Sevorane
*Company:
AbbVie LimitedStatus:
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 13 May 2024
File name
PL_Sevo_MT-MAHT_25Apr24.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Change to the Marketing Authorisation Holder for Malta
Updated on 25 February 2021
File name
PL_Sevo_Aescia removal_24Feb21.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Section 6
- Under Manufacturer, removal of Aescica Queenborough site
Updated on 06 January 2021
File name
PL_Sevo_Malta_CRN008Q3T_Summer_Maltatransfer29Mar19.pdf
Reasons for updating
- Addition of information on reporting a side effect.
Free text change information supplied by the pharmaceutical company
Irish Sevorane pack is shared with Malta.
Section 4 has been updated to include the Competant Authority details in Malta (for the reporting of an adverse event)
Updated on 21 February 2019
File name
PL_Sevo_CRN008Q3T_Summer_18Feb19.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
Updated on 21 February 2019
File name
SPC_Sevo_CRN008Q3T_Summer_18Feb19.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- 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
Summary of Changes
Section 4.4
The statement:
“Patients with repeated exposures to halogenated hydrocarbons, including sevoflurane, within a relatively short interval may have an increased risk of hepatic injury.”
has been amended to:
“It has been reported that previous exposure to halogenated hydrocarbon anaesthetics, especially if the interval is less than 3 months, may increase the potential for hepatic injury.”
Section 4.6
The following has been added:
“Studies in animals have shown reproductive toxicity (see section 5.3).”
Section 5.1
The following has been added:
“Pharmacotherapeutic Group: anaesthetics, general; halogenated hydrocarbons.
ATC Code: N01AB08.”
Section 5.3
The following has been added:
“Published studies in animals (including primates) at doses resulting in light to moderate anaesthesia demonstrate that the use of anaesthetic agents during the period of rapid brain growth or synaptogenesis results in cell loss in the developing brain that can be associated with prolonged cognitive deficiencies. The clinical significance of these nonclinical findings is not known.”
Section 10
Date of Revision amended to February 2019
Updated on 15 August 2018
File name
SPC_Sevorane_CRN2172684_address change_13Jan16.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 January 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 January 2016
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
from
AbbVie Limited
Block B
Liffey Valley Office Campus
Quarryvale
Co. Dublin
to
AbbVie Limited
Citywest Business Park
Dublin 24
Ireland
Updated on 19 January 2016
File name
PIL_9048_976.pdf
Reasons for updating
- New PIL for new product
Updated on 19 January 2016
Reasons for updating
- Change to MA holder contact details
Updated on 30 July 2015
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- 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 4.3 Contraindications:
Update the statement:
“Sevoflurane should not be used in patients with known or suspected sensitivity to sevoflurane or to other halogenated anaesthetics (e.g. history of liver function disorder, fever or leucocytosis of unknown cause after anaesthesia with one of these agents).”
to read:
“Sevoflurane should not be used in patients with known or suspected sensitivity to sevoflurane or to other halogenated inhalational anaesthetics (e.g. history of hepatotoxicity, usually including elevated liver enzymes, fever, leukocytosis and/or eosinophilia temporally related to anesthesia with one of these agents.”
Section 4.6 Fertility, Pregnancy and lactation
Inclusion of the following statement:
“Sevoflurane, like other inhalational agents, has relaxant effects on the uterus with the potential risk for uterine bleeding. Clinical judgment should be observed when using sevoflurane during obstetric anaesthesia.”
Updated on 28 July 2015
Reasons for updating
- Change to warnings or special precautions for use
Updated on 20 April 2015
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 March 2015
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
The following statement has been added:
Sevoflurane may cause respiratory depression, which may be augmented by narcotic premedication or other agents causing respiratory depression. Respiration should be supervised and if necessary, assisted.
Section 4.5
The following has been added:
Beta-sympathomimetic agents like isoprenaline and alpha- and beta-sympathomimetic agents like adrenaline and noradrenaline should be used with caution during Sevoflurane narcosis, due to a potential risk of ventricular arrhythemia.
Non-selective MAO-inhibitors: Risk of crisis during the operation. It is generally recommended that treatment should be stopped 2 weeks prior to surgery.
Sevoflurane may lead to marked hypotension in patients treated with calcium antagonists, in particular dihydropyridine derivates.
Caution should be exercised when calcium antagonists are used concomitantly with inhalation anesthetics due to the risk of additive negative inotropic effect.
Concomitant use of succinylcholine with inhaled anesthetic agents has been associated with rare increases in serum potassium levels that have resulted in cardiac arrhythmias and death in pediatric patients during the post-operative period.
Section 4.8
Delirium has been added to list of adverse reactions observed in postoperative period.
QT prolongation associated with Torsade (frequency unknown) has been added to Table 2 (Summary of Most Frequent Adverse Drug Reactions in Sevoflurane Clinical Trials and Post-marketing Experience)
The following paragraph has been added:
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.
Section 6.6
The sentence
Any unused product or waste material should be disposed of in accordance with local requirements.
has been amended to:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Updated on 10 March 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 18 February 2014
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 17 September 2013
Reasons for updating
- Change to date of revision
Updated on 18 July 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 Posology and Method of Administration
- Formatting changes have been made to Table 1 (MAC Values for Adults and Paediatric Patients According to Age).
Section 4.4 Special Warnings and Special Precautions for Use
- The existing wording on malignant hyperthermia has been updated to inform physicians that post marketing reports of malignant hyperthermia, some fatal have been received.
- Additional language regarding supportive therapy for the treatment of malignant hyperthermia has been added.
Section 4.8 Undesirable Effects
- Table number added to Summary of Most Frequent Adverse Drug Reactions in Sevoflurane Clinical Trials and Post-marketing Experience
Updated on 12 July 2013
Reasons for updating
- Change to side-effects
Updated on 12 December 2012
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)
Free text change information supplied by the pharmaceutical company
Section 9: Marketing Authorisation Number chngaed to PA 1824/4/1
Updated on 06 December 2012
Reasons for updating
- Change to marketing authorisation holder
Updated on 10 October 2012
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2 Posology and Method of Administration
Information on premedication added. Elderly and Paediatric Population subsections also added.
4.3 Contraindications
The existing contraindication regarding use in patients with known sensitivity was updated with examples. Contraindiation in patients in whom general anaesthesia is contraindicated also added.
4.4 Warnings and Precautions
Warning added regarding patients who are hypovolemic, hypotensive, or otherwise hemodynamically compromised.
Warning added regarding maintenance of haemodynamic stability in patients with coronary artery disease.
Statement added that impact of sevoflurane on intellectual function for two or three days following anaesthesia has not been studied and as with other anaesthetics, small changes in moods may persist for several days following administration.
Symptoms of malignant hyperthermia added.
Warning added regarding use of sevoflurane in patients with underlying hepatic conditions or under treatment with drugs known to cause hepatic dysfunction.
Neurosurgery, Seizures and Paediatric subsections added.
4.5 Drug Interactions
The Drug Interactions section updated to include information relating to 'Epinephrine/Adrenaline, Indirect-acting Sympathomimetics, beta blockers, Verapamil, Inducers of CYP2EI, St. John's Wort, Barbiturates, Benzodiazepines and Opioids, Nitrous Oxide and Neuromuscular Blocking Agents'.
4.6 Pregnancy and Lactation
Pregnancy, Labour and Delivery, Breast-feeding & Fertility subsections was added.
4.8 Adverse Reactions
Summary of most frequent adverse drug reactions in sevoflurane clincal trials and post-marketing experience have been combined in one table. Hypothermia has been added as a common adverse drug reaction. A subsection describing selected adverse events & Paediatric Population was added.
4.9 Overdose
Minor revision to wording
Updated on 24 September 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
Updated on 25 July 2012
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
- 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 2: Slight rewording
Section 4.4: Updated the paragraph regarding monitoring of anaesthetic concentration, to clarify existing information and align with common medical knowledge
Section 4.4: Statement added regarding mitochondrial disease
Section 4.4: Information added related to QT prolongation & torsades de pointes.
Section 4.6: Updated text regarding use in nursing mothers.
Section 4.8: 'cardiac arrest' added to the Post-Marketing Adverse Drug Reactions section.
Section 6.6: Statement added that any unused product or waste material should be disposed of in accordance with local requirements.
Section 9: Date of last Renewal has been added (19 April 2010)
Section 10: Date of revision of text is July 2012
Updated on 18 July 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
Updated on 22 March 2011
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 26 October 2009
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- In Section 4.2 - The MAC values have been updated to align with the Company Core Data Sheet.
- In Section 4.4 - A warning regarding repeat exposure to Sevorane within a short interval, potentially increasing the risk of liver damage has been added. Also, A statement regarding cases of ventricular arrhythmia reported in paediatric patients with Pompe's disease has also been added.
- In Section 4.5 - A warning regarding the use of Opioids such as alfentanil and sufentanil in combination with Sevorane can lead to a synergistc fall in heart rate, blood pressue and respiratory rate.
