CLONAMP Capsules Hard 250 Anhyd Milligrams
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
08-05-2024
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अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
AMPICILLIN TRIHYDRATE
थमां उपलब्ध:
Clonmel Healthcare Ltd
डोज़:
250 Anhyd Milligrams
फार्मास्यूटिकल फॉर्म:
Capsules Hard
प्राधिकरण की तारीख:
1981-07-02
उत्पाद विशेषताएं
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clonamp 250 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains ampicillin trihydrate equivalent to 250 mg ampicillin.
_For full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Capsule, hard. (Capsule).
Size ‘2’ hard gelatin capsules with a red body and a grey cap marked ‘CLON AMP 250’ containing an off-white
powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For treatment of infections due to organisms sensitive to ampicillin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 20Kg b.w.:
The usual dose is 250mg every six hours.
For treatment of severe infections the dosage may be increased at the discretion of the physician.
Children under 20Kg b.w.:
50 to 100mg/Kg per day in divided doses.
Route of administration
Oral.
4.3 CONTRAINDICATIONS
Ampicillin is penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics
(e.g. ampicillin, penicillins, cephalosporins) or excipients.
Excipients:
Amaranth (E123)
0.150 mg
Tartrazine (E102)
0.071 mg
Brilliant Black (E151) 0.008 mg
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 19/05/2010_
_CRN 2082962_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
(i)
Prolonged use of an anti-infective may result in the development of superinfection due to organisms resistant
to that anti-infective.
(ii)
Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid
origin are suspected. The occurrence of a skin rash has been associated with these conditions following the
administration of ampicillin.
(iii)
The dosage should be reduced
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