Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rixubis

Document Subject

Generated Narrative: MedicinalProductDefinition mpefe0db2f668263967f135ff38dffab9d

identifier: http://ema.europa.eu/identifier/EU/1/14/970/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: RIXUBIS 250 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-efe0db2f668263967f135ff38dffab9d

identifier: http://ema.europa.eu/identifier/EU/1/14/970/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - rixubis

Attesters

What is in this leaflet

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

RIXUBIS contains the active substance nonacog gamma and is a coagulation factor IX product. Factor IX is a normal constituent of human blood necessary for effective blood clotting. RIXUBIS is used in patients with haemophilia B (Christmas disease, an inherited bleeding disorder caused by lack of factor IX). It works by replacing the missing factor IX to enable the patient s blood to clot. RIXUBIS is used for the treatment and prevention of bleeding in patients with haemophilia B of all age groups.

Do not use RIXUBIS

if you are allergic to nonacog gamma or any of the other ingredients of this medicine (listed in section 6)

if you are allergic to hamster proteins Warnings and precautions Allergic-type hypersensitivity reactions are possible with RIXUBIS. Stop your infusion and contact your doctor immediately or seek emergency medical care if you experience early signs of hypersensitivity/allergic reactions like hives, rash, tightness of the chest, wheezing, low blood pressure or anaphylaxis (severe allergic reaction that can cause difficulty in swallowing and/or breathing, red or swollen face and/or hands). Your doctor may need to treat you promptly for these reactions. Your doctor may also do a blood test to check if you have developed activity-neutralising antibodies (inhibitors) against your medicine, as inhibitors may develop together with allergies. Patients with factor IX inhibitors may be at an increased risk of anaphylaxis during future treatment with factor IX. Talk to your doctor immediately if your bleeding does not stop as expected or if you experience a significant increase in your usage of RIXUBIS in order to control a bleed. Your doctor will do a blood test to check if you have developed activity-neutralising antibodies (inhibitors) against RIXUBIS. The risk for developing inhibitors is highest in patients who have not been treated with a factor IX replacement medicine before or in the early phases of treatment, i.e. for small children. The production of factor IX in the body is controlled by the factor IX gene. Patients who have specific mutations of their factor IX gene such as major deletion may be more likely to have factor IX inhibitors and an allergic reaction in the early period with any factor IX concentrate. Therefore if you are known to have such a mutation, your doctor will monitor you more closely for signs of an allergic reaction. If you suffer from liver or cardiac disease or if you have recently had major surgery, please inform your doctor, as there is an increased risk for blood clotting (coagulation) complications. Kidney disorders (nephrotic syndrome) have been reported following high doses of Factor IX in haemophilia B patients with factor IX inhibitors and a history of allergic reactions. Whenever possible, please record the name of the product and the batch number every time you use RIXUBIS (e.g. in your diary) to keep track of the products and product batches you have used. Other medicines and RIXUBIS Tell your doctor if you are using or have recently used or might use any other medicines. No interactions of RIXUBIS with other medicines are known. Pregnancy, breast-feeding and fertility 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 using this medicine. Haemophilia B very rarely occurs in women. Driving and using machines RIXUBIS has no influence on the ability to drive and use machines. RIXUBIS contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially sodium- free . However, depending on your body weight and your dose of RIXUBIS, you could receive more than one vial. This should be taken into consideration if you are on a controlled sodium diet.

Treatment with RIXUBIS will be started by a doctor who is experienced in the care of patients with haemophilia B. Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor will decide the dose of RIXUBIS you will receive. This dose and duration will depend on the severity of your factor IX deficiency, on the location and extent of the bleeding and on your clinical condition, age and how quickly your body uses up factor IX which will have to be checked regularly. RIXUBIS is administered by intravenous infusion (IV) after reconstitution of the powder with the provided solvent by your doctor or nurse. You or somebody else might also administer RIXUBIS as an injection but only after receiving adequate training. Reconstitution and administration

For reconstitution use only the solvent and the reconstitution device (BAXJECT II) provided in the pack.

For administration the use of a luer-lock syringe is required.

Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration. Reconstitution Use Aseptic Technique

1. If the product is stored in a refrigerator, take both the RIXUBIS powder and solvent vials from the refrigerator and let them reach room temperature (between 15 C and 30 C).
2. Wash your hands thoroughly using soap and warm water.
3. Remove caps from powder and solvent vials.
4. Cleanse stoppers with alcohol swabs. Place the vials on a flat clean surface.
5. Open the package of BAXJECT II device by peeling away the paper lid without touching the inside (Fig. a). Do not remove the device from the package.
6. Turn the package over and insert the clear plastic spike through the solvent stopper. Grip the package at its edge and pull the package off BAXJECT II (Fig. b). Do not remove the blue cap from the BAXJECT II device.
7. With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device. Insert the white plastic spike through the RIXUBIS stopper. The vacuum will draw the solvent into the RIXUBIS vial (Fig. c).
8. Swirl gently until all material is dissolved. The product dissolves rapidly (within 2 minutes). Be sure that RIXUBIS is completely dissolved, otherwise not all reconstituted solution will pass through the device filter. Reconstituted medicinal products should be inspected visually for particulate matter and discoloration prior to administration. The solution should be clear or slightly opalescent. Do not use solution that are cloudy or have deposits. Fig. a Fig. b Fig. c Do not refrigerate the preparation after reconstitution. Use immediately. Administration Use Aseptic Technique
9. Remove the blue cap from BAXJECT II. Do not draw air into the syringe. Connect the syringe to BAXJECT II (Fig. d).
10. Invert the system (the vial with the reconstituted solution has to be on top). Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Fig. e).
11. Disconnect the syringe.
12. Attach a butterfly needle to the syringe. Inject intravenously. The solution should be administered slowly, at a rate as determined by the patient s comfort level, not to exceed 10 ml per minute. Fig. d Fig. e Whenever possible, please record the name of the product and the batch number every time you use RIXUBIS (e.g. in your diary) to keep track of the products and product batches you have used. Any unused product or waste material should be disposed of in accordance with local requirements. If you use more RIXUBIS than you should Always use RIXUBIS exactly as your doctor has told you. If you are not sure check with your doctor. If you injected more RIXUBIS than recommended, tell your doctor as soon as possible. If you forget to use RIXUBIS Do not inject a double dose to make up for a forgotten dose. Proceed with the next injection as scheduled and continue as advised by your doctor. If you stop using RIXUBIS Do not stop using RIXUBIS without consulting your doctor. 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. Allergic-type hypersensitivity reactions are possible with RIXUBIS. Such reactions may include burning sensations and stinging at the infusion site, chills, flushing, lethargy, restlessness, tingling, hives, itching and rash, low blood pressure, fast heart rate, tightness of the chest, wheezing, swelling of the throat, anaphylaxis (severe allergic reaction), headache, nausea and vomiting. Please, contact your doctor immediately if you experience such signs. Your doctor may need to treat you promptly for these reactions (see section 2 Warnings and precautions ). The following side effects have been observed with RIXUBIS: Common side effects (may affect up to 1 in 10 patients)

altered taste

pain in limbs. Side effects with unknown frequency (frequency cannot be estimated from the available data)

allergic reactions (hypersensitivity). Problems from exaggerated blood clotting (thromboembolic episodes) have not been observed with this product, but may occur with any factor IX products. These may include heart attack, blood clots in the veins or blood clots in the lung. 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 which is stated on the outer box and vial label after EXP. The expiry date refers to the last day of that month. Store below 30 C. Do not freeze. Use the reconstituted solution immediately. Do not use RIXUBIS if the solution is not clear and colourless. Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What RIXUBIS contains

The active substance is nonacog gamma (recombinant human coagulation Factor IX). Each powder vials contains nominally 250, 500, 1000, 2000 or 3000 IU, corresponding to a concentration of 50, 100, 200, 400 or 600 IU/ml after reconstitution with 5 ml solvent.

The other ingredients in the powder are sucrose, mannitol, sodium chloride, calcium chloride, L-histidine, polysorbate 80. Solvent vial: 5 ml sterilised water for injections. What RIXUBIS looks like and contents of the pack RIXUBIS is provided as a powder and solvent for solution for injection. The contents of the pack are:

one vial of RIXUBIS 250, 500, 1000, 2000 or 3000 IU powder in a glass vial with a rubber stopper

one vial of 5 ml sterilised water for injections in a glass vial with a rubber stopper

one BAXJECT II (needle-less reconstitution device) Marketing Authorisation Holder Baxalta Innovations GmbH Industriestrasse A-1221 Vienna Austria Manufacturer Baxalta Belgium Manufacturing SA Boulevard Ren Branquart B-7860 Lessines Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Takeda Belgium NV T l/Tel: +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 T l/Tel: +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 Drugsales Ltd Tel: +356 21419safety@drugsalesltd.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 T l: + 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 . Detailed information on this medicine is available on the European Medicines Agency web site: