Dexamethasone Phosphate 4 mg/ml Solution for Injection

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Dexamethasone sodium phosphate

Dostupné s:

Pfizer Healthcare Ireland

ATC kód:

H02AB; H02AB02

INN (Mezinárodní Name):

Dexamethasone sodium phosphate

Dávkování:

4 milligram(s)/millilitre

Léková forma:

Solution for injection

Druh předpisu:

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

Terapeutické oblasti:

Glucocorticoids; dexamethasone

Stav Autorizace:

Marketed

Datum autorizace:

1986-07-28

Informace pro uživatele

Page
1
of
9
2022-0081684, 2021-0073344, 2023-0087016
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 medicine, 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.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Dexamethasone Phosphate Solution for Injection is and what it
is used for
2. What you need to know before you use Dexamethasone Phosphate
Solution for
Injection
3. How to use Dexamethaso

Charakteristika produktu

Health Products Regulatory Authority
21 September 2023
CRN00DV3J
Page 1 of 10
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 3.32 milligrams (mg)
dexamethasone (as sodium phosphate) which is equivalent to 4.00
mg of dexamethasone phosphate or 4.37 mg dexamethasone sodium
phosphate.
Each 2 ml of solution contains 6.64 mg dexamethasone (as sodium
phosphate) which is equivalent to 8.00 mg of
dexamethasone phosphate or 8.74 mg dexamethasone sodium phosphate.
Excipients with known effect:
Each ml of solution contains 0.07 mg of sodium sulfite (E 221). Each
vial of 2 ml of solution contains 0.14 mg of sodium sulfite
(E 221).
_ _
For the 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_._
Health Products Regulatory Authority
21 September 2023
CRN00DV3J
Page 2 of 10
High-dose therapy should be continu