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: 16/09/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 16/9/2020
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.

Click on this link to Download PDF directly

Shire Pharmaceuticals Limited

Shire_Logo_Blue_rgb

Company Products

Medicine NameActive Ingredients
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 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 Susoctocog alfa
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 VEYVONDI 650 IU and 1300 IU powder and solvent for solution for injection Active Ingredients Vonicog alfa
1 - 0 of 17 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 16 September 2020 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

  • Section 1. What HyQvia is and what it is used for.

Removal and addition of the following text: 

  • patients with a certain kind of blood cancer (chronic lymphocytic leukaemia) which leads to a lack of antibody production and recurrent infections when preventative antibiotics have failed.
  • patients with a specific cancer of the bone marrow (multiple myeloma) and lack of antibody production with recurrent infections who have failed to respond to a vaccine against certain bacteria (pneumococci).
  • patients with low antibody production prior and after transplantation of bone marrow cells from another person.
  • patients who experience severe or recurrent infections due to a weakened immune system resulting from other conditions or treatments
  •  2.           What you need to know before you use HyQvia

    HyQvia contains sodium 

    Addition of the following text:

    This medicine contains 5.0 – 60.5 mg sodium (main component of cooking/table salt) in each recombinant human hyaluronidase vial of HyQvia. This is equivalent to 0.25 – 3% of the recommended maximum daily dietary intake of sodium for an adult. The IG 10% component is essentially sodium-free.

  • 4.       Possible side effects

Removal of the duplicated text:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

  • Revision date: 03 September 2020
  •  

Updated on 16 September 2020

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

  • Minor Administrative Changes to Sections 1, 2, 4.6, 5.1, 5.2, 6.5
  • Section 3 PHARMACEUTICAL FORM: 

    IG 10% is a clear or slightly opalescent and colourless or pale yellow solution. The solution has a of pH 4.6-5.1 and an osmolality of 240 – 300 mOsmol/kg.

    Recombinant human hyaluronidase is a clear, colourless solution. The solution has a pH of 6.5-8.0 and an osmolality of 290 – 350 mOsmol/kg.

  • 4.1 Therapeutic indications. Extension of indication: “Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l. (*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines). Removal of: 

Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra‑indicated.

Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients.

Hypogammaglobulinaemia in patients pre‑ and post‑allogeneic hematopoietic stem cell transplantation (HSCT).

  • 4.2     Posology and method of administration

    In replacement therapy the dose may need to be individualized for each patient dependent on the pharmacokinetic and clinical response. Dose based on bodyweight may require adjustment in underweight or overweight patients.

    The following dosage regimens are given as a guideline:

    Replacement therapy in primary immunodeficiency syndromes (as defined in 4.1)

    Secondary immunodeficiencies (as defined in 4.1.)

    The recommended dose is 0.2-0.4 g/kg every three to four weeks.

    IgG trough levels should be measured and assessed in conjunction with the incidence of infection. Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free.

  • 4.4     Special warnings and precautions for use:

    Removal of: The IG 10% component contains trace amounts of sodium. Recombinant human hyaluronidase contains 4.03 mg sodium per ml, with a maximum daily dose of approximately 120 mg. This should be taken into consideration in patients on a controlled sodium diet.

         Sodium content- updated​​​​​​​

  • 4.7     Effects on ability to drive and use machines:

Hyqvia has no or negligible influence on the ability to drive and use machines, e.g. dizziness (see section 4.8).

Previously: The ability to drive and operate machines may be impaired by some adverse reactions associated with HyQvia. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines

  • 4.8     Undesirable effects- removal of  frequencies from the table.

Updated on 5 May 2020 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 14 January 2020 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer

Updated on 14 January 2020

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

Free text change information supplied by the pharmaceutical company

Section 4.4: The following statement has been removed:  It is strongly recommended that every time that HyQvia is administered to a patient, the name and batch number of the product is recorded in order to maintain a link between the patient and the batch number of the product and has been replaced with In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

​​

Section 4.8: The following information has been added

Ireland:
HPRA Pharmacovigilance
Website: www.hpra.ie
Section 5.1: The following information has been amended to: J06BA01

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

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

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 SPC

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

    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 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 4.5 - 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 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 1 April 2016 SPC

    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 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