HyQvia 100 mg/ml solution for infusion for subcutaneous use

  • Name:

    HyQvia 100 mg/ml solution for infusion for subcutaneous use

  • Company:
    info
  • Active Ingredients:

    Human Normal Immunoglobulin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/09/18

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Summary of Product Characteristics last updated on medicines.ie: 12/9/2018
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Shire Pharmaceuticals Limited

Shire_Logo_Blue_rgb

Address: Shire Pharmaceuticals Ireland Limited, Block 2, Miesian Plaza, 50-58 Baggot St, Dublin 2, Ireland

Medical Information E-mail: medinfoEMEA@shire.com

Customer Care direct line: 01800837470

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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 Cuvitru 200 mg/ml solution for subcutaneous injection Active Ingredients Human Normal Immunoglobulin
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 Flexbumin 200 g/l solution for infusion Active Ingredients Human Albumin
Medicine Name GAMMAGARD S/D Human Normal Immunoglobulin for Intravenous Administration Powder and solvent for solution for infusion Active Ingredients Human Normal Immunoglobulin
Medicine Name Human Albumin Baxalta 50 g/l Solution for Infusion Active Ingredients Human Albumin
Medicine Name HyQvia 100 mg/ml solution for infusion for subcutaneous use Active Ingredients Human Normal Immunoglobulin
Medicine Name KIOVIG 100 mg/ml solution for infusion Active Ingredients Human Normal Immunoglobulin
Medicine Name OBIZUR 500 U powder and solvent for solution for injection Active Ingredients
Medicine Name Prothromplex TOTAL 600 IU powder and solvent for solution for injection Active Ingredients Human Prothrombin Complex
Medicine Name Revestive 1.25 mg powder and solvent for solution for injection Active Ingredients Teduglutide
Medicine Name Revestive 5 mg powder and solvent for solution for injection Active Ingredients Teduglutide
Medicine Name SUBCUVIA 160 g/l Solution for injection Active Ingredients Human Normal Immunoglobulin
Medicine Name VEYVONDI 650 IU and 1300 IU powder and solvent for solution for injection Active Ingredients Vonicog alfa
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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 13 September 2018 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 12 September 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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

In section 4.2 (posology and method of administration), changes have been made in line with CCDS.

In section 4.8 (undesirable effects), a new subheading "Infections and infestations: Meningitis aseptic" has been added to the post table adverse reactions reported from post‑marketing experience.

In section 9 (date of first authorisation/renewal of the authorisation), the date of renewal "8 January 2018" has been added.

In section 10 (date of revision of the text), the new date of revision has been added.

Updated on 16 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 June 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 25 May 2017 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 24 May 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

  • In section 4.2 (posology and method of administration), information about infusion site leakage has been included.
  • In section 4.8 (undesirable effects), information about infusion site leakage has been included.

 

    Updated on 24 May 2017 SmPC

    Reasons for updating

    • New SmPC for new product

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

    Updated on 6 June 2016 PIL

    Reasons for updating

    • Change to, or new use for medicine
    • Change to warnings or special precautions for use
    • Change to side-effects

    Updated on 6 June 2016 SmPC

    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 4.5 - Interaction with other medicinal products and other forms of interaction
    • Change to Section 4.8 – Undesirable effects - how to report a side effect
    • Change to section 5.1 - Pharmacodynamic properties
    • 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 4.1 – Inclusion of children and adolescents (0-18 years) in indications

    Section 4.2 - Inclusion of information on paediatric population

    Section 4.4 - Inclusion of information on paediatric population

    Section 4.5 - Inclusion of information on paediatric population

    Section 4.8 – Update to tabulated list of AEs and inclusion of information on paediatric population

    Section 5.1 – Inclusion of information on extension clinical study and update to information on paediatric population

     

    Updated on 1 April 2016 SmPC

    Reasons for updating

    • Change to section 2 - Qualitative and quantitative composition
    • Change to section 4.1 - Therapeutic indications
    • 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 4.5 - 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 4.9 - Overdose
    • Change to section 5.1 - Pharmacodynamic properties
    • Change to section 5.2 - Pharmacokinetic properties
    • Change to section 5.3 - Preclinical safety data
    • 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

    

    Section 2, Qualitative and quantitative composition:

    Amendment to wording for vial contents to “human normal immunoglobulin” and amendment to quantification of total sodium content.

     

    Section 4.1, Therapeutic indications:

    Rewording of indications in line with EU core SmPC.

     

    Section 4.2, Posology and method of administration:

    Repositioning of tables and text, rewording of text on administration and inclusion of table on infusion rates.

     

    4.3, Contraindications:

    Addition of “must not be given intravenously”.

     

    4.4, Special warnings and precautions for use:

    Prominence given to “If HyQvia is accidentally administered into a blood vessel patients could develop shock.” Repositioning of text on potential complications, addition of sub-section “Immunogenicity of recombinant human hyaluronidase”, rewording of sub-sections

    ·         Hypersensitivity to IG 10%

    ·         Hypersensitivity to recombinant human hyaluronidase

    ·         Thromboembolism

    ·         Haemolytic anaemia

    ·         Acute renal failure

    ·         Aseptic meningitis syndrome

    ·         Interference with serological testing

    ·         Transmissible agents

     

    4.5, Interactions; 4.6, Fertility, pregnancy and lactation:

    Minor change

     

    4.7, Effects on ability to drive and use machines:

    Changes to effects.

     

    4.9, Overdose:

    Removal of text on intravenous use.

     

    5.1, Pharmacodynamic properties:

    Rewording of “Mechanism of action” sub-section.

     

    5.2, Pharmacokinetic properties:

    Minor rewording.

     

    5.3, Preclinical safety data:

    Changes to wording regarding non-clinical studies.

     

    6.6. Special precautions:

    Addition of “Do not use heating devices including microwaves” and rewording on visual inspection.

     

     

     

     

     

     

     

     

    Updated on 1 April 2016 PIL

    Reasons for updating

    • Change to, or new use for medicine
    • Change to date of revision
    • Change to appearance of the medicine
    • Change to dosage and administration

    Updated on 15 February 2016 PIL

    Reasons for updating

    • New PIL for medicines.ie

    Updated on 12 February 2016 SmPC

    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