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

bausch health us, llc - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older. diazepam rectal gel is contraindicated in patients with a known hypersensitivity to diazepam. diazepam rectal gel may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma. controlled substance: diastat contains diazepam, a schedule iv controlled substance. abuse: diastat is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. 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. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings, abuse, misuse, and addiction). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). dependence: physical dependence after use of diastat more frequently than recommended diastat may produce physical dependence if used more frequently than recommended. 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. although diastat is indicated only for intermittent use (see indications and usageand dosage and administration) , if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings, dependence and withdrawal reactions) . for patients using diastat more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue diastat ( see warnings, dependence and withdrawal reactions) . acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance tolerance to diastat may develop after use more frequently than recommended. 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). tolerance to the therapeutic effect of benzodiazepines may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Israel - English - Ministry of Health

teva medical ltd - calcium chloride; glucose hydrous; lactic acid as sodium; magnesium chloride; sodium chloride - solution for peritoneal dialysis - glucose hydrous 1.5 g / 100 ml; calcium chloride 18.3 mg / 100 ml; sodium chloride 538 mg / 100 ml; lactic acid as sodium 448 mg / 100 ml; magnesium chloride 5.08 mg / 100 ml - combinations of electrolytes - combinations of electrolytes - for use in chronic renal failure patients being maintained in peritoneal dialysis.

Israel - English - Ministry of Health

teva medical ltd - calcium chloride; glucose hydrous; lactic acid as sodium; magnesium chloride; sodium chloride - solution for peritoneal dialysis - glucose hydrous 2.5 g / 100 ml; calcium chloride 18.3 mg / 100 ml; sodium chloride 538 mg / 100 ml; lactic acid as sodium 448 mg / 100 ml; magnesium chloride 5.08 mg / 100 ml - combinations of electrolytes - combinations of electrolytes - for use in chronic renal failure patients being maintained in peritoneal dialysis.

Israel - English - Ministry of Health

fresenius medical care israel p.b. ltd - calcium chloride; glucose as monohydrate; lactic acid as sodium; magnesium chloride; sodium chloride - solution for peritoneal dialysis - magnesium chloride 0.1017 g/l; sodium chloride 5.786 g/l; calcium chloride 0.2573 g/l; glucose as monohydrate 16.5 g/l; lactic acid as sodium 3.925 g/l - combinations of electrolytes - combinations of electrolytes - for use in patients with end-stage (decompensated) chronic renal failure of any origin being maintained on peritoneal dialysis.

Israel - English - Ministry of Health

fresenius medical care israel p.b. ltd - calcium chloride; glucose as monohydrate; lactic acid as sodium; magnesium chloride; sodium chloride - solution for peritoneal dialysis - lactic acid as sodium 3.925 g/l; calcium chloride 0.2573 g/l; glucose as monohydrate 46.75 g/l; magnesium chloride 0.1017 g/l; sodium chloride 5.786 g/l - combinations of electrolytes - combinations of electrolytes - for use in patients with end-stage (decompensated) chronic renal failure of any origin being maintained on peritoneal dialysis.

Israel - English - Ministry of Health

fresenius medical care israel p.b. ltd - calcium chloride; glucose as monohydrate; lactic acid as sodium; magnesium chloride; sodium chloride - solution for peritoneal dialysis - calcium chloride 0.2573 g/l; sodium chloride 5.786 g/l; glucose as monohydrate 25 g/l; lactic acid as sodium 3.925 g/l; magnesium chloride 0.1017 g/l - combinations of electrolytes - combinations of electrolytes - for use in patients with end-stage (decompensated) chronic renal failure of any origin being maintained on peritoneal dialysis.

Israel - English - Ministry of Health

teva medical ltd - calcium chloride; glucose hydrous; lactic acid as sodium; magnesium chloride; sodium chloride - solution for peritoneal dialysis - glucose hydrous 4.25 g / 100 ml; magnesium chloride 5.08 mg / 100 ml; sodium chloride 538 mg / 100 ml; lactic acid as sodium 448 mg / 100 ml; calcium chloride 18.3 mg / 100 ml - electrolytes in combination with other drugs - electrolytes in combination with other drugs - for use in chronic renal failure patient being maintained in peritoneal dialysis.

Philippines - English - FDA (Food And Drug Administration)

baxter healthcare philippines, inc. - peritoneal dialysis solution with 2.5% dextrose - dialysis solution - [see reverse for formulation]

Philippines - English - FDA (Food And Drug Administration)

baxter healthcare philippines, inc. - peritoneal dialysis solution with 4.25% dextrose - dialysis solution - [see reverse for formulation]

Philippines - English - FDA (Food And Drug Administration)

baxter healthcare philippines, inc. - peritoneal dialysis solution with 1.5% dextrose - dialysis solution - [see reverse for formulation]