VENTOLIN I.V. infusion solution - GlaxoSmithKline

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Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS..................................................................................4 ADVERSE REACTIONS....................................................................................................7 DRUG INTERACTIONS ....................................................................................................8 DOSAGE AND ADMINISTRATION................................................................................9 OVERDOSAGE ................................................................................................................10 ACTION AND CLINICAL PHARMACOLOGY ............................................................10 STORAGE AND STABILITY..........................................................................................10 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................10 PART II: SCIENTIFIC INFORMATION ...............................................................................11 PHARMACEUTICAL INFORMATION..........................................................................11 DETAILED PHARMACOLOGY.....................................................................................12 TOXICOLOGY .................................................................................................................13 REFERENCES ..................................................................................................................16 PART III: CONSUMER INFORMATION..............................................................................19 October 03, 2007 Page 2 of 21
Pr VENTOLIN ® I.V. infusion solution salbutamol sulphate for injection PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Intravenous (I.V.) salbutamol I.V. Infusion / Not Applicable 1000 mcg/mL For a complete listing see Dosage Forms, Composition and Packaging section. INDICATIONS AND CLINICAL USE VENTOLIN ® (salbutamol sulphate) I.V. infusion solution is indicated for: • the relief of severe bronchospasm associated with acute exacerbations of chronic bronchitis and bronchial asthma, • the treatment of status asthmaticus. In many patients, VENTOLIN ® infusion solution will be no more effective, and likely less well tolerated, than VENTOLIN ® HFA inhalation aerosol or VENTOLIN ® respirator solution. However, patients who are severely ill with airway inflammation and mucus plugging may respond well to parenteral salbutamol after failing to benefit from the inhaled drug. This product should be administered under the supervision of a qualified health professional who is experienced in the use of parenteral preparations and in the management of asthma. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available. CONTRAINDICATIONS • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. • Patients with cardiac tachyarrhythmias • Patients at risk of threatened abortion during the first or second trimester. October 03, 2007 Page 3 of 21
Page 1: PRODUCT MONOGRAPH Pr VENTOLIN ® I.
Page 5 and 6: concurrently receiving corticostero
Page 7 and 8: In worsening asthma it is inadequat
Page 9 and 10: DOSAGE AND ADMINISTRATION Recommend
Page 11 and 12: PART II: SCIENTIFIC INFORMATION PHA
Page 13 and 14: Intravenous salbutamol raised the b
Page 15 and 16: Long-Term Toxicity Chronic toxicity
Page 17 and 18: 13. Jenkins CR, Marlin GE. The meta
Page 19 and 20: IMPORTANT: PLEASE READ PART III: CO
Page 21: IMPORTANT: PLEASE READ REPORTING SU

VENTOLIN I.V. infusion solution - GlaxoSmithKline

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