CEREZYME 200 U Proszek do sporządzania koncentratu do roztworu do infuzji
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Treść ulotki
Cerezyme 400 Units powder for concentrate for solution for infusion
Imiglucerase
Read this leaflet carefully before you start to use this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4 Contents of this leaflet:
- 1. What Cerezyme is and what it is used for
- 2. What you need to know before you use Cerezyme
- 3. How to use Cerezyme
- 4. Possible side effects
- 5. How to store Cerezyme
- 6. Contents of the pack and other information
1. What is Cerezyme and what is it used for
Cerezyme contains the active substance imiglucerase and is used in the treatment of patients with Type 1 or Type 3 and who manifest signs of the disease such as: anemia (low number of red blood cells), tendency to bleeding (due to a low number of platelets – a type of blood cell), enlargement of the spleen or liver or bone disease.
People affected by Gaucher's disease have low levels of an enzyme called acid-glucosidase.
This enzyme helps the body control levels of glucosylceramide, a natural substance in the body, composed of sugars and fats. In Gaucher's disease, levels of glucosylceramide can increase excessively.
Cerezyme is the artificial enzyme imiglucerase capable of replacing the natural acid-glucosidase enzyme that is deficient or not sufficiently active in patients with Gaucher's disease.
including children, adolescents, adults and the elderly.
2. What you need to know before using Cerezyme
Do not use Cerezyme:
- If you are allergic to imiglucerase, or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsTalk to your doctor or pharmacist before using Cerezyme:
- if you are undergoing treatment with Cerezyme, you may develop an allergic reaction during the administration of the medicine, or shortly after. If you develop a reaction of this type you must immediately inform your doctor. Your doctor will perform a test to verify if you are allergic to imiglucerase.
- some patients affected by Gaucher's disease have high blood pressure in the pulmonary vessels (pulmonary hypertension). The cause may be unknown or may depend on problems with the heart, lungs or liver. It can occur independently of whether the
patient is undergoing treatment with Cerezyme. But, if you suffer from shortness of breath, you should
inform your doctor.
Other medicines and Cerezyme
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Cerezyme should not be administered mixed with other medicines in the same infusion (drip).
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine. It is
recommended to use Cerezyme with caution during pregnancy and breastfeeding.
Cerezyme contains sodium
This medicine contains 41 mg of sodium (the main component of table salt) per vial
This is equivalent to 2% of the maximum recommended daily intake of sodium for an adult
.It is administered in 0.9% sodium chloride solution for intravenous infusion. This must
be taken into consideration in patients who are following a diet with a controlled sodium content.
3. How to use Cerezyme
Instructions for correct use
Cerezyme is administered intravenously via an infusion (intravenous infusion).
The medicine is supplied in the form of a powder which is then mixed with sterile water before
administration.
Cerezyme should be used exclusively under the supervision of a doctor experienced in the treatment of
Gaucher's disease. Your doctor may advise home treatment, provided you meet certain criteria. Contact your doctor if you wish to be treated
at home.
Your dose will be specific to you. The doctor will determine the dosage based on the severity of your
symptoms and other factors. The recommended dose is 60 units/kg of body weight administered once
every two weeks.
The doctor will closely monitor your response to treatment and may adjust the dosage
(increasing or decreasing it) until they find the most suitable dose for symptom control.
Once the dosage has been identified, the doctor will continue to monitor your responses to ensure that
you are using the correct dose. This may happen every 6 or 12 months.
There is no information available on the effect of Cerezyme on the cerebral symptoms of patients with
chronic neuropathic Gaucher's disease. Consequently, a specific dosage regimen cannot be recommended.
ICGG Gaucher Registry
You may ask your doctor to register your patient data in the “ICGG Gaucher Registry”. The
objectives of the Registry are to improve understanding of Gaucher's disease and to evaluate
the effectiveness of enzyme replacement therapy, such as Cerezyme, resulting in improved
safety and effectiveness of Cerezyme use. Your data will be recorded anonymously; no one
will know that the information relates to you.
If you use more Cerezyme than you should
No cases of overdose have been reported.
If you forget to use Cerezyme
If you have missed an infusion, contact your doctor.
If you have any doubts about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common(may affect up to 1 in 10 people):
- shortness of breath
- cough
- urticaria/localized swelling of the skin or inner tissue of the mouth or throat
- itching
- erythema Uncommon(may affect up to 1 in 100):
- dizziness
- headache
- sensation of tingling, prickling, burning or numbness of the skin
- increased heart rate
- bluish discoloration
- hot flushes
- low blood pressure
- vomiting
- nausea
- abdominal cramps
- diarrhoea
- joint pain
- discomfort at the infusion site
- burning at the infusion site
- swelling at the infusion site
- abscess at the injection site
- feeling of tightness in the chest
- fever
- chills
- fatigue
- back pain Rare(may affect up to 1 in 1,000):
- anaphylactoid reactions Some side effects have been observed during the administration of the medicine or shortly after. These include itching, redness, urticaria/localized swelling of the tissues or mucous membrane of the mouth and throat, feeling of tightness in the chest, increased heart rate, bluish discoloration, shortness of breath, sensation of tingling, prickling, burning or numbness of the skin, low blood pressure and back pain. If any of these symptoms occur, inform your doctor immediately.You may need to take other medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids). Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help to provide more information on the safety of this medicine.
5. How to store Cerezyme
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after Exp. The expiry date refers to the last day of that month.
