SOLONE prednisolone 25 mg tablet bottle

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

prednisolone, Quantity: 25 mg

可用日期:

iNova Pharmaceuticals (Australia) Pty Ltd

药物剂型:

Tablet, uncoated

组成:

Excipient Ingredients: wheat starch; magnesium stearate; Gelatin; lactose monohydrate; maize starch; propyl hydroxybenzoate

给药途径:

Oral

每包单位数:

1000 tablets, 30 tablets

类:

Medicine Registered

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

INDICATIONS AS AT 26 MARCH 1997 : Wherever corticosteroid therapy is indicated.

產品總結:

Visual Identification: White round biconvex tablet, uncoated one face plain, other with break bar radius of curvature 3/8" diameter 3/8"; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

授权状态:

Registered

授权日期:

1991-08-30

资料单张

SOLONE
_Prednisolone (Pred-NISS-oh-lone)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SOLONE
(prednisolone tablets). It does not
contain all the available information
about SOLONE tablets. It does not
replace talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
SOLONE against the benefits he or
she expects it will have.
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 IS SOLONE
The name of your medicine is
SOLONE and is available in 5 mg
and 25 mg tablet strengths.
The active ingredient is called
prednisolone.
Prednisolone belongs to a group of
medicines called corticosteroids.
Corticosteroids are used to help
reduce inflammation in your body or
suppress your immune system, when
a disease may be due to an auto-
immune reaction (where your body
fights against itself).
WHAT SOLONE IS USED
FOR
SOLONE is used to treat a number of
medical conditions.
Your doctor will be able to help
decide if SOLONE is suitable for
your condition.
Ask your doctor if you have any
questions about why SOLONE has
been prescribed for you.
If you have any concerns, you should
discuss this with your doctor.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE
SOLONE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SOLONE IF YOU ARE
ALLERGIC TO:
•
Prednisolone or other cortisone
type medications, or any of the
ingredients listed at the end of
this leaflet including lactose
monohydrate.
Some of the symptoms of an allergic
reaction to SOLONE may include
urticaria and other skin rashes,
difficulty breathing, swelling of the
face or throat or faintness.
DO NOT TAKE SOLONE IF YOU:
•
have a peptic ulcer
•
suffer from osteoporosis (brittle
bones)
•
have severe disturbances in
thoughts, feelings and behaviours
(psychoneuroses)
•
have tuberculosis.
DO NOT TAKE SOLONE IF YOU ARE

产品特点

1
AUSTRALIAN PRODUCT INFORMATION – SOLONE (PREDNISOLONE)
TABLET
1
NAME OF THE MEDICINE
Prednisolone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Solone tablets contain 5 mg or 25 mg prednisolone as the active
ingredient.
List of excipients with known effect:
Contains sugars as lactose monohydrate and hydroxybenzoates.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablet, uncoated.
5 mg tablet: – White, round, biconvex tablet with a breakline on one
side and marking ‘L’ on other
side.
25 mg tablet: – White, round, biconvex tablet with a breakline on
one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Wherever corticosteroid therapy is indicated.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults:
10 to 100 mg daily in divided doses.
Children:
1 to 5 years: 2.5 to 10 mg twice daily.
6 to 12 years: 5 to 20 mg twice daily.
4.3
C
ONTRAINDICATIONS
Systemic fungal infections and known hypersensitivity to prednisolone
or any of the excipients.
Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses.
Patients with active or doubtfully
quiescent tuberculosis should not be given these hormones except as
adjuncts to treatment with
tuberculostatic drugs.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
Corticosteroids should be used with caution in the presence of
diminished cardiac reserve or
congestive heart failure, in patients with diabetes mellitus,
infectious diseases, chronic renal failure,
uraemia and in elderly persons.
2
In patients on corticosteroid therapy subjected to unusual stress,
increased dosage of rapidly acting
corticosteroids before, during, and after the stressful situation is
indicated.
Corticosteroids may mask some signs of infection, and new infections
may appear during their use.
Infections with any pathogen including viral, bacterial, fungal,
protozoan or helminthic infections,
in any location of the body, may be associated with the use of
corticosteroids alone or in
combination
with
other
immunosuppressive
agents