Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - advate

Document Subject

Generated Narrative: MedicinalProductDefinition mp3c5fecfadf023622829e4ed4e3f92507

identifier: http://ema.europa.eu/identifier/EU/1/03/271/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: ADVATE 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-3c5fecfadf023622829e4ed4e3f92507

identifier: http://ema.europa.eu/identifier/EU/1/03/271/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - advate

Attesters

What is in this leaflet:

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

ADVATE contains the active substance octocog alfa, human coagulation factor VIII produced by recombinant DNA technology. Factor VIII is necessary for the blood to form clots and stop bleedings. In patients with haemophilia A (inborn lack of factor VIII), it is missing or not working properly. ADVATE is used for the treatment and prevention of bleeding in patients of all age groups with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). ADVATE is prepared without the addition of any human- or animal-derived protein in the entire manufacturing process.

Do not use ADVATE

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

if you are allergic to mouse or hamster proteins If you are unsure about this, ask your doctor. Warnings and precautions Talk to your doctor before using ADVATE. You should tell your doctor if you have been previously treated with Factor VIII products, especially if you developed inhibitors, since there might be a higher risk that it happens again. Inhibitors are blocking antibodies against factor VIII that reduce the efficacy of ADVATE to prevent or control bleeding. Development of inhibitors is a known complication in the treatment of haemophilia A. If your bleeding is not controlled with ADVATE, tell your doctor immediately. There is a rare risk that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ADVATE. You should be aware of the early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness. These symptoms can constitute an early symptom of an anaphylactic shock, manifestations of which may additionally include extreme dizziness, loss of consciousness, and extreme difficulty in breathing. If any of these symptoms occur, stop the injection immediately and contact your doctor. Severe symptoms, including difficulty in breathing and (near) fainting, require prompt emergency treatment. Patients developing Factor VIII inhibitors The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors. If you or your child s bleeding is not being controlled with ADVATE, tell your doctor immediately. Children and adolescents The listed warnings and precautions apply to both adults and children (from 0 to 18 years of age). Other medicines and ADVATE Tell your doctor if you are using, have recently used or might use 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 using this medicine. Driving and using machines ADVATE has no influence on your ability to drive or to use machines. ADVATE contains sodium This medicine contains 10 mg sodium (main component of cooking salt) per vial. This is equivalent to 0.5 % of the recommended maximum daily dietary intake of sodium for an adult.

Treatment with ADVATE will be started by a doctor who is experienced in the care of patients with haemophilia A. Your doctor will calculate your dose of ADVATE (in international units or IU) depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding. The frequency of administration will depend on how well ADVATE is working for you. Usually, the replacement therapy with ADVATE is a life-long treatment. Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Prevention of bleeding The usual dose of octocog alfa is 20 to 40 IU per kg body weight, administered every 2 to 3 days. However, in some cases, especially in younger patients, more frequent injections or higher doses may be necessary. Treatment of bleeding The dose of octocog alfa is calculated depending on your body weight and the factor VIII levels to be achieved. The target factor VIII levels will depend on the severity and location of the bleeding. Dose (IU) = body weight (kg) x desired Factor VIII rise (% of normal) x 0.5 If you have the impression that the effect of ADVATE is insufficient, talk to your doctor. Your doctor will perform appropriate laboratory tests to make sure that you have adequate Factor VIII levels. This is particularly important if you are having major surgery. Use in children and adolescents (from 0 to 18 years of age) For the treatment of bleeding the dosing in children does not differ from adult patients. For the prevention of bleeding in children under the age of 6, doses of 20 to 50 IU per kg body weight 3 to 4 times weekly are recommended. The administration of ADVATE in children (intravenously) does not differ from the administration in adults. A central venous access device (CVAD) may become necessary to allow frequent infusions of factor VIII products. How ADVATE is given ADVATE is usually injected into a vein (intravenously) by your doctor or nurse. You or someone else might also administer ADVATE as an injection, but only after receiving adequate training. Detailed instructions for self-administration are given at the end of this package leaflet. If you use more ADVATE than you should Always take ADVATE exactly as your doctor has told you. You should check with your doctor if you are not sure. If you inject more ADVATE than recommended, tell your doctor as soon as possible. If you forget to use ADVATE 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 ADVATE Do not stop using ADVATE without consulting your doctor. 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, sudden allergic reactions (anaphylactic) occur, the injection must be stopped immediately. You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions:

rash, hives, wheals, generalised itching,

swelling of lips and tongue,

difficulty in breathing, wheezing, tightness in the chest,

general feeling of being unwell,

dizziness and loss of consciousness. Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment. For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 people); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in people). If this happens your or your child s medicines may stop working properly and you or your child may experience persistent bleeding. If this happens, you should contact your doctor immediately. Very common side effects (may affect more than 1 in 10 people) Factor VIII inhibitors (for children not previously treated with Factor VIII medicines). Common side effects (may affect up to 1 in 10 people) headache and fever. Uncommon side effects (may affect up to 1 in 100 people) Factor VIII inhibitors (for patients who have received previous treatment with Factor VIII (more than 150 days of treatment)), dizziness, flu, fainting, abnormal heartbeat, red itchy bumps on the skin, chest discomfort, injection site bruise, injection site reaction, itching, increased sweating, unusual taste in the mouth, hot flushes, migraines, memory impairment, chills, diarrhoea, nausea, vomiting, shortness of breath, sore throat, infection of the lymphatic vessels, whitening of skin, eye inflammation, rashes, excessive sweating, foot and leg swelling, reduced percentage of red blood cells, increase in a type of white blood cells (monocytes), and pain in the upper abdomen or lower chest. Related to surgery catheter-related infection, decreased red cell blood count, swelling of limbs and joints, prolonged bleeding after drain removal, decreased Factor VIII level and post-operative bruise. Related to central venous access devices (CVAD) catheter-related infection, systemic infection and local blood clot at the catheter site. Side effects with unknown frequency (frequency cannot be estimated from the available data) potentially life-threatening reactions (anaphylaxis) and other allergic reactions (hypersensitivity), general disorders (tiredness, lack of energy). Additional side effects in children Other than the development of inhibitors in previously untreated paediatric patients (PUPs), and catheter-related complications, no age-specific differences in side effects were noted in the clinical studies. 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 label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C 8 C). Do not freeze. During the shelf life the powder vial may be kept at room temperature (up to 25 C) for a single period not exceeding 6 months. In this case, this medicine expires at the end of this 6 month period or the expiration date printed on the product vial, whichever is earlier. Please record the end of the 6 months storage at room temperature on the product carton. The product may not be returned to refrigerated storage after storage at room temperature. Keep the vial in the outer carton in order to protect from light. This product is for single use only. Discard any unused solution appropriately. Use the product immediately once the powder is completely dissolved. Do not refrigerate the solution after preparation. 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 protect the environment.

What ADVATE contains

The active substance is octocog alfa (human coagulation Factor VIII produced by recombinant DNA technology). Each powder vial contains nominally 250, 500, 1000, 1500, 2000, or 3000 IU octocog alfa.

The other ingredients are mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, and glutathione (reduced). Solvent vial: 5 ml sterilised water for injections What ADVATE looks like and contents of the pack ADVATE is a white to off-white friable powder. After reconstitution, the solution is clear, colourless and free from foreign particles. Each pack also contains a device for reconstitution (BAXJECT II). Marketing Authorisation Holder Takeda Manufacturing Austria AG Industriestrasse A-1221 Vienna Tel: +800 66838e-mail: medinfoEMEA@takeda.com 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 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 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 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 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

Proton Medical (Cyprus) Ltd .: +357 22866admin@protoncy.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: