DEXAMETHASONE MEDSURGE dexamethasone phosphate (as dexamethasone sodium phosphate) 4 mg/1 mL solution for injection ampoule

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

dexamethasone sodium phosphate, Quantity: 4.37 mg (Equivalent: dexamethasone phosphate, Qty 4 mg)

متاح من:

Medsurge Pharma Pty Ltd

الشكل الصيدلاني:

Injection, solution

تركيب:

Excipient Ingredients: sodium citrate dihydrate; creatinine; water for injections; sodium hydroxide; disodium edetate

طريقة التعاطي:

Intramuscular, Intravenous, Intrasynovial

الوحدات في الحزمة:

10 x 1 mL ampoules, 5 x 1 mL ampoules

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

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.

ملخص المنتج:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; 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

الوضع إذن:

Registered

تاريخ الترخيص:

2023-04-04

نشرة المعلومات

Dexamethasone Medsurge CMI Edition 03 Mar 2023
1
DEXAMETHASONE MEDSURGE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
1.
WHY AM I USING DEXAMETHASONE MEDSURGE?
Dexamethasone Medsurge contains the active ingredient dexamethasone
sodium phosphate. Dexamethasone (as sodium
phosphate) 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 (as sodium phosphate) does
not cure disease; it treats the symptoms.
For more information, see Section 1. Why am I using Dexamethasone
Medsurge? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DEXAMETHASONE?
Do not use if you have ever had an allergic reaction to dexamethasone
sodium phosphate 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 use
Dexamethasone? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with dexamethasone and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE DEXAMETHASONE MEDSURGE?
•
The dose of dexamethasone Injection is variable, depending upon the
condition being treated. It may be given as a course
of injections or as a single dose. Your doctor will decide what dose
will receive. This depends on your condition and other
factors, such as your weight.
•
Dexamethasone Injection is given as a slow injection or infusion
(intravenous drip) into the veins. It may also be given as an
injection into an injured muscle or joint. Dexamethasone Injection
should only

خصائص المنتج

DEXAMETHASONE MEDSURGE
Dexamethasone Medsurge, version 0.3, Mar 2023
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AUSTRALIAN PRODUCT INFORMATION –
DEXAMETHASONE MEDSURGE (DEXAMETHASONE
SODIUM PHOSPHATE) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Dexamethasone sodium phosphate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
millilitre
of
Dexamethasone
Medsurge
injection
contains
dexamethasone
sodium
phosphate equivalent to 4 mg of dexamethasone phosphate. It does not
contain preservatives
or antioxidants.
There are no excipients with known effect.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Dexamethasone Medsurge 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;
•
Primary and secondary adrenocortical insufficiency.
M
medsurge
DEXAMETHASONE MEDSURGE
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