CEPROTIN 1000 IU powder and solvent for solution for injection

  • Name:

    CEPROTIN 1000 IU powder and solvent for solution for injection

  • Company:
    info
  • Active Ingredients:

    Protein C

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/11/20

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Summary of Product Characteristics last updated on medicines.ie: 17/11/2020

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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1 - 0 of 62 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 17 November 2020 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 7 - Marketing authorisation holder
  • 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

Change

 

2              QUALITATIVE AND QUANTITATIVE COMPOSITION

*One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 ml of normal plasma.

Excipients with known effect (1000 IU only):

Sodium chloride: 88 mg/vial

Sodium citrate. 2H2O: 44 mg/vial

This medicinal product contains 44.9 mg sodium per vial. (1000 IU presentation)

Excipients with known effect (500 IU only):

Sodium chloride: 44 mg/vial

Sodium citrate. 2H2O: 22 mg/vial

This medicinal product contains 22.5 mg sodium per vial. (1000 IU presentation)

For the full list of excipients see section 6.1

*              One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 ml of normal plasma.

3.             Pharmaceutical form

Human protein C, powder and solvent for solution for injection.

Lyophilised white or cream coloured powder or friable solid. After reconstitution the solution has a pH of between 6.7 and 7.3 and an osmolality of not lower than 240 mosmol/kg.

4.2 Posology and administration

Based on the limited clinical experience in children from reports and studies covering 83 patients, dosing guidelines for adult subjects are considered valid for neonatal and paediatric patient population (see section 5.1).

Now moved down and with a proper heading:

Paediatric population

Based on the limited clinical experience in children from reports and studies covering 83 patients, dosing guidelines for adult subjects are considered valid for neonatal and paediatric patient population (see section 5.1).

4.4 Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

It is strongly recommended that every time that CEPROTIN is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Addition of headings: Tracebility, Hypersensitivity, Renal and/or hepatic impairment, Inhibitors, Transmissible agents, Heparin induced thrombocytopenia, Concurrent anticoagulant medication, Sodium.

Sodium

The quantity of sodium in the maximum daily dose may exceed 200 mg. This should be taken into consideration by patients on a controlled sodium diet. This medicinal product contains 44.9 mg sodium per vial, equivalent to 2.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

 

4.5 Interaction with other medicinal products and other forms of interaction

Addition of heading: Interaction with Vitamin K antagonists

4.6 fertility, pregnancy and lactation

See section 4.4 for information on parvovirus B19 infection, see section 4.4.

4.7 Effects on ability to drive and use machines

CEPROTIN has no influence or negligible influence on the ability to drive and use machines

4.8           Undesirable effects

Addition of the headings: Summary of the safety profile, Tabulated list of adverse reactions

Frequencies have been evaluated according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000); not known (cannot be estimated from the available data).

a CIOMS frequency categories: Very Common (>=10%); Common (>=1% - <10%), Uncommon (>=0.1% - <1%), Rare (>=0.01% - <0.1%), Very Rare (<0.01%).

Post-marketing experience

 

The following ADRs have been reported in the post marketing experience and the frequency of these ADRs is not known: (..)

Reporting of suspected adverse reactions (IE)

Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance,

Website: www.hpra.ie

the national reporting system listed below:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland

HPRA Pharmacovigilance

Website: www.hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

5.1           Pharmacodynamic properties

Addition of headings: Mechanism of action, Clinical efficacy and safety, Paediatric population

6.1 list of excipient

Trisodium citrate dihydrate

Sodium chloride

Sodium citrate. 2H20

Sodium chloride

Solvent

Sterilised Water for Injections

 

7. marketing authorization holder

Takeda Manufacturing Austria AG

Industriestrasse 67

A 1221 Vienna

Austria

10. date of revision

28 October 2020

Updated on 17 November 2020 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 24 February 2020 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

SmPC – Sections 4.8, 7 and 10

4.8- Update to ADR reporting details for Ireland as per latest QRD.

7- Transfer of Marketing Authorization Holder from Baxter AG to Takeda Manufacturing AG Austria

10- revision date (4 feb 2020)

Updated on 24 February 2020 PIL

Reasons for updating

  • Change to section 6 - what the product contains

Updated on 2 October 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 2 October 2018 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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



Following issuance of an update of the Company Core Safety Information (CCSI) the SmPC and PIL of Ceprotin are revised: The section 4.8 of the SmPC is revised with regard to information on adverse events and it is also modified with regard to moving the paragraph on the development of inhibitors into section 4.4. Summary of the changes are given below:

- In section 4.4, a warning regarding use in patients with severe congenital protein C deficiency has been added.

- In section 4.8, the ADRs have been updated and also tabulated in line with MedDRA.

- The date of revision of the text in section 10 has been updated in line with the CHMP opinion date (i.e. variation approval date).

Updated on 4 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 December 2017 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 19 September 2017 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 15 February 2016 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 February 2016 SPC

Reasons for updating

  • New SPC for new product

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