CEFTRIAXONE Powder for solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Ceftriaxone 1g Powder for solution for injection.
Qualitative and quantitative composition
Each vial contains ceftriaxone sodium equivalent to 1g of ceftriaxone. Excipient with known effect: Each gram of ceftriaxone contains approximately 82 mg (3.6mmol) of sodium. For the full list of excipients, ...
Pharmaceutical form
Powder for solution for injection (Powder for injection). White to pale yellow crystalline powder.
Therapeutic indications
Ceftriaxone is indicated in the treatment of the following infections in adults and children including term neonates (from birth): Bacterial Meningitis Community acquired pneumonia Hospital acquired pneumonia ...
Posology and method of administration
Posology The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient. The doses recommended in the tables below are the generally ...
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 reactions As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported (see section 4.8). In case of severe hypersensitivity ...
Interaction with other medicinal products and other forms of interaction
Calcium-containing diluents, such as Ringers solution or Hartmanns solution, should not be used to reconstitute Ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration ...
Fertility, pregnancy and lactation
Pregnancy Ceftriaxone crosses the placental barrier. There are limited amounts of data from the use of ceftriaxone in pregnant women. Animal studies do not indicate direct or indirect harmful effects with ...
Effects on ability to drive and use machines
During treatment with ceftriaxone, undesirable effects may occur (e.g. dizziness), which may influence the ability to drive and use machines (see section 4.8). Patients should be cautious when driving ...
Undesirable effects
The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and hepatic enzymes increased. Data to determine the frequency of ceftriaxone ...
Overdose
In overdose, the symptoms of nausea, vomiting and diarrhoea can occur. Ceftriaxone concentrations cannot be reduced by haemodialysis or peritoneal dialysis. There is no specific antidote. Treatment is ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, Third-generation cephalosporins ATC code: J01DD04 Mechanism of action Ceftriaxone inhibits bacterial cell wall synthesis following attachment ...
Pharmacokinetic properties
Absorption Intramuscular administration Following intramuscular injection, mean peak plasma ceftriaxone levels are approximately half those observed after intravenous administration of an equivalent dose. ...
Preclinical safety data
There is evidence from animal studies that high doses of ceftriaxone calcium salt led to formation of concrements and precipitates in the gallbladder of dogs and monkeys, which proved to be reversible. ...
List of excipients
None.
Incompatibilities
Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides and labetalol. Solutions containing ceftriaxone should not be mixed with or added ...
Shelf life
Shelf life: Unopened – 3 years. For reconstituted solution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C and for four days at 2-8°C. From a microbiological point of ...
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 section 6.3 for complete storage instructions.
Nature and contents of container
Ceftriaxone is supplied in Type II 15ml clear glass vials, closed with a Type I rubber stopper uncoated/coated in Omniflex and sealed with an aluminium/plastic cap. The vials are packed in boxes of 1, ...
Special precautions for disposal and other handling
Concentrations for the intravenous injection: 100 mg/ml, Concentrations for the intravenous infusion: 50 mg/ml (Please refer to section 4.2 for further information). Reconstitution table Water for Injection ...
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Marketing authorization number(s)
PL 29831/0034
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 October 2007
Date of revision of the text
20/04/2018
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