ADVATE 2000 IU and 3000 IU powder and solvent for solution for injection 5 ml water - Baxject III

  • Name:

    ADVATE 2000 IU and 3000 IU powder and solvent for solution for injection 5 ml water - Baxject III

  • Company:
    info
  • Active Ingredients:

    Octocog Alfa

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/04/21

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Summary of Product Characteristics last updated on medicines.ie: 11/4/2021

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Actos tablets Active Ingredients pioglitazone hydrochloride
Medicine Name Adcetris 50 mg powder for concentrate for solution for infusion Active Ingredients Brentuximab vedotin
Medicine Name ADVATE 2000 IU and 3000 IU powder and solvent for solution for injection 5 ml water - Baxject III Active Ingredients Octocog Alfa
Medicine Name ADVATE 250 IU, 500 IU, 1000 IU and 1500 IU powder and solvent for solution for injection 2 ml solvent - Baxject III Active Ingredients Octocog Alfa
Medicine Name Alofisel 5 million cells/mL suspension for injection Active Ingredients Human Allogeneic Mesenchymal Adult Stem Cells
Medicine Name Alunbrig Active Ingredients Brigatinib
Medicine Name Blopress Plus Tablets Active Ingredients Candesartan Cilexetil, Hydrochlorothiazide
Medicine Name Blopress tablets Active Ingredients Candesartan Cilexetil
Medicine Name Calcichew 500mg Chewable Tablets Active Ingredients Calcium Carbonate
Medicine Name Calcichew-D3 Forte Chewable Tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Calcichew-D3 Forte Double Strength 1000 mg/800 IU chewable tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name CEPROTIN 1000 IU powder and solvent for solution for injection Active Ingredients Protein C
Medicine Name CEPROTIN 500 IU powder and solvent for solution for injection Active Ingredients Protein C
Medicine Name Cinryze 500 IU powder and solvent for solution for injection Active Ingredients C1 inhibitor (human)
Medicine Name Competact 15 mg/850 mg film-coated Tablets Active Ingredients Metformin Hydrochloride, pioglitazone hydrochloride
Medicine Name Condyline Cutaneous Solution 5 mg/ml Active Ingredients Podophyllotoxin
Medicine Name Cuvitru 200 mg/ml solution for subcutaneous injection Active Ingredients Human Normal Immunoglobulin
Medicine Name Edarbi Tablets Active Ingredients Azilsartan medoxomil potassium
Medicine Name Elaprase 2mg/ml concentrate for solution for infusion Active Ingredients Idursulfase
Medicine Name Entyvio 108 mg solution for injection in pre-filled syringe/pre-filled pen Active Ingredients Vedolizumab
Medicine Name Entyvio 300 mg powder for concentrate for solution for infusion Active Ingredients Vedolizumab
Medicine Name Equasym XL 10, 20 & 30mg Modified Release Capsules Active Ingredients Methylphenidate Hydrochloride
Medicine Name FEIBA 25 U/ml powder and solvent for solution for infusion Active Ingredients Factor VIII Inhibitor Bypassing Fraction
Medicine Name FEIBA 50 U/ml powder and solvent for solution for infusion Active Ingredients Factor VIII Inhibitor Bypassing Fraction
Medicine Name Firazyr 30 mg solution for injection in pre-filled syringe Active Ingredients Icatibant Acetate
1 - 0 of 62 items.Total: Infinity pages

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 11 April 2021 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 11 April 2021 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 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 main changes to the SmPC:

Section 2:

Excipients with known effect:

This medicinal product contains 0.45 mmol sodium (10 mg) per vial.

Section 4.4.

Excipient related considerations

Sodium

After reconstitution this medicinal product contains 0.45 mmol sodium (10 mg) per vial. To be taken into consideration by patients on a controlled sodium diet. This medicinal product contains 10 mg sodium per vial, equivalent to 0.5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Section 10 date of revision: 24 February 2021

Updated on 15 April 2020 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 15 April 2020 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder
  • 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 15 April 2020 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 15 April 2020 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder

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

Updated on 4 March 2020 SPC

Reasons for updating

  • 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)

Updated on 4 March 2020 SPC

Reasons for updating

  • 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)

Updated on 2 March 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 2 March 2020 SPC

Reasons for updating

  • 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)

Updated on 17 September 2018 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Section 5.1 (Pharmacodynamic properties), updated with the rewording of information regarding Immune Tolerance Induction (ITI)

Updated on 15 August 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 14 August 2018 PIL

Reasons for updating

  • Change to date of revision

Updated on 14 August 2018 SPC

Reasons for updating

  • 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 10 (date of revision of thew text), updated. Change to the joint SPC with UK - ADR statement for UK was updated accoriding to QRD template.

Updated on 14 August 2018 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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), deletion of specific information that the use of 2 ml presentations has not been documented for paediatric subjects below 2 years of age.

Updated on 19 December 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 19 December 2017 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 5.1 - Pharmacodynamic properties
  • 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 4.4 (Special warnings and precautions for use), updated with scientific information on inhibitors.
  • In section 4.8 (undesirable effects), updated with scientific information on inhibitors.
  • In section 5.1 (Pharmacodynamic properties), removed scientific information on inhibitor development.
  • In section 9 (DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION), updated with the latest renewal date.

Updated on 14 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 December 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 6 July 2017 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 February 2016 SPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided