Junior Ibuprofen Suspension
国: マルタ
言語: 英語
ソース: Malta Medicines Authority
情報リーフレット 有効成分:
IBUPROFEN
から入手可能:
Galpharm Healthcare Limited Wrafton, Braunton, North Devon, EX33 2DL, United Kingdom
ATCコード:
M01AE01
INN（国際名）:
IBUPROFEN 100 mg/5ml
医薬品形態:
ORAL SUSPENSION
構図:
IBUPROFEN 100 mg/5ml
処方タイプ:
OTC
治療領域:
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
認証ステータス:
Withdrawn
承認日:
2006-12-20
製品の特徴
Page 1 of 5
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.
Page 2 of 5
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
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