Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - aldurazyme

Document Subject

Generated Narrative: MedicinalProductDefinition mp5ffbf24d0777fe10834621c6432afea6

identifier: http://ema.europa.eu/identifier/EU/1/03/253/001-003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Aldurazyme 100 U/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-5ffbf24d0777fe10834621c6432afea6

identifier: http://ema.europa.eu/identifier/EU/1/03/253/001-003

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - aldurazyme

Attesters

What is in this leaflet:

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

Aldurazyme is used to treat patients with MPS I disease (Mucopolysaccharidosis I). It is given to treat the non-neurological manifestations of the disease.

People with MPS I disease have either a low level or no level of an enzyme called -L-iduronidase, which breaks down specific substances (glycosaminoglycans) in the body. As a result, these substances do not get broken down and processed by the body as they should. They accumulate in many tissues in the body, which causes the symptoms of MPS I.

Aldurazyme is an artificial enzyme called laronidase. This can replace the natural enzyme which is lacking in MPS I disease.

You should not be given Aldurazyme If you are allergic (hypersensitive) to laronidase or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor before using Aldurazyme.
Contact your doctor immediately if treatment with Aldurazyme causes: Allergic reactions, including anaphylaxis (a severe allergy reaction) see under section 4. Possible side effects . Some of these reactions may be life-threatening. Symptoms may include respiratory failure/distress (inability of lungs to work properly), stridor (high-pitched breathing sound) and other disorders due to obstruction of airways, rapid breathing, excessive contraction of the airway muscles causing breathing difficulty (bronchospasm), lack of oxygen in body tissues (hypoxia), low blood pressure, slow heart rate, or itchy rash (urticaria).

 Infusion-associated reactions, i.e. any side effect occurring during the infusion or until the end 

of the infusion day- see under section 4 Possible Side Effects below for symptoms.

If these reactions occur, the Aldurazyme infusion should be stopped immediately and appropriate treatment will be started by your doctor.
These reactions may be particularly severe if you have a pre-existing MPS I-related upper airway obstruction. You may be given additional medications to help prevent allergic-type reactions, such as antihistamines, medicine to reduce fever (e.g. paracetamol) and/or corticosteroids. Your doctor will also decide if you can continue receiving Aldurazyme.

Other medicines and Aldurazyme Inform your doctor if you are using medicines containing chloroquine or procaine, due to a possible risk of decreasing the action of Aldurazyme.

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

Pregnancy, breast-feeding and fertility There is not enough experience of the use of Aldurazyme in pregnant women. You should not be given Aldurazyme during pregnancy unless clearly necessary. It is not known whether Aldurazyme appears in breast milk. It is recommended to stop breast-feeding during treatment with Aldurazyme. No information is available on the effects of Aldurazyme on fertility.

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 using this medicine.

Driving and using machines The effects on the ability to drive and to use machines have not been studied.

Aldurazyme contains sodium This medicine contains 30 mg sodium (main component of cooking/table salt) per vial. This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.

Instruction for use - dilution and administration The concentrate for solution for infusion has to be diluted before administration and is for intravenous use (see information for health care professionals). Administration of Aldurazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.

Home infusion Your doctor may consider that you can have home infusion of Aldurazyme if it is safe and convenient to do so. If you get a side effect during an infusion of Aldurazyme, your infusion staff member may stop the infusion and start appropriate medical treatment.

