Claforan Powder for Solution for Injection 500mg * Pharmacy Only: Prescription
Company:
SANOFIStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 July 2021
File name
1.3.1 Patient Leaflet Claforan 500mg & 1g IE292_1567680035_1626106095.pdf
Reasons for updating
- XPIL Removed
Updated on 06 July 2020
File name
1.3.1 Patient Leaflet Claforan 500mg & 1g IE292_1567680035.pdf
Reasons for updating
- XPIL Removed
Updated on 05 September 2019
File name
1.3.1 SPC Claforan 500mg IE292_1567680122.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 September 2019
File name
1.3.1 Patient Leaflet Claforan 500mg & 1g IE292_1567680035.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 12 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 January 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 January 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 updated: Haematological reactionsBlood disorders
Leukopenia, neutropenia and, more rarely, bone marrow failure, pancytopenia or agranulocytosis may develop during treatment with cefotaxime, particularly if given over long periods. For treatment courses lasting longer than 7-10 days, the blood white cell count should be monitored and treatment stopped in the event of neutropenia.
Some cases of eosinophilia and thrombocytopenia, rapidly reversible on stopping treatment, have been reported. Cases of haemolytic anemia have also been reported. (see section 4.8)
Section 4.7 updated: There is no evidence that cefotaxime directly impairs the ability to drive or to operate machines. In the case of side effects such as dizziness the patient's ability to concentrate and to react properly may be impaired. In such cases patients should refrain from driving cars and using machines. High doses of cefotaxime, particularly in patients with renal insufficiency, may cause encephalopathy (e.g. impairment of consciousness, abnormal movements and convulsions) (see section 4.8). Patients should be advised not to drive or operate machinery if any such symptoms occur.
Section 4.8: tablet updated:
Blood and the lymphatic system disorders: additional text 'Bone marrow failure Pancytopenia'
Skin and subcutaneous tissue disorders: addtional text 'Acute generalised exanthematous pustulosis (AGEP)'
Renal and Urinary disorders: additional text 'Acute renal failure (See Section 4.4)'
New paragraphs:
Superinfection:
As with other antibiotics, the use of cefotaxime, especially if prolonged, may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
For IM Formulations:
Since the solvent contains lidocaine, systemic reactions to lidocaine may occur, especially in the event of inadvertent intravenous injection or injection into highly vascularised tissue or in the event of an overdose.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie.
Updated on 23 December 2014
File name
PIL_12343_311.pdf
Reasons for updating
- New PIL for new product
Updated on 23 December 2014
Reasons for updating
- Change to side-effects
- Change to information about driving or using machinery
- Change to date of revision
Updated on 16 April 2013
Reasons for updating
- Change of manufacturer
- Change due to user-testing of patient information
Updated on 03 September 2012
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 05 October 2011
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 24 August 2007
Reasons for updating
- New PIL for medicines.ie
Updated on 15 March 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 01 September 2006
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 July 2006
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 June 2006
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 6.6 of SPC & administrative changes.
Updated on 22 February 2006
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 September 2005
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)