DBL DEXAMETHASONE SODIUM PHOSPHATE INJECTION 8mg/2mL (as sodium) injection vial

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

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

Disponible desde:

Pfizer Australia Pty Ltd

Designación común internacional (DCI):

Dexamethasone sodium phosphate

formulario farmacéutico:

Injection, solution

Composición:

Excipient Ingredients: sodium hydroxide; sodium citrate dihydrate; water for injections; sodium sulfite; disodium edetate; hydrochloric acid

Vía de administración:

Intramuscular, Intrasynovial, Intravenous

Unidades en paquete:

10 vials, 5 vials

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 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

Estado de Autorización:

Registered

Fecha de autorización:

2011-03-18

Información para el usuario

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:

Ficha técnica

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