CIPROFLOXACIN Solution for infusion (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Ciprofloxacin 2mg/ml solution for infusion.
Qualitative and quantitative composition
Each bag contains 2 mg/ml ciprofloxacin (as lactate). The 50 ml bag contains 100 mg ciprofloxacin (as lactate). The 100 ml bag contains 200 mg ciprofloxacin (as lactate). The 200 ml bag contains 400 mg ...
Pharmaceutical form
Solution for infusion. Clear, colourless solution.
Therapeutic indications
Ciprofloxacin 2mg/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 ...
Posology and method of administration
The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient and, in children ...
Contraindications
Hypersensitivity to the active substance, to other quinolones or to any of the excipients (see section 6.1). Concomitant administration of ciprofloxacin and tizanidine (see section 4.5).
Special warnings and precautions for use
Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population. Therefore, fluoroquinolones should only be used ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on ciprofloxacin: Drugs known to prolong QT interval Ciprofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong ...
Pregnancy and lactation
Pregnancy The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity of ciprofloxacin. Animal studies do not indicate direct or ...
Effects on ability to drive and use machines
Due to its neurological effects, ciprofloxacin may affect reaction time. Thus, the ability to drive or to operate machinery may be impaired.
Undesirable effects
The most commonly reported adverse drug reactions (ADRs) are nausea, diarrhoea, vomiting, transient increase in transaminases, rash, and injection and infusion site reactions. ADRs derived from clinical ...
Overdose
An overdose of 12 g has been reported to lead to mild symptoms of toxicity. An acute overdose of 16 g has been reported to cause acute renal failure. Symptoms in overdose consist of dizziness, tremor, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Fluoroquinolones ATC code: J01MA02 Mechanism of action As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both ...
Pharmacokinetic properties
Absorption Following an intravenous infusion of ciprofloxacin the mean maximum serum concentrations were achieved at the end of infusion. Pharmacokinetics of ciprofloxacin were linear over the dose range ...
Preclinical safety data
Non-clinical data reveal no special hazards for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential, or toxicity to reproduction. Like a number ...
List of excipients
Lactic acid solution Sodium chloride Water for injection
Incompatibilities
This medicinal product must not be mixed with other medicinal products. Unless compatibility with other solutions/drugs has been confirmed, the infusion solution must always be administered separately. ...
Shelf life
Two years.
Special precautions for storage
Do not refrigerate or freeze. Store in the original package.
Nature and contents of container
50ml, 100ml or 200ml PVC bag contained in a polypropylene/polyester- aluminium/polyester pouch. Pack sizes of 5 or 10 bags.
Special precautions for disposal and other handling
Since the infusion solution is photosensitive, the infusion bags should be removed from the box only immediately before use. In daylight conditions complete efficacy is guaranteed for a period of three ...
Marketing authorization holder
Villerton Invest SA, Rue Edward Steichen 14, 2540 Luxembourg
Marketing authorization number(s)
PL 24780/0001
Date of first authorization / renewal of the authorization
07/01/2009
Date of revision of the text
18/02/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
