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Pediatric Subjects Aged 4 to 11 Years : Results from the ventolin 2-week clinical trial in ventolin pediatric subjects with ventolin asthma aged 4 to 11 years showed that this pediatric population had an adverse reaction profile similar to that of the adult and adolescent populations. Exercise-Induced Bronchospasm One controlled clinical trial in adult subjects with asthma (N 24) demonstrated that 2 inhalations of ventolin non HFA ventolin taken approximately 30 minutes prior to exercise significantly prevented exerciseinduced bronchospasm (as measured by maximum percentage fall in FEV1 following. Breathe out slowly as long as you can. BA single inhalation of ventolin HFA in a 70-kg adult without use of a valved holding chamber and mask delivers approximately 90 mcg,.3 mcg/kg. Frequency Of Use Inform patients that the action of ventolin HFA should non last up to 4 to 6 hours. Your pharmacist may be able to advise you on managing side effects. Serial FEV1 measurements demonstrated that 2 inhalations of ventolin HFA produced significantly greater improvement in pulmonary function than placebo. The data from adults and adolescents is based upon 2 clinical trials in which 202 subjects with asthma aged 12 years and older were treated with Ventolin HFA 2 inhalations 4 times daily for 12 weeks duration. An open vial of medicine must be used right away. Although the clinical significance of these non effects is not known, caution is advised in the coadministration of ventolin HFA with non- potassium -sparing diuretics. These trials included a total of 610 subjects (323 males, 287 females). Shake the inhaler ventolin well and spray it 1 time into the air away non from your face. There were no significant differences in asthma symptom scores and mean change from baseline in an asthma symptom score between Ventolin HFA 180 mcg and Ventolin HFA 360 mcg. You may report side effects to FDA at 1-800-FDA-1088. Store unopened vials of this medicine at room temperature, away from heat and direct light. Do not use a Ventolin HFA canister with an actuator from any other inhaler. Two 4-week randomized, double-blind, placebo-controlled trials were conducted in 163 pediatric subjects aged from birth to 48 months with symptoms of bronchospasm associated with obstructive airway disease (presenting symptoms included: wheeze, cough, dyspnea, or chest tightness). More puffs may be needed to relieve symptoms during a more severe attack. Use the face mask or mouthpiece to breathe in the medicine. If you need to use the inhaler before it is completely dry, shake off the excess water, replace the canister, and spray it 2 times in the air away from the face. Do not keep outdated medicine or medicine no longer needed. Also, ask your doctor to check regularly how ventolin you or your child use the inhaler to make sure you are using it properly. You can ask your healthcare provider or pharmacist for information about Ventolin HFA that was written for healthcare professionals. If you become pregnant while using albuterol, call your doctor. Storage Keep the medicine in the foil pouch until you are ready to use. Each depression of the valve delivers 100 g of salbutamol (as sulfate). Call your doctor or pharmacist for a refill prescription of prescription or medicine. Check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine. Cleft palate also occurred in 22 of 72 (30.5) fetuses from females treated subcutaneously with isoproterenol non (positive control). If your healthcare provider has told you to us e more s prays, wait 1 minute and shake the inhaler again. Ventolin, ventolin HFA, prescription in Canada, alti-Salbutamol Inhalation Aerosol, apo-Salvent. Animal Toxicology and/or Pharmacology Preclinical Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately.0 of the plasma concentrations. Follow the manufacturer's directions carefully and ask your doctor or pharmacist if you have any questions about cleaning your inhaler or nebulizer. After you have breathed in all the way, take the inhaler out of your mouth and close your mouth. This Patient prescription Information and Instructions for Use have been approved by the.S. The blue actuator supplied with Ventolin HFA should not be used with any other product canisters, non and actuators from other products should not be used with a Ventolin HFA canister. Although not all of these side effects may occur, if they do occur they may need medical attention. Your inhaler is now ready to use. Use In Specific Populations Pregnancy Teratogenic Effects Pregnancy Category. Some subjects who participated in these clinical trials were using concomitant inhaled steroid therapy. There are no adequate and well-controlled trials with Ventolin HFA or albuterol sulfate in pregnant women. Therefore, patients with asthma should not normally be treated with beta-blockers. Because of the potential for beta-agonist interference with uterine contractility, use of Ventolin HFA during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Thyroid disease: Salbutamol can increase the activity of the thyroid gland. Over the 4-week treatment period, there were no treatment differences in asthma symptom scores between the groups receiving ventolin HFA 90 mcg, ventolin HFA 180 mcg, and placebo in either trial. The other brands listed are trademarks of their respective owners and are not trademarks of the GSK group of companies. Kidney diseaseUse with caution.

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