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

alphapharm pty ltd - dipotassium clorazepate, quantity: 7.5 mg - tablet - excipient ingredients: potassium carbonate; sodium chloride; croscarmellose sodium; microcrystalline cellulose; light magnesium oxide; magnesium stearate; sodium lauryl sulfate; sunset yellow fcf aluminium lake

Philippines - English - FDA (Food And Drug Administration)

msd animal health (phils.), inc.; distributor: msd animal health (phils.), inc. - sterile phosphate buffer solution - solution for injection (im/sc) - formulation: each 800 ml contains: sucrose................40 g n-z amine ............................. 13.9 g dipotassium hydrogen phosphate ................880 mg phenol red.................. 8 mg - 16 mg sodium hydroxide .......................up to 320 mg reagent grade water........................... 800 ml

Philippines - English - FDA (Food And Drug Administration)

boehringer ingelheim animal health philippines, inc.; distributor: boehringer ingelheim animal health philippines, inc. - sterile phosphate buffer saline (vet.) - solution for injection (sc) - formulation: each ml contains: nz amine ........... . 15 mg dipotassium hydrogen phosphate ......... ............ 1.25 mg sucrose ......... ............. 512.5 mcg potassium dihydrogen phosphate ..... ............. 460 mcg phenol red ........ .. 10 mcg deionized water ...... .... . . . . . . ... 1 ml

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

aurolife pharma llc - clorazepate dipotassium (unii: 63fn7g03xy) (clorazepic acid - unii:d51wo0g0l4) - clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. the effectiveness of  clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. long-term studies in epileptic patients, however, have shown continued therapeutic activity. the physician should reassess periodically the usefulness of the drug for the individual patient. clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal. clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma. clorazepate dipotassium tablets contains clorazepate, a schedule iv controlled substance. clorazepate dipotassium 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). physical dependence clorazepate dipotassium may produce physical dependence from continued therapy. 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. abrupt discontinuation or rapid dosage reduction of benzodiazepines 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). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue clorazepate dipotassium or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of clorazepate dipotassium and 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 to clorazepate dipotassium may develop from continued therapy. 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 clorazepate dipotassium may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

fresenius kabi sa-nv - calcium gluconate monohydrate 2,69 mg/ml; magnesium lactate dihydrate 0,95 mg/ml; zinc acetate dihydrate 6,72 µg/ml; copper sulfate pentahydrate 1,18 mg/l; selenium dioxide 70 mg/ml; manganese chloride tetrahydrate 0,36 mg/l; chromic chloride hexahydrate 0,1 mg/l; dipotassium hydrogen phosphate 1,39 g/l; ferric sulfate heptahydrate 2,49 mg/l; cobalt chloride hexahydrate 0,61 mg/l; ammonium molybdate tetrahydrate 0,09 mg/l; glycine 0,48 g/l; glutamic acid 1,63 g/l; valine 0,83 g/l; arginine 0,94 g/l; leucine 1,61 g/l; potassium chloride 0,67 mg/ml; sodium fluoride 1,11 mg/l; serine 0,87 g/l; proline 1,29 g/l; alanine 1,45 g/l; histidine 0,48 g/l; threonine 0,83 g/l; tryptophan 0,32 g/l; sodium chloride 1,75 g/l; taurine 0,07 g/l; lysine monohydrate 1,45 mg/ml - eq. lysine 1,29 g/l; aspartic acid 0,94 g/l; glucose monohydrate 165 mg/ml - eq. glucose anhydrous 150 g/l; tyrosine 0,11 g/l; isoleucine 0,71 g/l; methionine 0,3 g/l; phenylalanine 0,62 g/l; potassium iodide 0,07 mg/l; acetylcysteine 0,31 g/l - eq. cysteine 0,23 g/l - solution for infusion - alanine 1.45 g/l; arginine 0.94 g/l; aspartic acid 0.94 g/l; acetylcysteine 0.31 g/l; glutamic acid 1.63 g/l; glycine 0.48 g/l; histidine 0.48 g/l; isoleucine 0.71 g/l; leucine 1.61 g/l; lysine monohydrate 1.45 mg/ml; methionine 0.3 g/l; phenylalanine 0.62 g/l; proline 1.29 g/l; serine 0.87 g/l; taurine 0.07 g/l; threonine 0.83 g/l; tryptophan 0.32 g/l; tyrosine 0.11 g/l; valine 0.83 g/l; dipotassium phosphate 1.39 g/l; glucose monohydrate 165 mg/ml; calcium gluconate monohydrate 2.69 mg/ml; magnesium lactate dihydrate 0.95 mg/ml; sodium chloride 1.75 g/l; potassium chloride 0.67 mg/ml; zinc acetate dihydrate 6.72 µg/ml; copper sulfate pentahydrate 1.18 mg/l; sodium fluoride 1.11 mg/l; selenium dioxide 70 mg/ml; manganese chloride tetrahydrate 0.36 mg/l; potassium iodide 0.07 mg/l; chrome chloride hexahydrate 0.1 mg/l; ferric sulfate heptahydrate 2.49 mg/l; cobalt chloride hexahydrate 0.61 mg/l; ammonium molybdate tetrahydrate 0.09 mg/l - combinations