Intact vials:
Store in a refrigerator (2 C – 8 C)
Diluted solution:
It is recommended to use Cerezyme immediately after mixing it with sterile water. The solution
mixed in the vial cannot be stored and must be promptly diluted in an infusion bag; only the diluted solution can be stored for a maximum of 24 hours if kept cool
(2°C – 8°C) and protected from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Cerezyme contains
- The active ingredient is imiglucerase. Imiglucerase is a modified form of human enzyme - acid glucosidase produced by recombinant DNA technology. One vial contains 400 units of imiglucerase. The reconstituted solution contains 40 units of imiglucerase per ml.
- The other ingredients are: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80. Description of Cerezyme and package contentsCerezyme 400 Units is presented as a powder for concentrate for solution for infusion (in a vial, pack of 1, 5 or 25). Not all pack sizes may be marketed. Cerezyme is supplied as a powder ranging from white to off-white. The reconstituted liquid is clear, colourless, and free from particulate matter. The reconstituted solution must be further diluted. Marketing Authorisation Holder and ManufacturerMarketing Authorisation HolderSanofi B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands ManufacturerGenzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland For further information on this medicinal product, contact the local representative of the marketing authorisation holder: België/Belgique/Belgien/Luxembourg/LuxemburgSanofi Belgium Tél/Tel: + 32 2 710 54 00 MagyarországSANOFI-AVENTIS Zrt. Tel: +36 1 505 0050
БългарияMalta
Sanofi S.r.l.
+39 02 39394275
Česká republika
sanofi-aventis, s.r.o.
Tel: +420 233 086 111
Nederland
Sanofi B.V.
Tel: +31 20 245 4000
Danmark
sanofi A/S
Tlf: +45 45 16 70 00
Norge
sanofi-aventis Norge AS
Tlf: + 47 67 10 71 00
Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 04 36 996
Tel. aus dem Ausland: +49 69 305 70 13
Österreich
sanofi-aventis GmbH
Tel: + 43 1 80 185 - 0
EestiPolska
sanofi-aventis Sp. z o.o.
Tel.: +48 22 280 00 00
Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600
Portugal
Sanofi – Produtos Farmacêuticos, Lda.
Tel: +351 21 35 89 400
España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36
France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23
Slovenija
HrvatskaSlovenská republika
Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00
Suomi/Finland
Sanofi Oy
Puh/Tel: + 358 201 200 300
Ísland
Vistor hf.
Sími: +354 535 7000
Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00
Italia
Sanofi S.r.l.
Tel: 800 536 389
United Kingdom
Κύπρος
Latvija
1
Lietuva
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/. In addition, links to other websites on rare diseases and related therapeutic treatments are provided.
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The following information is intended for healthcare professionals only:
Instructions for use – reconstitution, dilution and administration
Each vial of Cerezyme is for single use only. After reconstitution, each vial of Cerezyme contains 400 units of imiglucerase in 10.0 ml (40 units per ml).
Determine the number of vials that must be reconstituted based on the dosages of the therapeutic regimens for individual patients and remove the vials from the refrigerator.
Use aseptic technique
Reconstitution
Reconstitute each vial with 10.2 ml of water for injection; it is necessary to avoid a strong jet of water onto the powder and gently mix to avoid foaming in the solution; the reconstituted volume is 10.6 ml. The pH of the reconstituted solution is approximately 6.2.
After reconstitution, it is a clear, colourless liquid, free from particulate matter. The reconstituted solution must be further diluted. Before further dilution, the reconstituted solution from each vial must be visually inspected to exclude the presence of particulate matter and discoloration. Do not use vials that present with particulate matter and discoloration.
After reconstitution, dilute immediately and do not store for later use.
Dilution
The reconstituted solution contains 40 units of imiglucerase per ml. The reconstituted volume allows for accurate aspiration of 10.0 ml (equivalent to 400 units) from each vial. Withdraw 10.0 ml of reconstituted solution from each vial and combine the extracted volumes. Then dilute the combined volumes with 0.9% sodium chloride solution for intravenous administrations to obtain a final volume of 100 to 200 ml. Mix the infusion solution slowly.
Administration
It is recommended to administer the diluted solution through an in-line low protein binding filter of 0.2 µm to remove any protein particles. This will not cause any loss of imiglucerase activity. It is recommended to administer the diluted solution within 3 hours. The product diluted in 0.9% sodium chloride solution for intravenous infusion will maintain chemical stability if stored for up to 24 hours at 2°C to 8°C in the dark, but microbiological safety will depend on the fact that reconstitution and dilution are carried out aseptically.
Cerezyme does not contain preservatives. Unused product and waste derived from this medicinal product must be disposed of in accordance with local legal requirements.
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- Kraj rejestracji
- Postać farmaceutycznaPowder for concentrate for infusion solution, 200 U
- Kod ATCA16AB02
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki KERETSYMEPostać farmaceutyczna: Concentrate for infusion solution, 500 USubstancja czynna: laronidaseProducent: SANOFI B.V.Wymaga receptyPostać farmaceutyczna: Infusion solution, 150 MGSubstancja czynna: cerliponase alfaProducent: BIOMARIN INTERNATIONAL LIMITEDBez receptyPostać farmaceutyczna: Concentrate for infusion solution, 2 MG/MLSubstancja czynna: idursulfaseWymaga recepty
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KERETSYME wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w KERETSYME jest imiglucerase. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
KERETSYME jest produkowany przez SANOFI B.V.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie KERETSYME jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić KERETSYME w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (imiglucerase) to m.in. ALDURATSYME, BRINEURA, ELAPRASE. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
