Oxis 12 Microgram Turbohaler
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1. Trade Name of the Medicinal Product
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2. Qualitative and Quantitative Composition
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3. Pharmaceutical Form
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Clinical Particulars
4.1. Therapeutic Indications
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4.2. Posology and Method of Administration
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4.3. Contra-indications
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4.4. Special Warnings and Precautions for Use
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4.5. Interactions with other Medicaments and other forms of Interaction
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4.6. Pregnancy and Lactation
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4.7. Effects on Ability to Drive and Use Machines
4.8. Undesirable Effects
Not applicable.
4.9. Overdose
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Pharmacological Properties
5.1. Pharmacodynamic Properties
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5.2. Pharmacokinetic Properties
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5.3. Preclinical Safety Data
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Pharmaceutical Particulars
6.1. List of Excipients
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6.2. Incompatibilities
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6.3. Shelf Life
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6.4.
Special Precautions for Storage
6.5. Nature and Contents of Container
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6.6. Instruction for Use/Handling
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SUMMARY OF PRODUCT CHARACTERISTICS Product Summary
1. NAME OF THE MEDICINAL PRODUCT
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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Not applicable
3. PHARMACEUTICAL FORM
Not applicable
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Not applicable
4.2. Posology and method of administration
Not applicable
4.3. Contraindications
Not applicable
4.4. Special warnings and precautions for use
4.5. Interactions with other medicinal products and other forms of interaction
Not applicable
4.6. Pregnancy and lactation
Not applicable
4.7. Effects on ability to drive and use machines
Not applicable
4.8. Undesirable effects
Not applicable
4.9. Overdose
Not applicable
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Not applicable
5.2. Pharmacokinetic properties
Not applicable
5.3. Preclinical safety data
Not applicable
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
6.2. Incompatibilities
Not applicable
6.3. Shelf life
Not applicable
6.4. Special precautions for storage
Not applicable
6.5. Nature and contents of container
Not applicable
6.6. Instruction for use and handling (, and disposal)
Not applicable
Administrative Data
7. MARKETING AUTHORISATION HOLDER
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8. MARKETING AUTHORISATION NUMBER
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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
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10. DATE OF REVISION OF THE TEXT
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