DUPIXENT 300 MG

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

DUPILUMAB

Dostupné s:

SANOFI ISRAEL LTD

ATC kód:

D11AH05

Léková forma:

SOLUTION FOR INJECTION

Složení:

DUPILUMAB 150 MG/ML

Podání:

S.C

Druh předpisu:

Required

Výrobce:

SANOFI-AVENTIS GROUPE, FRANCE

Terapeutické oblasti:

DUPILUMAB

Terapeutické indikace:

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.

Datum autorizace:

2023-02-28

Informace pro uživatele

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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

Charakteristika produktu

_ _
_ _
_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