DEXAMETHASONE PHOSPHATE 4 Mg/Ml Solution for Injection

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

DEXAMETHASONE SODIUM PHOSPHATE

थमां उपलब्ध:

Hospira UK Limited

ए.टी.सी कोड:

H02AB02

INN (इंटरनेशनल नाम):

DEXAMETHASONE SODIUM PHOSPHATE

डोज़:

4 Mg/Ml

फार्मास्यूटिकल फॉर्म:

Solution for Injection

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may not be renewed (A)

चिकित्सीय क्षेत्र:

Glucocorticoids

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

1986-07-28

सूचना पत्रक

Page 1 of 9
PFLEET 2017-0026115
2.
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXAMETHASONE PHOSPHATE 4 MG/ML SOLUTION FOR INJECTION
DEXAMETHASONE PHOSPHATE

DEXAMETHASONE IS A STEROID MEDICINE, prescribed for many different
conditions, including serious illnesses.

YOU NEED TO TAKE IT REGULARLY to get the maximum benefit.

DON'T STOP TAKING THIS MEDICINE without talking to your doctor - you
may
need to reduce the dose gradually.

DEXAMETHASONE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read section 4
below). Some problems such as mood changes (feeling depressed, or
'high'),
or stomach problems can happen straight away. If you feel unwell in
any way,
keep taking your tablets, but SEE YOUR DOCTOR STRAIGHT AWAY.

SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS. These include
weakness of arms and legs, or developing a rounder face (read section
4 for
more information).

IF YOU TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE 'STEROID
CARD':
always keep it with you and show it to any doctor or nurse treating
you.

KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN-POX OR SHINGLES, if you have
never had them. They could affect you severely. If you do come into
contact
with chicken pox or shingles, SEE YOUR DOCTOR STRAIGHT AWAY.
NOW READ THE REST OF THIS LEAFLET. It includes other important
information on the safe
and effective use of this medicine that might be especially important
for you.
THIS LEAFLET WAS LAST UPDATED ON MM/YYYY
DEXAMETHASONE – BENEFIT INFORMATION
Dexamethasone belongs to a group of medicines called steroids. Their
full name is
corticosteroids. Corticosteroids occur naturally in the body, and help
to maintain
health and well-being. Boosting your body with extra corticosteroid
(such as
Dexamethasone) is an effective way to treat various illnesses
involving inflammation
in the body. Dexamethasone reduces this inflammation, which could
otherwise go on
making your condition worse. You must take this medicine regularly to
get maximum
benefit from it.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone Phosphate 4 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre (ml) of solution contains 4 milligrams (mg) of
dexamethasone phosphate (as sodium salt). Each 2 ml of
solution contains 8 mg of dexamethasone phosphate (as sodium salt).
Each millilitre (ml) contains 0.12 mmol (2.76mg) of sodium. Total
quantity per vial is 0.24 mmol (5.52 mg) of sodium.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of acute adrenocortical insufficiency, pre and post
operative support, shock and in the active
management of corticosteroid responsive conditions.
In the management of inflammatory diseases of joints and soft tissue
such as rheumatoid arthritis.
In the short term management of acute self-limited allergic conditions
such as angioneurotic oedema or acute
exacerbations of chronic allergic disorders such as bronchial asthma
or serum sickness.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration:
Intravenous
Intramuscular
Intra-articular and intralesional
Recommended Dosage:
N.B. All doses are expressed as mg dexamethasone phosphate.
The usual dosage is 0.5- 24 mg daily depending on the individual
patient's condition and response.
In Shock:
Usually a dose of 2 to 6 mg/kg bodyweight is given intravenously as a
single dose. This may be repeated if required, in 2 to
6 hours, or followed by the same dose as an intravenous infusion.
High-dose therapy should be continued only until the patient's
condition has stabilised and usually for no longer than 48-72
hours. This bolus injection can then be followed by continuous I.V.
infusion of 3 mg/kg bodyweight per 24 hours.
Dexamethasone Injection can be diluted with Sodium Chloride Injection
B.P. or Glucose Injection B.P.
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