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Boehringer Ingelheim Limited
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 298
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 04/04/2011
SPC Metalyse

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 04/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   04-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.5 Nature and Contents of Container

 

An error in the second sentence of this section has been corrected, to now read:

 

10 ml plastic syringe pre-filled with 8 ml or 10 ml of water for injections for reconstitution.

 

The text … or 10 ml … has been added.
Updated on 18/06/2010 and displayed until 04/04/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2 Qualitative and Quantitative Composition

The word recombinant has been deleted from the fifth paragraph.  The text produced in a Chinese hamster ovary cell line by recombinant DNA technology has been added to the fifth paragraph, which now reads: Tenecteplase is a fibrin-specific plasminogen activator produced in a Chinese hamster ovary cell line by recombinant DNA technology.

 

Section 3 Pharmaceutical Form

The following text has been added as a second sentence to the second paragraph of this section: The reconstituted preparation is a clear and colourless to slightly yellow solution.

 

Section 4.1 Therapeutic Indications

The words in adults have been added to this section.

 

Section 4.2 Posology and Method of Administration

The text and other handling has been added to the sentence For details see section 6.6: Special precautions for disposal and other handling in the table in this section.

 

The sub heading Paediatric population has been added before the seventh paragraph of this section.

 

Section 4.3 Contraindications

A new first paragraph has been added to this section, commencing with the text Metalyse must not be administered …

 

The word Furthermore, has been added to the beginning of what is now the second paragraph of this section.

 

The following text has been deleted from the list of contraindications situations: Hypersensitivity to the active substance tenecteplase and to any of the excipients

 

Section 4.4 Special Warnings and Precautions for Use

The word special has been deleted from before the word precautions in this section’s header.

 

The word Hypersensitivity has been added to the sub-heading Hypersensitivity/Re-administration of this section.  Text has been re-positioned (re antibody formation),  added to (re anaphylactic reaction) and deleted from this section.

 

A new final sub-heading and paragraph regarding Paediatric population has been added to this section.

 

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

The final paragraph of this section has been amended to read: Concomitant use of GPIIb/IIIa antagonists increases bleeding risk.

 

Section 4.6 Fertility, Pregnancy and Lactation

The word Fertility has been added to this section’s heading.

 

Pregnancy and Lactation sub-headings have been added before the first and second paragraphs respectively in this section.

 

A new final sub-heading and paragraph regarding Fertility has been added to this section.

 

Section 4.8 Undesirable Effects

A new second paragraph regarding adverse reaction frequencies and system organ classes has been added to this section.

 

A new Table 1 displaying the frequency of adverse reactions has been added to this section, replacing the previous listing of various undesirable effects disorders.

 

The words cardiac and myocardial have been added to and the words heart and re have been deleted from the list of common events reported as sequelae of myocardial infarction and/or thrombolytic administration in the penultimate paragraph of this section.

 

The words valve incompetence have been added to and the word insufficiency has been deleted from the list of uncommon events reported as sequelae of myocardial infarction and/or thrombolytic administration in the penultimate paragraph of this section.

 

Section 5.1 Pharmacodynamic Properties

The word Antithrombotic in the section sentence of this section has been un-italicised.

 

Section 5.2 Pharmacokinetic Properties

The typographical error labeled has been corrected to read labelled in the fourth sentence of the first paragraph of this section.

 

Section 6.3 Shelf-Life

The word up to have been deleted from before the text 24 hours in the Reconstituted solution paragraph of this section.

 

Section 6.5 Nature and Contents of Container

The text or 10 ml has been deleted from after the text with 8 ml from the 10 ml paragraph of this section.

 

Section 6.6 Special Precautions for Disposal and Other Handling

The text and other handling has been added to the heading of this section.

 

Section 8 Marketing Authorisation Number(s)

The header of this section has been updated from Number(s) in the community register of medicinal products to Marketing Authorisation Number.

 

The text (8,000 units) has been added to the number EU/1/00/169/005.

 

The text (10,000 units) has been added to the number EU/1/00/169/006.

 

Section 10 Date of Revision of the Text

The date has been updated from March 2007 to 04 June 2010.
Updated on 08/06/2007 and displayed until 18/06/2010
Reasons for adding or 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.2  Adjunctive therapy section rewritten.
4.3 haemorrhagic stroke/ischaemic stroke/dementia warnings rewritten,
4.4 Addtion of PCI warning.
4.8 Rewritten/reworded.
5.1 Addition of information on ASSENT-4 PCI study.
Updated on 05/12/2006 and displayed until 08/06/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 2, 3, 4.1, 4.7, 4.8, 5.1, 6.1, 6.4, 6.6, 8, 9 - minor changes to wording.
 
Section 4.2 Addition of 'Metalyse is not recommended for use in children (below 18y) due to a lack of data on safety and efficacy.'
 
Section 4.4 Addition of 'Concomitant use of GP11b/111a antagonists increases bleeding risk.'
 
Section 10 Date updated.
Updated on 23/07/2004 and displayed until 05/12/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/01/2004 and displayed until 23/07/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 6 - Instruction for Use/Handling
  • Removal of Black Triangle
Updated on 20/03/2003 and displayed until 29/01/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 11/02/2002 and displayed until 20/03/2003
Reasons for adding or updating:
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 09/08/2001 and displayed until 11/02/2002
Reasons for adding or updating:
  • New SPC for new product
Updated on 18/07/2001 and displayed until 09/08/2001
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  tenecteplase