Section 1 -
Name amended to include full pharmaceutical form
Section 2 -
Reference to sodium content included
Section 4.3 -
Text added:
Previous immediate and/or severe hypersensitivity reaction to a penicillin or to any other type of beta‑lactam drug.
Cefotaxime constituted with Lidocaine Injection BP must never be used:
- by the intravenous route
- in infants under 30 months
- in subjects with a previous history of hypersensitivity to Lidocaine Injection BP
- in patients who have an unpaced heart block
in patients with severe heart failure.
Section 4.4 -
Text added:
Cefotaxime is contraindicated in patients who have had a previous hypersensitivity reaction to any cephalosporin. It is also contraindicated in patients who have had a previous immediate and/or any severe hypersensitivity reaction to any penicillin or to any other beta‑lactam drug (see section 4.3, Contraindications). Cefotaxime should be given with caution to patients who have had any other type of hypersensitivity reaction to a penicillin or any other beta‑lactam drug.
Since haematological abnormalities may develop during treatment with cefotaxime, blood count should be monitored if treatment lasts for longer than 7 days. In case of neutropenia (<1400 neutrophils/mm3), treatment should be interrupted.
Text deleted:
Cefotaxime constituted with lignocaine must never be used:
- by the intravenous route
- in infants under 30 months
- in subjects with a previous history of hypersensitivity to this product
- in patients who have an unpaced heart block
in patients with severe heart failure.
Section 4.5 -
Typographical amendments
Section 4.6 -
Text added:
Lactation: Cefotaxime is excreted in the milk in small amounts and is usually compatible with breast feeding, but careful monitoring of the infant is recommended. Consequently caution should be exercised when cefotaxime is administered to a nursing woman.
Section 4.7 -
Text added:
None known.
Cefotaxime has been associated with dizziness, which may affect the ability to drive or operate machinery.
Section 4.8 -
Deletion of text:
A very small number of cases of arrhythmias have occurred following rapid bolus infusion through a central venous catheter.
Section 5.1 -
Section amended to include data concerning sensitivity and resistance.
Section 6.2 -
Text added:
Cefotaxime should not be admixed with aminoglycosides. If they are used concurrently they should be administered in separate sites.
Cefotaxime should not be mixed with other medicinal products except those listed in section 6.6.
Section 6.6 -
Typographical amendments.
Section 7 -
‘CP Pharmaceuticals Ltd’ amended to ‘Wockhardt UK Ltd’
Section 8 -
PL number amended from PL 04543/0421 to PL 29831/0029
Section 9 -
Date of first authorisation amended
|
