Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - obizur

Document Subject

Generated Narrative: MedicinalProductDefinition mp4361504119fec5762723adfabb108410

identifier: http://ema.europa.eu/identifier/EU/1/15/1035/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: OBIZUR 500 U 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-4361504119fec5762723adfabb108410

identifier: http://ema.europa.eu/identifier/EU/1/15/1035/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - obizur

Attesters

What is in this leaflet

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

OBIZUR contains the active substance susoctocog alfa, antihaemophilic factor VIII, porcine sequence. Factor VIII is necessary for the blood to form clots and stop bleedings. In patients with acquired haemophilia, factor VIII is not working properly because the patient has developed antibodies to his own factor VIII which neutralize this blood clotting factor.

OBIZUR is used for the treatment of bleeding episodes in adults with acquired haemophilia (a bleeding disorder caused by lack of factor VIII activity due to antibody development). These antibodies have less neutralizing effect against OBIZUR than against human factor VIII.

OBIZUR restores this missing factor VIII activity and helps blood to form clots at the site of bleeding.

The medicine is for in-patient administration only. It requires clinical supervision of the bleeding status of the patient.

You must not be given OBIZUR:

• if you are allergic to susoctocog alfa or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to hamster proteins (trace amounts may be present in OBIZUR arising from the manufacturing process);
• if you have congenital haemophilia A with inhibitors (CHAWI).

If you are not sure, talk to your doctor before you are given this medicine.

Warnings and precautions Talk to your doctor before you are given OBIZUR. Hypersensitivity There is a rare chance that you may experience an allergic reaction to OBIZUR. You should be aware of the early signs of allergic reactions (see section 4 for signs and symptoms). If any of these symptoms occur, the injection should be stopped. Severe symptoms, including difficulty in breathing and (near) fainting, require emergency treatment in the hospital.

Inhibitors Your doctor may check if you have inhibitory antibodies to porcine factor VIII and for increases in these antibodies. Your doctor will check your blood factor VIII to confirm that enough factor VIII is being given to you. Your doctor will also check if the bleeding is adequately controlled.

Cardiovascular events Talk to your doctor if you currently have, or have had cardiovascular disease in the past or if you have a known risk of thrombosis (diseases from blood clots in normal vasculature), because the possiblity of developing thromboembolic diseases at high and sustained blood factor VIII levels cannot be excluded.

Children and adolescents There is no information on the use of OBIZUR in children and adolescents aged under 18 years

Other medicines and OBIZUR Tell your doctor if you are using, have recently used or might use any other medicines. No interactions of OBIZUR with other medicines are known.

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 using this medicine.

Driving and using machines OBIZUR has no influence on your ability to drive and use machines.

OBIZUR contains sodium This medicine contains 4.6 mg sodium (main component of cooking/table salt) per milliliter once it is made up. This is equivalent to 0.23% of the recommended maximum daily dietary intake of sodium for an adult. Multiple vials must be taken per dose.

Talk to your doctor if you are on a controlled sodium diet.

Treatment with OBIZUR will be conducted by a doctor who is experienced in the care of patients with haemophilia (bleeding disorders).

Your doctor will calculate your dose of OBIZUR (in units or U) depending on your condition and body weight. The frequency and duration of administration will depend on how well OBIZUR is working for you. Usually, the replacement therapy with OBIZUR is a temporary treatment until bleeding is resolved or the antibodies against your own factor VIII are eradicated.

Your doctor will monitor you for antibodies to OBIZUR.

The recommended first dose is 200 U per kilogram bodyweight given by intravenous injection.

Your doctor will measure your factor VIII activity regularly to decide the subsequent dose and frequency of OBIZUR. The bleeding will usually respond within the first 24 hours, your doctor will adjust the dose and duration of OBIZUR until the bleeding stops. The total volume of reconstituted OBIZUR should be administered at a rate of 1 to 2 mL per minute.

If you have any further questions on the use of this medicine, ask your doctor.

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

If severe and sudden allergic reactions occur, the injection must be stopped immediately. You must contact your doctor immediately if you have any of the following early symptoms:

• Swelling of lips and tongue;
• Burning and stinging at the injection site;
• Chills, flushing;
• Hives, generalised itching;
• Headache, low blood pressure;
• Lethargy, sickness, restlessness;
• Rapid beating of the heart, tightness of the chest;
• Tingling, vomiting;
• Wheezing.

Very common side effects (may affect more than 1 in 10 people)

• Development of antibodies and increases in pre-existing antibodies against the medicine, which may result in lack of efficacy with continued bleeding.

Reporting of side effects If you get any side effects, talk to your doctor. 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, on the vial and on the pre-filled syringe after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C). Do not freeze.

Use the reconstituted solution immediately but no longer than 3 hours once the powder is completely dissolved.

After reconstitution the solution should be clear and colourless. Do not administer if particulate matter or discolouration is found.

Since this medicine is used during hospitalisation, the hospital staff are responsible for the correct storage of this medicine before and during its use, as well as for correct disposal.

Name and batch number It is strongly recommended that every time that OBIZUR is used, the name and batch number of the medicine are recorded by the medical professional to maintain a link between your treatment and the batch of the medicine.

What OBIZUR contains

• The active substance is susoctocog alfa (antihaemophilic factor VIII, porcine sequence produced by recombinant DNA technology). Each powder vial contains 500 U of susoctocog alfa.
• The other ingredients in the powder are polysorbate 80, sodium chloride (see also section 2), calcium chloride dihydrate, sucrose, trometamol, trometamol hydrochloride, sodium citrate.
• The solvent is 1 ml sterilised water for injections.

What OBIZUR looks like and contents of the pack One pack contains 1, 5 or 10 of the following:

• glass vial of OBIZUR 500 U white, friable powder with a butyl rubber stopper coated with FluroTec and a flip-off seal;
• pre-filled glass syringe with a stopper of bromobutyl rubber coated with FluroTec foil on the contact side of 1 ml sterilised water for injections with a bromobutyl rubber tip cap and a Luer lock adapter;
• fluid transfer device with an integral plastic spike.

Marketing Authorisation Holder Baxalta Innovations GmbH Industriestrasse 1221 Vienna Austria

Manufacturer Takeda Manufacturing Austria AG Industriestrasse 1221 Vienna Austria

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 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 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 .

This medicine has been authorised under exceptional circumstances . This means that because of the rarity of this disease it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.

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