Ilaris Powder for Solution for Injection 150mgvial

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

Canakinumab

Dostępny od:

NOVARTIS (SINGAPORE) PTE LTD

Kod ATC:

L04AC08

Dawkowanie:

150mg

Forma farmaceutyczna:

POWDER, FOR SOLUTION

Skład:

Canakinumab 150mg

Droga podania:

SUBCUTANEOUS

Typ recepty:

Prescription Only

Wyprodukowano przez:

Novartis Pharma Stein AG

Status autoryzacji:

ACTIVE

Data autoryzacji:

2010-09-20

Ulotka dla pacjenta

ILARIS



Interleukin – 1 beta inhibitors. 

DESCRIPTION AND COMPOSITION 

PHARMACEUTICAL FORM 

Powder for solution for injection. 
The powder is a white  lyophilisate. 

ACTIVE SUBSTANCE 

Each vial contains 150 mg of canakinumab(plus
30mg of canakinumab as overfill). 

Canakinumab  is  a  recombinant  fully  human  monoclonal  antibody  expressed  in  mouse 
hybridoma Sp2/0 cell. 

EXCIPIENTS 

Sucrose, L-Histidine, L-Histidine HCl monohydrate, Polysorbate 80. 

INDICATIONS 

CRYOPYRIN-ASSOCIATED PERIODIC SYNDROMES (CAPS) 

Ilaris is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), in 
adults and children aged 2 years and older including: 
 
  Familial Cold Autoinflammatory Syndrome (FCAS) /Familial Cold Urticaria (FCU), 
    Muckle-Wells Syndrome (MWS), 
    Neonatal-Onset
  Multisystem   Inflammatory   Disease   (NOMID)   /
  Chronic   Infantile 
Neurological, Cutaneous, Articular Syndrome (CINCA). 

SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) 
Ilaris is indicated for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in 
patients  aged  2  years  and  older  who  have  responded  inadequately  to  previous  therapy  with 
NSAIDS and systemic corticosteroids. Ilaris can be given as monotherapy or in combination 
with methotrexate. 

DOSAGE AND ADMINISTRATION 

DOSAGE FOR CAPS 

The recommended starting dose of Ilaris for CAPS patients is 

Adults and children ≥4 years of age: 
•           150 mg with body weight >40 kg 

•           2 mg/kg with
body weight ≥15 kg and ≤40 kg 

•           4mg/kg with body weight
≥7.5 kg and <15 kg 

Children 2 to <4 years of age: 

•           4 mg/kg for pa

Charakterystyka produktu

ILARIS

Interleukin – 1 beta inhibitors.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
POWDER FOR SOLUTION FOR INJECTION.
The powder is a white lyophilisate.
ACTIVE SUBSTANCE
Each vial contains 150 mg of canakinumab (plus 30mg of canakinumab
(20%) as overfill).
Canakinumab is a recombinant fully human monoclonal antibody expressed
in mouse
myeloma Sp2/0 cell.
EXCIPIENTS
Sucrose, L-Histidine, L-Histidine HCl monohydrate, Polysorbate 80.
INDICATIONS
CRYOPYRIN-ASSOCIATED PERIODIC SYNDROMES (CAPS)
Ilaris is indicated for the treatment of Cryopyrin-Associated Periodic
Syndromes (CAPS), in
adults and children aged 2 years and older including:
•
Familial Cold Autoinflammatory Syndrome (FCAS) /Familial Cold
Urticaria (FCU),
•
Muckle-Wells Syndrome (MWS),
•
Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic
Infantile
Neurological, Cutaneous, Articular Syndrome (CINCA).
SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA)
Ilaris is indicated for the treatment of active Systemic Juvenile
Idiopathic Arthritis (SJIA) in
patients aged 2 years and older who have responded inadequately to
previous therapy with
NSAIDS and systemic corticosteroids. Ilaris can be given as
monotherapy or in combination
with methotrexate.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN FOR CAPS
The recommended starting dose of Ilaris for CAPS patients is
ADULTS AND CHILDREN ≥4 YEARS OF AGE:
• 150 mg with body weight >40 kg
• 2 mg/kg with body weight ≥15 kg and ≤40 kg
• 4mg/kg with body weight ≥7.5 kg and <15 kg
CHILDREN 2 TO <4 YEARS OF AGE:
• 4 mg/kg for patients with body weight ≥7.5 kg
This is administered every eight weeks as a single dose via
subcutaneous injection.
FOR PATIENTS WITH A STARTING DOSE OF 150 MG OR 2 MG/KG
, Iif a satisfactory clinical response
(resolution of rash and other generalized inflammatory symptoms) has
not been achieved 7
days after treatment start, a second dose of Ilaris at 150 mg or 2
mg/kg can be considered. If a
full treatment response is subsequently achieved, the intensified