innohep 14,000 IU in 0.7 ml syringe (Treatment in VTE)
*Company:
LEO PharmaStatus:
No Recent UpdateLegal 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
Updated on 17 March 2023
File name
ie-spc-innohep-14000-syr-latex-24-Feb-2023-cl.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 January 2023
File name
SPC_Innohep14000_syr_IE_Jan-2020.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 April 2021
File name
069129_5 - 20k-pl-crop.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 03 December 2020
File name
ie-pl-20k_syr-cl.pdf
Reasons for updating
- Change to section 3 - how to take/use
Updated on 24 January 2020
File name
060388-2_20k syr ins.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.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-14000-syr-0090RW-cl.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.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 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
File name
PIL_9323_210.pdf
Reasons for updating
- New PIL for new product
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
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
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 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
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
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 4.3:
‘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.
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.
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 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
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.
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.
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 08 May 2013
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 08 May 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)