Dexamethasone (base) 6.6mg/2ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexamethasone sodium phosphate

Available from:

base) 6.6mg/2ml solution for injection vials (Pfizer Ltd

ATC code:

H02AB02

INN (International Name):

Dexamethasone sodium phosphate

Dosage:

3.3mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intrabursal; Intraarticular; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200; GTIN: 5015997210153

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXAMETHASONE 3.3 MG/ML SOLUTION FOR INJECTION
(6.6 mg/2 ml vials)
Dexamethasone

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 04/2016.
DEXAMETHASONE – BENEFIT INFORMATION
Dexamethasone belongs to a group of medicines called steroids. Their
full name is
_corticosteroids_.
These 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 YOU START USIN

Summary of Product characteristics

OBJECT 1
DEXAMETHASONE 3.3 MG/ML SOLUTION FOR INJECTION
(VIAL)
Summary of Product Characteristics Updated 08-Jun-2016 | Hospira UK
Ltd
1. Name of the medicinal product
Dexamethasone 3.3 mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each ml of solution contains 3.3 mg dexamethasone (as sodium
phosphate) which is equivalent to 4 mg
dexamethasone phosphate or 4.3 mg dexamethasone sodium phosphate.
Each 2 ml contains 6.6 mg dexamethasone (as sodium phosphate) which is
equivalent to 8 mg
dexamethasone phosphate or 8.6 mg dexamethasone sodium phosphate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
A clear, colourless solution free from particulate matter
4. Clinical particulars
4.1 Therapeutic indications
Dexamethasone Solution for Injection is indicated in acute conditions
in which oral glucocorticoid
therapy is not feasible such as:
Shock: of haemorrhagic, traumatic, surgical or septic origin; cerebral
oedema associated with cerebral
neoplasm; inflammatory diseases of joints and soft tissue such as
rheumatoid arthritis.
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.
High doses of dexamethasone are intended for the adjunctive treatment
of shock where massive doses of
corticosteroids are needed. There is a lack of evidence that use of
corticosteroids in septic shock affects
mortality in the long term. Use must be accompanied by the appropriate
concomitant systemic antibiotic
treatment and supportive measures which the patient's condition may
require.
4.2 Posology and method of administration
Not for intrathecal use – contains sulphites.
N.B. All doses are expressed as mg dexamethasone base.
The lowest effective dose should be used for the minimum period and
this should be reviewed frequently
to appropriately titrate the dose against disease activity (See
Warnings Section).
Dexamethasone 3.3 mg/ml Soluti