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.
Section 4.2 Change of text in section and to table (Dose change in first table under ‘Major Nerve Block’) with change of footnotes 3 and 4 and additional footnote 6. Additional text: Experience to date indicates that 400 mg administered over 24 hours is well tolerated in the average adult. Deletion of text: These solutions should also be used cautiously and in carefully restricted quantities in areas of the body supplied by end arteries, such as digits, or otherwise having a compromised blood supply. Section 4.4 Additional bullet point of text There have been post-marketing reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics. The majority of reported cases of chondrolysis have involved the shoulder joint. Due to multiple contributing factors and inconsistency in the scientific literature regarding mechanism of action, causality has not been established. Intra-articular continuous infusion is not an approved indication for Marcain. Section 4.5 Additional text: Neuroleptics such as phenothiazines may oppose the vasoconstrictor effects of adrenaline giving rise to hypotensive responses and tachycardia. Section 4.6 Change of text for Pregnancy and Lactation. Section 4.8 Change of text 4.8.1 and 4.8.2 Section 4.9 Change of text to whole section: Accidental intravascular injections of local anaesthetics may cause immediate (within seconds to a few minutes) systemic toxic reactions. In the event of overdose, systemic toxicity appears later (15–60 minutes after injection) due to the slower increase in local anaesthetic blood concentration (See section 4.8.1 Acute systemic toxicity and 4.8.2 Treatment of acute systemic toxicity). Section 10 Revision date of text: 19th October 2010
Change from ampoule to single dose vial
Section 6.3
Current shelf life: 18 months
New shelf life: 2 years
Current text: Do not store above 25°C
New text: Store in a refrigerator (2-8°C). Do not freeze. Protect from light.
Current text: 5 ml ampoules of Ph.Eur. Type I glass – packed in PVC trays. 5 ampoules per carton.
New text: 20ml single dose vials of Ph.Eur. Type I glass. 5 single dose vials per carton.
New revision date of text: 28 March 2007
· A sentence stating that ‘The concurrent use of adrenaline-containing solutions and oxytocic drugs of the ergot type may cause severe, persistent hypertension and possibly cerebrovascular and cardiac accidents.’ has been added.
· The sentence ‘Solutions containing adrenaline should be used with caution in patients undergoing general anaesthesia with inhalation agents such as halothane and enflurane, due to the risk of serious cardiac arrhythmias.’ has been added.
· The sentence ‘Non-selective beta-blockers such as propranolol enhance the pressor effects of adrenaline, which may lead to severe hypertension and bradycardia.’ has been added.
· A paragraph on foetal adverse effects due to local anaesthetics has been added.
This section has been divided into
4.8.1 – General
4.8.2 – Acute systemic toxicity
4.8.3 – Treatment of acute toxicity
Text has been moved from section 4.9 to this section.
· The sentence ‘Neurological damage is a rare but well recognised consequence of regional, and particularly epidural and spinal anaesthesia.’ has been added.
· Paresis and Paraplegia have been added to the rare nervous system disorders.
· A paragraph on systemic toxic reactions, CNS reactions, and cardiovascular toxic effects has been added.
· A sentence on the difficulty of detecting early signs of local anaesthetic toxicity in children has been added.
· Paragraphs stating actions to be taken should circulatory arrest or cardiovascular depression occur have been added.
Text from this section has been moved to sections 4.8.1 – 4.8.3