Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
dexamethasone sodium phosphate, Quantity: 4.37 mg/mL (Equivalent: dexamethasone phosphate, Qty 4 mg/mL)
Pfizer Australia Pty Ltd
Dexamethasone sodium phosphate
Injection, solution
Excipient Ingredients: sodium hydroxide; sodium citrate dihydrate; water for injections; sodium sulfite; disodium edetate; hydrochloric acid
Intramuscular, Intrasynovial, Intravenous
10 vials, 5 vials
(S4) Prescription Only Medicine
Replacement therapy - adrenocortical insufficiency Dexamethasone has predominantly glucocorticoid activity and therefore is not a complete replacement therapy in cases of adrenocortical insufficiency. Dexamethasone should be supplemented with salt and/or a mineralocorticoid, such as deoxycorticosterone. When so supplemented, dexamethasone is indicated in: Acute adrenocortical insufficiency - Addison's disease, bilateral adrenalectomy; Relative adrenocortical insufficiency - Prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. The reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. Should a patient be subjected to sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. Steroid therapy should therefore be reinstituted to help cope with stress such as that associated with surgery, trauma, burns, or severe infections where specific antibiotic therapy is available; Primary and secondary adrenocortical insufficiency. Disease therapy Dexamethasone is indicated for therapy of the following diseases: Collagen diseases: Systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, giant cell arteritis, adjunctive therapy for short term administration during an acute episode or exacerbation, acute rheumatic carditis ? during an exacerbation or as maintenance therapy. Pulmonary disorders: Status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency. Blood disorders: Leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia. Rheumatic diseases: Rheumatoid arthritis, osteoarthritis, adjunctive therapy for short term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis. Skin diseases: Psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis. Gastrointestinal disorders: Ulcerative colitis, regional enteritis. Oedema: Cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis). Eye disorders: Allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy. Neoplastic states: Cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children. Endocrine disorders: Adrenal insufficiency. Preoperative and postoperative support Dexamethasone may be used in any surgical procedure when the adrenocortical reserve is doubtful. This includes the treatment of shock due to excessive blood loss during surgery. Shock Dexamethasone may be used as an adjunct in the treatment of shock. Dexamethasone should not be used as a substitute for normal shock therapy.
Visual Identification: Clear colourless solution free from visible particular matter.; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2011-03-18
DBL™ DEXAMETHASONE SODIUM PHOSPHATE INJECTION _Dexamethasone Phosphate (as sodium)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL Dexamethasone Sodium Phosphate Injection. 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 DBL Dexamethasone Sodium Phosphate Injection against the benefits they expect it will have for you. If you have any concerns about being given this medicine, ask your doctor or pharmacist. Keep this leaflet in a safe place. WHAT DBL DEXAMETHASONE SODIUM PHOSPHATE INJECTION IS USED FOR Dexamethasone phosphate (as sodium) is a glucocorticoid and belongs to a group of medicines called corticosteroids. It may be used to treat an inactive or underactive adrenal gland or to treat a number of different diseases such as certain immune disorders and skin problems, asthma or arthritis. Corticosteroids reduce inflammation, one of the body’s reactions to injury. Except for its use in the treatment of underactive adrenal glands, dexamethasone phosphate (as sodium) does not cure disease; it treats the symptoms. YOUR DOCTOR MAY HAVE PRESCRIBED DBL DEXAMETHASONE SODIUM PHOSPHATE INJECTION FOR ANOTHER REASON. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DBL DEXAMETHASONE SODIUM PHOSPHATE INJECTION HAS BEEN PRESCRIBED FOR YOU. DBL Dexamethasone Sodium Phosphate Injection is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN DBL DEXAMETHASONE SODIUM PHOSPHATE INJECTION _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU SHOULD NOT BE GIVEN DBL DEXAMETHASONE SODIUM PHOSPHATE INJECTION IF YOU HAVE AN ALLERGY TO DEXAMETHASONE PHOSPHATE (AS SODIUM) OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. The 8mg/2mL vial formulation is contraindicated in patients with a known hypersensitivity to sulfites. Symptoms of an allergic reaction may include: Lestu allt skjalið
Version: pfpdexai11021 Supersedes: pfpdexai10321 Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION – DBL™ DEXAMETHASONE SODIUM PHOSPHATE INJECTION (DEXAMETHASONE SODIUM PHOSPHATE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Dexamethasone sodium phosphate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre of DBL Dexamethasone Sodium Phosphate Injection contains dexamethasone sodium phosphate equivalent to 4 mg of dexamethasone phosphate. It does not contain preservatives or antioxidants. EXCIPIENT(S) WITH KNOWN EFFECT Sodium sulfite (8 mg/2 mL vial only) For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM DBL Dexamethasone Sodium Phosphate Injection is a clear colourless solution for injection, free from visible particulate matter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS REPLACEMENT THERAPY - ADRENOCORTICAL INSUFFICIENCY Dexamethasone has predominantly glucocorticoid activity and therefore is not a complete replacement therapy in cases of adrenocortical insufficiency. Dexamethasone should be supplemented with salt and/or a mineralocorticoid, such as deoxycorticosterone. When so supplemented, dexamethasone is indicated in: • Acute adrenocortical insufficiency - Addison's disease, bilateral adrenalectomy; • Relative adrenocortical insufficiency - Prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. The reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. Should a patient be subjected to sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. Steroid therapy should therefore be reinstituted to help cope with stress such as that associated with surgery, trauma, burns, or severe infections where specific antibiotic therapy is available; Version: pfpdexai11021 Supersedes: pfpdexai10321 Page 2 of 15 • Primary and secondar Lestu allt skjalið