Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cablivi

Document Subject

Generated Narrative: MedicinalProductDefinition mp2d5ce8dc4824b4100ae659aba75ae904

identifier: http://ema.europa.eu/identifier/EU/1/18/1305/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Cablivi 10 mg 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-2d5ce8dc4824b4100ae659aba75ae904

identifier: http://ema.europa.eu/identifier/EU/1/18/1305/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - cablivi

Attesters

What is in this leaflet

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

Cablivi contains the active substance caplacizumab. It is used to treat an episode of acquired thrombotic thrombocytopenic purpura in adults and adolescents of 12 years of age and older weighing at least 40 kg. This is a rare blood clotting disorder in which clots form in small blood vessels. These clots can block blood vessels and damage the brain, heart, kidneys, or other organs. Cablivi prevents the formation of these blood clots by stopping platelets in the blood from clumping together. By doing so, Cablivi reduces the risk of experiencing another episode of aTTP soon after the first.

Do not use Cablivi

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

Warnings and precautions

Tell your doctor if you:

• bleed excessively or experience unusual symptoms such as headache, shortness of breath, tiredness, or fainting which may indicate serious internal bleeding. Your doctor may ask you to stop the treatment. The doctor will say when you can start your treatment again.
• are using medicines that prevent or treat blood clots such as warfarin, heparin, rivaroxaban, apixaban. Your doctor will decide how you should be treated.
• are using anti-platelet agents such as aspirin, or low molecular weight heparin (which prevent blood clots). Your doctor will decide how you should be treated.
• have a bleeding disorder such as haemophilia. Your doctor will decide how you should be treated.
• have severely reduced liver function. Your doctor will decide how you should be treated.
• are going to have an operation or dental treatment. Your doctor will decide if it can be postponed or if you should stop Cablivi before your surgery or dental treatment.
  Children and adolescents Cablivi is not recommended for children under 12 years and below 40 kg body weight.

Other medicines and Cablivi Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Also tell your doctor if you are using an anticoagulant medicine such as vitamin K antagonists, rivaroxaban, or apixaban which treat blood clots or anti-platelet agents, such as aspirin, or low molecular weight heparin which prevent blood clots.

Pregnancy and breast-feeding Tell your doctor if you are pregnant or plan to get pregnant. Use of Cablivi is not recommended during pregnancy.

Tell your doctor if you are breastfeeding. Your doctor will advise you whether to discontinue breastfeeding or not use Cablivi, considering the benefit of breastfeeding to the baby and the benefit of Cablivi to you.

Driving and using machines Cablivi is not expected to influence the ability to drive or use machines.

Cablivi contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .

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

Treatment with Cablivi is started by a doctor experienced in blood disorders.

The recommended treatment is

• first dose

• 1 vial injected into a vein by a healthcare professional
• the medicine will be given before starting plasma exchange.

• subsequent doses

• 1 vial once daily as a subcutaneous injection (under the skin of the belly)
• the subcutaneous injection will be given after each daily plasma exchange
• after the daily plasma exchange finishes, your treatment with Cablivi will continue for at least 30 days with injection of 1 vial once daily
• your doctor may ask you to continue daily treatment until the underlying signs of your disease are resolved.

Your doctor may decide that you or your caregiver may inject Cablivi. In this case, your doctor or healthcare provider will train you or your caregiver on how to use Cablivi.

Instructions for use
The first injection of Cablivi into your vein must be given by a healthcare professional. Instructions for healthcare professionals on how to inject Cablivi into your vein are at the end of the leaflet.

For each injection, use a fresh kit package to prepare the injection solution. Do not try to inject Cablivi until you have been taught how to do so by a healthcare professional. Never use the kit for another injection. Step 1 - Cleaning

• Wash your hands thoroughly with soap and water.
• Prepare a clean flat surface for placing the kit package.
• Make sure you have a disposal container at hand.

Step 2 - Before use

• Make sure the kit package is complete.
• Check the expiry date. Do not use if the expiry date has passed.
• Do not use the kit if the packaging or the items in it are damaged in any way.
• Place all components of the kit on the clean flat surface.
• If the kit was not stored at room temperature, allow the vial and the syringe to reach room temperature (15 C 25 C) by letting them stand at room temperature for a few minutes. Do not warm them up in any other way.

