Innohep 20,000 IU/ml Solution for Injection (Treatment in VTE)

Product Information *

  • Company:

    LEO Pharma
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 24 January 2020

File name

060395-2_20k vial ins_1579860865.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • 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-vial-0090RW-cl_1579856900.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • 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-20k-vial-0090RW-cl_1579856756.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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • 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

053978-insert-20k-vial-cl_1542792890.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 - pregnancy, breast feeding and fertility
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

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 14 November 2016

File name

PIL_8463_585.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 November 2016

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

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.

 

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 11 June 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

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 23 December 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • 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

Section 4.2: QRD and editorial updates.

Section 4.3:

‘bleeding’ changed to ‘haemorrhage’

Treatment doses of innohep (175 IU/kg) are contraindicated in patients who receive neuraxial anaesthesia. If treatment doses were administered prior to 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. Patients should be closely monitored for signs and symptoms of neurological injury.

Section 4.4:

Editorial updates throughout.

‘bleeding’ changed to ‘haemorrhage’

Updated information on heparin-induced thrombocytopenia and renal impairment.

Heparin-induced thrombocytopenia

Because of the risk of immune-mediated heparin-induced thrombocytopenia (Type II), platelet count should be measured before the start of treatment and periodically thereafter. innohep must be discontinued in patients who develop immune-mediated heparin-induced thrombocytopenia (type II) (see Ssections 4.3 and 4.8). Platelet counts will usually normalise within 2 to 4 weeks after withdrawal.

Renal Failure:

As tinzaparin sodium is excreted at least partially via the kidney, care should be taken when treating DVT and PE patients with severe renal failure.

Renal Impairment:

All available evidence demonstrates no accumulation in patients with creatinine clearance levels down to 20 ml/minute. Although anti-Xa monitoring is the most appropriate measure of the pharmacodynamic effects of innohep®, it remains a poor predictor of bleeding risk, nonetheless monitoring of anti-factor Xa activity may be considered in patients with severe renal impairment (creatinine clearance < 30 ml/minute). Caution is recommended when treating patients with severe renal impairment (creatinine clearance < 30 ml/minute). There is limited data available in patients with an estimated creatinine clearance level below 20 ml/minute.

 

Renal impairment

Available evidence demonstrates no accumulation in patients with creatinine clearance levels down to 20 ml/minute. Although anti-Xa monitoring is the most appropriate measure of the pharmacodynamic effects of innohep, it remains a poor predictor of haemorrhage risk. Nonetheless, monitoring of anti-factor Xa activity may be considered in patients with severe renal impairment (creatinine clearance <30 ml/minute).

Caution is recommended when treating patients with severe renal impairment (creatinine clearance < 30 ml/minute).

There is limited data available in patients with an estimated creatinine clearance level below 20 ml/minute.


Section 4.8: ‘bleeding’ changed to ‘haemorrhage;Inclusion of national adverse event reporting statement.

Section 4.9: ‘bleeding’ changed to ‘haemorrhage

Section 6.1: Editorial

Section 9: Editorial

Section 10: 28 November 2014

Updated on 11 December 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 09 September 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 08 May 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

SmPC is updated in line with the latest clinical information in CCSI_09.

Updated on 09 February 2012

Reasons for updating

  • Change to name of manufacturer

Updated on 17 November 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 19 May 2011

Reasons for updating

  • Change of contraindications

Updated on 05 May 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.2 Posology and method of administration

The following wording has been added to the section:

Renal Impairment:

If renal impairment is suspected, renal function should be assessed using a formula based on serum creatinine to estimate creatinine clearance level. All available evidence demonstrates no accumulation in patients with creatinine clearance levels down to 20 ml/minute, however, caution is recommended when treating patients with severe renal impairment (creatinine clearance < 30 ml/minute). There is limited data available in patients with an estimated creatinine clearance level below 20 ml/minute. See Section 4.4.

 

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.

 

Section 4.3 Contraindications

The following contraindication has been removed:

'Patients at age 90 years and above with renal insufficiency'

Section 4.4 Special warnings and special precautions for use

The following wording has been added to the section:

 

Renal Impairment:All available evidence demonstrates no accumulation in patients with creatinine clearance levels down to 20 ml/minute. Although anti-Xa monitoring is the most appropriate measure of the pharmacodynamic effects of innohep®,

it remains a poor predictor of bleeding risk, nonetheless monitoring of anti-factor Xa activity may be considered in patients with severe renal impairment (creatinine clearance < 30 ml/minute). Caution is recommended when treating patients with severe renal impairment (creatinine clearance < 30 ml/minute). There is limited data available in patients with an estimated creatinine clearance level below 20 ml/minute.

 

 

Elderly:

Elderly are more likely to have reduced renal function, (see Section 4.4: Renal impairment); therefore caution should be exercised when prescribing innohep® to the elderly.

 

New SmPC revision date: April 2011

April 2011

Updated on 27 April 2010

Reasons for updating

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

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 10 June 2008

Reasons for updating

  • Change of contraindications
  • Change to date of revision

Updated on 08 March 2006

Reasons for updating

  • Change of active ingredient

Updated on 12 November 2004

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 02 September 2004

Reasons for updating

  • New PIL for medicines.ie