Label:Information for the User

Cerezyme 400Units Powder for Concentrate for Infusion Solution

Imiglucerase

Read this label carefully before starting to use the medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this label. See section 4.

6. Contents of the pack and additional information

Cerezyme contains the active ingredient imiglucerase and is used to treat patients with a confirmed diagnosis of type I or III Gaucher's disease who exhibit symptoms of the disease such as:anemia (low red blood cell count), a tendency to bleed easily (due to a low platelet count, a type of blood cell), hepatosplenomegaly (enlargement of the liver or spleen) or osteopathy (bone disease).

People suffering from Gaucher's disease have a low concentration of an enzyme known as?-acid glucosidase.This enzyme helps the body control glucoseceramide concentrations.Glucoseceramide is a natural substance in the body formed by sugar and fat.When suffering from Gaucher's disease, glucoseceramide concentrations can be too high.

Cerezyme is composed of an artificial enzyme called imiglucerase that can replace the deficient or insufficiently active natural?-acid glucosidase enzyme in patients suffering from Gaucher's disease.

The information in this prospectus is applicable to all patient groups, including children, adolescents, adults, and the elderly.

You should not use Cerezyme

• if you are allergictoimiglucerase or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cerezyme:

-if you are being treatedwith Cerezyme, you may experience an allergic reaction while the medication is being administered or shortly after. If you experience this type of reaction, you mustimmediately inform your doctor. Your doctor will be able to check if you have an allergic reaction to imiglucerase.

• Some patients with Gaucher's disease may experience pulmonary hypertension (high blood pressure in the lungs).The cause may be unknown or due to heart, lung, or liver problems.This can occur regardless of whether the patient is being treated with Cerezyme.However, if you experiencedifficulty breathing, you should inform your doctor.

Other medications and Cerezyme

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Cerezyme should not be administered mixed with other medications in the same infusion (IV).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Cerezyme should be used with caution during pregnancy and breastfeeding.

Cerezyme contains sodium

This medication contains 41 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 2% of the maximum daily sodium intake recommended for an adult.It is administered through a 0.9% sodium chloride solution.This should be taken into accountin patients with low-sodium diets.

Instructions for Proper Use

Cerezyme is administered through a catheter connected to a vein (intravenous infusion).

It is supplied as a powder to be mixed with sterile water before administration.

Cerezyme can only be administered under the supervision of a doctor who is familiar with the treatment of Gaucher's disease. Your doctor may recommend that you follow the treatment at home if you meet certain criteria. Contact your doctor if you wish to receive treatment at home.

The dose you receive will be specific to you. Your doctor will adjust the dose based on the severity of your symptoms, among other factors. The recommended dose is 60 units/kg of body weight administered once every two weeks.

Your doctor will closely monitor your response to treatment and may change your dose (increase or decrease) to find the best dose to control your symptoms.

Once this dose is determined, your doctor will check your response to ensure you are using the correct dose, probably every 6-12 months.

No information is available on the effect of Cerezyme on the neurological symptoms of patients with chronic neuropathic Gaucher's disease.Therefore, no special dosing regimen can be recommended.

ICGG Gaucher Registry

You may ask your doctor to register your patient data in the "ICGG Gaucher Registry" (ICGG: International Collaborative Gaucher Group). The purpose of this registry is to expand knowledge about Gaucher's disease and to verify the functioning of enzyme replacement therapy, such as Cerezyme. This should lead to an improvement in the safety and efficacy of Cerezyme use. Your patient data will be registered anonymously: no one will know that it is your data.

If you use more Cerezyme than you should

No cases of Cerezyme overdose have been reported.

If you forget to use Cerezyme

If you miss a treatment appointment for any reason, contact your doctor.

