Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
nirmatrelvir, ritonavir
Pfizer Europe MA EEIG
J05AE30
nirmatrelvir, ritonavir
COVID-19 virus infection
Paxlovid is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID 19.
Revision: 15
Authorised
2022-01-28
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Paxlovid 150 mg + 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pink film-coated tablet contains 150 mg of nirmatrelvir. Each white film-coated tablet contains 100 mg of ritonavir. Excipients with known effect Each pink 150 mg film-coated tablet of nirmatrelvir contains 176 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nirmatrelvir Film-coated tablet (tablet). Pink, oval, with a dimension of approximately 17.6 mm in length and 8.6 mm in width debossed with ‘PFE’ on one side and ‘3CL’ on the other side. Ritonavir Film-coated tablet (tablet). White to off white, capsule shaped tablets, with a dimension of approximately 17.1 mm in length and 9.1 mm in width, debossed with 'H' on one side and 'R9' on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paxlovid is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19 (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosage is 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) all taken together orally every 12 hours for 5 days. Paxlovid should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset. Completion of the full 5-day treatment course is recommended even if the patient requires hospitalisation due to severe or critical COVID-19 after starting treatment with Paxlovid. If the patient misses a dose of Paxlovid within 8 hours of the time it is usually taken, the patient should take it as soon a Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Paxlovid 150 mg + 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pink film-coated tablet contains 150 mg of nirmatrelvir. Each white film-coated tablet contains 100 mg of ritonavir. Excipients with known effect Each pink 150 mg film-coated tablet of nirmatrelvir contains 176 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nirmatrelvir Film-coated tablet (tablet). Pink, oval, with a dimension of approximately 17.6 mm in length and 8.6 mm in width debossed with ‘PFE’ on one side and ‘3CL’ on the other side. Ritonavir Film-coated tablet (tablet). White to off white, capsule shaped tablets, with a dimension of approximately 17.1 mm in length and 9.1 mm in width, debossed with 'H' on one side and 'R9' on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paxlovid is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19 (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosage is 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) all taken together orally every 12 hours for 5 days. Paxlovid should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset. Completion of the full 5-day treatment course is recommended even if the patient requires hospitalisation due to severe or critical COVID-19 after starting treatment with Paxlovid. If the patient misses a dose of Paxlovid within 8 hours of the time it is usually taken, the patient should take it as soon a Прочетете целия документ