Mivacron 2mg/ml Solution for Injection

  • Name:

    Mivacron 2mg/ml Solution for Injection

  • Company:
    info
  • Active Ingredients:

    Mivacurium Chloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/09/17

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 16/8/2017
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Aspen

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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 September 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 21 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 September 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 16 August 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Text in red = new text
Text strikethrough = deleted text

 

7.         MARKETING AUTHORISATION HOLDER

           

GlaxoSmithKline (Ireland) Limited

12 Riverwalk,

Citywest Business Campus,

Dublin 24

Aspen Pharma Trading Limited,

3016 Lake Drive,

Citywest Business Campus,

Dublin 24,

Ireland

 

 

8.         MARKETING AUTHORISATION NUMBER

 

PA 1077/69/1 PA 1691/031/001

 

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

 

            01 July 2015August 2017

Updated on 16 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 15 August 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 15 July 2015 SmPC

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

Section 7 - change to Ireland MAH address

Updated on 15 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 8 June 2015 SmPC

Reasons for updating

  • 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 4.8 - update to the reporting of adverse events from IMB to new name of HPRA.

Updated on 5 June 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 8 July 2014 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 June 2014 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.2 - Administrative changes
Sectin 4.4 - Administrative changes
Section 4.5 - Addition of selective serotonin reuptake inhibitors
Section 4.6 - Administrative changes
Section 4.8 - Update to Reporting Side Effects
Section 5.1 - Addition of ATC code

Additional administrative and formatting changes throughout the SPC.

Updated on 9 June 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration

Updated on 23 December 2013 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 23 December 2013 SmPC

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Update

Updated on 1 June 2012 SmPC

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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Change to:

Section 4.3 - Contraindications,
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction, Section 4.6 - Pregnancy and lactation,
Section 4.8 - Undesirable effects

Updated on 22 November 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 28 July 2009 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

Summary of Renewal (R3) changes- Mivacron May09

Amendments highlighted in red text

 

 

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each ml contains 2mg mivacurium (As mivacurium chloride)

 

Each 5ml ampoule contains 10mg mivacurium. (as mivacurium chloride)

Each 10ml ampoule contains 20mg mivacurium. (as mivacurium chloride)

 

For a full list of excipients see section 6.1

 

3.       PHARMACEUTICAL FORM

 

Solution for injection. (Short term: Injection)

A clear, pale yellow solution.

 

 

………………………………………..

 

6.1     List of Excipients

 

Hydrochloric acid (for pH adjustment)

Water for injections

 

6.2     Incompatibilities

 

Mivacron injection is acidic (approximately pH 4.5) and should not be mixed with highly alkaline solutions e.g. barbiturates.

 

This medicinal product must not be mixed with other medicinal products except those mentioned in Section 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such a medicinal product and other handling of the product

 

 

6.3     Shelf-life

 

Unopened: 18 months

Once opened, use immediately and discard any unused contents.

 

When diluted with the listed infusion solutions in Section 6.6, in the proportion of 1 plus 3 (i.e. to give 0.5 mg/ml), Mivacron injection has been shown to be chemically and physically stable for at least 48 hours at 30°C.  However, since the product contains no antimicrobial preservative, dilution should be carried out immediately prior to use, administration should commence as soon as possible thereafter, and any remaining solution should be discarded.

 

6.4     Special Precautions for Storage

 

Store below 25°C. Do not freeze. Keep the ampoules in the outer carton in order to protect from light.

 

6.5     Nature and Contents of Container

 

5 x 5ml glass ampoules (Type I) in an outer cardboard carton

5 x 10ml glass ampoules (Type I) in an outer cardboard carton

 

6.6         Special precautions for disposal of a used medicinal product or waste materials derived from such a medicinal product and other handling of the product

 

For single use only.

 

Since no antimicrobial preservative is included, Mivacron Injection must be used under full aseptic conditions and any dilution carried out immediately before use.  Any unused solution in open ampoules should be discarded.

 

Mivacron Injection has been shown to be compatible with some commonly used peri-operative drugs supplied as acidic solutions. Where such agents are administered through the same indwelling needle or cannula as used for Mivacron Injection, and compatibility has not been demonstrated, it is recommended that each drug is flushed through with physiological saline.

 

Mivacron is compatible with the following infusion fluids:

 

Sodium chloride Intravenous Infusion (0.9% w/v)

Glucose Intravenous Infusion (5% w/v)

Sodium chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion

Lactated Ringer’s Injection, USP

 

When diluted with the listed infusion solutions in the proportion of 1 plus 3 (i.e. to give 0.5 mg/ml) Mivacron injection has been shown to be chemically and physically stable for at least 48 hours at 30°C.  However, since the product contains no antimicrobial preservative, dilution should be carried out immediately prior to use, administration should commence as soon as possible thereafter, and any remaining solution should be discarded.

 

Instructions to open the ampoule:

Ampoules are equipped with the OPC (One Point Cut) opening system and must be opened following the below instructions:

 

-          Hold with the hand the bottom part of the ampoule

-          Put the other hand on the top of the ampoule positioning the thumb above the coloured point and press

 

7.       MARKETING AUTHORISATION HOLDER

 

GlaxoSmithKline (Ireland) Limited,

Stonemasons Way,

Rathfarnham,

Dublin 16.

