CIPROFLOXACIN PFIZER
Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Αρχείο Π.Χ.Π.
(SPC)
24-05-2024
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Δραστική ουσία:
CIPROFLOXACIN LACTATE
Διαθέσιμο από:
Pfizer Healthcare Ireland
Δοσολογία:
2 Mg/Ml
Φαρμακοτεχνική μορφή:
Solution for Infusion
Ημερομηνία της άδειας:
2012-03-16
Αρχείο Π.Χ.Π.
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin Pfizer 2 mg/ml Solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each presentation of Ciprofloxacin Pfizer 2 mg/ml infusion contains the following:
CIPROFLOXACIN PFIZER 100 MG/50 ML SOLUTION FOR INFUSION
1 ml of solution for infusion contains 2 mg ciprofloxacin as 2.544 mg ciprofloxacin lactate.
Each 50 ml vial contains 100 mg ciprofloxacin (as ciprofloxacin lactate).
Excipient: Each 50 ml contains 7.7 mmol (177 mg) sodium.
CIPROFLOXACIN PFIZER 200 MG/100 ML SOLUTION FOR INFUSION
1 ml of solution for infusion contains 2 mg ciprofloxacin as 2.544 mg ciprofloxacin lactate.
Each 100 ml bottle contains 200 mg ciprofloxacin (as ciprofloxacin lactate).
Excipient: Each 100 ml contains 15.4 mmol (354 mg) sodium.
CIPROFLOXACIN PFIZER 400 MG/200 ML SOLUTION FOR INFUSION
1 ml of solution for infusion contains 2 mg ciprofloxacin as 2.544 mg ciprofloxacin lactate.
Each 200 ml bottle contains 400 mg ciprofloxacin (as ciprofloxacin lactate).
Excipient: Each 200 ml contains 30.8 mmol (708 mg) sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion (IV).
Clear, colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciprofloxacin Pfizer 2 mg/ ml Solution for infusion is indicated for the treatment of the following infections (see
sections 4.4 and 5.1). Special attention should be paid to available information on resistance to ciprofloxacin before
commencing therapy.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Adults
•
Lower respiratory tract infections due to Gram-negative bacteria.
- exacerbations of chronic obstructive pulmonary disease.
- broncho-pulmonary infections in
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