Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ronapreve

Document Subject

Generated Narrative: MedicinalProductDefinition mp0d50af8d664b571d625f5732b765b8b5

identifier: http://ema.europa.eu/identifier/EU/1/21/1601/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ronapreve 300 mg + 300 mg solution for injection/infusion

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-0d50af8d664b571d625f5732b765b8b5

identifier: http://ema.europa.eu/identifier/EU/1/21/1601/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - ronapreve

Attesters

What is in this leaflet

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

What Ronapreve is

Ronapreve is made up of the active substances casirivimab and imdevimab . Casirivimab and imdevimab are a type of protein called monoclonal antibodies .

What Ronapreve is used for

Ronapreve is used to treat adults and adolescents aged from 12 years weighing at least 40 kg with COVID-19 who do not require oxygen to treat COVID-19, and are at increased risk for the illness becoming severe based on the evaluation of your doctor.

Ronapreve is used to treat COVID-19 in adults and adolescents aged from 12 years weighing at least 40 kg who require oxygen to treat COVID-19, and who test negative for antibodies (proteins in the body s defence system) against COVID-19. Ronapreve is used to prevent COVID-19 in adults and adolescents aged from 12 years weighing at least 40 kg.

How Ronapreve works

Ronapreve attaches to a protein on the surface of the coronavirus called the spike protein . This stops the virus from getting into your cells and from spreading between cells.

You must not be given Ronapreve

if you are allergic to casirivimab, imdevimab, or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor or nurse as soon as possible, if this applies to you.

Warnings and precautions

This medicine can cause allergic reactions or reactions following the infusion or injection. The signs of these reactions are listed in Section 4. Tell your doctor straight away if you get any of these signs or symptoms.

Children and adolescents

Do not give this medicine to children under 12 years of age or adolescents that weigh less than 40 kg.

Other medicines and Ronapreve

Before you have Ronapreve, tell the doctor or nurse who is giving it to you about any other medicines you are taking, or have recently taken.
After you have had Ronapreve:

tell the doctor, nurse or pharmacist that you have had this medicine to treat or prevent COVID-

tell the doctor, nurse or pharmacist you have had this medicine, if you are getting a COVID-vaccine.

Pregnancy and breast-feeding

Tell your doctor or nurse if you are pregnant, or if you might be pregnant.

This is because there is not enough information to be sure that this medicine is safe for use in pregnancy.

This medicine will only be given if the potential benefits of treatment outweigh the potential risks to the mother and the unborn child.

Tell your doctor or nurse if you are breast-feeding.

This is because it is not yet known whether this medicine passes into human breast milk - or what the effects might be on the baby or milk production.

Your doctor will help you decide whether to keep breast-feeding or to start treatment with this medicine.

Driving and using machines

This medicine is not expected to have any effect on your ability to drive.

How much is given?

The recommended dose for treatment of COVID-19 will depend on the severity of your illness.

The recommended dose for treatment of COVID-19 in adults and in adolescents 12 years of age and older weighing at least 40 kg, who do not need oxygen therapy, is 600 mg of casirivimab and 600 mg of imdevimab.

The recommended dose for treatment of COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kg, who need oxygen therapy, is 4 000 mg of casirivimab and 4 000 mg of imdevimab.

The recommended dose for prevention of COVID-19 in adults and in adolescents 12 years of age and older weighing at least 40 kg is 600 mg of casirivimab and 600 mg of imdevimab.

The recommended dose for continuous prevention of COVID-19 in adults and in adolescents 12 years of age and older weighing at least 40 kg is 600 mg of casirivimab and 600 mg of imdevimab as the initial dose, and the subsequent doses are 300 mg of casirivimab and 300 mg of imdevimab once every four weeks.

How is this medicine given?

Casirivimab and imdevimab may be given together as a single infusion (drip) into a vein over 20 to 60 minutes. In patients who do not need oxygen therapy, this medicine may also be given as injections, given immediately one after the other, under the skin made at separate body sites if an infusion would delay treatment. Your doctor or nurse will decide how long you will be monitored after you are given the medicine. This is in case you have any side effects.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with Ronapreve.

