Section

Changes

Package leaflet: Information for the patient

user

Do not use Prothromplex TOTAL must not be administered 

2.What you need to know before you use administration of Prothromplex TOTAL

Warnings and pPrecautions

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 administration Prothromplex TOTAL

Virus safety

Please note

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.

Children and adolescents

The safety and efficacy of the use of Prothromplex TOTAL in patients under 18 years have not been established in Baxter clinical trials.

Prothromplex TOTAL contains sodium and heparin

This 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:

Prothromplex TOTAL contains 80 mg sodium per vial (calculated value) or 0.13 mg sodium per IU/ kg dose. This is to be taken into consideration in patients on a controlled sodium diet.

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

The following information is intended for medical or healthcare professionals only:

In severe haemorrhages or before operations....

6. Date of revision

October 2020 

Section

Changes

2              QUALITATIVE AND QUANTITATIVE COMPOSITION

Excipients with known effect: Prothromplex TOTAL 600 IU contains the calculated value of 81.70 80 mg sodium per vial. Furthermore, each vial contains heparin sodium (max. 0.5 IU/IU factor IX).

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 Baxter clinical trials.

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.

In the patient’s interests, it is strongly recommended that every time Prothromplex TOTAL 600 IU is administered to a patient, the name and batch number of the product are documented with the enclosed self-adhesive label in order to maintain a link between the patient and the batch of the product.

Sodium:

Prothromplex TOTAL 600 IU contains the calculated value of 80 mg sodium per vial or

0.13 mg sodium per international unit Prothromplex TOTAL 600 IU (e.g a dose of 50 IU/kg body weight contains 6.5 mg sodium/kg body weight; a dose of 35 IU/kg body weight contains 4.6 mg sodium/kg body weight and a dose of 25 IU/kg body weight contains 3.3 mg sodium/kg body weight). This is to be taken into consideration in patients on a controlled sodium diet

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

Immune system disorders:

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)

Vascular disorder:

(…)

Class reactions

Skin 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, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 676 4971; Fax: +353 1 676 2517; Website: www.hpra.ie.; E-mail: medsafety@hpra.ie

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: 29/08/2015  29 August 2015

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

According to country specific labelling the following combinations of devices are packed with the product:

1 aeration needle, 1 filter needle, 1 transfer needle

[1 disposable syringe, 1 triple set (aeration needle, butterfly needle and disposable needle), 1 filter needle, 1 transfer needle]

[1 triple set (aeration needle, butterfly needle and disposable needle), 1 filter needle, 1 transfer needle]

[1 transfer needle, 1 filter needle, 1 aeration needle, 1 butterfly needle, 1 disposable needle]

[1 transfer needle, 1 filter needle, 1 disposable syringe, 1 aeration needle, 1 twin set (butterfly needle, disposable needle)]