CEPROTIN 500 IU powder and solvent for solution for injection

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