SOLU-MEDROL ACT-O-VIAL 125mg powder for injection and diluent in one vial

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

methylprednisolone sodium succinate, Quantity: 165.78 mg (Equivalent: methylprednisolone, Qty 125 mg)

Διαθέσιμο από:

Pfizer Australia Pty Ltd

INN (Διεθνής Όνομα):

methylprednisolone sodium succinate

Φαρμακοτεχνική μορφή:

Injection, powder for

Σύνθεση:

Excipient Ingredients: monobasic sodium phosphate; sodium hydroxide; dibasic sodium phosphate

Οδός χορήγησης:

Intramuscular, Intravenous, Rectal

Μονάδες σε πακέτο:

and diluent 2mL in separate chambers, 1x ACT-O-VIAL with powder 125mg

Τρόπος διάθεσης:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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, SOLU-MEDROL Powder for Injection is indicated only for intravenous or intramuscular use in the following conditions:,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,? Epicondylitis,? Synovitis of osteoarthritis,? Acute gouty arthritis,? Acute nonspecific tenosynovitis,? Post-traumatic osteoarthritis,? Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy).,Collagen Disease,During an exacerbation or as maintenance therapy in selected cases of:,? Systemic lupus erythematosus,? Systemic dermatomyositis (polymyositis),? Acute rheumatic carditis.,Dermatological Diseases,? Bullous dermatitis herpetiformis,? Pemphigus,? Severe psoriasis,? Severe seborrhoeic dermatitis,? Exfoliative dermatitis,? Mycosis fungoides,? Severe erythema multiforme (Stevens-Johnson Syndrome).,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,? Serum sickness,? Acute noninfectious laryngeal oedema (adrenaline is the drug of first choice).,Ophthalmic Diseases,Severe acute and chronic allergic and inflammatory processes involving the eye, such as:,? Allergic corneal marginal ulcers,? Allergic conjunctivitis,? Chorioretinitis,? Anterior segment inflammation,? Herpes zoster ophthalmicus,? Iritis, iridocyclitis,? Diffuse posterior uveitis and choroiditis,? Keratitis,? Optic neuritis,? Sympathetic ophthalmia.,Gastrointestinal Diseases,To tide the patient over a critical period of the disease in:,? Ulcerative colitis (systemic therapy),? Regional enteritis (systemic therapy).,Respiratory Diseases,? Symptomatic sarcoidosis,? Berylliosis,? Aspiration pneumonitis,? Loeffler?s syndrome not manageable by other means,? Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.,Haematologic Disorders,? Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated),? Secondary thrombocytopenia in adults,? Acquired (autoimmune) haemolytic anaemia,? Erythroblastopenia (RBC anaemia),? Congenital (erythroid) hypoplastic anaemia.,Neoplastic Diseases,For palliative management of:,? Leukaemias and lymphomas in adults,? Acute leukaemia of childhood.,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.,Nervous System,? Acute exacerbations of multiple sclerosis.,Miscellaneous,? Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.,? Trichinosis with neurologic or myocardial involvement.,? SOLU-MEDROL is beneficial as adjunctive therapy in the treatment of acquired immunodeficiency syndrome (AIDS) patients with moderate to severe Pneumocystis jiroveci pneumonia (PCP) when given within the first 72 hours of initial anti-pneumocystis treatment.

Περίληψη προϊόντος:

Visual Identification: White freeze dried cake in bottom half of vial/; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2010-09-23

Φύλλο οδηγιών χρήσης

SOLU-MEDROL
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I GIVEN SOLU-MEDROL?
SOLU-MEDROL contains the active ingredient methylprednisolone sodium
succinate. SOLU-MEDROL is used for treatment of
various medical conditions including skin diseases, allergic
reactions, inflammation of the eyes, respiratory diseases and certain
respiratory infections, diseases of the gut, multiple sclerosis,
rheumatic disorders, diseases of the blood and treatment of certain
glandular conditions. For more information, see Section 1. Why am I
given SOLU-MEDROL? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I RECEIVE SOLU-MEDROL?
Do not use if you have ever had an allergic reaction to
methylprednisolone sodium succinate or any of the ingredients listed
at the
end of the CMI. Talk to your doctor if you have any other medical
conditions, take any other medicines, or are pregnant or plan to
become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I
receive SOLU-MEDROL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines and food may interfere with SOLU-MEDROL and affect how
it works. Tell your doctor if you are taking any other
medicines including medicines used to relieve pain or swelling, some
antibiotics, oral contraceptives, anticoagulants, anticonvulsants
and antidiabetic medicines.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS SOLU-MEDROL GIVEN?
This medicine will be administered under medical supervision.
SOLU-MEDROL must be administered by intravenous or
intramuscular injection. You must not administer this medicine to
yourself.
The dose, how often and how long you are treated with SOLU-MEDROL will
depend on your medical condition and also on your
weight. Your doctor may change the dose and how many times a day you
have it, as your condition ch

Αρχείο Π.Χ.Π.

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AUSTRALIAN
PRODUCT
INFORMATION
–
SOLU-MEDROL
®
AND
SOLU-MEDROL
ACT-O-VIAL
®
(METHYLPREDNISOLONE
SODIUM SUCCINATE)
1.
NAME OF THE MEDICINE
Methylprednisolone sodium succinate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SOLU-MEDROL is available in several strengths for intravenous (IV) or
intramuscular (IM)
administration.
40 MG ACT-O-VIAL SYSTEM
- Each mL (when mixed) contains methylprednisolone sodium
succinate equivalent to 40 mg methylprednisolone;
125 MG ACT-O-VIAL SYSTEM
- Each 2 mL (when mixed) contains methylprednisolone
sodium succinate equivalent to 125 mg methylprednisolone;
500 MG VIAL WITH DILUENT
- Each 8 mL (when mixed as directed) contains
methylprednisolone sodium succinate equivalent to 500 mg
methylprednisolone;
1 G VIAL WITH DILUENT
- Each 15.6 mL (when mixed as directed) contains methylprednisolone
sodium succinate equivalent to 1 g methylprednisolone;
2 G VIAL WITH DILUENT
- Each 31.2 mL (when mixed as directed) contains methylprednisolone
sodium succinate equivalent to 2 g methylprednisolone;
500 MG PLAIN VIAL
- Each vial contains methylprednisolone sodium succinate equivalent to
500 mg methylprednisolone;
1 G PLAIN VIAL
- Each vial contains methylprednisolone sodium succinate equivalent to
1 g
methylprednisolone;
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
SOLU-MEDROL 40 mg and 125 mg ACT-O-VIAL System
-
Powder for injection: White freeze dried cake
_ _
-
Diluent: Clear colourless liquid
_ _
SOLU-MEDROL 500 mg, 1 g and 2 g Vials with Diluent
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Powder for injection: White freeze dried cake
_ _
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Diluent: Clear colourless liquid
_ _
SOLU-MEDROL 500 mg and 1 g Plain Vials
-
Powder for injection: White freeze dried cake
When necessary, the pH of each formula was adjusted with sodium
hydroxide so that the pH
of the reconstituted solution is within the USP specified range of 7
to 8 and the tonicities are,
for the 40 mg per m