Reactions following the infusion

Tell your doctor straight away if you get any of these signs of an allergic reaction or reaction listed below during or following the infusion. The infusion may need to be slowed down, interrupted or stopped and you may need other medicines to treat the symptoms. The signs or symptoms of allergic reaction or infusion-related reactions may include:

Uncommon: may affect up to 1 in 100 people

• feeling sick (nausea)
• chills
• dizziness
• flushing
• itching
• abnormally fast breathing
• rash

Rare: may affect up to 1 in 1 000 people

• severe allergic reaction (anaphylaxis)
• allergic reactions
• itchy rash

Other side effects that have been reported (frequency not known):

fainting which may be accompanied by muscle spasm or twitching

Reactions following the subcutaneous (under the skin) injection

Tell your doctor straight away if you get any of these signs of a reaction following the injections.

Common: may affect up to 1 in 10 people

• redness, bruising, swelling, pain or itchy rash at the injection site

Uncommon: may affect up to 1 in 100 people

dizziness

swollen lymph nodes close to injection site

Rare: may affect up to 1 in 1 000 people

• itching

Other side effects that have been reported (frequency not known):

fainting which may be accompanied by muscle spasm or twitching

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

Ronapreve will be stored by the healthcare professionals at the hospital or clinic under the following conditions:

Before use, store unopened Ronapreve concentrated solution in a refrigerator until the day it is needed. Before diluting it, allow the concentrated solution to come up to room temperature.

Once diluted, Ronapreve should be used immediately. If necessary, bags of diluted solution can be stored at 2 C to 8 C for no more than 72 hours and at room temperature up to 25 C for no more than 20 hours. If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 30 minutes prior to administration.

Prepared syringes should be used immediately. If necessary, store the prepared syringes at 2 C to 8 C for no more than 72 hours and at room temperature up to 25 C for no more than 24 hours. If refrigerated, allow the syringes to equilibrate to room temperature for approximately 10-15 minutes prior to administration.

Do not use this medicine if you notice particulate matter or discolouration.

What Ronapreve contains

The active substances are casirivimab and imdevimab. Each 6 mL single-use vial contains 300 mg of casirivimab or 300 mg of imdevimab.

The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injections.

What Ronapreve looks like and contents of the pack

Ronapreve is a solution for injection/infusion. It is a clear to slightly opalescent and colourless to pale yellow solution and is available in cartons that contain 2 vials per package, one vial for each active substance.

Marketing Authorisation Holder

Roche Registration GmbH
Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany

Manufacturer

Roche Pharma AG
Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany

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

Belgi /Belgique/Belgien N.V. Roche S.A. T l/Tel: +32 (0) 2 525 82 Lietuva UAB Roche Lietuva
Tel: +370 5 2546

: +359 2 818 44 Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)

esk republika Roche s. r. o. Tel: +420 - 2 20382Magyarorsz g Roche (Magyarorsz g) Kft. Tel: +36 1 279 4Danmark Roche Pharmaceuticals A/S Tlf: +45 - 36 39 99 Malta (See Ireland)

Deutschland Roche Pharma AG Tel: +49 (0) 7624 Nederland Roche Nederland B.V. Tel: +31 (0) 348 438Eesti Roche Eesti O
Tel: + 372 - 6 177 Norge Roche Norge AS Tlf: +47 - 22 78 90
Roche (Hellas) A.E.
: +30 210 61 66 sterreich Roche Austria GmbH Tel: +43 (0) 1 27Espa a Roche Farma S.A. Tel: +34 - 91 324 81 Polska Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 88. France Roche T l: +33 (0)1 47 61 40 Portugal Roche Farmac utica Qu mica, Lda Tel: +351 - 21 425 70 Hrvatska Roche d.o.o. Tel: + 385 1 47 22 Ireland Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0Rom nia Roche Rom nia S.R.L. Tel: +40 21 206 47 Slovenija Roche farmacevtska dru ba d.o.o. Tel: +386 - 1 360 26 sland Roche Pharmaceuticals A/S c/o Icepharma hf S mi: +354 540 8Slovensk republika Roche Slovensko, s.r.o. Tel: +421 - 2 52638Italia Roche S.p.A. Tel: +39 - 039 2Suomi/Finland Roche Oy
Puh/Tel: +358 (0) 10 554
. . & . : +357 - 22 76 62 Sverige Roche AB Tel: +46 (0) 8 726 1Latvija Roche Latvija SIA Tel: +371 - 6 7039United Kingdom (Northern Ireland) Roche Products (Ireland) Ltd. Tel: +44 (0) 1707 366This leaflet was last revised in.

Other sources of information

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