Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
DUPILUMAB
SANOFI ISRAEL LTD
D11AH05
SOLUTION FOR INJECTION
DUPILUMAB 150 MG/ML
S.C
Required
SANOFI-AVENTIS GROUPE, FRANCE
DUPILUMAB
Atopic DermatitisDUPIXENT is indicated for the treatment of treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.AsthmaDUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.Limitation of UseDUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus. Chronic Rhinosinusitis with Nasal PolyposisDUPIXENT 300mg is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).Eosinophilic EsophagitisDUPIXENT is indicated for the treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE).Prurigo NodularisDupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
2023-02-28
Article Item code Based on Brand name Dosage Quantity Manuf. site Country Date of creation By Date of modification By Proof n° Tech. specif. Tech. area Size (mm) Datamatrix Font size DUPIXENT PFS-S 300 MG 2 SRG LE TRAIT ISRAEL LEAFLET 843429 827984 14/03/2022 I. MERLETTE 1 TRA-P041412C TRA-P041412-1A 296X472,5 52,5X148 FOLDED 843429 N/A THIS ARTWORK PROOF INDICATES COLOUR POSITION ONLY. Please refer to Pantone Colour Formula Guide 1000 for exact references Colours used: 4 PACKAGING ADMINISTRATION SANOFI WINTHROP INDUSTRIE - LE TRAIT - FRANCE CYAN MAGENTA YELLOW BLACK PLAN THE MOST COMMON SIDE EFFECTS: ∙ injection site reactions ∙ eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision ∙ pain in the throat (oropharyngeal pain) ∙ cold sores in the mouth or on the lips ∙ high count of a certain white blood cell (eosinophilia) ∙ trouble sleeping ∙ toothache ∙ gastritis ∙ joint pain THE FOLLOWING ADDITIONAL SIDE EFFECTS HAVE BEEN REPORTED: ∙ facial rash or redness IF A SIDE EFFECT OCCURS, IF ANY OF THE SIDE EFFECTS WORSEN, OR WHEN YOU ARE SUFFERING FROM A SIDE EFFECT NOT MENTIONED IN THE LEAFLET, CONSULT WITH THE DOCTOR. Side effects can be reported to the Ministry of Health by clicking on the link “Report Side Effects of Drug Treatment” found on the Ministry of Health homepage (www.health.gov.il) that directs you to the online form for reporting side effects, or by entering the link: https://sideeffects.health.gov.il 5. HOW SHOULD THE MEDICINE BE STORED? Avoid poisoning! This medicine and any other medicine must be kept in a safe place out of the reach and sight of children and/or infants in order to avoid poisoning. Do not induce vomiting unless explicitly instructed to do so by the doctor. Do not use the medicine after the expiry date (exp. date) that appears on the package. The expiry date refers to the last day of that month. STORAGE CONDITIONS: Do not store different medicines in the same package. Store in a refrigerator (2°-8°C). If necessa Prečítajte si celý dokument
_ _ _ _ _Dupixent_200_and_300-SFI_SPC-version 11.0_October-2023 _ Page 1 of 53 Internal NAME OF THE MEDICINAL PRODUCT Dupixent 200mg Dupixent 300mg 1. DOSAGE FORMS AND STRENGTHS DUPIXENT is a clear to slightly opalescent, colorless to pale yellow solution available in a : Single-dose pre-filled syringe with needle shield as: • Injection: 300 mg/2 mL (150 mg/ml) in a single-dose pre-filled syringe with needle shield • Injection: 200 mg/1.14 mL (175 mg/ml) in a single-dose pre-filled syringe with needle shield Single-dose pre-filled pen as: • Injection: 300 mg/2 mL (150 mg/ml) • Injection: 200 mg/1.14 mL (175 mg/ml) 2. THERAPEUTIC INDICATIONS DUPIXENT is indicated for the following diseases: 2.1 Atopic Dermatitis DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. 2.2 Asthma DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus. 2.3 Chronic Rhinosinusitis with Nasal Polyposis DUPIXENT 300mg is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). 2.4 Eosinophilic Esophagitis DUPIXENT 300mg is indicated for the treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE). _ _ _ _ _Dupixent_200_and_300-SFI_SPC-version 11.0_October-2023 _ Page 2 of 53 Internal 2.5 Prurigo Nodularis DUPIXENT 300mg is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for sys Prečítajte si celý dokument