Cosentyx 150mg1ml solution for injection pre-filled syringes

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Secukinumab

Disponible depuis:

Novartis Pharmaceuticals UK Ltd

DCI (Dénomination commune internationale):

Secukinumab

Dosage:

150mg/1ml

forme pharmaceutique:

Solution for injection

Mode d'administration:

Subcutaneous

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 10010300; GTIN: 5010678903195

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COSENTYX
® 150 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Secukinumab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cosentyx is and what it is used for
2.
What you need to know before you use Cosentyx
3.
How to use Cosentyx
4.
Possible side effects
5.
How to store Cosentyx
6.
Contents of the pack and other information
1.
WHAT COSENTYX IS AND WHAT IT IS USED FOR
Cosentyx contains the active substance secukinumab. Secukinumab is a
monoclonal antibody.
Monoclonal antibodies are proteins that recognise and bind
specifically to certain proteins in the body.
Cosentyx belongs to a group of medicines called interleukin (IL)
inhibitors. This medicine works by
neutralising the activity of a protein called IL-17A, which is present
at increased levels in diseases
such as psoriasis, psoriatic arthritis and ankylosing spondylitis.
Cosentyx is used for the treatment of the following inflammatory
diseases:

Plaque psoriasis

Psoriatic arthritis

Ankylosing spondylitis
PLAQUE PSORIASIS
Cosentyx is used to treat a skin condition called “plaque
psoriasis”, which causes inflammation
affecting the skin. Cosentyx reduces the inflammation and other
symptoms of the disease. Cosentyx is
used in adults with moderate t

Résumé des caractéristiques du produit

OBJECT 1
COSENTYX 150 MG SOLUTION FOR INJECTION IN PRE-
FILLED PEN
Summary of Product Characteristics Updated 17-May-2018 | Novartis
Pharmaceuticals UK Ltd
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
Cosentyx
®
150 mg solution for injection in pre-filled syringe
Cosentyx
®
150 mg solution for injection in pre-filled pen
2. Qualitative and quantitative composition
Each pre-filled syringe contains 150 mg secukinumab* in 1 ml.
Each pre-filled pen contains 150 mg secukinumab* in 1 ml.
*Secukinumab is a recombinant fully human monoclonal antibody
selective for interleukin-17A.
Secukinumab is of the IgG1/κ-class produced in Chinese Hamster Ovary
(CHO) cells.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection in pre-filled syringe (injection)
Solution for injection in pre-filled pen (SensoReady pen)
The solution is clear and colourless to slightly yellow.
4. Clinical particulars
4.1 Therapeutic indications
Plaque psoriasis
Cosentyx is indicated for the treatment of moderate to severe plaque
psoriasis in adults who are
candidates for systemic therapy.
Psoriatic arthritis
Cosentyx, alone or in combination with methotrexate (MTX), is
indicated for the treatment of active
psoriatic arthritis in adult patients when the response to previous
disease-modifying anti-rheumatic drug
(DMARD) therapy has been inadequate (see section 5.1).
Ankylosing spondylitis
Cosentyx is indicated for the treatment of active ankylosing
spondylitis in adults who have responded
inadequately to conventional therapy.
4.2 Posology and method of administration
Cosentyx is intended for use under the guidance and supervision of a
physician experienced in the
diagnosis and treatment of conditions for which Cosentyx is indicated.
Posology
_Plaque psoriasis _
The recommen