Last Updated on eMC 07-11-2016 View medicine  | Leo Laboratories Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • 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 10 - Date of revision of the text

Date of revision of text on the SPC:29-09-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SmPC has been updated following an EU harmonisation work-sharing procedure. Sections 4.1 and 4.2 have been updated, with consequential changes to sections 4.4 and 4.8. Information on use in patients with active cancer also included.

Changes detailed below:

 

4.1     Therapeutic indications – revised wording

Treatment of venous thrombosis and thromboembolic disease including deep vein thrombosis and pulmonary embolus in adults.

Extended treatment of venous thromboembolism and prevention of recurrences in adult patients with active cancer.

For some patients with pulmonary embolism (e.g. those with severe haemodynamic instability) alternative treatment, such as surgery or thrombolysis, may be indicated.

 

4.2     Posology and method of administration – revised wording

Posology

Treatment in adults

175 anti-Xa IU/kg body weight given subcutaneously once daily for at least 6 days and until adequate oral anticoagulation is established.

Extended treatment in adult patients with active cancer

175 anti-Xa IU/kg body weight given subcutaneously once daily for a recommended treatment period of 6 months. The benefit of continued anticoagulation treatment beyond 6 months should be evaluated.

Neuraxial anaesthesia

Treatment doses of innohep (175 IU/kg) are contraindicated in patients who receive neuraxial anaesthesia, see section 4.3. If neuraxial anaesthesia is planned, innohep should be discontinued at least 24 hours before the procedure is performed. innohep should not be resumed until at least 4-6 hours after the use of spinal anaesthesia or after the catheter has been removed.

Interchangeability

For interchangeability with other LMWHs, see section 4.4.

Renal impairment

If renal impairment is suspected, renal function should be assessed using a formula based on serum creatinine to estimate creatinine clearance level.

Use in patients with a creatinine clearance level <30 ml/minute is not recommended, as dosage in this population has not been established. Available evidence demonstrates no accumulation in patients with creatinine clearance levels down to 20 ml/min. When required in these patients, innohep treatment can be initiated with anti-Xa monitoring, if the benefit outweighs the risk (see section 4.4: Renal impairment). In this situation, the dose of innohep should be adjusted, if necessary, based on anti-factor Xa activity. If the anti-factor Xa level is below or above the desired range, the dose of innohep should be increased or reduced respectively, and the anti-factor Xa measurement should be repeated after 3-4 new doses. This dose adjustment should be repeated until the desired anti-factor Xa level is achieved. For guidance, mean levels between 4 and 6 hours after administration in healthy volunteers and patients without severe renal insufficiency have been between 0.5 and 1.5 IU/anti-factor Xa IU/ml. Anti-factor Xa activity determinations were by a chromogenic assay.

Elderly

innohep should be used in the elderly in standard doses. Precaution is recommended in the treatment of elderly patients with renal impairment. If renal impairment is suspected, see section 4.2: Renal impairment and section 4.4: Renal impairment.

 

4.4     Special warnings and precautions for use

The following subsections have been updated in line with the revised statements in Section 4.2.

·       Heparin-induced thrombocytopenia

·       Renal impairment

Interchangeability with other LMWHs: Minor revision to wording.

 

4.8     Undesirable effects

Information added on patients with cancer on extended treatment.

 

10 Date of revision of SmPC

Updated to September 2016

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:13-05-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:


Please refer to the below changes in line with the QRD template including minor editorial changes.

2          QUALITATIVE AND QUANTITATIVE COMPOSITION

Tinzaparin sodium 20,000 anti-Factor Xa IU/ml

Excipients with known effect:

Benzyl alcohol (10 mg/ml), sodium metabisulphite (1.83 mg/ml) and sodium (in total < 23 mg/dose).

 

For the full list of excipients, see section 6.1.

3          PHARMACEUTICAL FORM

Solution for injection.

Vials of 2 ml filled with a colourless to straw coloured liquid, free from turbidity and from matter that deposits on standing.




6.2       Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.innohep should be given by subcutaneous injection.  It should not be mixed with any other injection.

6.3       Shelf life

            2 years.

The vial should be discarded 14 days after first use.

6.4       Special precautions for storage

Do not store above 25°C.

6.5       Nature and contents of container

2 ml multi-dose glass vial containing 20,000 anti-Factor Xa IU/ml.

Pack sizes:  in packs of 1 or 10 vials.

Not all pack sizes may be marketed.

 

6.6       Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.The vial should be discarded 14 days after first use.


10        DATE OF REVISION OF THE TEXT

6 March 201513/05/2016

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC:06-03-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0Update to SmPC as result of Paediatric workshare assessment:$0$0Section 4.1:addition of adults to indication$0$0Section 4.2:addition of sub section for paediatric population re lack of data for specificposology$0$0Section 4.8:addition of sub section for paediatric population re side effect profile beingsimilar to adults$0$0Section 5.2:addition of sub section for paediatric population re difference sin PK foryounger and older children$0

Reasons for adding or updating:

  • New individual SPC (was previously included in joint SPC)

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO