Tambocor 10 mg/ml Solution for the injection or infusion
*Company:
Mylan IRE Healthcare LtdStatus:
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 26 June 2023
File name
ie-spc-10mg-injsol-pr3142072-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 19 November 2020
File name
ie-pl-tambocor-inj-pr1585358-clean - corrected.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 23 October 2020
File name
ie-spc-tambocor-inj-pr1585358-clean.pdf
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 - how to report a side effect
- Change to section 4.9 - Overdose
- 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 23 October 2020
File name
ie-pl-tambocor-inj-pr1585358-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 08 November 2018
File name
ie-pl-tambocor-inj-clean-mahtransfer.pdf
Reasons for updating
- New PIL for new product
Updated on 07 November 2018
File name
ie-spc-tambocor-inj-mahtransfer-clean.pdf
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)
Updated on 17 July 2018
File name
TambocorInjectionSmPCjul2018.docx
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 4.9 - Overdose
- 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
In section 4.2: Information regarding significant hepatic impairment has been added.
In section 4.4: Information regarding ventricular arrhythmias has been added. Information regarding increase in plasma levels have been added.
In section 4.5: Information regarding anti-virals (lopinavir and indinavir), diuretics and anti-coagulants has been changed.
In section 4.6: Information about limit use in pregnancy has been added.
In section 4.8: Convulsion has been changed to seizure. Musculoskeletal and connective tissue disorders with frequency not known has been added.
In section 4.9: Information regarding overdose has been added
In section 10: Date of revision changed.
Updated on 22 December 2014
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 December 2014
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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
In section 3: the word infusion has been added to the pharmaceutical form
In section 4.2: reference to elderly patients has been changed to older patients
In section 4.3: Additional contraindications have been added
In section 4.4: Additional warnings and precautions have been added
In section 4.5: Additional information regarding Interaction with other medicinal products and other forms of interaction has been added
In section 4.6: This section has been divided into sub-sections. Additional text has been added. Information in relation to New Zealand White rabbits has been removed.
In section 4.8: This entire section has been restricted and divided into system organ class and frequencies. Adverse reaction reporting statement has been added.
In section 4.9: Additional information regarding over dose and treatment has been added.
In section 5.1: Pharmacotherapeutic group has been added and other pharmacodynamic information has been added.
In section 5.2: A correction has been made and additional pharmacokinetic property information has been added.
In section 5.3: Information regarding preclinical data has been removed and replaced by further text
In section 10: date of revision has changed
Updated on 22 December 2014
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 3: the word infusion has been added to the pharmaceutical form
In section 4.2: reference to elderly patients has been changed to older patients
In section 4.3: Additional contraindications have been added
In section 4.4: Additional warnings and precautions have been added
In section 4.5: Additional information regarding Interaction with other medicinal products and other forms of interaction has been added
In section 4.6: This section has been divided into sub-sections. Additional text has been added. Information in relation to New Zealand White rabbits has been removed.
In section 4.8: This entire section has been restricted and divided into system organ class and frequencies. Adverse reaction reporting statement has been added.
In section 4.9: Additional information regarding over dose and treatment has been added.
In section 5.1: Pharmacotherapeutic group has been added and other pharmacodynamic information has been added.
In section 5.2: A correction has been made and additional pharmacokinetic property information has been added.
In section 5.3: Information regarding preclinical data has been removed and replaced by further text
In section 10: date of revision has changed
Updated on 03 December 2012
Reasons for updating
- Change to section 10 - Date of revision of the text
- 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
in section 4.7; the following statement has been added: Driving ability, operation of machinery and work without a secure fit may be affected by adverse reactions such as
dizziness and visual disturbances, if present.
In section 10; the date of revision has been changed to November 2012
Updated on 03 December 2012
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 4.7 - Effects on ability to drive and use machines
Free text change information supplied by the pharmaceutical company
in section 4.7; the following statement has been added: Driving ability, operation of machinery and work without a secure fit may be affected by adverse reactions such as
dizziness and visual disturbances, if present.
In section 10; the date of revision has been changed to November 2012
Updated on 22 February 2012
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 5.1 - Pharmacodynamic properties
- 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 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 1 - Name of medicinal product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 2; quantitative values have been added
In section 4.4; soduoum warning has been added
In section 5.1; ATC code has been added
In section 6.2; additional text added
In section 6.3; do not store above 25 degrees has been added
In section 6.4; additional text has been added
In section 6.6; text for single use only has been added
In section (; date of last renewal has been changed
In section 10; date of revision has been changed
Updated on 22 February 2012
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 5.1 - Pharmacodynamic properties
- 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 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 1 - Name of medicinal product
Free text change information supplied by the pharmaceutical company
In section 2; quantitative values have been added
In section 4.4; soduoum warning has been added
In section 5.1; ATC code has been added
In section 6.2; additional text added
In section 6.3; do not store above 25 degrees has been added
In section 6.4; additional text has been added
In section 6.6; text for single use only has been added
In section (; date of last renewal has been changed
In section 10; date of revision has been changed
Updated on 07 April 2011
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
In section 10; the date of revision has changed
Updated on 07 April 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 10; the date of revision has changed
Updated on 04 September 2009
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 8: the marketing authorisation holder has chamged
Updated on 04 September 2009
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Free text change information supplied by the pharmaceutical company
In section 8: the marketing authorisation holder has chamged
Updated on 20 December 2005
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 December 2005
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Updated on 21 November 2005
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 November 2005
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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
Updated on 03 August 2004
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- 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 03 August 2004
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.4 - Special warnings and precautions for use
Updated on 23 June 2003
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 June 2003
Reasons for updating
- Correction of spelling/typing errors
Updated on 10 June 2003
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 June 2003
Reasons for updating
- New SPC for new product