenidate and/or its metabolites) was observed in milk and levels were generally similar to those in plasma. methylphenidate hcl extended-release tablets should not be used in children under six years, since safety and efficacy in this age group have not been established. long-term effects of methylphenidate in children have not been well established. methylphenidate hcl extended-release tablets have not been studied in patients greater than 65 years of age. methylphenidate hydrochloride extended-release tablets contain methylphenidate a schedule ii controlled substance. methylphenidate hcl extended-release tablets have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions (5.1)] . methylphenidate hcl extended-release tablets can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including methylphenidate hcl extended-release tablets, can result in overdose and death [see overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. in two placebo-controlled human abuse potential studies, single oral doses of methylphenidate hcl extended-release tablets were compared to single oral doses of immediate-release methylphenidate (ir mph) and placebo in subjects with a history of recreational stimulant use to assess relative abuse potential. for the purpose of this assessment, the response for each of the subjective measures was defined as the maximum effect within the first 8 hours after dose administration. in one study (n=40), both methylphenidate hcl extended-release tablets (108 mg) and 60 mg ir mph compared to placebo produced statistically significantly greater responses on the five subjective measures suggestive of abuse potential. in comparisons between the two active treatments, however, methylphenidate hcl extended-release tablets (108 mg) produced variable responses on positive subjective measures that were either statistically indistinguishable from (abuse potential, drug liking, amphetamine and morphine benzedrine group [euphoria]) or statistically less than (stimulation – euphoria) responses produced by 60 mg ir mph. in another study (n=49), both doses of methylphenidate hcl extended-release tablets (54 mg and 108 mg) and both doses of ir mph (50 mg and 90 mg) produced statistically significantly greater responses compared to placebo on the two primary scales used in the study (drug liking, euphoria). when doses of methylphenidate hcl extended-release tablets (54 mg and 108 mg) were compared to ir mph (50 mg and 90 mg), respectively, methylphenidate hcl extended-release tablets produced statistically significantly lower subjective responses on these two scales than ir mph. methylphenidate hcl extended-release tablets (108 mg) produced responses that were statistically indistinguishable from the responses on these two scales produced by ir mph (50 mg). differences in subjective responses to the respective doses should be considered in the context that only 22% of the total amount of methylphenidate in methylphenidate extended-release tablets are available for immediate release from the drug overcoat [see system components and performance (11.1)] . although these findings reveal a relatively lower response to methylphenidate hcl extended-release tablets on subjective measures suggestive of abuse potential compared to ir mph at roughly equivalent total mph doses, the relevance of these findings to the abuse potential of methylphenidate hcl extended-release tablets in the community is unknown. physical dependence methylphenidate hcl extended-release tablets may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including methylphenidate hcl extended-release tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance methylphenidate hcl extended-release tablets may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

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

icu medical inc. - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient. none known. to open: tear outer wrap at notch and remove solution container. if supplemental medication is desired, follow directions below before preparing for administration. to add medication - 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. - the additive port may be protected by covering with an additive cap. - mix container contents thoroughly. preparation for administration (use aseptic technique) - close flow control clamp of administration set. - 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: when using a vented administration set, replace bacterial retentive air filter with piercing pin cover. insert piercing pin with twisting motion until shoulder of air filter housing rests against the outlet port flange. - suspend container from hanger. - squeeze and release drip chamber to establish proper fluid level in chamber. - attach venipuncture device to set. - open clamp to expel air from set and venipuncture device. close clamp. - perform venipuncture. - regulate rate of administration with flow control clamp. warning: do not use flexible container in series connections.

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

interpharma pty ltd - sodium chloride, quantity: 90 mg - injection, solution - excipient ingredients: water for injections - sodium chloride injection solution is used for the restoration and maintenance of salt and extracellular fluid levels or as a vehicle for the administration of parenteral drugs.

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

aspen veterinary - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), sodium gluconate (unii: r6q3791s76) (sodium cation - unii:lyr4m0nh37, gluconic acid - unii:r4r8j0q44b), sodium acetate (unii: 4550k0sc9b) (sodium cation - unii:lyr4m0nh37, acetate ion - unii:569dqm74sc), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698), magnesium chloride (unii: 02f3473h9o) (magnesium cation - unii:t6v3lhy838, chloride ion - uni - sodium chloride 526 mg in 100 ml - electrosol™ injection ph 7.4 (multiple electrolytes injection, type 1, usp) is indicated as a source of water and electrolytes for all species. it is also used as an alkalinizing agent. electrosol™ injection ph 7.4 (multiple electrolytes injection, type 1, usp) is compatible with blood or blood components. it may be administered prior to or following the infusion of blood through the same administration set (i.e., as a priming solution), added to or infused concurrently with blood components, or used as a diluent in the transfusion of packed erythrocytes. none known

New Zealand - English - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - sodium chloride 0.9%;  ;   - solution for injection - 0.9 % - active: sodium chloride 0.9%     excipient: hydrochloric acid sodium hydroxide water for injection - sodium chloride injection bp 0.9% can be used as the vehicle for the restoration of electrolytes, as the vehicle for parenteral drug administration or as a sterile irrigation medium.

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

american regent, inc. - 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.

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

b. braun medical inc. - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - this intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. 0.9% sodium chloride injection usp is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. 0.9% sodium chloride injection usp is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells. sodium chloride injection usp is also indicated as a pharmaceutic aid and diluent for the infusion of compatible drug additives. refer to prescribing information accompanying additive drugs. this solution is contraindicated where the administration of sodium or chloride could be clinically detrimental. directions for use of plastic container caution: do not use plastic container in series connection. to open check for minute leaks by squeezing solution container firmly. if leaks are found, discard solut