Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - afstyla

Document Subject

Generated Narrative: MedicinalProductDefinition mpc832a88299d92f8a87ef0072aef518b9

identifier: http://ema.europa.eu/identifier/EU/1/16/1158/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: AFSTYLA 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-c832a88299d92f8a87ef0072aef518b9

identifier: http://ema.europa.eu/identifier/EU/1/16/1158/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - afstyla

Attesters

What is in this leaflet:

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

AFSTYLA is a human clotting (coagulation) factor VIII product that is produced by recombinant DNA technology. The active substance in AFSTYLA is lonoctocog alfa.

AFSTYLA is used to treat and prevent bleeding episodes in patients with haemophilia A (inborn factor VIII deficiency). Factor VIII is a protein needed for blood to clot. Patients with haemophilia A lack this factor, so blood does not clot as quickly as it should and they have an increased tendency to bleed. AFSTYLA works by replacing the missing factor VIII in haemophilia A patients enabling their blood to clot normally.

AFSTYLA can be used for all age groups.

Do not use AFSTYLA

• if the AFSTYLA patient had an allergic reaction to AFSTYLA, or any of its ingredients (listed in section 6).
• if the AFSTYLA patient is allergic to hamster proteins.

Warnings and precautions

Traceability It is important to keep a record of the batch number of your AFSTYLA. So, every time you get a new package of AFSTYLA, note down the date and the batch number (which is on the packaging after Lot ) and keep this information in a safe place.

Talk to your doctor, pharmacist or nurse before using AFSTYLA.

• Allergic (hypersensitivity) reactions are possible. The product contain traces of hamster proteins (see also Do not use AFSTYLA ). If symptoms of allergic reactions occur, stop using the medicine immediately and contact your doctor. Your doctor should inform you of the early signs of allergic reactions. These include hives, generalised skin rash, tightness of the chest, wheezing, fall in blood pressure and anaphylaxis (a serious allergic reaction that causes severe difficulty in breathing, and dizziness).
• 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. You or your child will be monitored carefully for the development of inhibitors. If you or your child s bleeding is not being controlled with AFSTYLA, tell your doctor immediately.
• If you or your child have been told you have heart disease or are at risk for heart disease, tell your doctor or pharmacist.
• If a central venous access device (CVAD) is used for injection of AFSTYLA, the risk of complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot (thrombosis) in the blood vessel where it is inserted should be considered by your doctor and discussed with you.

Other medicines and AFSTYLA Tell your doctor or pharmacist 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 or pharmacist for advice before taking this medicine.
• During pregnancy and breast-feeding, AFSTYLA should be given only if it is clearly needed.

Driving and using machines AFSTYLA does not affect your ability to drive and use machines.

AFSTYLA contains sodium AFSTYLA contains up to 35.0 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult.

Your treatment should be monitored by a doctor who is experienced in the treatment of blood clotting disorders.

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Dose The amount of AFSTYLA you or your child need to take and the duration of treatment depend on:

• the severity of your disease
• the site and intensity of the bleeding
• your clinical condition and response
• your body weight

Follow the directions given to you by your doctor. Reconstitution and administration

General instructions

• The powder must be mixed with the solvent (liquid) and withdrawn from the vial under aseptic conditions.
• AFSTYLA must not be mixed with other medicines or solvents except those mentioned in section 6. * The solution should be clear or slightly opalescent, yellow to colourless, i.e., it might be sparkling when held up to the light but must not contain any obvious particles. After filtering or withdrawal (see below) the solution should be checked again, before it is used. Do not use the solution if it is visibly cloudy or if it contains flakes or particles.
• Any unused product or waste material should be disposed of in accordance with local requirements and as instructed by your doctor.

Reconstitution and administration Without opening the vials, ensure the AFSTYLA powder and the liquid is at room or body temperature. This can be done either by leaving the vials at room temperature for about an hour, or by holding them in your hands for a few minutes.
Do not expose the vials to direct heat. The vials must not be heated above body temperature (37 C).

Carefully remove the protective caps from the vials, and clean the exposed rubber stoppers with an alcohol swab. Allow the vials to dry before opening the Mix2Vial package (which contains the filter transfer device), then follow the instructions given below.

