Last Updated on eMC 30-03-2017 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 4.4 - Special warnings and precautions for use
  • Correction of spelling/typing errors

Date of revision of text on the SPC:07-03-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Minor alignment and correction of discrepancies in section 4.4 of the SmPC compared with the previous version of the SmPC following the approval of EU harmonisation work-sharing procedure dated 07/03/2017. 

Note that the date of revision (07-Mar-2017) in section 10 of the SmPC is unchanged.  

Refer to the change details of the previous version of the SmPC for more information.

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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:07-03-2017

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. Information on prophylactic use in VTE for non-surgical patients is also included.

Changes are detailed below:

 

4.1     Therapeutic indications – revised wording

Prophylaxis of venous thromboembolism in adult patients undergoing surgery, particularly orthopaedic, general or oncological surgery.

Prophylaxis of venous thromboembolism in non-surgical adult patients immobilised due to acute medical illness including: acute heart failure, acute respiratory failure, severe infections, active cancer, as well as exacerbation of rheumatic diseases.

Prevention of clotting in extracorporeal circuits during haemodialysis and haemofiltration in adults.

 

4.2     Posology and method of administration – revised wording

Posology

Prophylaxis of thromboembolic events in adults:

Administration is by subcutaneous injection.

Surgical patients at moderate risk of thromboembolic events:

3,500 anti-Xa IU given SC 2 hours before surgery and then once daily for as long as the patient is considered to be at risk of VTE.

Surgical patients at high risk of thromboembolic events e.g. undergoing orthopaedic or cancer surgery:

4,500 anti-Xa IU given SC 12 hours before surgery and then once daily for as long as the patient is considered to be at risk of VTE.

Non-surgical patients immobilised due to acute medical illness:

3,500 anti-Xa IU given SC once daily in patients at moderate risk of VTE, or 4,500 anti-Xa IU given SC once daily in patients at high risk of VTE. Administration should continue for as long as the patient is considered to be at risk of VTE.

Neuraxial anaesthesia

Caution is advised when performing neuraxial anaesthesia or lumbar puncture in patients receiving prophylactic doses of innohep, see section 4.4: Neuraxial anaesthesia. If neuraxial anaesthesia is planned, a minimum delay of 12 hours should be allowed between the last prophylactic dose and the needle or catheter placement. innohep should not be resumed until at least 4-6 hours after the use of spinal anaesthesia or after the catheter has been removed. Thus, the 2 hours preoperative initiation of thromboprophylaxis with innohep is not compatible with neuraxial anaesthesia.

Haemodialysis and haemofiltration in adults:

 

Duration of 4 hours or less:

A bolus injection of 2,000 to 2,500 anti-Xa IU at the start of dialysis.

Duration of more than 4 hours:

A bolus injection of 2,500 anti-Xa IU at the start of dialysis/filtration, followed by 750 anti-Xa IU/hour as a continuous infusion.

Dose adjustment:

If necessary, the bolus dose may be increased or decreased gradually in increments of 500 anti-Xa IU until a satisfactory response is obtained. The usual dose is within 2,000–4,500 anti-Xa IU.

In case of concomitant transfusion of blood or concentrated red corpuscles, an extra bolus injection of 500–1,000 anti-Xa IU can be administered.

Dose monitoring:

Determination of plasma anti-Xa activity can be used to monitor the innohep dose during haemodialysis/haemofiltration. The plasma anti-Xa level should be approximately 0.5 anti-Xa IU/ml one hour after administration.

Interchangeability

For interchangeability with other LMWHs, see section 4.4.

Special populations

Paediatric population

The safety and efficacy of innohep in children below 18 years have not yet been established. Currently available data are described in section 5.2, but no recommendation on a posology can be made.

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 administration can be initiated with anti-Xa monitoring, if the benefit outweighs the risk (see section 4.4: Renal impairment).

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.

 

Weight

For patients with very low or very high body weight, 50 anti-Xa IU per kg body weight once daily may be considered as an alternative to fixed dosing. For surgical patients, the first dose is given SC 2 hours before surgery. The administration should continue once daily for as long as the patient is considered to be at risk of VTE.

Method of administration

Parenteral products should be inspected visually prior to administration. Do not use if cloudiness or precipitate is observed. The liquid may turn yellow during storage but is still useable.

Administration is by subcutaneous injection when given as prophylaxis of thromboembolic events in adults. This can be done in abdominal skin, the outer side of the thigh, lower back, upper leg or upper arm. Do not inject in the area around the navel, near scars or in wounds.

For abdominal injections, the patient should be in a supine position, alternating the injections between the left and right side. The air-bubble within the syringe should not be removed. During the injection, the skin should be held in a fold.

For haemodialysis, the dose of innohep should be given into the arterial side of the dialyser or intravenously. The dialyser can be primed by flushing with 500-1,000 ml isotonic sodium chloride (9 mg/ml) containing 5,000 anti-Xa IU innohep per litre.

 

 

4.4     Special warnings and precautions for use

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

·       Neuraxial anaesthesia

·       Renal impairment

Interchangeability: Minor revision to wording.
Heparin-induced thrombocytopenia: Revision to the wording.

 

5.1       Pharmacodynamic properties
Pharmacotherapeutic group and ATC code added.

 

10 Date of revision of SmPC

Updated to March 2017

 

 

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 see changes below in line with the QRD template including minor editorial changes.



2          QUALITATIVE AND QUANTITATIVE COMPOSITION

Tinzaparin sodium 10,000 anti-Factor Xa IU/ml

Excipients with known effect:

Benzyl alcohol (10 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 not be mixed with any other injection.

6.3       Shelf life

2 years.

The vial should be discarded 14 days after first opening.



6.5       Nature and contents of container

2 ml multi-dose glass vial containing 10,000 anti-Factor Xa IU/ml.

Pack sizes:  in packs of 1, 2, 5 and 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:

Update to SmPc in line with Paediatric workshare.$0Section 4.1: addition of adults to indication$0$0Section 4.2: addition of sub section for paediatric population re lack of data for specific posology$0$0Section 4.8: addition of sub section for paediatric population re side effect profile being similar to adults$0$0Section 5.2: addition of sub section for paediatric population re difference sin PK for younger 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