When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
In Section 4.4, Special warnings and precautions for use, the statements ‘Gemzar 200 mg contains 3.5 mg (<1 mmol) sodium per vial. This should be taken into consideration by patients on a controlled sodium diet.’ And ‘Gemzar 1000 mg contains 17.5 mg (<1 mmol) sodium per vial. This should be taken into consideration by patients on a controlled sodium diet.’ Are replaced by ‘Gemzar 200 mg contains 3.5 mg (<1 mmol) sodium per vial, i.e., essentially sodium free.’ And ‘Gemzar 1000 mg contains 17.5 mg (<1 mmol) sodium per vial, i.e., essentially sodium free.’ In Section 4.6, Fertility, pregnancy and lactation, the section header is been amended in line with QRD. In Section 4.8, Undesirable Effects, the frequencies of occurrence all adverse reactions listed under frequency not known have been determined. Nervous system disorders - ‘Uncommon-Cerebrovascular accident’ Cardiac disorders - ‘Uncommon-Arrhythmias, predominantly supraventricular in nature and Heart failure’ Vascular disorders - ‘Rare-Clinical signs of peripheral vasculitis and gangrene’ Respiratory, thoracic and mediastinal disorders - ‘Rare-Pulmonary oedema and Adult respiratory distress syndrome (see section 4.4.)’ Gastrointestinal disorders - ‘Very rare-Ischaemic colitis’ Hepatobiliary disorders - ‘Uncommon-Serious hepatotoxicity, including liver failure and death’ Skin and subcutaneous tissue disorders - ‘Severe skin reactions, including desquamation and bullous skin eruptions’ is moved from Very rare to Rare Skin and subcutaneous tissue disorders - ‘Very rare-Toxic epidermal necrolysis and Stevens-Johnson Syndrome’ Renal and urinary disorders - ‘Uncommon-Renal failure (see section 4.4) and Haemolytic uraemic syndrome (see section 4.4)’ Injury, poisoning, and procedural complications. - ‘Rare-Radiation recall’ In Section 10, Date of revision of the text, the revision date is updated.
‘Gemzar 200 mg contains 3.5 mg (<1 mmol) sodium per vial. This should be taken into consideration by patients on a controlled sodium diet.’ And ‘Gemzar 1000 mg contains 17.5 mg (<1 mmol) sodium per vial. This should be taken into consideration by patients on a controlled sodium diet.’ Are replaced by ‘Gemzar 200 mg contains 3.5 mg (<1 mmol) sodium per vial, i.e., essentially sodium free.’ And ‘Gemzar 1000 mg contains 17.5 mg (<1 mmol) sodium per vial, i.e., essentially sodium free.’
In Section 4.6, Fertility, pregnancy and lactation, the section header is been amended in line with QRD. In Section 4.8, Undesirable Effects, the frequencies of occurrence all adverse reactions listed under frequency not known have been determined. Nervous system disorders - ‘Uncommon-Cerebrovascular accident’ Cardiac disorders - ‘Uncommon-Arrhythmias, predominantly supraventricular in nature and Heart failure’ Vascular disorders - ‘Rare-Clinical signs of peripheral vasculitis and gangrene’ Respiratory, thoracic and mediastinal disorders - ‘Rare-Pulmonary oedema and Adult respiratory distress syndrome (see section 4.4.)’ Gastrointestinal disorders - ‘Very rare-Ischaemic colitis’ Hepatobiliary disorders - ‘Uncommon-Serious hepatotoxicity, including liver failure and death’ Skin and subcutaneous tissue disorders - ‘Severe skin reactions, including desquamation and bullous skin eruptions’ is moved from Very rare to Rare Skin and subcutaneous tissue disorders - ‘Very rare-Toxic epidermal necrolysis and Stevens-Johnson Syndrome’ Renal and urinary disorders - ‘Uncommon-Renal failure (see section 4.4) and Haemolytic uraemic syndrome (see section 4.4)’ Injury, poisoning, and procedural complications. - ‘Rare-Radiation recall’ In Section 10, Date of revision of the text, the revision date is updated.
In Section 4.8, Undesirable Effects, the frequencies of occurrence all adverse reactions listed under frequency not known have been determined.
Nervous system disorders - ‘Uncommon-Cerebrovascular accident’
Cardiac disorders - ‘Uncommon-Arrhythmias, predominantly supraventricular in nature and Heart failure’
Vascular disorders - ‘Rare-Clinical signs of peripheral vasculitis and gangrene’
Respiratory, thoracic and mediastinal disorders - ‘Rare-Pulmonary oedema and Adult respiratory distress syndrome (see section 4.4.)’
Gastrointestinal disorders - ‘Very rare-Ischaemic colitis’
Hepatobiliary disorders - ‘Uncommon-Serious hepatotoxicity, including liver failure and death’ Skin and subcutaneous tissue disorders - ‘Severe skin reactions, including desquamation and bullous skin eruptions’ is moved from Very rare to Rare Skin and subcutaneous tissue disorders - ‘Very rare-Toxic epidermal necrolysis and Stevens-Johnson Syndrome’ Renal and urinary disorders - ‘Uncommon-Renal failure (see section 4.4) and Haemolytic uraemic syndrome (see section 4.4)’ Injury, poisoning, and procedural complications. - ‘Rare-Radiation recall’ In Section 10, Date of revision of the text, the revision date is updated.
Skin and subcutaneous tissue disorders - ‘Severe skin reactions, including desquamation and bullous skin eruptions’ is moved from Very rare to Rare
Skin and subcutaneous tissue disorders - ‘Very rare-Toxic epidermal necrolysis and Stevens-Johnson Syndrome’
Renal and urinary disorders - ‘Uncommon-Renal failure (see section 4.4) and Haemolytic uraemic syndrome (see section 4.4)’
Injury, poisoning, and procedural complications. - ‘Rare-Radiation recall’
In Section 10, Date of revision of the text, the revision date is updated.
4.6 Fertility, Ppregnancy and lactation
Sub-heading change only.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16 October 1998
Date of last renewal: 12 May 2010 16 October 2008
10. DATE OF REVISION OF THE TEXT
New date:
25 March 2011
6.5 Nature and contents of container
Deletions in strikethrough text.
Type I flint glass vials, stoppered with a grey bromobutyl rubber stopper and sealed with an aluminium seal, combined with a polypropylene cap.
Each pack contains 1 vial.
14 May 2010
This SPC has been revised/re-formatted in its entirety due to EU harmonisation, Referral & Ovarian updates.
08 April 09
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Added:
Excipients: Each 200mg vial contains 3.5 mg (<1 mmol) sodium.
Excipients: Each 1g vial contains 17.5 mg (<1 mmol) sodium.
For a full list of excipients, see section 6.1.
6 PHARMACEUTICAL PARTICULARS
6.2 Incompatibilities
For more information, see section 6.6, Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product.
Deleted:
For more information, see 6.6.
9 DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Changed:
Date of last renewal: 16 October 2008
16 January 2009
7. MARKETING AUTHORISATION HOLDER
Change of address from Basingstoke manufacturing site to Lilly House
Eli Lilly and Company Limited
Lilly House
Priestley Road
Basingstoke
Hampshire
RG24 9NL
United Kingdom
9 August 2007
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted as directed, the resulting solution contains 38mg/ml of gemcitabine.
4. CLINICAL PARTICULARS
4.2 Posology and method of administration
Added (new text in bold):
Children: Gemcitabine has been studied in limited Phase 1 and 2 trials in children in a variety of tumour types. These studies did not provide sufficient data to establish the efficacy and safety of gemcitabine in children.
Removed:
Gemcitabine has not been studied in children.
6. PHARMACEUTICAL PARTICULARS
6.6 Instructions for use, handling and disposal
6.6 Instructions for use and handling, and disposal
To reconstitute, add 5ml of Sodium Chloride Injection BP to the 200mg vial or 25ml of Sodium Chloride Injection BP to the 1g vial. Shake to dissolve. These dilutions yield a gemcitabine concentration of 38mg/ml, which includes accounting for the displacement volume of the lyophilised powder (0.26ml for the 200mg vial or 1.3ml for the 1g vial). The total volume upon reconstitution will be 5.26ml or 26.3ml, respectively. Complete withdrawal of the vial contents will provide 200mg or 1g of gemcitabine, respectively.
To reconstitute, add at least 5ml of Sodium Chloride Injection BP to the 200mg vial, or at least 25ml of Sodium Chloride Injection BP to the 1g vial. Shake to dissolve.
26 June 2006