Stelara

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Ustekinumab 45mg;  

Dostępny od:

Janssen-Cilag (New Zealand) Ltd

INN (International Nazwa):

Ustekinumab 45 mg

Dawkowanie:

45 mg

Forma farmaceutyczna:

Solution for injection

Skład:

Active: Ustekinumab 45mg   Excipient: Histidine as hydrochloride Polysorbate 80 Sucrose Water for injection

Sztuk w opakowaniu:

Syringe, glass, Prefilled, 0.5 mL

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

Janssen Biologics BV

Wskazania:

Stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Podsumowanie produktu:

Package - Contents - Shelf Life: Syringe, glass, Prefilled - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days not refrigerated stored at or below 30°C protect from light. no return to refrigeration - Vial, glass, single dose, - 0.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Data autoryzacji:

2009-09-01

Ulotka dla pacjenta

STELARA (231016) ACMI
1
STELARA
® INJECTION
_Ustekinumab (rmc)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
STELARA (pronounced stel-ahr-
uh). It does not contain all the
available information. It does not
take the place of talking to your
doctor, nurse or pharmacist.
All medicines have risks and
benefits
.
Your doctor has weighed
the risks of you using STELARA
against the benefits this medicine
is expected to have for you.
If you have any concerns about
using STELARA, ask your doctor
or pharmacist.
IT IS IMPORTANT THAT YOU READ THIS
LEAFLET.
Keep this leaflet with your
medicine. You may need to read it
again.
WHAT STELARA IS
USED FOR
STELARA is a prescription
medicine that is used to treat:
•
adults with moderate to severe
plaque psoriasis that is chronic
(doesn’t go away),
•
adults with active psoriatic
arthritis, an inflammatory
disease of the joints that is
usually accompanied by
psoriasis,
•
adults with moderately to
severely active Crohn’s
Disease, an inflammatory
disease of the bowel
•
adults with moderate to severe
ulcerative colitis, an
inflammatory disease of the
bowel.
STELARA contains the active
ingredient ustekinumab, a
monoclonal antibody.
Monoclonal antibodies are
proteins that recognise and bind to
other unique proteins.
Ustekinumab blocks the action of
two proteins in your body called
interleukin 12 (IL-12) and
interleukin 23 (IL-23). IL-12 and
IL-23 are made by your body's
immune system. In people with
psoriasis, psoriatic arthritis,
Crohn’s disease or ulcerative
colitis, IL-12 and IL-23 can cause
their immune system to attack
normal healthy parts of their body
like the skin and nails.
Ustekinumab can block IL-12 and
IL-23 from causing the immune
system to attack the skin, nails,
joints or the digestive tract.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed it for
another reason.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR’S PRESCRIPTION.
BE

Charakterystyka produktu

51.230601
1
STELARA (231016) ADS
STELARA

USTEKINUMAB
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
STELARA 45 mg solution for injection in vial.
STELARA 45 mg solution for injection in pre-filled syringe.
STELARA 90 mg solution for injection in pre-filled syringe.
STELARA 130 mg concentrate for solution for infusion.
2. QUALITATIVE AND QUANTIITATIVE COMPOSITION
SOLUTION FOR INJECTION VIAL AND PRE-FILLED SYRINGE _(FOR SUBCUTANEOUS
ADMINISTRATION)_
Each vial contains 45 mg ustekinumab in 0.5 mL.
Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL or 90 mg
ustekinumab in 1 mL.
CONCENTRATE FOR SOLUTION FOR INFUSION _(FOR INTRAVENOUS INFUSION AS
THE INDUCTION DOSE FOR USE _
_IN CROHN’S DISEASE AND ULCERATIVE COLITIS ONLY)_
Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL).
STELARA (ustekinumab) is a human IgG1kappa monoclonal antibody with an
approximate
molecular weight of 148,600 daltons. STELARA is produced by a
recombinant cell line cultured
by continuous perfusion and is purified by a series of steps that
includes measures to inactivate
and remove viruses.
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
SOLUTION FOR INJECTION VIAL AND PRE-FILLED SYRINGE _(FOR SUBCUTANEOUS
ADMINISTRATION)_
The
solution
is
clear
to
slightly
opalescent,
colourless
to
light
yellow
with
a
pH
of
approximately 6.0.
CONCENTRATE FOR SOLUTION FOR INFUSION _(FOR INTRAVENOUS INFUSION)_
The solution is clear, colourless to light yellow with a pH of
approximately 6.0.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PLAQUE PSORIASIS
STELARA is indicated for the treatment of adult patients (18 years or
older) with moderate to
severe plaque psoriasis who are candidates for phototherapy or
systemic therapy.
51.230601
2
STELARA (231016) ADS
PSORIATIC ARTHRITIS (PSA)
STELARA, alone or in combination with methotrexate, is indicated for
the treatment signs and
symptoms, including reduction of the rate of progression of peripheral
joint damage as measured
by X-ray, of active psoriatic arthritis in adult patie