Revestive

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Teduglutide 5mg; Water for injection 0.5 mL

Fáanlegur frá:

Takeda New Zealand Limited

Skammtar:

5 mg

Lyfjaform:

Powder for injection with diluent

Samsetning:

Active: Teduglutide 5mg Excipient: Dibasic sodium phosphate heptahydrate Histidine Hydrochloric acid Mannitol Monobasic sodium phosphate monohydrate Sodium hydroxide Water for injection Active: Water for injection 0.5 mL

Gerð lyfseðils:

Prescription

Ábendingar:

Revestive is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Patients should be stable at least to 4 weeks on their parenteral support regimen before initiating teduglutide therapy

Vörulýsing:

Package - Contents - Shelf Life: Combination pack, Drug product powder in Type I glass vial closed with rubber stopper, diluent in PFS - 28 dose units - 48 months from date of manufacture stored at or below 25°C. Do not freeze. - Syringe, glass, Diluent in PFS closed with rubber stopper - 1 dose units - 48 months from date of manufacture stored at or below 30°C. Do not freeze. - Vial, glass, Drug product powder in Type I glass vial closed with rubber stopper - 1 dose units - 48 months from date of manufacture stored at or below 25°C. Do not freeze.

Leyfisdagur:

2017-08-10

Upplýsingar fylgiseðill

REVESTIVE
®
NZ CMI V2.0
1
REVESTIVE
®
_teduglutide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET BEFORE YOU
START USING REVESTIVE.
This leaflet answers some common
questions about REVESTIVE. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using REVESTIVE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
The information in this leaflet was
last updated on the date listed in
'Product description' section'. More
recent information on the medicine
may be available. You should ensure
that you speak to your pharmacist or
doctor to obtain the most up to date
information on this medicine.
WHAT REVESTIVE IS
USED FOR
REVESTIVE is used to treat adults
with Short Bowel Syndrome who
need additional nutrition or fluids
from intravenous feeding (parenteral
support). Short Bowel Syndrome is a
disorder arising from an inability to
absorb food nutrients and fluid across
the gastrointestinal tract (gut). It is
often caused by surgical removal of
all or part of the small intestine.
REVESTIVE contains the active
substance teduglutide. It improves
the absorption of nutrients and fluid
from your remaining gut.
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 not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
REVESTIVE
_WHEN YOU MUST NOT USE IT _
DO NOT USE REVESTIVE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
teduglutide
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, t

Vara einkenni

NEW ZEALAND DATA SHEET
REVESTIVE DS V2.0 (CCDS V8)
1
1 REVESTIVE 5 mg powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 5 mg of teduglutide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
REVESTIVE contains teduglutide powder and solvent for solution for
injection. Each single-use vial
contains 5 mg of teduglutide as a white lyophilised powder. The
solvent is water for injections. After
reconstitution, each vial contains 5 mg teduglutide in 0.5 mL of
solution, corresponding to a
concentration of 10 mg/mL with pH 6.9-7.9.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
REVESTIVE is indicated for the treatment of adult patients with Short
Bowel Syndrome (SBS) who are
dependent on parenteral support.
Patients should be stable at least to 4 weeks on their parenteral
support regimen before initiating
teduglutide therapy.
4.2
Dose and method of administration
Treatment should be initiated under the supervision of a medical
professional with experience in the
treatment of SBS.
Dose
The recommended daily dose of REVESTIVE is 0.05 mg/kg body weight
administered by
subcutaneous injection once daily.
After reconstitution with the solvent (0.5 mL water for injections),
the prepared solution from each
vial contains 10 mg/mL of teduglutide.
Treatment effect should be evaluated on an ongoing basis. Clinical
assessment by the physician
should consider individual treatment objectives and patient
preferences. If no overall improvement
is achieved after 12 months, the need for continued treatment should
be assessed.
Continued treatment is recommended for patients who have weaned off
parenteral nutrition.
_Special populations _
_Elderly: _No dose adjustment is necessary in patients above the age
of 65 years.
_Hepatic impairment: _No dose adjustment is necessary for patients
with mild and moderate hepatic
impairment based on a study conducted in Child-Pugh grade B subjects.
Teduglutide has not