CORTATE cortisone acetate 25mg tablet bottle

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

cortisone acetate, Quantity: 25 mg

Dostopno od:

Aspen Pharmacare Australia Pty Ltd

Farmacevtska oblika:

Tablet, uncoated

Sestava:

Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate; povidone

Pot uporabe:

Oral

Enote v paketu:

30, 60, 100, 1000, bulk tablets

Razred:

Medicine Registered

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Addison's disease; allergic disorders including status asthmaticus; angioneurotic oedema. serum sickness and drugs sensitisation; periarteritis nodosa; disseminated lupus erythematosus; giant cell arteritis.

Povzetek izdelek:

Visual Identification: Round, flat, white tablets with breakline on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Status dovoljenje:

Registered

Datum dovoljenje:

1991-10-21

Navodilo za uporabo

CORTATE
®
- Consumer Medicine Information
Page 1 of 5
CORTATE
®
_cortisone acetate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CORTATE. 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 CORTATE
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 WITH THE MEDICINE.
You may need to read it again.
WHAT CORTATE IS
USED FOR
CORTATE contains cortisone
acetate as the active ingredient. It
belongs to a group of medicines
called corticosteroids which is a
synthetic version of a naturally
occurring cortisol hormone secreted
by the adrenal glands in your body.
CORTATE is used in the treatment
of many different conditions,
including severe allergic reactions
(such as reactions to drugs), severe
asthma, severe itchy skin rashes,
chronic inflammatory diseases and
'auto-immune' diseases.
CORTATE is only able to prevent or
reduce symptoms of your condition;
it does not cure it.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CORTATE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
CORTATE is not addictive.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CORTATE IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO:
•
any medicine containing
cortisone
•
any of the tablet ingredients listed
at the end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty in breathing;
swelling of the face, lips, tongue or
any other parts of the body; rash,
itching or hives on the skin.
DO NOT TAKE IT IF YOU HAVE AN
UNCONTROLLED INFECTION.
DO NOT TAKE CORTATE AFTER THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK.
If it has expired or is damaged, return
it to your

Lastnosti izdelka

CORTATE (cortisone acetate) – Product Information
Page 1 of 11
AUSTRALIAN PRODUCT
I
NFO
R
MAT
I
O
N
CORTATE (CORTISONE ACETATE)
TABLETS
1.
NAME OF THE MEDICINE
Cortisone acetate.
2 AND 3.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
AND
PHARMACEUTICAL FORM
CORTATE 5 mg are round, flat, white tablets containing 5 mg cortisone
acetate as the active
ingredient.
CORTATE 25 mg are round, flat, white, scored tablets containing 25 mg
cortisone acetate as the
active ingredient.
CORTATE tablets contain an excipient with known effect, lactose
monohydrate. For the full list
of excipients, see Section 6.1 - List of excipients.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Addison's disease; allergic disorders including status asthmaticus;
angioneurotic oedema, serum
sickness and drug sensitisation; periarteritis nodosa; disseminated
lupus erythematosus; giant
cell arteritis.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage requirements are variable and must be individualised on the
basis of the disease and the
response of the patient. 25 mg once every 6 hours for an adult may be
used to initiate treatment.
Once remission is achieved, the daily dosage is reduced by 10 to 20 mg
every few days until the
optimum maintenance dose results. Acute and severe sensitivity or
anaphylactic states may
require much larger doses.
4.3
CONTRAINDICATIONS
Hypersensitivity to cortisone acetate or any ingredients listed in
Section 6.1
-
LIST OF
EXCIPIENTS, uncontrolled infections.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Since complications of treatment with glucocorticoids are dependent on
the size of the dose
and the duration of treatment, a risk/benefit decision must be made in
each individual case as
to dose and duration of treatment and as to whether daily or
intermittent therapy should be
used.
Patients, including those with Addison’s disease, should be observed
closely for signs that may
require dosage adjustment, including changes in clinical status
resulting from remissions or
CORTATE (cortisone acetate) – Product Information
Pa