If you have any other questions about the use of this product, consult your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

-shortness of breath

-coughing

-localized skin or mucous membrane swelling of the mouth or throat

-pruritus (itching)

-skin rash

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

-dizziness

-headache

-sensation of tingling, itching, stinging, or numbness of the skin

-increased heart rate

-cutaneous cyanosis (blue discoloration)

-rubefaction

-decreased blood pressure

-vomiting

-nausea

-abdominal colic pain

-diarrhea

-arthralgia (joint pain)

-discomfort at the infusion site

-stinging at the infusion site

-swelling at the infusion site

-sterile abscess at the injection site

-chest discomfort

-fever

-chills

-fatigue

-back pain

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

• anaphylactoid reactions

Some side effects have been observed mainly while patients were receiving the medication or immediately after receiving it. These include pruritus, rubefaction, localized skin or mucous membrane swelling of the mouth or throat, chest discomfort, increased heart rate, cutaneous cyanosis, shortness of breath, sensation of tingling, itching, stinging, or numbness of the skin, decreased blood pressure, and back pain. If you experience any of these symptoms,inform your doctor immediately. You may need other medications to prevent an allergic reaction (e.g., antihistamines and/or corticosteroids).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated..

Unopened vials:
Store in the refrigerator (between 2°C and 8°C).

Diluted solution:

It is recommended to use Cerezyme immediately after mixing it with sterile water.The mixed solution in the vial cannot be stored and must be diluted immediately in a perfusion bag; the diluted solution can be stored for a maximum of 24 hours if kept fresh (2-8°C) and protected from light.

Medications should not be disposed of through drains or trash.Ask your pharmacist how to dispose of the packaging and medications that you do not need.This will help protect the environment.

Composition of Cerezyme

• The active ingredient is imiglucerase.Imiglucerase is a modified form of the human enzyme acid alpha-glucosidase produced by recombinant DNA technology.?Each vial contains 400 units of imiglucerase.After reconstitution, the solution contains 40 units of imiglucerase per milliliter.
• The other components are: mannitol, sodium citrate, citric acid monohydrate, and polisorbate 80.

Appearance of Cerezyme and contents of the package

Cerezyme 400Units, is presented in the form of a powder for concentrate for solution for infusion (in a vial – package size of 1, 5 or 25 vials).Only some package sizes may be commercially available.

Cerezyme is supplied as a white or off-white powder.After reconstitution, a clear and transparent liquid without foreign particles is observed.The reconstituted solution must be diluted subsequently.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sanofi B.V.,Paasheuvelweg 25, 1105 BP Amsterdam,Netherlands

Manufacturer

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

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.It also provides links to other websites on rare diseases and their treatments..

--------------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

Instructions for use: reconstitution, dilution, and administration

Each vial of Cerezyme is for single use. After reconstitution, each vial of Cerezyme contains 400units of imiglucerase in 10.0 ml (40 units per ml).

Use aseptic technique

Reconstitution

Reconstitute each vial with 10.2 ml ofwater for injection,avoiding violent impact of the water for injection on the powder and the formation of foam in the solution, mixing it gently. The reconstituted volume is 10.6 ml. The pH of the reconstituted solution is approximately 6.2.

After reconstitution, a clear and transparent liquid without foreign particles is observed. The reconstituted solution must be diluted subsequently. Before any additional dilution, visually examine the diluted solution in each vial to detect possible foreign particles and color alteration.Donot use the vials that present foreign particles or color alteration.

After reconstitution,dilute rapidlythe vials and do not store them for subsequent use.

Dilution

The reconstituted solution contains 40 units of imiglucerase per ml. The reconstituted volume allows the exact extraction of 10.0 ml (equal to 400 units) from each vial. Extract 10.0 ml of the reconstituted solution from each vial, collect the extracted volumes, and then dilute them withsodium chloride 0.9% solutionto a total volume of100 to200 ml. Mix the infusion solution gently.

Administration

It is recommended to administer the diluted solution through a 0.2 µm in-line filter with low protein binding to eliminate any protein particles. This will not cause a decrease in the activity of imiglucerase. It is recommended to administer the diluted solution within 3 hours. The diluted product in sodium chloride 0.9% solution can maintain its chemical stability for up to 24 hours, if stored between2°Cand8°Cprotected from light, but microbiological safety will depend on whether the reconstitution and dilution were performed aseptically.

Cerezyme does not contain preservatives. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.