Step 3 - Disinfect the rubber stopper

• Remove the plastic flip-off cap from the vial. Do not use the vial if the green plastic cap is missing.
• Clean the exposed rubber stopper using one of the alcohol pads provided and allow it to dry for a few seconds.
• After cleaning, do not touch the rubber stopper or allow it to touch any surface.

Step 4 - Attaching the adapter

• Take the packed vial adapter and remove the paper cover. Leave the adapter in its opened plastic packaging. Do not touch the adapter itself.

• Place the adapter over the vial, while keeping the adapter in its plastic packaging.

• Press down firmly until the adapter snaps into place, with the adapter spike going through the vial stopper. Leave the adapter attached to the vial, still in its outer packaging.

Step 5 - Prepare the syringe

• Holding the syringe in your hand, break off the white cap with your other hand.

• Do not use the syringe if this white cap is missing, loose or damaged.

• Do not touch the syringe tip or allow it to come into contact with any surfaces.

• Place the syringe on the clean flat surface.

Step 6 - Connect syringe with adapter and vial

• Take the vial with the attached adapter.

• Remove the plastic packaging from the adapter by holding the vial with one hand, pressing the sides of the adapter packaging with your other hand, and then lifting the packaging upwards. Take care that the adapter does not come away from the vial.

• Hold the adapter with the attached vial with one hand. Place the tip of the syringe on the connector part of the vial adapter.

• Gently lock the syringe onto the vial by turning it clockwise until resistance is felt.

Step 7 - Prepare the solution

• Keep the vial standing vertically on the surface with the syringe pointing downwards.

• Slowly push the syringe s plunger down until the syringe is empty. Do not remove the syringe from the vial.

• With the syringe still connected to the vial adapter, gently swirl the vial with connected syringe until the powder is dissolved. Avoid foaming. Do not shake the vial.

• Allow the vial with connected syringe to stand on the surface for 5 minutes at room temperature to allow the solution to completely dissolve. The plunger may rise up by itself again - this is normal.

• Go to step 8 immediately after these 5 minutes.

Step 8 - Draw up solution

• Check the solution for particles. All powder must be dissolved and the solution must be clear.
• Slowly press the syringe s plunger fully down.
• Turn the whole - vial, adapter and syringe - upside down.
• While keeping it vertical, slowly pull the plunger to transfer all the solution into the syringe. Do not shake it.

Step 9 - Prepare the syringe for administration

• Turn the whole - vial, adapter and syringe - right-side up (with the syringe at the top). Disconnect the filled syringe from the adapter by holding the adapter in one hand and gently turning the syringe counter-clockwise.
• Put the vial and the attached adapter into the supplied disposal container.
• Do not touch the syringe tip or allow it to touch the surface. Place the syringe on the clean flat surface.
• Go to step 10 to inject caplacizumab under the skin of the belly. Instructions for healthcare professionals on how to inject Cablivi into your vein are at the end of the leaflet.

Step 10 - Attach the needle

• Unpack the needle by tearing the paper cover off the needle packaging and removing the needle with protective cap.

• Without removing the needle cap, attach the needle to the syringe by turning clockwise until resistance is felt.

• Pull back the needle safety shield.

• Check the content of the syringe. Do not use the medicine if you see any cloudiness, clumps or anything else that looks abnormal. Contact your doctor or nurse if this happens.

Step 11 - Prepare injection site for injection under the skin

• Select a suitable place ( injection site ) on your belly for injection under your skin. Avoid the area around the belly button. Select a different injection site from the one you used on the previous day to help the skin to recover after the injection.'
• Use the second alcohol pad to clean the injection site you have chosen.

Step 12 - Administration

• Carefully remove the needle protection cap from the needle and throw it away. Make sure the needle does not touch anything before the injection.

• Hold the syringe at eye level with the needle pointing upwards.

• Remove any air bubbles by tapping the side of the syringe with your finger to make the bubbles rise towards the tip. Then, slowly push the plunger until a small amount of liquid comes out of the needle.

• Gently pinch the cleaned skin between your thumb and forefinger to make a fold.

• Hold this skin fold during the entire injection.

• Insert the full length of the needle into the skin fold at an angle as shown in the illustration.

• Press the plunger down as far as it goes.

• Pull out the needle at the same angle you inserted it. Do not rub the injection site.

Step 13 - After administration

• Immediately after the injection, move the needle safety shield over the needle, until it clicks into place.

• Put the syringe with the needle in a disposal container.