1

1. Open the Mix2Vial by peeling off the lid. Do not remove the Mix2Vial from the blister package! 2
2. Place the solvent vial on an even, clean surface and hold the vial tight. Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper. 3
3. Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards. Make sure that you only pull away the blister package and not the Mix2Vial set. 4
4. Place the powder vial on an even and firm surface. Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the powder vial stopper. The solvent will automatically flow into the powder vial. 5
5. With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully counterclockwise into two pieces. Discard the solvent vial with the blue Mix2Vial adapter attached. 6
6. Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved. Do not shake. 7
7. Draw air into an empty, sterile syringe. While the product vial is upright, connect the syringe to the Mix2Vial's Luer Lock fitting by screwing clockwise. Inject air into the product vial.

Withdrawal and administration

8 8. While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly. 9 9. Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counterclockwise.

Use the venipuncture kit supplied with the product, insert the needle into a vein. Let blood flow back to the end of the tube. Attach the syringe to the threaded, locking end of the venipuncture kit. Inject the reconstituted solution slowly (as comfortable for you, up to a maximum of 10 ml/min) into the vein following the instructions given to you by your doctor. Take care not to get any blood in the syringe containing the product.

Check yourself for any side effects that might happen straight away. If you have any side effects that might be related to the administration of AFSTYLA, the injection should be stopped (see also section 2). Use in children and adolescents AFSTYLA can be used in children and adolescents of all ages. In children below the age of 12 higher doses or more frequent injections may be needed. Children above 12 years of age can use the same dose as adults.

If you use more AFSTYLA than you should If you have injected more AFSTYLA than you should, please inform your doctor.

If you forget to use AFSTYLA
Do not take a double dose to make up for a forgotten dose. Proceed with the next dose immediately and continue as advised by your doctor.

If you stop using AFSTYLA If you stop using AFSTYLA you may no longer be protected against bleeding or a current bleed may not stop. Do not stop using AFSTYLA without consulting your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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

Please stop using the medicine immediately and contact your doctor if:

• you notice symptoms of allergic reactions
  Allergic reactions may include the following symptoms: hives, generalised urticaria (itchy rash), tightness of the chest, wheezing, low blood pressure, and anaphylaxis (a serious reaction that causes severe difficulty in breathing or dizziness). If this happens, you should stop using the medicine immediately and contact your doctor.
• you notice that the medicine has stopped working properly (bleeding is not stopped) For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section

2. may form very commonly (more than 1 in 10 patients); however, in patients who have received previous treatment with Factor VIII (more than 150 days of treatment) this is uncommon (less than 1 in 100 patients). If you or your child has developed an inhibitor with the medicine, you may experience persistent bleeding. If this happens, you should contact your doctor immediately.

Common side effects (may affect up to 1 in 10 users)

• tingling or numbness (paraesthesia)
• rash
• fever

Uncommon side effects (may affect up to 1 in 100 users)

• itching
• redness of the skin
• pain at the injection site
• chills
• feeling hot

Side effects in children and adolescents No age-specific differences in adverse reactions were observed between children, adolescents and adults.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist 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 label and carton.
• Store in a refrigerator (2 C to 8 C).
• Before the AFSTYLA powder is reconstituted it may be kept at room temperature (below 25 C) for a single period not exceeding 3 months, within the expiration date printed on the cartons and the vials. Please record the date from when you start to store AFSTYLA at room temperature on the product carton.
• Once the product has been taken out of the refrigerator, the product must not be returned to the refrigerator.
• Do not freeze.
• Keep the vial in the outer carton in order to protect from light.
• The reconstituted product should preferably be used immediately.
• If the reconstituted product is not administered immediately, storage times and conditions prior to use are the responsibility of the user.

What AFSTYLA contains

The active substance is: 250 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 100 IU/ml of lonoctocog alfa. 500 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 200 IU/ml of lonoctocog alfa.
1000 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 400 IU/ml of lonoctocog alfa. 1500 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 300 IU/ml of lonoctocog alfa. 2000 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 400 IU/ml of lonoctocog alfa. 2500 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 500 IU/ml of lonoctocog alfa. 3000 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 600 IU/ml of lonoctocog alfa.

