RONAPREVE Solution for injection/infusion (2021)
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Περιεχόμενα
1. Name of the medicinal product
Ronapreve 120 mg/mL solution for injection or infusion.
2. Qualitative and quantitative composition
Co-packaged 6 mL single-use vials Each casirivimab 6 mL vial contains 300 mg of casirivimab per 2.5 mL (120 mg/mL). Each imdevimab 6 mL vial contains 300 mg imdevimab per 2.5 mL (120 mg/mL). Co-packaged ...
3. Pharmaceutical form
Solution for injection/infusion (sterile concentrate). Clear to slightly opalescent and colourless to pale yellow solution with a pH of 6.0.
4.1. Therapeutic indications
Ronapreve is indicated for the prophylaxis and treatment of acute Covid-19 infection (see sections 4.2, 4.6 4.8, 5.1 and 5.2 for additional information on extent and limits of accepted clinical trial evidence). ...
4.2. Posology and method of administration
Preparation and administration of Ronapreve should be initiated and monitored by a qualified healthcare provider using aseptic technique. Administration should be under conditions where management of severe ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Subsequent doses of Ronapreve should not be given to those who have experienced severe allergic reactions (e.g. ...
4.4. Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity Reactions including ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Casirivimab and imdevimab are monoclonal antibodies, which are not renally excreted or metabolised by cytochrome P450 enzymes; therefore, interactions with concomitant ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of casirivimab and imdevimab in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. In a tissue crossreactivity ...
4.7. Effects on ability to drive and use machines
Ronapreve has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile Overall, approximately 7,116 subjects (approximately 4666 via IV administration and 2450 via subcutaneous administration) have been treated with Ronapreve in clinical trials ...
4.9. Overdose
Doses up to 8,000 mg (4,000 mg each of casirivimab and imdevimab, approximately 7-times the recommended dose) have been administered in clinical trials with no new safety concerns identified. There is ...
5.1. Pharmacodynamic properties
Casirivimab: Pharmacotherapeutic group: Not yet assigned. ATC code: Not yet assigned. Imdevimab: Pharmacotherapeutic group: Not yet assigned. ATC code: Not yet assigned. Mechanism of action Casirivimab ...
5.2. Pharmacokinetic properties
Both casirivimab and imdevimab exhibited linear and dose-proportional pharmacokinetics (PK) between 300 mg Ronapreve (150 mg casirivimab and 150 mg imdevimab) to 8,000 mg Ronapreve (4,000 mg casirivimab ...
5.3. Preclinical safety data
Carcinogenicity, genotoxicity, and reproductive toxicology studies have not been conducted with casirivimab and imdevimab. In a toxicology study in cynomolgus monkeys, casirivimab and imdevimab had no ...
6.1. List of excipients
L-histidine L-histidine monohydrochloride monohydrate Polysorbate 80 Sucrose Water for injection
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
<u>Unopened vial:</u> 12 months. Co-packaged 20 mL multidose vials After initial puncture: If not used immediately, the product in the vial can be stored for 6 hours at room temperature up to 25°C or for ...
6.4. Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Do not shake. Keep the vials in the original carton in order to protect from light. For storage conditions after dilution of the medicinal product, see ...
6.5. Nature and contents of container
Ronapreve is provided in clear Type 1 glass vials in 20 mL or 6 mL vials. Each carton contains 2 vials per package: <u>Ronapreve 120 mg/mL solution for infusion or injection, multidose vials:</u> Pack ...
6.6. Special precautions for disposal and other handling
General precautions Casirivimab and imdevimab vials should be inspected visually to ensure there is no particulate matter or discolouration prior to the administration. If particulate matter or discolouration ...
7. Marketing authorization holder
Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
8. Marketing authorization number(s)
PLGB 00031/0925
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 19 August 2021
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