Prothromplex TOTAL 600 IU powder and solvent for solution for injection
*Company:
Takeda Products Ireland 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 19 April 2022
File name
ie-spc-prothromplexTII 49 Fac II spec Nov 2021 clean-approved 28Mar22-amended (002).pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 April 2022
File name
ie-pl-prothromplex Fac II spec Nov 2021 clean-approved 28Mar22.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 07 April 2022
File name
ie-spc-prothromplex Nov 2021 clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 January 2022
File name
ie-mt-pl-prothromplexBR name chg-clean-Dec2021 (002).pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 10 November 2020
File name
ie-mt-pl-prothromplexTIB045-clean-Oct2020.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - manufacturer
- Improved presentation of PIL
- Addition of manufacturer
Free text change information supplied by the pharmaceutical company
Section |
Changes |
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Package leaflet: Information for the patient
Do not use Prothromplex TOTAL |
2.What you need to know before you use
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Warnings and p Traceability It is strongly recommended that every time you receive a dose of Prothromplex TOTAL the name and batch number of the product are recorded in order to maintain a record of the batches used. Talk to your doctor before using Virus safety
Children and adolescentsThe safety and efficacy of the use of Prothromplex TOTAL in patients under 18 years have not been established in Prothromplex TOTAL contains sodium and heparinThis medicine contains 81.7 mg sodium in each vial or 0.14 mg sodium (main component of cooking/table salt) per International Unit. This is equivalent to 4.1% of the recommended maximum daily dietary intake of sodium for an adult. Previously:
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Section 3 How to use Prothromplex total |
If you stop taking Prothromplex TOTAL If you have any further questions on the use of this medicine, ask your doctor. |
6. Contents of the pack and other information
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The following information is intended for In severe haemorrhages or before operations.... |
6. Date of revision |
October 2020 |
Updated on 10 November 2020
File name
ie-spc-prothromplexTIB045-clean-2Nov2020.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
- 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 |
Changes |
2 QUALITATIVE AND QUANTITATIVE COMPOSITION |
Excipients with known effect: Prothromplex TOTAL 600 IU contains |
4.1 Therapeutic indications 4.2 Posology and administration |
Spelling of haemorrhages was corrected |
4.2 Posology and administration |
Paediatric population The safety and efficacy of the use of Prothromplex TOTAL 600 IU in paediatric patients have not been established in |
4.4 Special warnings and precautions for use |
Traceability In order to improve the traceability of biological medicinal products, the name and the batch numberof the administered product should be clearly recorded. Patients receiving a vitamin K antagonist may have an underlying hypercoagulable state and infusion of human prothrombin complex may exacerbate this.
Sodium:
This medicinal product contains the calculated value of 81.7 mg sodium per vial or 0.14 mg sodium per International Unit equivalent to 4.1% of the WHO recommended maximum daily intake of 2 g sodium for an adult. |
4.8 Undesirable effects |
Summary of the safety profile
Replacement therapy with human prothrombin complex concentrates, including therapy with Prothromplex TOTAL 600 IU, may result in the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors. If such inhibitors occur, the condition will manifest itself as a poor clinical response. Formatting changes: The other adverse reactions included in the table have been reported from post-marketing experience only and the frequency category was assigned by statistics based on the assumption that each adverse reaction could have occurred in the clinical trial with 61 patients.(moved up)
(…)
Class reactionsSkin and subcutaneous tissue disorders: Angioedema, Paraesthesia Reporting of suspected adverse reactions (UK only)Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Reporting of suspected adverse reactions (IE only)Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, |
5.1 Pharmacodynamic properties |
Pharmacotherapeutic group: antihaemorrhagics, coagulation factors IX, II, VII and X in combination Correction of the spelling in : haemophilia and haemorrhage |
6.1 list of excipient |
Change in formatting |
6.5 Nature and contents of container |
Change in formatting Spelling correction: colourless |
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION |
Date of first authorisation: Content of package • 1 vial with Prothromplex TOTAL 600 IU powder for solution for injection • 1 vial with 20 ml sterilized water for injections 1 aeration needle • 1 filter needle • 1 transfer needle
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Updated on 06 August 2020
File name
ie-pl-prothromplex-TIB-042-May 2020-clean.pdf
Reasons for updating
- Change to name of medicinal product
Free text change information supplied by the pharmaceutical company
Name change in the Baltic countries (introduction of “TOTAL” as part of the invented name to increase supply flexibility).
Updated on 10 October 2017
File name
PIL_17137_853.pdf
Reasons for updating
- New PIL for new product
Updated on 10 October 2017
Reasons for updating
- Change to other sources of information section
Updated on 27 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 March 2017
Reasons for updating
- New PIL for medicines.ie