Kenacort A10 10mg/1mL injection ampoule

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

triamcinolone acetonide, Quantity: 10 mg/mL

Disponible des:

Aspen Pharma Pty Ltd

formulario farmacéutico:

Injection, suspension

Composición:

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

Vía de administración:

Intraarticular, Intradermal, Intrasynovial

Unidades en paquete:

5 x 1mL

clase:

Medicine Registered

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Intra-Articular: Kenacort-A 10 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 non-specific tenosynovitis, post-traumatic osteoarthritis. Intradermal: Intralesional administration of Kenacort-A 10 Injection is indicated for the treatment of Keloids, discoid lupus erythermatous, necrobiosis lipoidica diabeticorum, alopecia areata and localised hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus ( neurodermatitis), Kenacort-A 10 Injection also may be useful in cystic tumours of an aponeurosis or tendon ( ganglia).

Resumen del producto:

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

Estat d'Autorització:

Registered

Data d'autorització:

1991-09-30

Informació per a l'usuari

KENACORT
®
-A 10 – Consumer Medicine Information
Page 1 of 3
KENACORT
®
-A 10
_triamcinolone acetonide _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
KENACORT-A 10. 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 10 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 10
IS USED FOR
_ _
KENACORT-A 10 is a synthetic
corticosteroid containing
triamcinolone acetonide as the
active ingredient.
It is used to treat painful muscles,
joints or tendons by injecting
directly into the painful site.
KENACORT-A 10 can also be
used to treat inflammatory skin
lesions, psoriatic plaques & hair
loss by injecting directly into the
lesion or by sub-cutaneous
injection.
KENACORT-A 10 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 10 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 10 is not
suitable for intravenous,
intramuscular or intraocular use.
KENACORT-A 10 is not
suitable for injection into the
nasal turbinates or intralesional
injection about the head.
KENACORT-A 10 is not
recommended for use in children
under the age of six.
KENACORT-A 10 is not for use
in newborn or premature infants.
KENACORT-A 10 is a long-
acting preparation and is not
suitable for use in acute
situations.
BEFORE YOU ARE
GIVEN IT
_WHEN YOU MUST NOT BE GIVEN IT _
_ _
DO NOT USE KENACORT-A 10_ _
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:
�

Fitxa tècnica

1
AUSTRALIAN PRODUCT INFORMATION
KENACORT

-A 10 (STERILE TRIAMCINOLONE ACETONIDE SUSPENSION
USP)
10 MG/1 ML INJECTION AMPOULE
FOR INTRA-ARTICULAR, INTRASYNOVIAL OR INTRADERMAL USE
(NOT FOR INTRAVENOUS OR INTRAMUSCULAR USE)
1
NAME OF THE MEDICINE
Triamcinolone acetonide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of the sterile, aqueous suspension provides 10 mg of
triamcinolone acetonide.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Kenacort-A 10 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
10
is
suitable
for
intradermal,
intra-articular
and
intrasynovial injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
INTRA-ARTICULAR:
Kenacort-A
10
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.
INTRADERMAL: Intralesional administration of Kenacort-A 10 Injection
is indicated for the
treatment of keloids, discoid lupus erythematous, necrobiosis
lipoidica diabeticorum, alopecia
areata and localised hypertrophic, infiltrated, inflammatory lesions
of: lichen planus, psoriatic
plaques, granuloma annulare, and lichen simplex chronicus
(neurodermatitis), Kenacort-A 10
Injection also may be useful in cystic tumours of an aponeurosis or
tendon (ganglia).
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)
GENERAL:
2
The initial dose should be maintained or adjusted until a satisfactory
response is noted. If
after a reasonable period of time t