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

fresenius kabi sa-nv - calcium gluconate monohydrate 2,69 mg/ml; magnesium lactate dihydrate 0,95 mg/ml; zinc acetate dihydrate 6,72 µg/ml; copper sulfate pentahydrate 1,18 mg/l; selenium dioxide 70 mg/ml; manganese chloride tetrahydrate 0,36 mg/l; chromic chloride hexahydrate 0,1 mg/l; dipotassium hydrogen phosphate 1,39 g/l; ferric sulfate heptahydrate 2,49 mg/l; cobalt chloride hexahydrate 0,61 mg/l; ammonium molybdate tetrahydrate 0,09 mg/l; glycine 0,64 g/l; glutamic acid 2,17 g/l; valine 1,1 g/l; arginine 1,26 g/l; leucine 2,14 g/l; potassium chloride 0,67 mg/ml; sodium fluoride 1,11 mg/l; serine 1,16 g/l; proline 1,72 g/l; alanine 1,93 g/l; histidine 0,64 g/l; threonine 1,1 g/l; tryptophan 0,43 g/l; sodium chloride 1,75 g/l; taurine 0,09 g/l; lysine monohydrate 1,93 mg/ml - eq. lysine 1,72 g/l; aspartic acid 1,26 g/l; glucose monohydrate 220 mg/ml - eq. glucose anhydrous 200 g/l; tyrosine 0,15 g/l; isoleucine 0,95 g/l; methionine 0,4 g/l; phenylalanine 0,83 g/l; potassium iodide 0,07 mg/l; acetylcysteine 0,42 g/l - eq. cysteine 0,31 g/l - solution for infusion - alanine 1.93 g/l; arginine 1.26 g/l; aspartic acid 1.26 g/l; acetylcysteine 0.42 g/l; glutamic acid 2.17 g/l; glycine 0.64 g/l; histidine 0.64 g/l; isoleucine 0.95 g/l; leucine 2.14 g/l; lysine monohydrate 1.93 mg/ml; methionine 0.4 g/l; phenylalanine 0.83 g/l; proline 1.72 g/l; serine 1.16 g/l; taurine 0.09 g/l; threonine 1.1 g/l; tryptophan 0.43 g/l; tyrosine 0.15 g/l; valine 1.1 g/l; dipotassium phosphate 1.39 g/l; glucose monohydrate 220 mg/ml; calcium gluconate monohydrate 2.69 mg/ml; magnesium lactate dihydrate 0.95 mg/ml; sodium chloride 1.75 g/l; potassium chloride 0.67 mg/ml; zinc acetate dihydrate 6.72 µg/ml; copper sulfate pentahydrate 1.18 mg/l; sodium fluoride 1.11 mg/l; selenium dioxide 70 mg/ml; manganese chloride tetrahydrate 0.36 mg/l; potassium iodide 0.07 mg/l; chrome chloride hexahydrate 0.1 mg/l; ferric sulfate heptahydrate 2.49 mg/l; cobalt chloride hexahydrate 0.61 mg/l; ammonium molybdate tetrahydrate 0.09 mg/l - combinations

