Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cinryze

Document Subject

Generated Narrative: MedicinalProductDefinition mp117ee803a8e1cf06b103ca0933d5bdf2

identifier: http://ema.europa.eu/identifier/EU/1/11/688/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Cinryze 500 IU powder and solvent for solution for injection

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-117ee803a8e1cf06b103ca0933d5bdf2

identifier: http://ema.europa.eu/identifier/EU/1/11/688/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - cinryze

Attesters

What is in this leaflet

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

Cinryze contains the human protein called C1-esterase inhibitor as the active substance. C1-esterase inhibitor is a naturally occurring protein that is normally present in the blood. If you have a low amount of C1-esterase inhibitor in your blood or your C1-esterase inhibitor is not working properly, this can lead to swelling attacks (called angioedema). Symptoms may include stomach pains and swelling of the:

hands and feet

face, eyelids, lips or tongue

voice-box (larynx), which may make breathing difficult

genitals In adults and children, Cinryze can raise the amount of C1-esterase inhibitor in the blood and either prevent (prior to undergoing medical or dental procedures) these swelling attacks from occurring or stop swelling attacks once they have begun. In adults, adolescents and children (aged 6 years and above), Cinryze can raise the amount of C1- esterase inhibitor in the blood and routinely prevent swelling attacks from occurring.

Do not take Cinryze

If you are allergic to Human C1-esterase inhibitor or any of the other ingredients of this medicine (listed in section 6). It is important to tell your doctor if you think you have ever had an allergic reaction to any of the ingredients in Cinryze. Warnings and precautions

Before you start treatment with Cinryze, it is important that you tell your doctor if you have, or have had, problems with your blood clotting (thrombotic events). You will be carefully monitored if this is the case.

If you begin to suffer from rashes, tightness of the chest, wheezing, or a fast heart beat once you have taken Cinryze, you should tell your doctor immediately (see section 4).

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B and hepatitis C viruses, and for the non-enveloped hepatitis A and parvovirus B19 viruses.

Your doctor may recommend that you consider having vaccinations against hepatitis A and B if you regularly or repeatedly receive Human C1-esterase inhibitor products that have been taken from human plasma.

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded by your nurse or doctor. Children Cinryze is not for use in children below 6 years of age for routine prevention of angioedema attacks. Other medicines and Cinryze Tell your doctor 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 for advice before taking Cinryze. There is limited information on the safety of Cinryze use during pregnancy and breast-feeding. Your doctor will discuss with you the risks and benefits of taking this medicine. Driving and using machines Cinryze has minor influence on the ability to drive and use machines. Cinryze contains sodium This medicine contains 11.5 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.5% of the recommended maximum daily dietary intake of sodium for an adult.

Your treatment will be initiated and managed under supervision of a doctor experienced in the care of patients with hereditary angioedema (HAE). A doctor or nurse may prepare and inject Cinryze for you. If your doctor decides you can self- administer, your doctor or nurse will train you or a family member to prepare and inject Cinryze. Your doctor will regularly review the preparation and administration process with you or a family member or carer. The recommended dose of Cinryze for adults, adolescents, children, the elderly, or patients suffering from kidney or liver problems is as follows: Use in adults and adolescents (12 years and above) Treatment of swelling attacks

A dose of 1000 IU (two vials) of Cinryze should be injected at the first sign of a swelling attack.

A second injection of 1000 IU may be given if your symptoms do not improve after 60 minutes.

If you are experiencing a severe attack, particularly a swelling of the voice-box (larynx), or if initiation of treatment is delayed, the second 1000 IU dose may be given earlier than 60 minutes after the first dose, depending on your clinical response.

Cinryze should be injected intravenously (into the vein). Routine prevention of swelling attacks

A dose of 1000 IU (two vials) of Cinryze should be injected every 3 or 4 days for routine prevention of swelling attacks.

The dosing interval may be adjusted by your doctor depending upon your response to Cinryze.

Cinryze should be injected intravenously (into the vein). Prevention of swelling attacks prior to surgery

A dose of 1000 IU (two vials) of Cinryze should be injected up to 24 hours before a medical, dental, or surgical procedure.

Cinryze should be injected intravenously (into the vein). Use in children Treatment of angioedema attacks Pre-procedure prevention of angioedema attacks Routine prevention of angioedema attacks U2 to 11 years, >25 kg: A dose of 1000 IU (two vials) of Cinryze should be injected at the first sign of a swelling attack. A second injection of 1000 IU may be given if your symptoms do not improve after 60 minutes. U2 to 11 years, 10-25 kg: A dose of 500 IU (one vial) of Cinryze should be injected at the first sign of a swelling attack. A second injection of 500 IU may be given if your symptoms do not improve after 60 minutes. U2 to 11 years, >25 kg: A dose of 1000 IU (two vials) of Cinryze should be injected up to 24 hours before a medical, dental, or surgical procedure. U2 to 11 years, 10-25 kg: A dose of 500 IU (one vial) of Cinryze should be injected up to 24 hours before a medical, dental, or surgical procedure. U6 to 11 years: A dose of 500 IU (one vial) of Cinryze should be injected every 3 or 4 days for routine prevention of swelling attacks. The dosing interval may be adjusted by your doctor depending upon your response to Cinryze. Reconstitution and method of administration Cinryze is usually injected into a vein (intravenously) by your doctor or nurse. You or your carer might also administer Cinryze as an injection, but only after receiving adequate training. If you are injecting Cinryze yourself, always use it exactly as your doctor has instructed you. Check with your doctor if you are not sure. If your doctor decides that you may be suitable for such home-treatment, he/she will give you detailed instructions. You will be required to keep a diary in order to document each treatment received at home and to bring it to each of your visits to the doctor. Regular review of your/your carer s injection technique will be performed to ensure continued appropriate handling. 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. This can include allergic-type reactions. Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are rare, the symptoms can be severe. Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body). UVery common side effects (Umay affect more than 1 in 10 people): headache, nausea. UCommon side effectsU (may affect up to 1 in 10 people): hypersensitivity, dizziness, vomiting, rash, itching or redness, injection site rash or pain, fever. UUncommon side effectsU (may affect up to 1 in 100 people): high blood sugar, blood clot, painful veins, hot flush, cough, stomach pain, diarrhoea, skin flaking, joint swelling and pain, muscle pain, and chest discomfort. Side effects in children and adolescents are expected to be similar to those in adults. Reporting of side effects If you get any side effects, talk to your doctor 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 carton and vials after EXP . Store below 25 C. Do not freeze. Store in the original package in order to protect from light. Once reconstituted, Cinryze solution should be used immediately. 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 Cinryze contains The active substance is Human C1-esterase inhibitor produced from the plasma of human donors. Each powder vial contains 500 IU of Human C1-esterase inhibitor. After reconstitution, one vial contains 500 IU of Human C1-esterase inhibitor Pper 5 ml, corresponding to a concentration of IU/ml. Two vials of reconstituted Cinryze contain 1000 IU of Human C1-esterase inhibitor Pper 10 ml, corresponding to a concentration of 100 IU/ml. The total protein content of the reconstituted solution is 15 5 mg/ml. One International Unit (IU) is equivalent to the amount of C1-esterase inhibitor present in 1 ml of normal human plasma. UThe other ingredients are sodium chloride, sucrose, sodium citrate, L-valine, L-alanine and L- threonine. (See section 2). Solvent: water for injections. What Cinryze looks like and contents of the pack Powder and solvent for solution for injection. Cinryze is a white powder contained in a vial. After it has been dissolved in the water for injections the solution is clear and colourless to slightly blue. Each pack contains: 2 vials of Cinryze 500 IU powder for solution for injection 2 vials of water for injections (5 ml each) 2 filter transfer devices 2 disposable 10 ml syringes 2 venipuncture sets 2 protective mats Only use a silicone-free syringe (provided in the pack) for administration of the product. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Takeda Manufacturing Austria AG Industriestrasse 1221 Vienna Austria Manufacturer Takeda Manufacturing Austria AG Industriestrasse 1221 Vienna Austria Shire International Licensing B.V. Mercuriusplein 2132 HA Hoofddorp The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Takeda Belgium NV Tel/T l: +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 Tel/T l: +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 Tel. + 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 . Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. There are also links to other websites about rare diseases and treatments. The following information is intended for healthcare professionals only: Reconstitution and administration of Cinryze Reconstitution, product administration and handling of the administration set and needles must be done with caution. Use either the filter transfer device provided with Cinryze or a commercially available double-ended needle. Only use a silicone-free syringe (provided in the pack) for administration of the product. Preparation and handling Cinryze is intended for intravenous administration (into the vein) after reconstitution with water for injections. Cinryze vial is for single use only. Reconstitution For a dose of 500 IU: One powder vial, 1 solvent vial, 1 filter transfer device, 1 disposable 10 ml syringe, 1 venipuncture set and 1 protective mat are needed. Store the remaining vial and administration equipments for the next dose. For a dose of 1000 IU: Two powder vials, 2 solvent vials, 2 filter transfer devices, 1 disposable 10 ml syringe, 1 venipuncture set and 1 protective mat are needed. Each product vial should be reconstituted with 5 ml water for injections. One vial of reconstituted Cinryze corresponds to a dose of 500 IU. Therefore only reconstitute one vial of Cinryze for one dose of 500 IU. Two vials of reconstituted Cinryze correspond to a dose of 1000 IU. Therefore two vials are combined for one dose of 1000 IU.

