CEFTAZIDIME Powder for solution for injection (2017)
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Περιεχόμενα
Name of the medicinal product
Ceftazidime 1g Powder for solution for injection.
Qualitative and quantitative composition
Each vial contains ceftazidime 1g (as pentahydrate). Excipient with known effect: Each gram of ceftazidime contains approximately 52mg (2.26mmol) of sodium. For the full list of excipients, see section ...
Pharmaceutical form
Powder for solution for injection (Powder for injection). White to cream coloured, crystalline powder.
Therapeutic indications
Ceftazidime is indicated for the treatment of the infections listed below in adults and children including neonates (from birth). Nosocomial pneumonia. Broncho-pulmonary infections in cystic fibrosis. ...
Posology and method of administration
Posology Table 1. Adults and children ≥40 kg: Intermittent Administration Infection Dose to be administered Broncho-pulmonary infections in cystic fibrosis 100 to 150 mg/kg/day every 8h, maximum g per ...
Contraindications
Hypersensitivity to the active substance, to any other cephalosporin or to any of the excipients listed in section 6.1. History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type ...
Special warnings and precautions for use
Hypersensitivity As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been conducted with probenecid and furosemide. Concurrent use of high doses with nephrotoxic medicinal products may adversely affect renal function (see section 4.4). Chloramphenicol ...
Fertility, pregnancy and lactation
Pregnancy There are limited amounts of data from the use of ceftazidime in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy embryonal/foetal development, ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. dizziness), which may influence the ability to drive and use machines ...
Undesirable effects
The most common adverse reactions are eosinophilia, thrombocytosis, phlebitis or thrombophlebitis with intravenous administration, diarrhoea, transient increases in hepatic enzymes, maculopapular or urticarcial ...
Overdose
Overdose can lead to neurological sequelae including encephalopathy, convulsion and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment (see ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use. Third-generation cephalosporins ATC code: J01DD02 Mechanism of action Ceftazidime inhibits bacterial cell wall synthesis following attachment ...
Pharmacokinetic properties
Absorption After intramuscular administration of 500 mg and 1 g of ceftazidime, peak plasma levels of 18 and 37 mg/l, respectively, are achieved rapidly. Five minutes after intravenous bolus injection ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeat dose toxicity, genotoxicity, toxicity to reproduction. Carcinogenicity studies have not been performed ...
List of excipients
Sodium carbonate (anhydrous sterile)
Incompatibilities
n the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Ceftazidime is less stable in Sodium Bicarbonate Injection than other intravenous fluids. ...
Shelf life
Shelf life: Unopened 3 years. For reconstituted solution, chemical and physical in-use stability has been demonstrated for eight hours at 25°C and 24 hours at 4°C. From a microbiological point of view, ...
Special precautions for storage
Unopened: Do not store above 25°C. Keep the vials in the outer carton. After reconstitution: Store at 2-8°C (see 6.3 Shelf Life).
Nature and contents of container
Packs of one, five or ten Type II colourless glass 10ml vials stoppered with coated rubber stopper, capped with flip-off cap. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
For single use. Discard any unused contents. Instructions for reconstitution: See table for addition volumes and solution concentrations, which may be useful when fractional doses are required. PREPARATION ...
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham LL13 9UF, UK
Marketing authorization number(s)
PL 29831/0031
Date of first authorization / renewal of the authorization
15 October 2007
Date of revision of the text
26/10/2017
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