Junior Ibuprofen Suspension

国家: 马耳他

语言: 英文

来源: Malta Medicines Authority

有效成分:

IBUPROFEN

可用日期:

Galpharm Healthcare Limited Wrafton, Braunton, North Devon, EX33 2DL, United Kingdom

ATC代码:

M01AE01

INN（国际名称）:

IBUPROFEN 100 mg/5ml

药物剂型:

ORAL SUSPENSION

组成:

IBUPROFEN 100 mg/5ml

处方类型:

OTC

治疗领域:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

授权状态:

Withdrawn

授权日期:

2006-12-20

产品特点

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SUMMARY OF PRODUCT CHARACTERISTICS 

1.  TRADE NAME OF THE MEDICINAL PRODUCT 

Junior Ibuprofen Suspension 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

Active Ingredient: 
Ibuprofen BP 100 mg / 5ml                            

Excipients: 
Dispersible Cellulose (Avicel RC591),
Sodium Methylparaben, Sodium Propylparaben, Citric Acid 
Anhydrous, Saccharin Sodium, Sodium Benzoate, Juicy
Orange Flavour, Hydrogenated Glucose Syrup, 
Xanthan Gum, Polysorbate 80, Purified Water. 

3. PHARMACEUTICAL 
FORM 

Suspension for oral administration 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

For reduction of fever (including post immunisation fever;) and
relief of mild to moderate pain such as 
headache, sore throat, earache, teething pain and toothache, cold
and flu symptoms, minor aches and 
sprains. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

Children 8 to 12 years: 10 ml three to four times daily. 
Children 3 to 7 years:  5 ml three to four times daily. 
Children 1 to 2 years:  2.5 ml three to four times daily. 
Infants 6 months to 1 year:  2.5 ml three times daily. 

Not recommended for children under 6 months of age. 

For post immunisation fever: 2.5ml followed by one further 2.5ml 6
hours later, if necessary. No more 
than 2 doses in 24 hours. If fever is not reduced, consult your
doctor. 

4.3 CONTRAINDICATIONS 

Patients with a known hypersensitivity to Ibuprofen, Aspirin or any
of the products constituents. 

Patients with a history of bronchospasm, rhinitis
or urticaria particularly associated with therapy with 
aspirin or other anti-inflammatory drugs. 

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Patients with active peptic ulceration or a history of peptic
ulceration. 

Children under 6 months.  

4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE 

Should be used with care in patients with renal, hepa