1. Work on the mat provided and wash your hands before performing the following procedures.
2. Aseptic technique should be used during the reconstitution procedure.
3. Ensure the powder vial and the solvent vial are at room temperature (15 C - 25 C).
4. Release the powder vial label by tearing down the perforated strip indicated by the inverted triangle.
5. Remove plastic caps from the powder and solvent vials.
6. Cleanse stoppers with a disinfection swab and allow them to dry prior to use.
7. Remove protective covering from the top of the transfer device package. Do not remove the device from the package.
8. Note: the transfer device must be attached to the solvent vial before being attached to the powder vial, so that the vacuum in the powder vial is not lost. Place the solvent vial on a flat surface and insert the blue end of the transfer device into the solvent vial, pushing down until the spike penetrates through the centre of the solvent vial stopper and the device snaps in place. The transfer device must be vertical prior to penetrating the stopper closure.
9. Remove the plastic package from the transfer device and discard it. Take care not to touch the exposed end of the transfer device.
10. Place the powder vial on a flat surface. Invert the transfer device and the solvent vial containing water for injections and insert the clear end of the transfer device into the powder vial, pushing down until the spike penetrates the rubber stopper and the transfer device snaps into place. The transfer device must be vertical prior to penetrating the stopper closure of the powder vial. The vacuum in the powder vial will draw in the solvent. If there is no vacuum in the vial, do not use the product.
11. Gently swirl the powder vial until all powder is dissolved. Do not shake the powder vial. Make sure all the powder is completely dissolved.
12. Disconnect the solvent vial by turning it anti-clockwise. Do not remove the clear end of the transfer device from the powder vial. One vial of reconstituted Cinryze contains 500 IU of Human C1-esterase inhibitor in 5 ml, resulting in a concentration of 100 IU/ml. Proceed to administration process if patients receive a dose of 500 IU. Two vials of Cinryze powder must be reconstituted to make one dose (1000 IU/10 ml). Therefore repeat instructions 1 to 12 above using an additional package containing a transfer device to reconstitute the second of two powder vials. Do not reuse the transfer device. Once the two vials are reconstituted proceed to administration process for a dose of 1000 IU. Administration process for a dose of 500 IU
13. Aseptic technique should be used during the administration procedure.
14. After reconstitution, the Cinryze solutions are colourless to slightly blue and clear. Do not use the product if the solutions are turbid or discoloured.
15. Using a sterile, disposable 10 ml syringe, draw back the plunger to allow approximately 5 ml of air into the syringe.
16. Attach the syringe onto the top of the clear end of the transfer device by turning it clockwise.
17. Invert the vial gently and inject air into the solution and then slowly withdraw the reconstituted Cinryze solution into the syringe.
18. Detach the syringe from the vial by turning it anti-clockwise and releasing it from the clear end of the transfer device.
19. Inspect the reconstituted Cinryze solution for particulate matter prior to administration; do not use if particles are observed.
20. Attach the venipuncture set to the syringe containing Cinryze solution and inject intravenously (into the vein) into the patient. Administer 500 IU (reconstituted in 5 ml of water for injections) of Cinryze by intravenous injection at a rate of 1 ml per minute over 5 minutes. Administration process for a dose of 1000 IU
21. Aseptic technique should be used during the administration procedure.
22. After reconstitution, the Cinryze solutions are colourless to slightly blue and clear. Do not use the product if the solutions are turbid or discoloured.
23. Using a sterile, disposable 10 ml syringe, draw back the plunger to allow approximately 5 ml of air into the syringe.
24. Attach the syringe onto the top of the clear end of the transfer device by turning it clockwise.
25. Invert the vial gently and inject air into the solution and then slowly withdraw the reconstituted Cinryze solution into the syringe.
26. Detach the syringe from the vial by turning it anti-clockwise and releasing it from the clear end of the transfer device.
27. Using the same syringe, repeat steps 3 to 6 with a second vial of reconstituted Cinryze to make one complete 10 ml dose.
28. Inspect the reconstituted Cinryze solution for particulate matter prior to administration; do not use if particles are observed.
29. Attach the venipuncture set to the syringe containing Cinryze solution and inject intravenously (into the vein) into the patient. Administer 1000 IU (reconstituted in 10 ml of water for injections) of Cinryze by intravenous injection (into the vein) at a rate of 1 ml per minute over 10 minutes. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.