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Zyvox 100 mg/5 ml Granules for Oral Suspension
2014-06-21 14:37:56 来源: 作者: 【 】 浏览:579次 评论:0

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
 
1. Name of the medicinal product
 

Zyvox 100 mg/5 ml Granules for Oral Suspension

 
2. Qualitative and quantitative composition
 

 

Following reconstitution with 123 ml water, each 5 ml contains 100 mg linezolid.

Excipients: each 5 ml also contains 1052.9 mg sucrose, 500 mg mannitol (E421), 35.0 mg aspartame (E951), 8.5 mg sodium, 12 mg fructose, 36 mg sorbitol (E420).

For the full list of excipients, see section 6.1.

 
3. Pharmaceutical form
 

Granules for oral suspension.

White to light-yellow, orange flavoured granules.

 
4. Clinical particulars
     
4.1 Therapeutic indications
 

Nosocomial pneumonia

Community acquired pneumonia

Zyvox is indicated for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by

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