Dosage The recommended dosage regimen of Aldurazyme is 100 U/kg body weight given once every week as an intravenous infusion. The initial infusion rate of 2 U/kg/h may be gradually increased every fifteen minutes, if tolerated, to a maximum of 43 U/kg/h. The total volume of the administration should be delivered in approximately 3-4 hours.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

If you miss an infusion of Aldurazyme
If you have missed an Aldurazyme infusion, please contact your doctor.
If you are given more Aldurazyme than needed If the dose of Aldurazyme given is too high or the infusion is too fast, adverse drug reactions may occur. Receiving an excessively fast infusion of Aldurazyme may cause nausea, abdominal pain, headache, dizziness and difficulty breathing (dyspnoea). In such situations, the infusion should be stopped or the infusion rate slowed down immediately. Your doctor will decide if further intervention is required. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Side effects were mainly seen while patients were being given the medicine or shortly after (infusion- associated reactions). If you experience any reaction like this, you should contact your doctor immediately. The number of these reactions decreased the longer that patients were on Aldurazyme. The majority of these reactions were mild or moderate in intensity. However, severe systemic allergic reaction (anaphylactic reaction) has been observed in patients during or up to 3 hours after Aldurazyme infusions. Some of the symptoms of such a severe allergic reaction were life-threatening and included extreme difficulty breathing, swelling of the throat, low blood pressure, and low oxygen level in the body. A few patients who had a prior history of severe MPS I related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm (airway constriction), respiratory arrest, and swelling of the face. The frequency of bronchospasm and respiratory arrest is unknown. The frequency of severe allergic reaction (anaphylactic reaction) and swelling of the face is considered common and may affect up to 1 in 10 people.

Very common symptoms (may affect more than 1 in 10 people) which were not serious include
headache,
nausea,
abdominal pain,
rash,
joint disease,
joint pain,
back pain,
pain in arms or legs,
flushing, fever, chills,
increased heart rate,
increased blood pressure,
reaction at the infusion site such as swelling, redness, build-up of fluid, discomfort, itchy rash, pale colour of the skin, discoloured skin, or sensation of being warm.

Other side effects include the following:

Common (may affect up to 1 in 10 people)

• increased body temperature
• tingling
• dizziness
• cough
• difficulty in breathing
• vomiting
• diarrhoea
• rapid swelling under the skin in areas such as the face, throat, arms and legs which can be life- threatening if throat swelling blocks the airway
• hives
• itching
• hair loss
• cold sweat, heavy sweating
• muscle pain
• paleness
• cold hands or feet
• feeling hot, feeling cold
• fatigue
• influenza like illness
• pain at injection site
• restlessness

Not known (frequency cannot be estimated from the available data)

• allergic reactions (hypersensitivity)
• abnormally slower heart rate
• increased or abnormally high blood pressure
• voice box swelling
• bluish color of the skin (due to lower levels of oxygen in the blood)
• fast breathing
• redness of the skin
• leakage of the medicine into the surrounding tissue at the site of injection, where it can cause damage
• inability of the lungs to work properly (respiratory failure)
• throat swelling
• high-pitched breathing sound
• obstruction of airways causing difficulty in breathing
• lip swelling
• tongue swelling
• swelling especially of the ankles and feet due to fluid retention
• drug specific antibody, a blood protein produced in response to medicine
• antibody that neutralizes the effect of medicine

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.

You should not be given this medicine after the expiry date which is stated on the label 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).

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 Aldurazyme contains

• The active substance is laronidase. One ml of the solution in the vial contains 100 U of laronidase. Each vial of 5 ml contains 500 U of laronidase.
• The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, water for injections.

What Aldurazyme looks like and contents of the pack Aldurazyme is supplied as a concentrate for solution for infusion. It is a solution that is clear to slightly opalescent, and colourless to pale yellow.

Pack size: 1, 10 and 25 vials per carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

Manufacturer

Genzyme Ireland Ltd., 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. Tel: +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 7 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 Suomi/Finland Sanofi Oy Puh/Tel: + 358 201 200 sland Vistor hf. S mi: +354 535 7Sverige Sanofi AB Tel: +46 (0)8 634 50 Italia Sanofi S.r.l. Tel: 800536United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel +44 (0) 800 035 2
C.A. Papaellinas Ltd. : +357 22 741Latvija Swixx Biopharma SIA Tel: +371 6 616 47 Lietuva Swixx Biopharma UAB Tel. +370 5 236 91 This leaflet was last revised in

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