The other ingredients are: L-Histidine, polysorbate 80, calcium chloride dihydrate, sodium chloride (see last paragraph of section 2), sucrose.

Solvent: Water for injections.

What AFSTYLA looks like and contents of the pack

AFSTYLA is presented as white or slightly yellow powder or friable mass and clear, colourless solvent for solution for injection.

The reconstituted solution should be clear to slightly opalescent, yellow to colourless i.e., it might sparkle when held up to the light but must not contain any obvious particles.

Presentations One pack with 250, 500 or 1000 IU containing: 1 vial with powder 1 vial with 2.5 ml water for injections 1 filter transfer device 20/One inner box containing: 1 disposable 5 ml syringe 1 venipuncture set 2 alcohol swabs 1 non- sterile plaster

One pack with 1500, 2000, 2500 or 3000 IU containing: 1 vial with powder 1 vial with 5 ml water for injections 1 filter transfer device 20/One inner box containing: 1 disposable 10 ml syringe 1 venipuncture set 2 alcohol swabs 1 non- sterile plaster

Not all pack sizes may be marketed.

Immediate containers

250 IU Glass vial with a rubber stopper, an orange plastic disc, and a green striped aluminium cap 500 IU Glass vial with a rubber stopper, a blue plastic disc, and a green striped aluminium cap 1000 IU Glass vial with a rubber stopper, a green plastic disc, and a green striped aluminium cap 1500 IU Glass vial with a rubber stopper, a turquoise plastic disc, and a green striped aluminium cap 2000 IU Glass vial with a rubber stopper, a purple plastic disc, and a green striped aluminium cap 2500 IU Glass vial with a rubber stopper, a light grey plastic disc, and a green striped aluminium cap 3000 IU Glass vial with a rubber stopper, a yellow plastic disc, and a green striped aluminium cap

Marketing Authorization Holder and Manufacturer

CSL Behring GmbH Emil-von-Behring-Stra e 35041 Marburg Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien CSL Behring NV T l/Tel: +32 15 28 89 Luxembourg/Luxemburg CSL Behring NV T l/Tel: +32 15 28 89

: +359 2 810 3Magyarorsz g CSL Behring Kft. Tel.: +36 1 213 4 esk republika Malta CSL Behring s.r.o. Tel: + 420 702 137 AM Mangion Ltd. Tel: +356 2397 6Danmark CSL Behring AB Tel: +46 8 544 966 Nederland CSL Behring BV Tel: + 31 85 111 96 Deutschland CSL Behring GmbH Tel: +49 69 30584Eesti CentralPharma Communications O
Tel: +3726015Norge CSL Behring AB Tlf: +46 8 544 966
CSL Behring
: +30 210 7255 sterreich CSL Behring GmbH Tel: +43 1 80101 2Espa a CSL Behring S.A. Tel: +34 933 67 1Polska CSL Behring Sp.z o.o. Tel: +48 22 213 22 France CSL Behring S.A. T l: + 33 (0)-1 53 58 54 Portugal CSL Behring Lda Tel: +351 21 782 62 Hrvatska
Marti Farm d.o.o. Tel: +385 1 5588Rom nia Prisum Healthcare S.R.L. Tel: +40 21 322 0Ireland CSL Behring GmbH Tel: +49 69 30517Slovenija NEOX s.r.o.-podru nica v Sloveniji
Tel:+ 386 41 42 0 sland CSL Behring AB S mi: +46 8 544 966 Slovensk republika CSL Behring s.r.o. Tel: +421 911 653 Italia CSL Behring S.p.A. Tel: +39 02 34964 Suomi/Finland CSL Behring AB Puh/Tel: +46 8 544 966
CSL Behring
: +30 210 7255 Sverige CSL Behring AB Tel: +46 8 544 966 Latvija CentralPharma Communications SIA
Tel: +371 6 7450United Kingdom (Northern Ireland) CSL Behring GmbH Tel: +49 69 305 17Lietuva CentralPharma Communications UAB Tel: +370 5 243 0This leaflet was last revised in {MM/YYYY}.

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