Ventolin, Respirator Solution, Nebules - GlaxoSmithKline

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IMPORTANT: PLEASE READCare of the VENTOLIN ® Respirator Solution andNebulizerCleaning: after each use, clean the syringe and nebulizer asinstructed in the nebulizer manual or as follows:To clean the nebulizer:1. Disassemble the supply tube and the nebulizer.2. Wash in warm detergent solution. Rinse the tube withwater.3. To wash the suction tubes:a. Place 3 mL of detergent solution in the vial,assemble the unit and operate for 2 minutes.b. Disassemble and rinse the vial with warm water,place 3 mL of warm water in the vial, assemblethe unit and operate for 2 minutes.c. Disassemble and rinse with warm water.4. To dry the external passage:a. Connect the nebulizer tube to the pump with thesupply tube.b. Turn the pump and blow air through for 1minute.5. If there is evidence of clogging, clean the openings andtube connectors with the detergent, then rinse with water.6. Reassemble.To clean the syringe:1. Clean the syringe and needle several times in detergentsolution by alternatively drawing up and expelling thedetergent solution.2. Repeat using a rinse of warm water.3. Dry the needle by drawing air into the syringe severaltimes, by moving the plunger back and forth in the barrelof the syringe. Remove the needle.4. Remove the plunger from the syringe, allow to air dry.5. Keep unassembled needle, plunger and barrel of syringewrapped in clean tissue, stored in a refrigerator alongwith the VENTOLIN ® bottle.Missed Dose:If you forget to inhale a dose do not worry: inhale the next doseat the time you would normally take it or inhale a dose soonerthan when it is due if you become wheezy.SIDE EFFECTS AND WHAT TO DO ABOUT THEMSide effects may include:Effects on heart• Faster heart beat than usual• Palpitations• HypertensionEffects on nervous system• Headache• Feeling a little shaky• Feeling anxious or irritable• Feeling tired or weak• Trouble sleeping (insomnia)• Hyperactivity in children• Dizziness, vertigo• DrowsinessEffects on muscles and joints• Muscle crampsOther Effects• Nausea and vomiting• Chest pain or discomfort• Flushing• Difficulty urinating• Unusual taste in your mouth• Dry or irritated throatFollow all the instructions of the nebulizer and air pumpmanufacturers for the proper care and maintenance of theapparatus.Overdose:In case of drug overdose, contact a health care practitioner,hospital emergency department or regional Poison ControlCentre immediately, even if there are no symptoms. Take thisleaflet or your medication with you so that the hospital orpoison control centre will know what you have taken.If you accidentally take a larger dose than prescribed, youare more likely to get side effects like a faster heart beat,headaches and feeling shaky or restless. These effects usuallywear off within a few hours, but you should tell your doctor assoon as possible.October 2, 2014Page 32 of 37
IMPORTANT: PLEASE READSERIOUS SIDE EFFECTS, HOW OFTEN THEYHAPPEN AND WHAT TO DO ABOUT THEMSymptom / effectVeryRareRareBronchospasm:Increased wheezing ortightness in the chest ordifficulty in breathing.Allergic Reactions:(Hypersensitivity)Swelling of the eyelids,face, lips, tongue orthroat, accompanied bydifficulty in breathing,speaking or swallowing(signs of angioedema).Skin rash, skin eruptionor other effect on theskin or eyes, itching orfever. Fainting whenthe blood pressure istoo low (sign ofhypotension).Deep and rapidbreathing, vomiting,abdominal pain, weightloss, fatigue, malaise(sign of lactic acidosistoomuch lactic acid inthe blood)Low level of potassiumin your blood(hypokalemia)Hallucinations inChildren: see or hearthings that are not thereTalk with yourdoctor orpharmacistOnly ifsevereIn allcasesStop takingdrug andcall yourdoctor orpharmacistThis is not a complete list of side effects. If you have anyunexpected effects after receiving VENTOLIN ® RespiratorSolution, contact your doctor or pharmacist.HOW TO STORE ITKeep out of sight and reach of children.Keep the VENTOLIN ® Respirator Solution in a dry place andstore them between 15°C to 25°C. Protect from light.One month after opening the bottle, throw away any solutionwhich is left over.REPORTING SUSPECTED SIDE EFFECTSYou can report any suspected adverse reactions associatedwith the use of health products to the Canada VigilanceProgram by one of the following 3 ways:• Report online at www.healthcanada.gc.ca/medeffect• Call toll-free at 1-866-234-2345• Complete a Canada Vigilance Reporting Form and:o Fax toll-free to 1-866-678-6789, oro Mail to: Canada Vigilance ProgramHealth CanadaPostal Locator 0701EOttawa, OntarioK1A 0K9Postage paid labels, Canada Vigilance ReportingForm and the adverse reaction reportingguidelines are available on the MedEffect Canada Web site atwww.healthcanada.gc.ca/medeffect.NOTE: Should you require information related to themanagement of side effects, contact your healthprofessional. The Canada Vigilance Program does notprovide medical advice.MORE INFORMATIONYou may need to read this leaflet again. PLEASE DO NOTTHROW IT AWAY until you have finished your medicine.This document plus the full product monograph, prepared forhealth professionals can be found at:http://www.gsk.caor by contacting the sponsor, GlaxoSmithKline Inc7333 Mississauga RoadMississauga, OntarioL5N 6L41-800-387-7374This leaflet was prepared by GlaxoSmithKline Inc.Last revised:© 2014 GlaxoSmithKline Inc. All Rights Reserved® VENTOLIN is a registered trademark, used under license byGlaxoSmithKline Inc.October 2, 2014Page 33 of 37
Page 6 and 7: is unknown. However, it is suspecte
Page 8: Adverse Drug Reaction OverviewAdver
Page 11 and 12: Recommended Dose and Dosage Adjustm
Page 13 and 14: Lactic acidosis has been reported i
Page 15 and 16: Reconstituted VENTOLIN ® Respirato
Page 17 and 18: CLINICAL TRIALSIn controlled clinic
Page 19 and 20: while children with bronchitis or b
Page 21 and 22: The rate of respiration in test ani
Page 23 and 24: REFERENCES1. Ahrens RC, Smith GD. A
Page 25 and 26: 28. Farmer JB, Kennedy I, Levy GP,
Page 27 and 28: 55. Muittari A, Ahonen A. Compariso
Page 29 and 30: 83. Swenson ER, Aitken ML. Hypokale
Page 31: IMPORTANT: PLEASE READINTERACTIONS
Page 35 and 36: IMPORTANT: PLEASE READINTERACTIONS
Page 37: IMPORTANT: PLEASE READSERIOUS SIDE

Ventolin, Respirator Solution, Nebules - GlaxoSmithKline

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