Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vpriv

Document Subject

Generated Narrative: MedicinalProductDefinition mpc8101444f2f0d633367049eeed05567a

identifier: http://ema.europa.eu/identifier/EU/1/10/646/002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: VPRIV 400 Units powder for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-c8101444f2f0d633367049eeed05567a

identifier: http://ema.europa.eu/identifier/EU/1/10/646/002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - vpriv

Attesters

What is in this leaflet

1. What VPRIV is and what it is used for
2. What you need to know before VPRIV is used
3. How VPRIV is used
4. Possible side effects
5. How to store VPRIV
6. Contents of the pack and other information

VPRIV is a long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.

Gaucher disease is a genetic disorder caused by a missing or defective enzyme named glucocerebrosidase. When this enzyme is missing or does not work properly, a substance called glucocerebroside builds up inside cells in the body. The build-up of this material causes the signs and symptoms found in Gaucher disease.

VPRIV contains a substance called velaglucerase alfa which is designed to replace the missing or defective enzyme, glucocerebrosidase, in patients with Gaucher disease.

Do not use VPRIV

• if you are severely allergic to velaglucerase alfa or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor before VPRIV is used

• If you are treated with VPRIV, you may experience side effects during or following the infusion (see section 4, possible side effects). These are called infusion related reactions and might appear as a hypersensitivity reaction with symptoms like nausea, rash, difficulty in breathing, back pain, chest discomfort (chest tightness), hives, joint pain or headache.
• Apart from symptoms of hypersensitivity reactions infusion-related reactions might show as dizziness, high blood pressure, tiredness, fever, itching, blurry vision, or vomiting. If you experience any of the symptoms, you must tell your doctor immediately.
• You may be given additional medicines to treat or help prevent future reactions. These medicines may include antihistamines, antipyretics, and corticosteroids.
• If the reaction is severe, your doctor will stop the intravenous infusion immediately and start giving you appropriate medical treatment.
• If the reactions are severe and/or there is a loss of effect from this medicine, your doctor will perform a blood test to check for antibodies which may affect the outcome of your treatment
• Your doctor or nurse may decide to continue to administer VPRIV even if you experience any infusion related-reaction. Your condition will be closely monitored.

Tell your doctor if you have previously experienced an infusion-related reaction with other ERT for Gaucher disease.

Children Do not use in children under the age of 4 years because there is no experience of using the medicine in this age group.

Other medicines and VPRIV Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy
Gaucher disease may become more active in a woman during pregnancy and for a few weeks after birth. Women with Gaucher disease who are pregnant or considering pregnancy should talk with their doctor before this medicine is used.

Breast-feeding It is not known whether VPRIV can pass into breast milk. If you are breast-feeding or considering breast-feeding, you should talk to your doctor before this medicine is used. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop using VPRIV, considering the benefit of breast-feeding to the baby and the benefit of VPRIV to the mother.

Driving and using machines VPRIV has no or negligible influence on your ability to drive or use machines.

VPRIV contains sodium This medicine contains 12.15 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.6% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine is only to be used under appropriate medical supervision of a doctor who is knowledgeable in the treatment of Gaucher disease. It is given by a doctor or nurse by intravenous infusion.

Dose The recommended dose is 60 Units/kg given every other week.

If you are currently being treated for Gaucher disease with another ERT and your doctor wants to change you to VPRIV, you can initially receive VPRIV at the same dose and frequency you had been receiving the other ERT.

Use in children and adolescents VPRIV may be given to children and adolescents (4 to 17 years of age) at the same dose and frequency as in adults.

Use in elderly VPRIV may be given to the elderly (aged over 65 years) at the same dose and frequency as in adults.

Response to treatment Your doctor will monitor your response to treatment and may change your dose (up or down) over time.

If you are tolerating your infusions well in the clinic, your doctor or nurse may administer your infusions at home.

Administration VPRIV is supplied in a vial as a packed powder which is mixed with sterile water and further diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion prior to intravenous infusion.

After preparation, your doctor or nurse will give the medicine to you through a drip into a vein (by intravenous infusion) over a period of 60 minutes.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Commonly (may affect up to 1 in 10 people), patients experienced a severe allergic reaction, with difficulty breathing, chest discomfort (chest tightness), feeling sick (nausea), swelling of the face, lips, tongue or throat (anaphylactic/anaphylactoid reactions), common is also an allergic skin reaction such as hives, severe rash or itching. If any of these happen tell your doctor immediately.

