טבע מודיעה על השקת משאף התרסיס -™QVAR® RediHaler

QVAR^® RediHaler™ Inhalation Aerosol is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

Important Safety Information

• Do not use QVAR^® RediHaler™ to treat sudden severe symptoms of asthma. Always have a rescue inhaler with you to treat sudden symptoms.
• Do not use QVAR^® RediHaler™ if you are allergic to beclomethasone dipropionate or any of the ingredients in QVAR^® RediHaler™.
• Do not use QVAR^® RediHaler™ more often than prescribed.
• Tell your healthcare provider about all the medicines you take and about all of your health conditions.
• QVAR^® RediHaler™ may cause serious side effects, including:

o Fungal infections (thrush) in your mouth and throat. Rinse your mouth with water without swallowingafter using QVAR^® RediHaler™ to help prevent an infection in your mouth or throat.

o Worsening asthma or sudden asthma attacks. After using your rescue inhaler, contact your healthcare provider right away if you do not get relief from your sudden asthma attacks

o Reduced adrenal function (adrenal insufficiency). This potentially life-threatening condition can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines (such as QVAR® RediHaler™). Tell your healthcare provider right away about any signs and symptoms of adrenal insufficiency such as: feeling tired or exhausted (fatigue); lack of energy; low blood pressure (hypotension); dizziness or feeling faint; nausea and vomiting; or weakness

o Immune system effects and a higher chance for infections. Tell your healthcare provider about any signs or symptoms of infection such as: fever, chills, pain, feeling tired, body aches, nausea, or vomiting

o Increased wheezing (bronchospasm) right after using QVAR^®RediHaler™. Always have a rescue inhaler with you to treat sudden wheezing.

o Serious allergic reactions. Stop using QVAR^® RediHaler™ and call your healthcare provider or get emergency medical help right away if you get any of the following: hives; swelling of your lips, tongue, or face; rash; or breathing problems

o Slowed growth in children. Children should have their growth checked regularly while using QVAR^® RediHaler™.

o Lower bone density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).

o Eye problems. If you have had glaucoma, cataracts or blurred vision in the past, you should have regular eye exams while using QVAR^® RediHaler™.

• Common side effects of QVAR^® RediHaler™ include: yeast infection in the mouth (oral candidiasis); cold symptoms (upper respiratory tract infection); pain in the throat (oropharyngeal pain); pain or swelling in your nose and throat (nasopharyngitis); sinus irritation (sinusitis); and hay fever (allergic rhinitis)
• These are not all the possible side effects of QVAR^® RediHaler™. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information at  http://www.qvarredihaler.com/Pdf/PI.pdf

A copy may be requested from the US Medical Information Contact Center for Teva Specialty Medicines at 888-4-TEVA-RX (888-483-8279) and USMedInfo@tevapharm.com or Teva’s Public Relations or Investor Relations contacts.

• uncertainties relating to the potential benefits and success of our new structure and recent senior management changes as well as the potential success and our ability to effectively execute a restructuring plan;
• our generics medicines business, including: that we are substantially more dependent on this business, with its significant attendant risks, following our acquisition of Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”); our ability to realize the anticipated benefits of the acquisition (and any delay in realizing those benefits) or difficulties in integrating Actavis Generics; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our generic products, both from competing products and as a result of increased governmental pricing pressures; and our ability to take advantage of high-value biosimilar opportunities;
• our specialty medicines business, including: competition for our specialty products, especially Copaxone^®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; our ability to achieve expected results from investments in our product pipeline; competition from companies with greater resources and capabilities; and the effectiveness of our patents and other measures to protect our intellectual property rights;
• our substantially increased indebtedness and significantly decreased cash on hand, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, and may result in a downgrade of our credit ratings;
• our business and operations in general, including: our ability to develop and commercialize additional pharmaceutical products; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel;the restructuring of our manufacturing network, including potential related labor unrest; the impact of continuing consolidation of our distributors and customers; variations in patent laws that may adversely affect our ability to manufacture our products; our ability to consummate dispositions on terms acceptable to us; adverse effects of political or economic instability, major hostilities or terrorism on our significant worldwide operations; and our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions;
• compliance, regulatory and litigation matters, including: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; governmental investigations into sales and marketing practices; potential liability for sales of generic products prior to a final resolution of outstanding patent litigation; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
• other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; the significant increase in our intangible assets, which may result in additional substantial impairment charges; potentially significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;