KENACORT A40 triamcinolone acetonide 40mg/mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

triamcinolone acetonide, Quantity: 40 mg/mL

Available from:

Aspen Pharma Pty Ltd

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: benzyl alcohol; sodium chloride; polysorbate 80; carmellose sodium; water for injections; sodium hydroxide; hydrochloric acid

Administration route:

Intramuscular, Intraarticular, Intrasynovial

Units in package:

5 x 1mL ampoule

Prescription type:

(S4) Prescription Only Medicine

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 where oral corticosteroid therapy is not feasible. Intra-Articular: Kenacort-A 40 Injection 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 non-specific tenosynovitis; post-traumatic osteoarthritis.

Product summary:

Visual Identification: Opaque white suspension.; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1995-09-29

Patient Information leaflet

KENACORT
®
-A 40 – Consumer Medicine Information
Page 1 of 3
KENACORT
®
-A 40
_triamcinolone acetonide _
CONSUMER MEDICINE INFORMATION (CMI)
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 KENACORT-
A 40
IS USED FOR
_ _
KENACORT-A 40 is a synthetic
corticosteroid containing
triamcinolone acetonide as the
active ingredient.
KENACORT-A 40 is used to
treat allergic diseases, bad skin
problems or arthritis. It can also
be used to treat painful muscles,
joints or tendons by injecting
directly into the painful site.
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 suppresses
inflammation and swelling and
relieves pain. It does not cure the
underlying problem.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
KENACORT-A 40 HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed
it for another purpose.
This medicine 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 IT
_WHEN YOU MUST NOT BE GIVEN IT _
_ _
DO NOT USE KENACORT-A 40_ _
IF YOU HAVE AN ALLERGY TO
TRIAMCINOLONE ACETONIDE OR TO
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
may include:
•
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Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
KENACORT
®
-A 40 (STERILE TRIAMCINOLONE ACETONIDE SUSPENSION
USP)
40 MG IN 1 ML INJECTION AMPOULE
FOR INTRAMUSCULAR AND INTRA-ARTICULAR OR INTRASYNOVIAL USE
(NOT FOR INTRAVENOUS, INTRADERMAL OR INTRAOCULAR USE)
1
NAME OF THE MEDICINE
Triamcinolone acetonide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of the sterile, aqueous suspension provides 40 mg of
triamcinolone acetonide.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Kenacort-A 40 is a sterile, aqueous opaque white suspension. The pH is
adjusted using
sodium hydroxide and/or hydrochloric acid. At the time of manufacture,
the air in the container
is
replaced
by
nitrogen.
Kenacort-A
40
is
suitable for
intramuscular,
intra-articular
or
intrasynovial
injection.
This
formulation
is
not
suitable
for
intravenous,
intradermal
or
intraocular use.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
INTRAMUSCULAR: The intramuscular administration of Kenacort-A 40
Injection 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
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
D
OSE AND METHOD OF ADMINISTRATION
This preparation contains benzyl alcohol. Not for use in newborn or
premature infants (see
section 4.4 - PAEDIATRIC USE)
2
GENERAL:
The initial dose of Kenacort-A 40 Injection may vary from 2.5 to 60 mg
per day depending on
the specific disease