Most side effects, including the allergic reactions, occurred during the infusion or shortly after. These are called infusion related reactions. Other infusion related reactions that occurred very commonly (may affect more than 1 in 10 people) include headache, dizziness, fever/body temperature increased, back pain, joint pain and tiredness, as well as high blood pressure (commonly reported), blurry vision, and vomiting (uncommonly reported). If any of these happen tell your doctor immediately.

Other side effects include:

Very common side effects (may affect more than 1 in 10 people) are:

• bone pain
• weakness/loss of strength
• stomach ache

Common side effects (may affect up to 1 in 10 people) are:

• lengthening of the time it takes for a cut to stop bleeding may lead to easy/spontaneous bleeding/easy bruising
• skin flushing
• rapid heart beat
• developing antibodies to VPRIV (see section 2)
• decreased blood pressure

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP . The expiry date refers to the last day of that month.

Store in the refrigerator (2 C 8 C). Do not freeze. Keep the vial in the outer carton in order to protect from light.

Reconstituted and diluted solution for infusion: Use immediately. Do not exceed 24 hours at 2 C to 8 C.

Do not use if the solution is discoloured or if foreign particles are present.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throwaway medicines you no longer use. These measures will help to protect the environment.

What VPRIV contains

• The active substance is velaglucerase alfa.

Each vial contains 400 Units of velaglucerase alfa.

After reconstitution, one ml of solution contains 100 Units of velaglucerase alfa

• The other ingredients are sucrose, sodium citrate dihydrate, citric acid monohydrate and polysorbate 20 (see section 2 VPRIV contains sodium ).

What VPRIV looks like and contents of the pack 20 ml glass vial containing a white to off-white powder for solution for infusion.

Packs of 1, 5 or 25 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HWIreland

Manufacturer Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HWIreland

Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 58 Baggot Street Lower Dublin 2 Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com

Lietuva Takeda, UAB Tel: +370 521 09 medinfoEMEA@takeda.com

.: +359 2 958 27 medinfoEMEA@takeda.com

Luxembourg/Luxemburg Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com

esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 medinfoEMEA@takeda.com

Magyarorsz g Takeda Pharma Kft. Tel.: +36 1 270 7medinfoEMEA@takeda.com

Danmark Takeda Pharma A/S Tlf: +45 46 77 10 medinfoEMEA@takeda.com

Malta akeda HELLAS S.A. Tel: +30 210 6387medinfoEMEA@takeda.com

Deutschland Takeda GmbH Tel: +49 (0)800 825 3medinfoEMEA@takeda.com

Nederland Takeda Nederland B.V. Tel: +31 20 203 5medinfoEMEA@takeda.com

Eesti Takeda Pharma AS Tel: +372 6177 medinfoEMEA@takeda.com

Norge Takeda AS Tlf: +47 800 800 medinfoEMEA@takeda.com

akeda . . T : +30 210 6387medinfoEMEA@takeda.com

sterreich Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800-20 80 medinfoEMEA@takeda.com

Espa a Takeda Farmac utica Espa a S.A Tel: +34 917 90 42 medinfoEMEA@takeda.com

Polska Takeda Pharma Sp. z o.o. Tel.: +48223062medinfoEMEA@takeda.com

France Takeda France SAS T l: + 33 1 40 67 33 medinfoEMEA@takeda.com

Portugal Takeda Farmac uticos Portugal, Lda. Tel: + 351 21 120 1medinfoEMEA@takeda.com

Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 medinfoEMEA@takeda.com

Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 medinfoEMEA@takeda.com

Ireland Takeda Products Ireland Ltd Tel: 1800 937 medinfoEMEA@takeda.com Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o. Tel: + 386 (0) 59 082 medinfoEMEA@takeda.com sland Vistor hf. S mi: +354 535 7medinfoEMEA@takeda.com

Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 medinfoEMEA@takeda.com

Italia Takeda Italia S.p.A. Tel: +39 06 502medinfoEMEA@takeda.com

Suomi/Finland Takeda Oy Puh/Tel: 0800 774 medinfoEMEA@takeda.com

A.POTAMITIS MEDICARE LTD : +357 22583a.potamitismedicare@cytanet.com.cy

Sverige Takeda Pharma AB Tel: 020 795 medinfoEMEA@takeda.com

Latvija Takeda Latvia SIA Tel: +371 67840medinfoEMEA@takeda.com

United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 medinfoEMEA@takeda.com

This leaflet was last revised in .

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: