DEXAMETHASONE VIATRIS dexamethasone phosphate (as dexamethasone sodium phosphate) 8mg/2mL solution for injection vial

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

dexamethasone sodium phosphate, Quantity: 8.8 mg (Equivalent: dexamethasone phosphate, Qty 8 mg)

Disponibbli minn:

Alphapharm Pty Ltd

INN (Isem Internazzjonali):

Dexamethasone sodium phosphate

Għamla farmaċewtika:

Injection

Kompożizzjoni:

Excipient Ingredients: water for injections; sodium citrate; creatinine

Rotta amministrattiva:

Intrasynovial, Intramuscular, Intravenous

Unitajiet fil-pakkett:

5, 10

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

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 the following: ? 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 - 1. 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. 2. Pulmonary disorders. Status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency. 3. Blood disorders. Leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia. 4. Rheumatic diseases. Rheumatoid arthritis, osteoarthritis, adjunctive therapy for short-term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis. 5. Skin diseases. Psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis. 6. Gastrointestinal disorders. Ulcerative colitis, regional enteritis. 7. Oedema. Cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis). 8. Eye disorders. Allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy. 9. Neoplastic states. Cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children. 10. 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. Refer to section 4.2 Dose and Method of Administration. Dexamethasone should not be used as a substitute for normal shock therapy.

Sommarju tal-prodott:

Visual Identification: 2mL amber vial with rubber stopper and aluminium seal; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2011-03-25

Fuljett ta 'informazzjoni

DEXAMETHASONE
MYLAN
_dexamethasone sodium phosphate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about
DEXAMETHASONE MYLAN. 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
DEXAMETHASONE MYLAN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
DEXAMETHASONE
MYLAN IS USED FOR
DEXAMETHASONE MYLAN 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, skin
problems, asthma or arthritis.
Corticosteroids reduce inflammation,
one of the body's reactions to injury.
Except for its use in the treatment of
an underactive adrenal gland,
DEXAMETHASONE MYLAN does
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
DEXAMETHASONE
MYLAN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN
DEXAMETHASONE MYLAN IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
dexamethasone sodium phosphate
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
YOU SHOULD NOT BE GIVEN
DEXAMETHASONE MYLAN IF
YOU HAVE AN INTERNAL FUNGAL
INFECTION OR ANY OTHER INFECTION.
YOU SHOULD NOT BE GIVEN
DEXAMETHASONE MYLAN IF
YOU HAVE RECENTLY BEEN GIVEN A LIVE
VACCINE UNLESS YOU ARE BEING GIVEN
THIS MEDICINE FOR REPLACEMENT
THERAPY.
YOU SHOULD

Karatteristiċi tal-prodott

AUSTRALIAN PRODUCT INFORMATION
DEXAMETHASONE MYLAN
_dexamethasone sodium phosphate solution for injection _
1
NAME OF THE MEDICINE
Dexamethasone sodium phosphate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of DEXAMETHASONE MYLAN INJECTION contains dexamethasone sodium
phosphate 4.4 mg
(equivalent to 4 mg dexamethasone phosphate) as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
DEXAMETHASONE MYLAN is a clear, colourless solution, 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 the
following:
•
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:
_1._
_ _
_Collagen diseases._
Systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis,
giant cell
arteritis, adjunctive therapy for short-term adm