Dexamethasone SXP dexamethasone phosphate (as sodium) 4 mg/1 mL injection solution ampoule

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

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

Dostupno od:

Southern XP IP Pty Ltd

Farmaceutski oblik:

Injection, solution

Sastav:

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

Administracija rute:

Intravenous, Intrasynovial, Intramuscular

Jedinice u paketu:

5 ampoules, 10 ampoules

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

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.

Proizvod sažetak:

Visual Identification: Clear colourless to slightly yellowish solution for injection.; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

2023-06-13

Uputa o lijeku

DEXAMETHASONE SXP
1
DEXAMETHASONE SXP
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 BEING GIVEN DEXAMETHASONE SXP?
DEXAMETHASONE SXP injection contains the active ingredient
dexamethasone sodium phosphate. DEXAMETHASONE SXP injection is used to
treat an underactive adrenal gland, immune disorders, skin problems,
asthma, arthritis or in other situations to reduce inflammation.
For more information, see Section 1. Why am I being given
DEXAMETHASONE SXP?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN DEXAMETHASONE SXP?
Do not use if you have ever had an allergic reaction to DEXAMETHASONE
SXP injection 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 am
given DEXAMETHASONE SXP?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DEXAMETHASONE SXP injection 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 AM I GIVEN DEXAMETHASONE SXP?
•
DEXAMETHASONE SXP 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. It may be given as a course
of injections or as a single dose.
•
DEXAMETHASONE SXP injection should only be given by a doctor or nurse
who will decide the correct dose depending upon
the condition being treated, and other factors such as your weight.
More instructions can be found in Section 4. How am I given
DEXAMETHASONE SXP? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE I AM BEING GIVEN DEXAMETHASONE SXP?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are being
given this medicine.
•
If you are

Svojstava lijeka

1
AUSTRALIAN PRODUCT INFORMATION – DEXAMETHASONE SXP
(DEXAMETHASONE SODIUM PHOSPHATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Dexamethasone sodium phosphate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
millilitre
of
DEXAMETHASONE
SXP
injection
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 SXP injection is a clear colourless to slightly
yellowish solution for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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, giant cell
arteritis, adjunctive therapy for short-term administra