Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - elaprase

Document Subject

Generated Narrative: MedicinalProductDefinition mp0ed39b02c95e206c8989dd94965d2705

identifier: http://ema.europa.eu/identifier/EU/1/06/365/001-003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Elaprase 2 mg/ml concentrate 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

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-0ed39b02c95e206c8989dd94965d2705

identifier: http://ema.europa.eu/identifier/EU/1/06/365/001-003

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - elaprase

Attesters

What is in this leaflet:

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

Elaprase is used as enzyme replacement therapy to treat children and adults with Hunter syndrome (Mucopolysaccharidosis II) when the level of the enzyme iduronate-2-sulfatase in the body is lower than normal, helping improve the symptoms of the disease. If you suffer from Hunter syndrome, a carbohydrate called glycosaminoglycan which is normally broken down by your body, is not broken down and slowly accumulates in various organs in your body. This causes cells to function abnormally, thereby causing problems for various organs in your body which can lead to tissue destruction and organ malfunction and failure. Typical organs where glycosaminoglycan accumulates are spleen, liver, lungs, heart, and connective tissue. In some patients glycosaminoglycan accumulates also in the brain. Elaprase contains an active substance called idursulfase which works by acting as a replacement for the enzyme that is at a low level, thereby breaking down this carbohydrate in affected cells. Enzyme replacement therapy is usually administered as a long-term treatment.

Do not use Elaprase If you have experienced severe or potentially life-threatening allergic-type reactions to idursulfase or any of the other ingredients of this medicine (listed in section 6) and these cannot be controlled with appropriate medical treatment. Warnings and precautions Talk to your doctor or nurse before using this medicine. If you are treated with Elaprase you may experience side effects during or following an infusion (see section 4 Possible side effects). The most common symptoms are itching, rash, hives, fever, headache, increased blood pressure, and flushing (redness). Most of the time you can still be given this medicine even if these symptoms occur. If you experience an allergic side effect following administration of this medicine, you should contact your doctor immediately. You may be given additional medicines such as antihistamines and corticosteroids to treat or help prevent allergic-type reactions. If severe allergic reactions occur, your doctor will stop the infusion immediately, and start giving you suitable treatment. You may need to stay in hospital. The nature of your genotype (a genetic make up of all active genes in human cells, which determines one s specific, individual characteristics) may influence your therapeutic response to this medicine, as well as your risk of developing antibodies and infusion-related side effects. In individual cases, so- called neutralising antibodies may develop, which may diminish activity of Elaprase and your response to treatment. The longer term effects of antibody development on response to treatment have not been established. Please consult your doctor for additional information. Keeping a record In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded by your healthcare professional. Speak with your healthcare professional if you are not sure. Other medicines and Elaprase There is no known interaction of this medicine with other medicines. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines This medicine has no or negligible influence on the ability to drive and use machines. Elaprase contains sodium This medicine contains 11.1 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.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. This medicine will be given to you under the supervision of a doctor or nurse who is knowledgeable in the treatment of Hunter syndrome or other inherited metabolic disorders. The recommended dose is an infusion of 0.5 mg (half a milligram) for every kg you weigh Elaprase has to be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion before use. After dilution this medicine is given through a vein (drip feed). The infusion will normally last for 1 to 3 hours and will be given every week. Use in children and adolescents The recommended dosage in children and adolescents is the same as in adults. If you use more Elaprase than you should Consult your doctor if you have an overdose of this medication. If you forget to use Elaprase If you have missed an Elaprase infusion, please contact your doctor. If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate and associated with the infusion, however some side effects may be serious. Over time the number of these infusion-associated reactions decreases. If you have problems breathing, with or without bluish skin, tell your doctor straight away and seek immediate medical assistance. Very common side effects (may affect more than 1 in 10 people) are:

Headache

Flushing (redness)

Shortness of breath, wheezing

Abdominal pain, nausea, vomiting, frequent and/or loose stools

Chest pain

Hives, rash, itching, redness of the skin

Fever

Infusion-related reaction (see section entitled Warnings and precautions ) Common side effects (may affect up to 1 in 10 people) are:

Dizziness, tremor

Rapid heartbeat, irregular heartbeat, bluish skin

Increased blood pressure, decreased blood pressure

Difficulty breathing, cough, low oxygen levels in your blood

Swollen tongue, indigestion

Pain in the joints

Infusion-site swelling, swelling of the extremities, facial swelling Uncommon side effects (may affect up to 1 in 100 people) are:

Quickened breathing Side effects for which frequency is not known (cannot be estimated from available data) are:

Serious allergic reactions Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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 label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C 8 C) Do not freeze Do not use this medicine if you notice that there is discolouration or presence of foreign particles. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Elaprase contains The active substance is idursulfase, which is a form of the human enzyme iduronate-2-sulfatase. Idursulfase is produced in a human cell line by genetic engineering technology (it involves the introduction of genetic information into human cells in the lab, which will then produce the desired product). Each vial of Elaprase contains 6 mg of idursulfase. Each ml contains 2 mg of idursulfase. The other ingredients are Polysorbate 20, sodium chloride, dibasic sodium phosphate, heptahydrate, monobasic sodium phosphate, monohydrate and water for injections. What Elaprase looks like and contents of the pack This medicine is a concentrate for solution for infusion. It is supplied in a glass vial as a clear to slightly opalescent, colourless solution. Each vial contains 3 ml of concentrate for solution for infusion. Elaprase is supplied in pack sizes of 1, 4 and 10 vials per carton. 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

akeda . . : +30 210 6387medinfoEMEA@takeda.com 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 . This medicine has been authorised under exceptional circumstances . This means that because of the rarity of this disease it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary. Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: