innohep 12,000 IU in 0.6ml syringe (Treatment in VTE) *

  • Company:

    LEO Pharma
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 23 April 2021

File name

069129_5 - 20k-pl-crop_1619192548.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 03 December 2020

File name

ie-pl-20k_syr-cl_1607016785.pdf

Reasons for updating

  • Change to section 3 - how to take/use

Updated on 24 January 2020

File name

060388-2_20k syr ins_1579861409.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 24 January 2020

File name

ie-pil-20k-syr-0090RW-cl_1579856239.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 24 January 2020

File name

ie-spc-12000-syr-0090RW-cl_1579856138.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

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

Updated on 21 November 2018

File name

053979-insert-20k-syr-cl_1542792360.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 14 November 2016

Reasons for 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

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

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.

Method of administration

Information on injection site included. Dosage table added.

 

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 November 2016

Updated on 14 November 2016

File name

PIL_9323_210.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 November 2016

Reasons for 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

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.

Method of administration

Information on injection site included. Dosage table added.

 

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 November 2016

Updated on 14 November 2016

Reasons for updating

  • New SPC for new product

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

Updated on 09 June 2015

Reasons for updating

  • Change to paediatric information
  • 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

Free text change information supplied by the pharmaceutical company

$0Update to SmPC inline with Article 45 paediatric workshare variation:$0$0Section 4.1:addition of adult to the 2 indications$0$0Section 4.2:addition of paragraph relating to paediatric population$0$0Section 4.8:addition of paragraph relating to paediatric population$0$0Section 5.2:addition of paragraph relating to paediatric population$0$0 $0

Updated on 09 June 2015

Reasons for updating

  • Change to paediatric information
  • 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

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

Free text change information supplied by the pharmaceutical company

$0Update to SmPC inline with Article 45 paediatric workshare variation:$0$0Section 4.1:addition of adult to the 2 indications$0$0Section 4.2:addition of paragraph relating to paediatric population$0$0Section 4.8:addition of paragraph relating to paediatric population$0$0Section 5.2:addition of paragraph relating to paediatric population$0$0 $0

Updated on 17 March 2015

Reasons for updating

  • Addition of separate SPCs covering individual presentations

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 17 March 2015

Reasons for updating

  • Addition of separate SPCs covering individual presentations

Free text change information supplied by the pharmaceutical company

None provided