DEPO-MEDROL methylprednisolone acetate 40 mg/1 mL injection vial

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

methylprednisolone acetate, Quantity: 40 mg/mL

Inapatikana kutoka:

Pfizer Australia Pty Ltd

Dawa fomu:

Injection, suspension

Tungo:

Excipient Ingredients: sodium hydroxide; sodium chloride; miripirium chloride; hydrochloric acid; macrogol 3350; water for injections

Njia ya uendeshaji:

Intramuscular, Intraarticular, Intralesional

Vitengo katika mfuko:

1mL X 1, 1mL X 5

Darasa:

Medicine Registered

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

INDICATIONS AS AT 9 NOVEMBER 1993: A. For Intramuscular Administration: 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 condition, the intramuscular use of DEPO-MEDROL is indicated as follows: 1. Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone acetate 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 acetate 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. Congenital adrenal hyperplasia. Hypercalcaemia associated with cancer. No

Bidhaa muhtasari:

Visual Identification: White to off white suspension when mixed; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Idhini hali ya:

Registered

Idhini ya tarehe:

1991-08-02

Taarifa za kipeperushi

DEPO-MEDROL
®
_methylprednisolone acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before being treated with DEPO-
MEDROL suspension for injection.
This leaflet answers some common
questions about DEPO-MEDROL. 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 treated with
DEPO-MEDROL against the
benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Consider keeping this leaflet even
after treatment with DEPO-
MEDROL is finished. You may need
to read it again.
WHAT DEPO-MEDROL
IS USED FOR
DEPO-MEDROL is used to treat
disorders of many organ systems
such as skin, lung, eye,
gastrointestinal tract, nervous system,
joints and blood. DEPO-MEDROL
works by reducing inflammation and
changing the body's natural ability to
respond when the immune response
is not working properly. It is also
used in certain conditions where the
adrenal gland doesn't function
correctly.
Your doctor may have prescribed
DEPO-MEDROL for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DEPO-
MEDROL HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor's prescription.
BEFORE TREATMENT WITH
DEPO-MEDROL
Some information is provided below.
However, always talk to your doctor
if you have concerns or questions
about your treatment.
_WHEN DEPO-MEDROL MUST_
_NOT BE USED_
DEPO-MEDROL MUST NOT BE
USED:
1.
IF YOU HAVE AN ALLERGY TO:
•
methylprednisolone acetate
•
any of the other ingredients
listed under Product
Description at the end of this
leaflet.
Symptoms of an allergic reaction
may include skin rash, itching or
difficulty in breathing.
2.
IF YOU HAVE A SEVERE FUNGAL
INFECTION
3.
IT MUST NOT BE INJECTED INTO THE
SPINAL CORD (INTRATHECAL OR
EPIDURAL) OR INTO A VEIN
(INTRAVENOUS)
4.
IT MUST NOT BE GIVEN BY ANY
OTHER UNAPPROVED ROUTE OF

Tabia za bidhaa

Version: pfpdepmi10121
Supersedes: pfpdepmi11019
Page 1 of 24
AUSTRALIAN
PRODUCT
INFORMATION
–
[DEPO-MEDROL
®
(METHYLPREDNISOLONE
ACETATE)] SUSPENSION FOR INJECTION
For Intramuscular, Intra-articular, Soft Tissue or Intralesional
Injection Only
NOT FOR INTRAVENOUS, INTRATHECAL OR EPIDURAL USE
1.
NAME OF THE MEDICINE
Methylprednisolone acetate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of DEPO-MEDROL contains 40 mg of methylprednisolone acetate as
the active
substance
For the full list of excipients, see Section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
Suspension for Injection
White to off white suspension when mixed.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A.
FOR INTRAMUSCULAR ADMINISTRATION
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
condition, the intramuscular
use of DEPO-MEDROL is indicated as follows:
_1. _
_ENDOCRINE DISORDERS _
•
Primary or secondary adrenocortical insufficiency (hydrocortisone or
cortisone acetate 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
acetate 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
Version: pfpdepmi10121
Supersedes: pfpdepmi11019
Page 2 of 24
•
Congenital adrenal hyperplasia
•
Hypercalcaemia associated with cancer
•
Non-suppurative thyroiditis.
_2. _
_RHEUMATIC DISORDERS _
As adjunctive therapy for short-term administration (to tide the
patient over an acute episode
or exacerbation) in:
•
Post-traumatic osteoarthritis
•
Epicondylitis
•
Synovitis of osteoarthritis
•
Acute non-specific t