DUPIXENT 300 mg Solution for injection (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Dupixent 300 mg solution for injection in pre-filled syringe. Dupixent 300 mg solution for injection in pre-filled pen.
Qualitative and quantitative composition
<u>Dupilumab 300 mg solution for injection in pre-filled syringe:</u> Each single-use pre-filled syringe contains 300 mg of dupilumab in 2 ml solution (150 mg/ml). <u>Dupilumab 300 mg solution for injection ...
Pharmaceutical form
Solution for injection (injection). Clear to slightly opalescent, colourless to pale yellow sterile solution, which is free from visible particulates, with a pH of approximately 5.9.
Therapeutic indications
Atopic Dermatitis Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Asthma Adults and ...
Posology and method of administration
Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of conditions for which dupilumab is indicated (see section 4.1). Posology Atopic Dermatitis Adults ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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. Acute asthma exacerbations Dupilumab ...
Interaction with other medicinal products and other forms of interaction
Immune responses to vaccination were assessed in a study in which patients with atopic dermatitis were treated once weekly for 16 weeks with 300 mg of dupilumab. After 12 weeks of dupilumab administration, ...
Fertility, pregnancy and lactation
Pregnancy There are limited amount of data from the use of dupilumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section ...
Effects on ability to drive and use machines
Dupilumab has no or negligible influence on the ability to drive or operate machinery.
Undesirable effects
Summary of the safety profile The most common adverse reactions in atopic dermatitis, asthma, and CRSwNP are injection site reactions (includes erythema, oedema, pruritus, pain, and swelling), conjunctivitis, ...
Overdose
There is no specific treatment for dupilumab overdose. In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other dermatological preparations, agents for dermatitis, excluding corticosteroids <b>ATC code:</b> D11AH05 Mechanism of action Dupilumab is a recombinant human IgG4 ...
Pharmacokinetic properties
The pharmacokinetics of dupilumab is similar in patients with atopic dermatitis, asthma, CRSwNP, PN and EoE. Absorption After a single subcutaneous (SC) dose of 75-600 mg dupilumab to adults, median times ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity (including safety pharmacology endpoints) and toxicity to reproduction and development. The ...
List of excipients
Arginine hydrochloride Histidine Polysorbate 80 (E433) Sodium acetate trihydrate Glacial acetic acid (E260) Sucrose Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. If necessary, the pre-filled syringe or pre-filled pen can be removed from the refrigerator and kept in the pack for up to 14 days at room temperature up to 25°C, while protected from light. The ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original carton in order to protect from light.
Nature and contents of container
Dupixent 300 mg solution for injection in pre-filled syringe 2 ml solution in a siliconised type-1 clear glass pre-filled syringe with or without needle shield, with a fixed 27 gauge 12.7 mm (1⁄2 inch), ...
Special precautions for disposal and other handling
The instructions for the preparation and administration of Dupixent in a pre-filled syringe or in a pre-filled pen are given in the package leaflet. The solution should be clear to slightly opalescent, ...
Marketing authorization holder
Sanofi-aventis groupe, 54, rue La Boétie, 75008, Paris, France
Marketing authorization number(s)
EU/1/17/1229/001 EU/1/17/1229/002 EU/1/17/1229/004 EU/1/17/1229/005 EU/1/17/1229/006 EU/1/17/1229/008 EU/1/17/1229/017 EU/1/17/1229/018 EU/1/17/1229/020 EU/1/17/1229/026 EU/1/17/1229/027 EU/1/17/1229/028 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 September 2017 Date of latest renewal: 02 September 2022
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