Kenacort-A 40
Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Bijsluiter
(PIL)
18-01-2021
Productkenmerken
(SPC)
27-11-2022
Werkstoffen:
Triamcinolone acetonide 40 mg/mL; Triamcinolone acetonide 40 mg/mL
Beschikbaar vanaf:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
INN (Algemene Internationale Benaming):
Triamcinolone acetonide 40 mg/mL
Dosering:
40 mg/mL
farmaceutische vorm:
Suspension for injection
Samenstelling:
Active: Triamcinolone acetonide 40 mg/mL Excipient: Benzyl alcohol Carmellose sodium Polysorbate 80 Sodium chloride Water for injection Active: Triamcinolone acetonide 40 mg/mL Excipient: Benzyl alcohol Carmellose sodium Polysorbate 80 Sodium chloride Water for injection
Eenheden in pakket:
Ampoule, glass, 5x1mL, 5 mL
klasse:
Prescription
Prescription-type:
Prescription
Geproduceerd door:
Crystal Pharma SA
therapeutische indicaties:
Intramuscular: The intramuscular administration of Kenacort-A 40 (Sterile Triamcinolone Acetonide Suspension USP) is indicated for systemic corticosteroid therapy in such conditions as allergic diseases, dermatoses, or generalised rheumatoid arthritis and other connective tissue disorders. Intramuscular administration is particularly valuable in such conditions when oral corticosteroid therapy is not feasible.
Product samenvatting:
Package - Contents - Shelf Life: Ampoule, glass, 5x1mL - 5 mL - 36 months from date of manufacture stored at or below 30°C - Vial, glass, - 5 mL - 36 months from date of manufacture stored at or below 30°C
Autorisatie datum:
1969-01-29
Bijsluiter
NEW ZEALAND CONSUMER MEDICINE INFORMATION
KENACORT
®
-A 40
_triamcinolone acetonide _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about KENACORT-A 40. 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 taking KENACORT-A 40
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET. You may need to read it again.
WHAT IS KENACORT_-_A 40
USED FOR
_ _
KENACORT-A 40 is used to treat allergic diseases, bad skin problems or
arthritis. To treat these problems
it is injected deep into a muscle. From the muscle it is slowly
absorbed into the blood and carried by the
blood to all parts of the body.
KENACORT-A 40 can also be used to treat painful muscles, joints or
tendons by injecting directly into the
painful site.
However, your doctor may have prescribed KENACORT-A 40 for another
purpose. Ask your doctor if you
have any questions about why KENACORT-A 40 has been prescribed for
you.
The way that KENACORT-A 40 works is complicated. Put simply,
KENACORT-A 40 suppresses
inflammation and swelling and relieves pain. However, it does not cure
the underlying problem.
KENACORT-A 40 is available only with a doctor’s prescription.
KENACORT-A 40 is NOT suitable for intravenous, intradermal or
intraocular use. KENACORT-A 40 is not
suitable for injection into the nasal turbinates or intralesional
injection about the head.
KENACORT-A 40 is NOT recommended for use in children under the age of
six.
KENACORT-A 40 is NOT for use in newborn or premature infants
BEFORE YOU ARE GIVEN KENACORT-A 40
_WHEN YOU MUST NOT BE GIVEN IT _
_ _
DO NOT HAVE KENACORT-A 40_ _ IF YOU HAVE AN ALLERGY TO KENACORT-A 40,
UNLESS YOU HAVE
DISCUSSED IT WITH YOUR DOCTOR.
Symptoms of an allergic reaction may include:
•
chills/fever
•
fast heart beat
•
difficulty in breathing, shortness of brea
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Productkenmerken
KENACORT-A 40 – Data Sheet
Page 1 of 14
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
KENACORT-A 40 suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
KENACORT-A 40 contains 40 mg/1 mL triamcinolone acetonide.
For the list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
KENACORT-A 40 is a sterile, aqueous, opaque white suspension.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_INTRAMUSCULAR: _
The intramuscular administration of Kenacort-A 40 (Sterile
Triamcinolone Acetonide
Suspension USP) is indicated for systemic corticosteroid therapy in
such conditions
as allergic diseases, dermatoses, or generalised rheumatoid arthritis
and other
connective tissue disorders. Intramuscular administration is
particularly valuable in
such conditions when oral corticosteroid therapy is not feasible.
_INTRA-ARTICULAR: _
Kenacort-A
40
Injection
(Sterile
Triamcinolone
Acetonide
Suspension
USP)
is
indicated for intra-articular or intrasynovial administration, and for
injections into
tendon sheaths, as adjunctive therapy for short-term administration
(to tide the
patient
over
an
acute
episode
or
exacerbation)
in;
synovitis
of
osteoarthritis;
rheumatoid arthritis; acute and subacute bursitis; acute gouty
arthritis; epicondylitis;
acute nonspecific tenosynovitis; post-traumatic osteoarthritis.
4.2 DOSE AND METHOD OF ADMINISTRATION
Kenacort-A 40 is suitable for intramuscular, intra-articular and
intra-synovial injection.
This formulation is not suitable for intravenous, intradermal or
intraocular use.
This preparation contains benzyl alcohol. Not for use in newborn or
premature
infants (see section 4.4 Special warnings and precautions for use, Use
in children).
_GENERAL_:
The initial dose of Kenacort-A 40 Injection may vary from 5 to 60 mg
per day
depending on the specific disease entity being treated (see below
under Dosage). In
situations of less severity, lower doses will generally suffice while
in selected patients
KENACORT-A 40 – Data Sheet
Page 2 of 14
higher initial doses may be required. Usually the
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