Innohep 20,000 IU/ml Solution for Injection (Treatment in VTE)
- Name:
Innohep 20,000 IU/ml Solution for Injection (Treatment in VTE)
- Company:
LEO Pharma
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/01/20

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LEO Pharma

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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 PIL
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 PIL
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 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 14 November 2016 PIL
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 SPC
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 PIL
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 9 June 2015 SPC
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
Updated on 23 December 2014 SPC
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 4.3:
‘bleeding’ changed to ‘haemorrhage’
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;
Section 4.9: ‘bleeding’ changed to ‘haemorrhage
Section 6.1: Editorial
Section 9: Editorial
Section 10: 28 November 2014
Updated on 11 December 2014 PIL
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 9 September 2013 PIL
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 8 May 2013 SPC
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
Updated on 9 February 2012 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 17 November 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 19 May 2011 PIL
Reasons for updating
- Change of contraindications
Updated on 5 May 2011 SPC
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 2011Updated on 27 April 2010 SPC
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
Updated on 10 June 2008 PIL
Reasons for updating
- Change of contraindications
- Change to date of revision
Updated on 8 March 2006 PIL
Reasons for updating
- Change of active ingredient
Updated on 12 November 2004 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 2 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie