Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cerezyme

Document Subject

Generated Narrative: MedicinalProductDefinition mp40a0f9a5b184c9ac5cd6a0a61a321212

identifier: http://ema.europa.eu/identifier/EU/1/97/053/003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Cerezyme 400 Units Powder for 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

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-40a0f9a5b184c9ac5cd6a0a61a321212

identifier: http://ema.europa.eu/identifier/EU/1/97/053/003

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - cerezyme

Attesters

What is in this leaflet

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

Cerezyme contains the active substance imiglucerase and is used to treat patients who have a confirmed diagnosis of Type I or Type 3 Gaucher disease, who show signs of the disease such as: anaemia (low number of red blood cells), a tendency to bleed easily (due to low numbers of platelets
a type of blood cell), spleen or liver enlargement or bone disease.

People with Gaucher disease have low levels of an enzyme called acid -glucosidase. This enzyme helps the body control levels of glucosylceramide. Glucosylceramide is a natural substance in the body, made of sugar and fat. In Gaucher disease glucosylceramide levels can get too high.

Cerezyme is an artificial enzyme called imiglucerase - this can replace the natural enzyme acid -glucosidase which is lacking or not active enough in patients with Gaucher disease.

The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.

Do not use Cerezyme

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

Warnings and precautions
Talk to your doctor or pharmacist before using Cerezyme:

• if you are treated with Cerezyme, you may experience an allergic reaction while you are being given the medicine or shortly after. If you experience a reaction like this, you should tell your doctor immediately. Your doctor may test if you have an allergic reaction to imiglucerase.
• some patients with Gaucher disease have high blood pressure in the lungs (pulmonary hypertension). The cause can be unknown, or it can be due to heart, lung or liver problems. It can occur whether the patient is treated with Cerezyme or not. But, if you suffer with any shortness of breath you should tell your doctor.

Other medicines and Cerezyme Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Cerezyme should not be given as a mixture with other medicinal products in the same infusion (drip).

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. Cautious use of Cerezyme during pregnancy and breastfeeding is recommended.

Cerezyme contains sodium
This medicine contains 41 mg sodium (main component of cooking/table salt) per vial. This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult. It is administered in 0.9% sodium chloride intravenous solution. This should be taken into consideration by patients on a controlled sodium diet.

Instructions for proper use Cerezyme is given through a drip into a vein (by intravenous infusion).

It is supplied as a powder which will be mixed with sterile water before it is given.

Cerezyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Gaucher disease. Your doctor may advise that you can be treated at home provided you meet certain criteria. Please contact your doctor if you would like to be treated at home.

Your dose will be specific to you. Your doctor will work out your dose based on how severe your symptoms are, and other factors. The recommended dose is 60 units/kg body weight given once every 2 weeks.

Your doctor will keep a close check on your response to your treatment, and may change your dose (up or down) until he/she finds the best dose to control your symptoms.

Once this dose is found your doctor will still keep a check on your responses to make sure you are using the right dose. This might be every 6 to 12 months.

There is no information on the effect of Cerezyme on brain-based symptoms of patients with chronic neuronopathic Gaucher disease. Therefore no special dosage regimen can be recommended.

The ICGG Gaucher Registry You can ask your doctor to register your patient information into the ICGG Gaucher Registry . The aims of this Registry are to increase the understanding of Gaucher disease and to check how well enzyme replacement therapy, like Cerezyme, works. This should lead to improvement in the safe and effective use of Cerezyme. Your patient data will be registered anonymously nobody will know it is information about you.

If you use more Cerezyme than you should There are no cases of overdose of Cerezyme reported.

If you forget to use Cerezyme If you have missed an infusion, please contact your doctor.

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

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

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

• breathlessness
• coughing
• hives/ localised swelling of the skin or lining of the mouth or throat
• itching
• rash

Uncommon (may affect up to 1 in 100 people):

• dizziness
• headache
• a sensation of tingling, pricking, burning or numbness of the skin
• increased heart rate
• bluish skin
• flushing
• fall in blood pressure
• vomiting
• nausea
• abdominal cramping
• diarrhoea
• pain in the joints
• infusion site discomfort
• infusion site burning
• infusion site swelling
• injection site sterile abscess
• chest discomfort
• fever
• rigors
• fatigue
• backache

Rare (may affect up to 1 in 1,000 people):

• anaphylactoid reactions

Some side effects were seen primarily while patients were being given the medicine or shortly after. These have included itching, flushing, hives/localised swelling of the skin or lining of the mouth or throat, chest discomfort, increased heart rate, bluish skin, breathlessness, a sensation of tingling, pricking, burning or numbness of the skin, fall in blood pressure and backache. If you experience any of these symptoms, please tell your doctor immediately. You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids).

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 printed on the labelling after the letters EXP . The expiry date refers to the last day of that month.

Unopened vials: Store in a refrigerator (2 C 8 C)

Diluted solution: It is recommended that Cerezyme is used immediately after it has been mixed with sterile water. The mixed solution in the vial cannot be stored and should be promptly diluted in an infusion bag; only the diluted solution can be held for up to 24 hours if it is kept cool (2 C 8 C) and in the dark.

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 Cerezyme contains

• The active substance is imiglucerase. Imiglucerase is a modified form of the human enzyme acid -glucosidase produced by recombinant DNA technology. One vial contains 400 units of imiglucerase. After reconstitution, the solution contains 40 units of imiglucerase per ml.
• The other ingredients are: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80. What Cerezyme looks like and contents of the pack Cerezyme, 400 Units, is presented as a powder for concentrate for solution for infusion (in a vial, pack size of 1, 5 or 25). Not all pack sizes may be marketed.

Cerezyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless liquid, free from foreign matter. The reconstituted solution must be further diluted.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Sanofi B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, the Netherlands

Manufacturer Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland

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

Belgi /Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium T l/Tel: + 32 2 710 54 Magyarorsz g SANOFI-AVENTIS Zrt. Tel: +36 1 505 0
Swixx Biopharma EOOD .: +359 (0)2 4942 Malta Sanofi S.r.l. +39 02 39394 esk republika sanofi-aventis, s.r.o. Tel: +420 233 086 Nederland Sanofi B.V. Tel: +31 20 245 4Danmark Sanofi A/S
Tlf: +45 45 16 70 Norge sanofi-aventis Norge AS Tlf: + 47 67 10 71 Deutschland Sanofi-Aventis Deutschland GmbH Tel: 0800 04 36 Tel. aus dem Ausland: +49 69 305 70 sterreich sanofi-aventis GmbH Tel: + 43 1 80 185 - 0 Eesti Swixx Biopharma O
Tel: +372 640 10 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00
Sanofi-Aventis AEBE
: +30 210 900 1Portugal Sanofi Produtos Farmac uticos, Lda. Tel: +351 21 35 89 Espa a sanofi-aventis, S.A. Tel: +34 93 485 94 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 France Sanofi Winthrop Industrie T l: 0 800 222 Appel depuis l tranger : +33 1 57 63 23 Slovenija Swixx Biopharma d.o.o.
Tel: +386 1 235 51 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 sland Vistor hf. S mi: +354 535 7Suomi/Finland Sanofi Oy Puh/Tel: + 358 201 200 Italia Sanofi S.r.l. Tel: 800 536 Sverige Sanofi AB Tel: +46 (0)8 634 50
C.A. Papaellinas Ltd. : +357 22 741United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2Latvija Swixx Biopharma SIA
Tel: +371 6 616 47 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 This leaflet was last revised in:

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