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Klaricid Paediatric Suspension 250mg/5ml(Mylan Products Limite)
2017-02-20 11:07:33 来源: 作者: 【 】 浏览:522次 评论:0

1. Name of the medicinal product
Klaricid Paediatric Suspension 250mg/5ml
2. Qualitative and quantitative composition
Active

Clarithromycin  mg/5ml

250
Excipient:
 

Sucrose 455 mg/ml

Castor Oil: 6.4 mg/ml

For a full list of excipients, see section 6.1

3. Pharmaceutical form

White to off - white granules for oral suspension.

4. Clinical particulars
 
4.1 Therapeutic indications

Klaricid Paediatric Suspension 250mg/5ml is indicated in children 6 months to 12 years.

Klaricid Paediatric Suspension 250mg/5ml is indicated for the treatment of infections caused by susceptible organisms. Indications include:

- Lower respiratory tract infections (e.g. bronchitis, pneumonia) (see section 4.4 and 5.1 regarding Sensitivity Testing).

- Upper respiratory tract infections (e.g. pharyngitis, sinusitis).

- Skin and soft tissue infections (e.g. folliculitis, cellulitis, erysipelas) (see section 4.4 and 5.1 regarding Sensitivity Testing).

- Acute otitis media.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Paediatric patients under 12 years of age

Clinical trials have been conducted using Klaricid Paediatric Suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use Klaricid Paediatric Suspension.

Recommended doses and dosage schedules:

The usual duration of treatment is for 5 to 10 days depending on th

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