OBIZUR 500 U powder and solvent for solution for injection
- Name:
OBIZUR 500 U powder and solvent for solution for injection
- Company:
Shire Pharmaceuticals Limited
- 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: 14/12/20

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Shire Pharmaceuticals Limited

Company Products
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 14 December 2020 PIL
Reasons for updating
- Change to Section 1 - what the product is
- 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 - use in children and adolescents
- Change to section 2 - excipient warnings
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 14 December 2020 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of first authorisation/renewal of the 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
Changes (in red)
2. Qualitative and Quantitative Composition
|
Each powder vial contains nominally 500 OBIZUR contains approximately 500 U/ml of susoctocog alfa after reconstitution. OBIZUR (antihaemophilic It is produced by recombinant DNA Excipient(s) with known effect Each vial contains |
4.2. Posology and method of administration |
Addition of following: Treatment monitoring
During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries. Dose based on bodyweight may require adjustment in underweight or overweight patients. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable. When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients’ blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay. Also there can be significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the chromogenic assay according to Ph. Eur. This is of importance particularly when changing the laboratory and/or reagents used in the assay. Paediatric population The safety and efficacy of OBIZUR |
4.3 Contraindications |
|
4.4 Special warnings and precautions for use |
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Hypersensitivity (…)The medicinal product contains trace amounts of hamster proteins.
Cardiovascular events In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Sodium content OBIZUR contains 4.6 mg sodium in 1 mL of reconstituted solution in each vial, equivalent to 0.23% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Multiple vials must be taken per dose e.g A 70 kg patient using the recommended 200 U/kg dose would require 28 vials which results in a sodium intake of 128.8 mg per treatment. This is equivalent to 6.44% of the WHO recommended maximum daily intake of 2 g of sodium for an adult.
|
4.8 Undesirable effects |
Patients with acquired haemophilia may develop inhibitory antibodies to porcine Tabulated list of adverse reactions: The table presented below is according to the MedDRA system organ classification (SOC and |
5.1 Pharmacodynamic properties |
|
6.1 List of excipients
|
Powder Polysorbate 80 Sodium chloride Calcium chloride dihydrate Sucrose Trometamol hydrochloride
Solvent
|
6.5 Nature and contents of container
|
One pack of OBIZUR contains 1, 5 or 10 each of the following: • powder vials (type I glass) with a stopper (butyl rubber coated with FluroTec®) and a flip off seal; • pre filled (type I glass) syringes with a stopper (bromobutyl rubber coated with FluroTec® foil on the contact side), a bromobutyl rubber tip cap and a Luer |
9. Data of latest renewal 10 Date of revision of the text |
16th November 2020 16th November 2020 |
Updated on 14 December 2020 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of first authorisation/renewal of the 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
Changes (in red)
2. Qualitative and Quantitative Composition
|
Each powder vial contains nominally 500 OBIZUR contains approximately 500 U/ml of susoctocog alfa after reconstitution. OBIZUR (antihaemophilic It is produced by recombinant DNA Excipient(s) with known effect Each vial contains |
4.2. Posology and method of administration |
Addition of following: Treatment monitoring
During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries. Dose based on bodyweight may require adjustment in underweight or overweight patients. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable. When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients’ blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay. Also there can be significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the chromogenic assay according to Ph. Eur. This is of importance particularly when changing the laboratory and/or reagents used in the assay. Paediatric population The safety and efficacy of OBIZUR |
4.3 Contraindications |
|
4.4 Special warnings and precautions for use |
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Hypersensitivity (…)The medicinal product contains trace amounts of hamster proteins.
Cardiovascular events In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Sodium content OBIZUR contains 4.6 mg sodium in 1 mL of reconstituted solution in each vial, equivalent to 0.23% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Multiple vials must be taken per dose e.g A 70 kg patient using the recommended 200 U/kg dose would require 28 vials which results in a sodium intake of 128.8 mg per treatment. This is equivalent to 6.44% of the WHO recommended maximum daily intake of 2 g of sodium for an adult.
|
4.8 Undesirable effects |
Patients with acquired haemophilia may develop inhibitory antibodies to porcine Tabulated list of adverse reactions: The table presented below is according to the MedDRA system organ classification (SOC and |
5.1 Pharmacodynamic properties |
|
6.1 List of excipients
|
Powder Polysorbate 80 Sodium chloride Calcium chloride dihydrate Sucrose Trometamol hydrochloride
Solvent
|
6.5 Nature and contents of container
|
One pack of OBIZUR contains 1, 5 or 10 each of the following: • powder vials (type I glass) with a stopper (butyl rubber coated with FluroTec®) and a flip off seal; • pre filled (type I glass) syringes with a stopper (bromobutyl rubber coated with FluroTec® foil on the contact side), a bromobutyl rubber tip cap and a Luer |
9. Data of latest renewal 10 Date of revision of the text |
16th November 2020 16th November 2020 |
Updated on 14 December 2020 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of first authorisation/renewal of the 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
Changes (in red)
2. Qualitative and Quantitative Composition
|
Each powder vial contains nominally 500 OBIZUR contains approximately 500 U/ml of susoctocog alfa after reconstitution. OBIZUR (antihaemophilic It is produced by recombinant DNA Excipient(s) with known effect Each vial contains |
4.2. Posology and method of administration |
Addition of following: Treatment monitoring
During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries. Dose based on bodyweight may require adjustment in underweight or overweight patients. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable. When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients’ blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay. Also there can be significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the chromogenic assay according to Ph. Eur. This is of importance particularly when changing the laboratory and/or reagents used in the assay. Paediatric population The safety and efficacy of OBIZUR |
4.3 Contraindications |
|
4.4 Special warnings and precautions for use |
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Hypersensitivity (…)The medicinal product contains trace amounts of hamster proteins.
Cardiovascular events In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Sodium content OBIZUR contains 4.6 mg sodium in 1 mL of reconstituted solution in each vial, equivalent to 0.23% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Multiple vials must be taken per dose e.g A 70 kg patient using the recommended 200 U/kg dose would require 28 vials which results in a sodium intake of 128.8 mg per treatment. This is equivalent to 6.44% of the WHO recommended maximum daily intake of 2 g of sodium for an adult.
|
4.8 Undesirable effects |
Patients with acquired haemophilia may develop inhibitory antibodies to porcine Tabulated list of adverse reactions: The table presented below is according to the MedDRA system organ classification (SOC and |
5.1 Pharmacodynamic properties |
|
6.1 List of excipients
|
Powder Polysorbate 80 Sodium chloride Calcium chloride dihydrate Sucrose Trometamol hydrochloride
Solvent
|
6.5 Nature and contents of container
|
One pack of OBIZUR contains 1, 5 or 10 each of the following: • powder vials (type I glass) with a stopper (butyl rubber coated with FluroTec®) and a flip off seal; • pre filled (type I glass) syringes with a stopper (bromobutyl rubber coated with FluroTec® foil on the contact side), a bromobutyl rubber tip cap and a Luer |
9. Data of latest renewal 10 Date of revision of the text |
16th November 2020 16th November 2020 |
Updated on 5 November 2020 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 5 November 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 following changes have been made to the SmPC:
Section |
Changes |
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4.4 Special warnings and precautions for use
|
Addition of the following text: Anamnestic reactions with rise in human factor VIII and/or porcine factor VIII inhibitors have also been reported in patients treated with OBIZUR. These anamnestic rises may result in lack of response to OBIZUR. |
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4.8 Undesirable effects |
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Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Website: www.hpra.ie
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10 Date of revision of the text |
17 September 2020 |
Updated on 8 June 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 8 June 2017 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 18 April 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 18 April 2017 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 9, the date of first authorization has been included.
Updated on 13 June 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 13 June 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)