Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
methylprednisolone sodium succinate, Quantity: 53.05 mg (Equivalent: methylprednisolone, Qty 40 mg)
Pfizer Australia Pty Ltd
methylprednisolone sodium succinate
Injection, powder for
Excipient Ingredients: monobasic sodium phosphate; dibasic sodium phosphate; lactose monohydrate; sodium hydroxide
Intramuscular, Intravenous, Rectal
and diluent 1mL in separate chambers, 1 X ACT -O-VIALS with powder 40mg
Not scheduled. Not considered by committee, (S4) Prescription Only Medicine
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.
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
Registered
2010-09-23
SOLU-MEDROL ® S O L U - M E D R O L ® 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 Aqra d-dokument sħiħ
Version: pfpsolmv11221 Supersedes: pfpsolmv10321 Page 1 of 30 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 - Powder for injection: White freeze dried cake _ _ Version: pfpsolmv11221 Supersedes: pfpsolmv10321 Page 2 of 30 - 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 Aqra d-dokument sħiħ