HyQvia 100 mg/ml solution for infusion for subcutaneous use
*Company:
Takeda Products Ireland LtdStatus:
UpdatedLegal 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
File name
Ireland SD - HCP (P).pdf
Reasons for updating
- Replace File
File name
Ireland PP - HCP (P).pdf
Reasons for updating
- Replace File
File name
Ireland - English - Infusion Tracker - Logbook - patients (P).pdf
Reasons for updating
- Replace File
File name
Ireland SD - Patient (P).pdf
Reasons for updating
- Replace File
File name
Ireland PP - Patient (P).pdf
Reasons for updating
- Replace File
Updated on 29 May 2024
File name
ie-hyqvia-May2024-smpc-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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)
Free text change information supplied by the pharmaceutical company
SmPC update resulting from study 161406, as well as minor updates.
Updated on 29 May 2024
File name
ie-hyqvia-May2024-pil-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Minor editorial updates to sections 1, 2, 3, 5 & 6.
Updated on 06 February 2024
File name
ie-hyqvia-jan2024-pil-clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- 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 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- 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 - date of revision
Free text change information supplied by the pharmaceutical company
Amendment to Section 1, 2, 3, 4, 5, 6
Updated on 06 February 2024
File name
ie-hyqvia-jan2024-smpc-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.3 - 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 4.8 - Undesirable effects
- 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 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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
Amendment to the following sections:
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
10. DATE OF REVISION OF THE TEXT
File name
Ireland SD - HCP (P).pdf
Reasons for updating
- Add New Doc
File name
Ireland PP - HCP (P).pdf
Reasons for updating
- Add New Doc
File name
Ireland_Patient Diary.pdf
Reasons for updating
- Add New Doc
File name
Ireland SD - Patient (P).pdf
Reasons for updating
- Add New Doc
File name
Ireland PP - Patient (P).pdf
Reasons for updating
- Add New Doc
Updated on 01 November 2022
File name
ie-spc-hyqvia-pass+ccds-clean-approved27oct22.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 November 2022
File name
ie-pl-hyqvia-pass+ccds-clean-approved27oct22.pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 13 July 2022
File name
m1-3-1-Leaflet-Ireland-Art61-3_24 June2022-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 06 October 2021
File name
m1-3-1-Leaflet-Ireland-02.09.2021.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 06 October 2021
File name
m1-3-1-SmPC-Ireland-02.09.2021.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to section 4.6 of the SmPC to update the safety information concerning fertility, pregnancy and lactation
Updated on 09 September 2021
File name
ie-pl-hyqvia-art 61-3-27.08.2021.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The updates are to the administration instructions in the Patient Leaflet:
Step 3
Cap: Purple protective Protective
Step 5
Remove purple protective cap(s) and make sure the blue vial caps are removed. If not, manually remove the blue caps to expose the vial stoppers.
Updated on 04 January 2021
File name
IE HyQvia SmPC TII-56-Sept2020 update - clean.pdf
Reasons for updating
- Change from joint to individual SPCs
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 December 2020
File name
ie-pl-HyQvia-amend-Sep-2020-clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Joint PIL superseded by individual PILs
Free text change information supplied by the pharmaceutical company
|
Section |
Changes (in red) |
|
3. How to use HyQvia |
5. Open HyQvia dual vial unit(s): • Remove 6. Prepare recombinant human hyaluronidase vial (HY): - Image replacement (blue caps) 8. Prepare human normal immunoglobulin 10% vial: Image replacement (c ) |
|
4.8 Reporting of side effects |
Updated (join PIL superseded by individual PILs) |
|
10 Date of revision of the text |
September 2020 |
Updated on 16 September 2020
File name
HyQvia-PIL-UK-IE-TII-56-Sept2020.pdf
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
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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.
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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
File name
HyQvia SmPC UK-IE-TII-56-Sept2020-Clean.pdf
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
Legal category:Product subject to medical prescription which may not be renewed (A)
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).
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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.
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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 05 May 2020
File name
HyQvia-PIL-UK-IE-Art.61-3-0057-April2020-Clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 14 January 2020
File name
HyQvia leaflet UK-IE TIA-052G Dec-2019-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
Updated on 14 January 2020
File name
HyQvia SmPC UK-IE TIA-052G Jan-2020-clean.pdf
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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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
File name
HyQvia UK-IE leaflet August 2018.pdf
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
File name
HyQvia SmPC IE August 2018.pdf
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
File name
PIL_16639_660.pdf
Reasons for updating
- New PIL for new product
Updated on 16 June 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 25 May 2017
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 24 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 May 2017
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 06 June 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 4.5 - 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 06 June 2016
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 01 April 2016
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 01 April 2016
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
Reasons for updating
- New PIL for medicines.ie
Updated on 12 February 2016
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)