 

8.       MARKETING AUTHORISATION NUMBER

 

PA 1077/69/1

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

 

31st March 1995 / 31st March 2009

 

10.     DATE OF REVISION OF THE TEXT

 

May 2009

 

 

Updated on 1 July 2009 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 20 April 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 4.7 - Effects on ability to drive and use machines

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

Free text change information supplied by the pharmaceutical company

 

New text in red. Deleted text in blue.

 

 

4.2       Posology and Method of Administration

 

.

 

Prolonged and intensified neuromuscular blockade may also occur in patients with acute or chronic renal failure as a result of reduced levels of plasma cholinesterase (see section 4.4 Special Warnings and Special Precautions for Use)

 

Dose in patients with reduced plasma cholinesterase activity: 

Mivacurium is metabolised by plasma cholinesterase.  Plasma cholinesterase activity may be diminished in the presence of genetic abnormalities of plasma cholinesterase (e.g. patients heterozygous or homozygous for the atypical plasma cholinesterase gene), in various pathological conditions (see section 4.4 Special Warnings and Special Precautions for Use).  The possibility of prolonged neuromuscular block following administration of Mivacron must be considered in patients with reduced plasma cholinesterase activity.  Mild reductions (i.e. within 20% of the lower limit of the normal range) are not associated with clinically significant effects on duration.

(See section 4.3 Contraindications and section 4.4 Special Warnings and Special Precautions for Use, for information about homozygous and heterozygous patients).

 

 

 

4.4       Special Warnings and Special Precautions for Use

 

IN COMMON WITH ALL THE OTHER NEUROMUSCULAR BLOCKING AGENTS, MIVACRON PARALYSES THE RESPIRATORY MUSCLES AS WELL AS OTHER SKELETAL MUSCLES BUT HAS NO EFFECT ON CONSCIOUSNESS.  MIVACRON SHOULD BE ADMINISTERED ONLY BY OR UNDER THE CLOSE SUPERVISION OF AN EXPERIENCED ANAESTHETIST WITH ADEQUATE FACILITIES FOR ENDOTRACHEAL INTUBATION AND ARTIFICIAL VENTILATION.

 

Prolonged and intensified neuromuscular blockade following mivacurium may occur secondary to reduced plasma cholinesterase activity in the following states or pathological conditions:

         Physiological variation as in pregnancy and the puerperium (see section 4.6 Pregnancy and Lactation).

         Genetically determined abnormalities of plasma cholinesterase (see below and section 4.3 Contraindications).

         Severe generalised tetanus, tuberculosis and other severe or chronic infections.

         Chronic debilitating disease, malignancy, chronic anaemia and malnutrition.

         Myxoedema and collagen diseases.

         Decompensated heart disease

         Peptic ulcer

         Burns (see below)

         End-stage hepatic failure, (see section 4.2 Posology and Method of Administration)

         Acute, chronic or end-stage renal failure (see section 4.2 Posology and Method of Administration)

         Iatrogenic: following plasma exchange, plasmapheresis, cardiopulmonary bypass, and as a result of concomitant drug therapy (see Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction).

 

In common with suxamethonium/succinylcholine, patients homozygous for the atypical plasma cholinesterase gene (1 in 2500 patients) are extremely sensitive to the neuromuscular blocking effect of mivacurium.  In three such adult patients, a small dose of 0.03 mg/kg (approximately the ED10-20 in genotypically normal patients), produced complete neuromuscular block for 26 to 128 minutes.

 

In patients heterozygous for the atypical plasma cholinesterase gene, the clinically effective duration of block of mivacurium 0.15 mg/kg is approximately 10 min longer than in control patients.

 

Once spontaneous recovery had begun, neuromuscular block in these patients was antagonized with conventional doses of neostigmine.

 

Patients with burns may develop resistance to non-depolarising neuromuscular blocking agents and require increased doses. However, such patients may also have reduced plasma cholinesterase activity, requiring dose reduction. Consequently, burn patients should be given a test dose of 0.015 to 0.020 mg/kg mivacurium followed by appropriate dosing guided by monitoring of block with a nerve stimulator

 

Caution should be exercised in administering Mivacron to patients with a history suggestive of an increased sensitivity to the effects of histamine e.g. asthma.  If Mivacron is used in this group of patients it should be administered over 60 seconds.

 

Caution should also be exercised when administering Mivacron to patients who have shown hypersensitivity to other neuromuscular blocking agents since a high rate of cross sensitivity (greater than 50%) between neuromuscular blocking agents has been reported.

 

..

Deleted:

Patients with burns may develop resistance to non-depolarising neuromuscular blocking agents and require increased doses.  However, such patients may also have reduced plasma cholinesterase activity, requiring dose reduction.  Consequently, burn patients should be given a test dose of 0.015-0.020 mg/kg Mivacron followed by appropriate dosing guided by monitoring of block with a nerve stimulator.

 

 

4.7       Effects on Ability to Drive and Use Machines

 

This precaution is not relevant to the use of mivacurium.  Mivacurium will always be used in combination with a general anaesthetic and therefore the usual precautions relating to performance of tasks following general anaesthesia apply

 

Updated on 9 March 2007 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 1 March 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 5 January 2006 PIL

Reasons for updating

  • Change of active ingredient
  • Change to storage instructions

Updated on 26 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 1 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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