- In Section 4.8 - This whole section has been reformatted to use MedDRA system order calss terminology and frequency. Also, hypersensitivity and related reactions have been added to the post-marketing section.
Updated on 26 October 2009
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 24 June 2009
Reasons for updating
- Improved electronic presentation
Updated on 09 February 2009
Reasons for updating
- Change to name of manufacturer
Updated on 01 August 2007
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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
6.5 Nature and Contents of Container
July 2007.
Updated on 09 January 2007
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 October 2006
Reasons for updating
- Change to warnings or special precautions for use
Updated on 27 September 2006
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.2 - Incompatibilities
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sevoflurane
For excipients see 6.1.
4.4 Special Warnings and Special Precautions for Use
Rare cases of extreme heat, smoke, and/or spontaneous fire in the anaesthesia machine have been reported during sevoflurane use in conjunction with the use of desiccated CO2 absorbent,specifically those containing potassium hydroxide (e.g Baralyme). An unusually delayed rise or unexpected decline of inspired sevoflurane concentration compared to the vaporizer setting may be associated with excessive heating of the CO2 absorbent canister.An exothermic reaction , enhanced sevoflurane degragation, and production of degradation products can occur when CO2 absorbent becomes desiccated, such as after an extended period of dry gas flow through the CO2 absorbent canisters. Sevoflurane degradants (methanol, formaldehyde, carbon monoxide, and Compounds A, B, C and D) were observed in the respiratory circuit of an experimental anaesthesia machine using desiccated CO2 absorbents and maximum sevoflurane concentrations (8%) for extended periods of time (³ 2 hours). Concentrations of formaldehyde observed at the anaesthesia respiratory circuit ( using sodium hydroxide containing absorbents) were consistent with levels known to cause mild respiratory irritation. The clinical relevance of the degradants observed under this extreme experimental model is unknown.
4.8 Undesirable Effects
The most frequent adverse events (>1%) considered to be probably related to sevoflurane administration overall were: nausea, vomiting, increased cough, hypotension, agitation, somnolence, chills, bradycardia, dizziness, increased salivation, respiratory disorder, hypertension, tachycardia, laryngismus, and fever.
6.2 Incompatibilities
Sevoflurane is stable when stored under normal room lighting conditions. No discernible degradation of sevoflurane occurs in the presence of strong acids or heat. Sevoflurane is not corrosive to stainless steel, brass, alumimum, nickel-plated brass, chrome-plated brass or copper beryllium alloy.
Chemical degradation can occur upon exposure of inhaled anaesthetics to CO2 absorbent within the anaesthesia machine. When used as directed with fresh absorbents, degradation of sevoflurane is minimal and degradants are undetectable or non-toxic. Sevoflurane degradation and subsequent degradant formation are enhanced by increasing absorbent temperature, desiccated CO2 absorbent (especially potassium hydroxide-containing, e.g. Baralyme®), increased sevoflurane concentration and decreased fresh gas flow. Sevoflurane can undergo alkaline degradation by two pathways. The first results from the loss of hydrogen fluoride with the formation of pentafluoroisopropanyl fluoromethyl ether (PIFE or more commonly known as Compound A). The second pathway for degradation of sevoflurane occurs only in the presence of desiccated CO2 absorbents and leads to the dissociation of sevoflurane into hexafluoroisopropanol (HFIP) and formaldehyde. HFIP is inactive, non-genotoxic, rapidly glucoronidated, cleared and has toxicity comparable to sevoflurane. Formaldehyde is present during normal metabolic processes. Upon exposure to a highly desiccated absorbent, formaldehyde can further degrad into methanol and formate. Formate can contribute to the formation of carbon monoxide in the presence of high temperature. Methanol can react with compound A to form the methoxy addition product Compound B. Compound B can undergo further HF elimination to form Compounds C,D and E. With highly desiccated absorbents, especially those containing potassium hydroxide (e.g Baralyme®) the fomation of formaldehyde, methanol, carbon monoxide, Compound A and perhaps some of its degradants, Compounds B,C and D may occur.
Updated on 11 July 2006
Reasons for updating
- Change to drug interactions
Updated on 31 March 2006
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 February 2006
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 1 - Name of medicinal product
- 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 06 October 2004
Reasons for updating
- New PIL for new product
Updated on 27 September 2004
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 August 2004
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 August 2004
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 August 2004
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 August 2004
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 August 2004
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)
Updated on 09 August 2004
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 24 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
AbbVie Limited

Address:
Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 428 7900Fax:
+353 1 428 7940