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

fresenius kabi sa-nv - calcium gluconate monohydrate 3,59 mg/ml; magnesium lactate dihydrate 1,43 mg/ml; zinc acetate dihydrate 13,43 µg/ml; copper sulfate pentahydrate 2,36 mg/l; selenium dioxide 140 mg/ml; manganese chloride tetrahydrate 0,72 mg/l; chromic chloride hexahydrate 0,21 mg/l; dipotassium hydrogen phosphate 1,74 g/l; ferric sulfate heptahydrate 4,98 mg/l; cobalt chloride hexahydrate 1,21 mg/l; ammonium molybdate tetrahydrate 0,18 mg/l; glycine 0,8 g/l; glutamic acid 2,72 g/l; valine 1,74 g/l; arginine 1,57 g/l; leucine 2,68 g/l; potassium chloride 1,49 mg/ml; sodium fluoride 2,21 mg/l; serine 1,45 g/l; proline 2,14 g/l; alanine 2,41 g/l; histidine 0,8 g/l; threonine 1,38 g/l; tryptophan 0,54 g/l; sodium chloride 2,34 g/l; taurine 0,11 g/l; lysine monohydrate 2,4 mg/ml - eq. lysine 2,14 g/l; aspartic acid 1,57 g/l; glucose monohydrate 275 mg/ml - eq. glucose anhydrous 250 g/l; tyrosine 0,19 g/l; isoleucine 1,19 g/l; methionine 0,5 g/l; phenylalanine 1,03 g/l; potassium iodide 0,13 mg/l; acetylcysteine 0,51 g/l - eq. cysteine 0,38 g/l - solution for infusion - alanine 2.41 g/l; arginine 1.57 g/l; aspartic acid 1.57 g/l; acetylcysteine 0.51 g/l; glutamic acid 2.72 g/l; glycine 0.8 g/l; histidine 0.8 g/l; isoleucine 1.19 g/l; leucine 2.68 g/l; lysine monohydrate 2.4 mg/ml; methionine 0.5 g/l; phenylalanine 1.03 g/l; proline 2.14 g/l; serine 1.45 g/l; taurine 0.11 g/l; threonine 1.38 g/l; tryptophan 0.54 g/l; tyrosine 0.19 g/l; valine 1.74 g/l; dipotassium phosphate 1.74 g/l; glucose monohydrate 275 mg/ml; calcium gluconate monohydrate 3.59 mg/ml; magnesium lactate dihydrate 1.43 mg/ml; sodium chloride 2.34 g/l; potassium chloride 1.49 mg/ml; zinc acetate dihydrate 13.43 µg/ml; copper sulfate pentahydrate 2.36 mg/l; sodium fluoride 2.21 mg/l; selenium dioxide 140 mg/ml; manganese chloride tetrahydrate 0.72 mg/l; potassium iodide 0.13 mg/l; chrome chloride hexahydrate 0.21 mg/l; ferric sulfate heptahydrate 4.98 mg/l; cobalt chloride hexahydrate 1.21 mg/l; ammonium molybdate tetrahydrate 0.18 mg/l - combinations

Ireland - English - HPRA (Health Products Regulatory Authority)

boehringer ingelheim vetmedica gmbh - attenuated prrs 94881 virus - lyophilisate and solvent for suspension for injection - 104.4 - 106.6 tissue culture infective dose 50% / 1 millilitre - porcine reproductive and respiratory syndrome (prrs) virus

Ireland - English - HPRA (Health Products Regulatory Authority)

boehringer ingelheim vetmedica gmbh - live attenuated prrs 94881 virus - lyophilisate and solvent for suspension for injection - . - porcine reproductive and respiratory syndrome (prrs) virus

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - respiratory syncytial virus recombinant glycoprotein f stabilised in the pre-fusion conformation (rsvpref3) produced in chinese hamster ovary (cho) cells by recombinant dna technology - respiratory syncytial virus infections - vaccines - arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in adults 60 years of age and older.the use of this vaccine should be in accordance with official recommendations.