METHYLPRED methylprednisolone (as sodium succinate) 500mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methylprednisolone sodium succinate, Quantity: 663 mg (Equivalent: methylprednisolone, Qty 500 mg)

Available from:

MedTAS Pty Ltd

INN (International Name):

methylprednisolone sodium succinate

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: dibasic sodium phosphate; monobasic sodium phosphate dihydrate; sodium carbonate

Administration route:

Intravenous, Intramuscular

Units in package:

5's, 1's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

When oral therapy is not feasible & strength, dosage form & route of administration of drug reasonably lend preparation to treatment of following conditions. Intravenous or intramuscular use only.,Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is drug of choice; mineralocorticoid supplementation may be necessary particularly when synthetic analogues are used). Preoperatively & in event of serious trauma or illness in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or suspected, congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcaemia associated with cancer. Congenital adrenal hy

Product summary:

Visual Identification: White to off white lyophilised plug or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2009-04-08

Patient Information leaflet

METHYLPRED
_methylprednisolone (as sodium succinate) powder for injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about METHYLPRED. 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 being given
METHYLPRED against the benefits
they expect it will have for you.
FOLLOW THE INSTRUCTIONS GIVEN TO
YOU BY YOUR DOCTOR AND ADVICE
CONTAINED IN THIS LEAFLET.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT METHYLPRED IS
USED FOR
METHYLPRED contains
methylprednisolone (as
methylprednisolone sodium
succinate) as the active ingredient. It
belongs to a group of medicines
called corticosteroids.
It is used for the treatment of one or
more of the following conditions:
•
skin diseases
•
allergic reactions
•
inflammation of the eyes
•
respiratory diseases and certain
respiratory infections
•
diseases of the gut
(gastrointestinal tract)
•
multiple sclerosis
•
rheumatic disorders
•
diseases of the blood
•
treatment of certain glandular
conditions
_HOW YOUR MEDICINE WORKS_
METHYLPRED reduces
inflammation (pain, swelling, redness
and heat) which is one of the body's
reactions to injury and by reducing
the body's reaction to infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
It is available only with a doctor's
prescription.
There is no evidence that it is
addictive.
BEFORE YOU ARE GIVEN IT
_WHEN METHYLPRED MUST NOT_
_BE USED_
You must not be given
METHYLPRED if you have an
allergy to:
•
any medicine containing
methylprednisolone sodium
succinate
•
any of the ingredients listed at the
end of this leaflet.
The METHYLPRED 40 mg product
contains lactose from cow's milk.
TELL YOUR DOCTOR IF YOU A

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
METHYLPRED
_Methylprednisolone (as sodium succinate) powder for injection _
1
NAME OF THE MEDICINE
Methylprednisolone sodium succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
METHYLPRED powder for injection contains 40 mg, 125 mg, 500 mg or 1.0
g methylprednisolone (as
methylprednisolone sodium succinate) as the active ingredient.
List of excipients with known effect: lactose (40 mg strength only).
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
METHYLPRED is a white to off white lyophilised plug or powder
_ _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
When oral therapy is not feasible and the strength, dosage form and
route of administration of the drug reasonably
lend the preparation to the treatment of the following conditions.
For intravenous or intramuscular use only.
ENDOCRINE DISORDERS
•
Primary or secondary adrenocortical insufficiency (hydrocortisone or
cortisone is the drug of choice;
synthetic analogues may be used in conjunction with mineralocorticoids
where applicable; in infancy,
mineralocorticoid supplementation is of particular importance).
•
Acute adrenocortical insufficiency (hydrocortisone or cortisone is the
drug of choice; mineralocorticoid
supplementation may be necessary, particularly when synthetic
analogues are used).
•
Preoperatively and in the event of serious trauma or illness in
patients with known adrenal insufficiency
or when adrenocortical reserve is doubtful.
•
Shock unresponsive to conventional therapy if adrenocortical
insufficiency exists or is suspected
•
congenital adrenal hyperplasia,
•
nonsuppurative thyroiditis,
•
hypercalcaemia associated with cancer.
RHEUMATIC DISORDERS
As adjunctive therapy for short-term administration (to tide the
patient over an acute episode or exacerbation) in:
•
ankylosing spondylitis,
•
psoriatic arthritis,
•
acute and subacute bursitis,
•
synovitis of osteoarthritis,
•
acute nonspecific tenosynovitis,
•
epicondylitis,
•
acute gouty ar