Stelara 130mg26ml concentrate for solution for infusion vials

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Ustekinumab

Доступно од:

Janssen-Cilag Ltd

АТЦ код:

L04AC05

INN (Међународно име):

Ustekinumab

Дозирање:

5mg/1ml

Фармацеутски облик:

Solution for infusion

Пут администрације:

Intravenous

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: ; GTIN: 5012674902967

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE USER
STELARA 130 MG CONCENTRATE FOR SOLUTION FOR INFUSION
Ustekinumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
THIS LEAFLET HAS BEEN WRITTEN FOR THE PERSON TAKING THE MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Stelara is and what it is used for
2.
What you need to know before you use Stelara
3.
How Stelara will be given
4.
Possible side effects
5.
How to store Stelara
6.
Contents of the pack and other information
1.
WHAT STELARA IS AND WHAT IT IS USED FOR
WHAT STELARA IS
Stelara contains the active substance ‘ustekinumab’, a monoclonal
antibody. Monoclonal antibodies
are proteins that recognise and bind specifically to certain proteins
in the body.
Stelara belongs to a group of medicines called
‘immunosuppressants’. These medicines work by
weakening part of the immune system.
WHAT STELARA IS USED FOR
Stelara is used to treat moderate to severe Crohn’s disease in
adults.
CROHN’S DISEASE
Crohn’s disease is an inflammatory disease of the bowel. If you have
Crohn’s disease you will first be
given other medicines. If you do not respond well enough or are
intolerant to these medicines, you
may be given Stelara to reduce the signs and symptoms of your disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE STELARA
DO NOT USE STELARA:

IF YOU ARE ALLERGIC TO USTEKINUMAB
or any of the other ingredients of this medicine (listed in
section 6).

IF YOU HAVE AN ACTIVE INFECTION
which your doctor thinks is important.
If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using
Stelara.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Stelara. Your doctor
will check how

Карактеристике производа

OBJECT 1
STELARA 130 MG CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 22-Mar-2018 | Janssen-Cilag
Ltd
1. Name of the medicinal product
STELARA 130 mg concentrate for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL).
Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin
(IL)-12/23 produced in a murine
myeloma cell line using recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
The solution is clear, colourless to light yellow.
4. Clinical particulars
4.1 Therapeutic indications
Crohn's Disease
STELARA is indicated for the treatment of adult patients with
moderately to severely active Crohn's
disease who have had an inadequate response with, lost response to, or
were intolerant to either
conventional therapy or a TNFα antagonist or have medical
contraindications to such therapies.
4.2 Posology and method of administration
STELARA concentrate for solution for infusion is intended for use
under the guidance and supervision of
physicians experienced in the diagnosis and treatment of Crohn's
disease. STELARA concentrate for
solution for infusion should only be used for the intravenous
induction dose.
Posology
Crohn's Disease
STELARA treatment is to be initiated with a single intravenous dose
based on body weight. The infusion
solution is to be composed of the number of vials of STELARA 130 mg as
specified in Table 1 (see
section 6.6 for preparation).
_Table 1 Initial intravenous dosing of STELARA_
Body weight of patient at the time of dosing
Recommended dose
a
Number of 130 mg
STELARA Vials
≤ 55 kg
260 mg
2
> 55 kg to ≤ 85 kg
390 mg
3
> 85 kg
520 mg
4
a
Approximately 6 mg/kg
The first subcutaneous dose should be given at week 8 following the
intravenous dose. For the posology
of the subsequent subcutaneous dosing regimen, see section 4.2 of the
STELARA solution for injection
(vial) and solution for inject