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Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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Klacid IV 500mg Powder for Concentrate for Solution for Infusion
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Each vial contains 500 mg Clarithromycin
When reconstituted and diluted as directed, the final diluted solution contains approximately 1.9mg/ml of Clarithromycin.
For a full list of excipients, see section 6.1.
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Powder For Concentrate For Solution For Infusion
A white to off-white caked, lyophilised powder.
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Klacid IV is indicated whenever parenteral therapy is required for treatment of infections caused by susceptible organisms in the following conditions;
- Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia.
- Upper respiratory tract infections for example, sinusitis and pharyngitis.
- Skin and soft tissue infections.
Clarithromycin IV is indicated in adults and children 12 years and older.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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For intravenous administration only.
Intravenous therapy may be given for 2 to 5 days and should be changed to oral clarithromycin therapy when appropriate.
Adults: The recommended dosage of Klacid IV for Infusion is 1.0 gram daily, divided into two 500mg doses, appropriately diluted as described below.
Children under 12 years: Use of clarithromycin IV is not recommended for children younger than 12 years. Clinical trials have been conducted using clarithromycin paediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin paediatric suspension (granules for oral suspe |
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