Sevorane

  • Name:

    Sevorane

  • Company:
    info
  • Active Ingredients:

    Sevoflurane

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/02/19

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Summary of Product Characteristics last updated on medicines.ie: 21/2/2019

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AbbVie Limited

AbbVie Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Chirocaine 1.25mg/ml solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 7.5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Duodopa intestinal gel Active Ingredients Carbidopa Monohydrate, Levodopa
Medicine Name Forane 99.9% w/w, inhalation vapour liquid Active Ingredients Isoflurane
Medicine Name Humira 20 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Humira 40 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Humira 40mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Humira 80 mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Kaletra 200 mg/50 mg film-coated tablets Active Ingredients Lopinavir, Ritonavir
Medicine Name Kaletra oral solution Active Ingredients Lopinavir, Ritonavir
Medicine Name Maviret 100 mg-40 mg film-coated tablets Active Ingredients Glecaprevir, Pibrentasvir
Medicine Name Norvir 100 mg powder for oral suspension Active Ingredients Ritonavir
Medicine Name Norvir 100mg Film-coated Tablets Active Ingredients Ritonavir
Medicine Name RINVOQ 15 mg prolonged-release tablets Active Ingredients Upadacitinib
Medicine Name Sevorane Active Ingredients Sevoflurane
Medicine Name Skyrizi 75 mg solution for injection in pre-filled syringe Active Ingredients Risankizumab
Medicine Name Synagis Solution for Injection Active Ingredients Palivizumab
Medicine Name Venclyxto 10mg, 50mg and 100mg Film-coated Tablets Active Ingredients Venetoclax
Medicine Name Zemplar 5 microgram/ml Solution for Injection Active Ingredients Paricalcitol
Medicine Name Zemplar capsules, soft Active Ingredients Paricalcitol
1 - 0 of 22 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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.

Updated on 21 February 2019 PIL

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 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 20 January 2016 SmPC

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

Section 7:  Change to address of MAH,


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 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 January 2016 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 30 July 2015 SmPC

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 20 April 2015 SmPC

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

Section 4.5, 1st paragraph, spelling of "arrhythmia" has been corrected.

Updated on 12 March 2015 SmPC

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

Section 4.4:
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 PIL

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 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 17 September 2013 PIL

Reasons for updating

  • Change to date of revision

Updated on 18 July 2013 SmPC

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 12 December 2012 SmPC

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 7:  Marketing Authorisation holder changed from Abbott to AbbVie.
Section 9: Marketing Authorisation Number chngaed to PA 1824/4/1

Updated on 6 December 2012 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 10 October 2012 SmPC

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 PIL

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 SmPC

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 1: Name of medicinal product has been amended to  "Sevorane 100% v/v Inhalation gas
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 PIL

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 PIL

Reasons for updating

  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 26 October 2009 SmPC

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 PIL

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 9 February 2009 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 1 August 2007 SmPC

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

 

          100ml and 250ml USP/Ph.Eur. Type III amber glass bottles or PEN bottles with cap. PEN bottle 100ml or 250ml with roll on pilfer-proof cap (ROPP) or Quik-fil MkI or MkII.
 
9.       DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

   

         19 April 1995/19 April 2005
 
10.    DATE OF (PARTIAL) REVISION OF TEXT

 

July 2007.

Updated on 9 January 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 October 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 27 September 2006 SmPC

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 PIL

Reasons for updating

  • Change to drug interactions

Updated on 31 March 2006 SmPC

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 SmPC

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 6 October 2004 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 September 2004 SmPC

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 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 9 August 2004 SmPC

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 9 August 2004 SmPC

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 9 August 2004 SmPC

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 9 August 2004 SmPC

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 9 August 2004 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)