If you use more Cablivi than you should An overdose is unlikely since one vial contains only a single dose. Tell your doctor if you think you have had an overdose.

If you forget to use Cablivi If you miss a dose you should still take it if it is within 12 hours of the scheduled time. If more than hours have passed since the dose should have been given, do not take the missed dose, but inject the next dose at the usual time.

If you stop using Cablivi To get the most benefit from your treatment, it is important to use Cablivi as prescribed and for as long as your doctor tells you to use it. Please talk to your doctor before you stop the treatment because stopping it too early can cause your condition to come back.

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.

Contact your doctor immediately if any of the following serious side effects occur.
Long or excessive bleeding.
Your doctor may decide to keep you under closer observation or change your treatment.
Side effects in a clinical study were reported with the following frequencies:

Very common, may affect more than 1 in 10 people

• bleeding gums
• fever
• tiredness
• headache
• nosebleeds
• hives

Common, may affect up to 1 in 10 people

• bleeding from eye
• vomiting blood
• blood in the stools
• black, tarry stools
• bleeding from the stomach
• bleeding hemorrhoids
• rectal bleeding
• injection site reactions: rash, itching and bleeding
• bleeding in brain as evidenced by severe headache of rapid onset, vomiting, decreased level of consciousness, fever, sometimes seizures and neck stiffness or neck pain
• muscle pain
• stroke
• blood in urine
• excessive bleeding during periods
• vaginal bleeding
• coughing blood
• shortness of breath
• bruise

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 label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C - 8 C). Do not freeze. Store in the original package in order to protect from light.

Cablivi may be stored at a temperature not above 25 C for a single period of up to 2 months, but not beyond the expiry date. Do not return Cablivi to refrigerated storage after storage at room temperature. Never expose to temperatures above 30 C.

Do not use Cablivi if you notice any particulate matter or discolouration prior to administration.

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 Cablivi contains

• powder vial

• The active substance is caplacizumab. Each vial contains 10 mg caplacizumab.
• The other ingredients are sucrose, citric acid anhydrous, trisodium citrate dihydrate (see section 2 Cablivi contains sodium ) and polysorbate 80. * pre-filled syringe The pre-filled syringe contains 1 mL water for injections.

What Cablivi looks like and contents of the pack

Cablivi is provided as:

• a white powder for solution for injection in a glass vial, and
• water for injections in a pre-filled syringe to dissolve the powder After dissolving the powder in the solvent, the solution is clear, colourless or slightly yellowish.

Cablivi is available in

• single packs each containing 1 vial with caplacizumab powder, 1 pre-filled syringe with solvent, 1 vial adapter, 1 needle and 2 alcohol swabs
• multipacks each containing 7 single packs
• multidose packs each containing 7 vials with caplacizumab powder, 7 pre-filled syringes with solvent, 7 vial adapters, 7 needles and 14 alcohol swabs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Ablynx NV Technologiepark 9052 Zwijnaarde
Belgium

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

Belgi /Belgique/Belgien Sanofi Belgium T l/Tel: +32 (0)2 710 54 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91
Swixx Biopharma EOOD .: +359 (0)2 4942 Luxembourg/Luxemburg Sanofi Belgium
T l/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

esk republika sanofi-aventis, s.r.o. Tel: +420 233 086 Magyarorsz g SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0Danmark Sanofi A/S Tlf: +45 45 16 70 Malta Sanofi S.r.l. Tel: +39 02 39394Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 04 36 Tel. aus dem Ausland: +49 69 305 70 Nederland Genzyme Europe B.V. Tel: +31 20 245 4Eesti Swixx Biopharma O
Tel: +372 640 10 Norge sanofi-aventis Norge AS Tlf: +47 67 10 71
sanofi-aventis AEBE : +30 210 900 16 sterreich sanofi-aventis GmbH Tel: +43 1 80 185 0

Espa a sanofi-aventis, S.A. Tel: +34 93 485 94 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 France sanofi-aventis France T l: 0 800 222 Appel depuis l tranger : +33 1 57 63 23 Portugal Sanofi - Produtos Farmac uticos, Lda. Tel: +351 21 35 89 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Slovenija Swixx Biopharma d.o.o.
Tel: +386 1 235 51 sland Vistor hf. S mi: +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Italia Sanofi S.r.l. Tel: 800 536Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200
C.A. Papaellinas Ltd. : +357 22 741Sverige Sanofi AB Tel: +46 (0)8 634 50 Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in.

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