Cosentyx

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Secukinumab 150mg;  

Disponibil de la:

Novartis New Zealand Ltd

INN (nume internaţional):

Secukinumab 150 mg

Dozare:

150 mg

Forma farmaceutică:

Powder for injection

Compoziție:

Active: Secukinumab 150mg   Excipient: Histidine hydrochloride monohydrate Nitrogen Polysorbate 80 Sucrose

Tip de prescriptie medicala:

Prescription

Produs de:

Novartis Pharma SAS

Indicații terapeutice:

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.

Rezumat produs:

Package - Contents - Shelf Life: Vial, glass, - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). Store in original container. - Vial, glass, - 2 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). Store in original container.

Data de autorizare:

2015-05-01

Caracteristicilor produsului

NEW ZEALAND DATA SHEET
New Zealand Data Sheet Template v 1.3 November 2023
Page 1 of 47
1 PRODUCT NAME
COSENTYX

75mg/0.5 mL Solution for Injection
COSENTYX

150 mg Powder for Injection
COSENTYX

150 mg/mL Solution for Injection
COSENTYX

300mg/2 mL Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SECUKINUMAB 150MG
Each vial of powder for injection contains 150 mg of secukinumab
SECUKINUMAB 75MG/0.5ML
Each single-use pre-filled syringe contains 75 mg of secukinumab in
0.5 mL
SECUKINUMAB 150MG/ML
Each single-use pre-filled syringe contains 150 mg of secukinumab in 1
mL
Each single-use prefilled pen contains 150 mg of secukinumab in 1 mL
SECUKINUMAB 300MG/2ML
Each single-use pre-filled syringe contains 300 mg of secukinumab in 2
mL
Each single-use prefilled pen contains 300 mg of secukinumab in 2 mL
Secukinumab is a recombinant fully human monoclonal antibody selective
for interleukin-17A.
Secukinumab is composed of one heavy chain containing 457 amino acids
and one light chain
containing 215 amino acids.
Secukinumab is of the IgG1/κ-class produced in Chinese Hamster Ovary
(CHO) cells.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
POWDER FOR INJECTION
Each vial of powder for injection contains 150 mg of secukinumab as a
lyophilized cake in glass vials.
SOLUTION FOR INJECTION
Solution for injection in a single-use, pre-filled syringe and/or pen
(auto-injector). The solution is
clear and colourless to slightly yellow. The pH value ranges from 5.5
to 6.1 and Osmolality between
300- 400 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PLAQUE PSORIASIS
COSENTYX is indicated for the treatment of moderate to severe plaque
psoriasis in patients 6 years
and older who are candidates for systemic therapy or phototherapy.
_ _
PSORIATIC ARTHRITIS
COSENTYX is indicated for the treatment of adult patients with active
psoriatic arthritis when the
response to previous disease-modifying anti-rheumatic drug (DMARD)
therapy has been inadequate.
_ _