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

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

methylprednisolone acetate, Quantity: 40 mg/mL

Διαθέσιμο από:

Pfizer Australia Pty Ltd

Φαρμακοτεχνική μορφή:

Injection, suspension

Σύνθεση:

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

Οδός χορήγησης:

Intraarticular, Intramuscular, Intralesional

Μονάδες σε πακέτο:

1 mL X 1, 1mL X 5

Kατηγορία:

Medicine Registered

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

INDICATIONS AS AT 17 NOVEMBER 2004: 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-NISOLONE 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. 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 tenosynovitis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. Acute and subacute bursitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Acute rheumatic carditis. Systemic dermatomyositis (polymyositis). 4. Dermatological Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson Syndrome). Severe seborrhoeic dermatitis. Exfoliative dermatitis. Severe psoriasis. Mycosis fungoides. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: Bronchial asthma. Drug hypersensitivity reactions. Contact dermatitis.Urticarial transfusion reactions. Atopic dermatitis. Acute non-infectious laryngeal oedema (adrenaline is the drug of first choice). Serum sickness. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye, such as: Herpes zoster ophthalmicus. Sympathetic ophthalmia. Iritis, iridocyclitis. Anterior segment inflammation. Chorioretinitis. Allergic conjunctivitis. Diffuse posterior uveitis. Allergic corneal marginal ulcers. Optic neuritis. Keratitis. 7. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8. Respiratory Diseases.Symptomatic sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculous chemotherapy. Aspiration pneumonitis. Loeffler's Syndrome not manageable by other means. 9. Haematological Disorders. Acquired (autoimmune) haemolytic anaemia. Erythroblastopenia (RBC anaemia). Secondary thrombocytopenia in adults. Congenital (erythroid) hypoplastic anaemia. 10. Neoplastic Diseases. For palliative management of: Leukaemias and lymphomas in adults. Acute leukaemia in childhood. 11. Oedematous States. To induce diuresis or remission of proteinuria in the nephrotic syndrome without uraemia of the idiopathic type or that due to lupus erythematosus. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculous chemotherapy. Trichinosis with neurological or myocardial involvement. B. For Intra-Articular Or Soft Tissue Administration DEPO-NISOLONE is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Synovitis of osteoarthritis. Epicondylitis. Rheumatoid arthritis. Acute non-specific tenosynovitis. Acute and subacute bursitis. Post-traumatic osteoarthritis. Acute gouty arthritis. C. For Intralesional Administration. DEPO-NISOLONE is indicated for intralesional use in the following conditions: Keloids.Discoid lupus erythematosus. Necrobiosis lipoidica diabeticorum. Alopecia areata. Localised hypertrophic, infiltrated inflammatory lesions of Licen Planus, psoriatic plaques, Granuloma Annulare and Lichen Simplex Chronicus (neurodermatitis). DEPO-NISOLONE may also be useful in cystic tumours of an aponeurosis or tendon (ganglia).

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

1997-04-14

Φύλλο οδηγιών χρήσης

DEPO-NISOLONE
®
_methylprednisolone acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before being treated with DEPO-
NISOLONE suspension for injection.
This leaflet answers some common
questions about DEPO-NISOLONE.
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-NISOLONE 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-
NISOLONE is finished. You may
need to read it again.
WHAT DEPO-
NISOLONE IS USED FOR
DEPO-NISOLONE is used to treat
disorders of many organ systems
such as skin, lung, eye,
gastrointestinal tract, nervous system,
joints and blood. DEPO-NISOLONE
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-NISOLONE for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DEPO-
NISOLONE HAS BEEN PRESCRIBED
FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE TREATMENT WITH
DEPO-NISOLONE
Some information is provided below.
However, always talk to your doctor
if you have concerns or questions
about your treatment.
_WHEN DEPO-NISOLONE_
_MUST NOT BE USED_
DEPO-NISOLONE 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 AN

Αρχείο Π.Χ.Π.

Version: pfpdepni10121
Supersedes: pfpdepni11019
Page 1 of 25
AUSTRALIAN
PRODUCT
INFORMATION
–
[DEPO-NISOLONE
® (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-NISOLONE 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-NISOLONE 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: pfpdepni10121
Supersedes: pfpdepni11019
Page 2 of 25
•
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-spec