DEXAMETHASONE JUNO dexamethasone phosphate (as dexamethasone sodium phosphate) 8 mg/2 mL solution for injection ampoule

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

dexamethasone sodium phosphate, Quantity: 8.74 mg (Equivalent: dexamethasone phosphate, Qty 8 mg)

Disponible desde:

Juno Pharmaceuticals Pty Ltd

formulario farmacéutico:

Injection, solution

Composición:

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

Vía de administración:

Intramuscular, Intravenous, Intrasynovial

Unidades en paquete:

25 x 8 mg/2 mL, 5 x 8 mg/2 mL, 10 x 8 mg/2 mL

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

Visual Identification: Clear, colourless to light yellow 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

Estado de Autorización:

Registered

Fecha de autorización:

2022-12-23

Información para el usuario

DEXAMETHASONE JUNO
1
DEXAMETHASONE JUNO
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 USING DEXAMETHASONE JUNO?
DEXAMETHASONE JUNO contains the active ingredient dexamethasone
phosphate (as sodium). 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.
For more information, see Section 1. Why am I using Dexamethasone
Juno? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DEXAMETHASONE JUNO?
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 Juno? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with dexamethasone phosphate (as sodium)
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 JUNO?
•
Your doctor will decide the appropriate dose for you
•
A doctor or nurse will usually prepare and administer the injection,
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.
•
Follow all instructions given to you by your doctor or pharmacist.
More instructions can be f

Ficha técnica

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AUSTRALIAN
PRODUCT
INFORMATION
–
DEXAMETHASONE JUNO (DEXAMETHASONE
SODIUM PHOSPHATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Dexamethasone sodium phosphate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of Dexamethasone Juno contains dexamethasone sodium
phosphate equivalent
to 4 mg of dexamethasone phosphate. It does not contain preservatives
or antioxidants.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Dexamethasone Juno is a clear colourless to light yellow 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.
DISEASE THERAPY
Dexamethasone is indicated for therapy of the following diseases:
COLLAGEN DISEASES:
Systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis,
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giant cell arteritis, adjunct