Dexamethasone phosphate 4 mg/ml solution for injection/infusion

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Dexamethasone sodium phosphate

Fáanlegur frá:

AS Kalceks

ATC númer:

H02AB02

INN (Alþjóðlegt nafn):

Dexamethasone sodium phosphate

Lyfjaform:

Solution for injection/infusion

Lækningarsvæði:

dexamethasone

Leyfisdagur:

2022-03-11

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXAMETHASONE PHOSPHATE 4 MG/ML SOLUTION FOR INJECTION/INFUSION
dexamethasone phosphate
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 only. 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 is and what it is used for
2.
What you need to know before you are given Dexamethasone phosphate
3.
How Dexamethasone phosphate will be given
4.
Possible side effects
5.
How to store Dexamethasone phosphate
6.
Contents of the pack and other information
1.
WHAT DEXAMETHASONE PHOSPHATE IS AND WHAT IT IS USED FOR
Dexamethasone phosphate contains the active substance dexamethasone
phosphate (further referred to
as dexamethasone). Dexamethasone is a synthetic glucocorticoid
(adrenocortical hormone). It reduces
inflammatory symptoms and intervenes in essential metabolic processes.
SYSTEMIC USE (AFFECTS THE ENTIRE BODY)
Dexamethasone phosphate is often used following emergency treatment
started at high dose:
−
Treatment and prophylaxis of cerebral oedema (swelling of the brain)
in brain tumours (after
surgery and after X-ray radiation) and after spinal cord trauma.
−
State of shock due to a severe allergic reaction called
‘anaphylactic shock’ (e.g. contrast
medium reaction).
−
States of shock after severe injuries, prevention of post-traumatic
‘shock lung’
(acute respiratory insufficiency).
−
Persistent severe symptoms of an asthma attack.
−
Initial treatment of some extensive, acute, severe skin conditions
(e.g. pemphigus vulgaris,
erythroderma).
−
Severe blood diseases (e.g.

Vara einkenni

Health Products Regulatory Authority
25 April 2023
CRN00DDC3
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone phosphate 4 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 3.32 mg of dexamethasone (as dexamethasone
sodium phosphate) which is equivalent to 4 mg of
dexamethasone phosphate or 4.37 mg dexamethasone sodium phosphate.
Each 2 ml ampoule contains 6.64 mg of dexamethasone (as dexamethasone
sodium phosphate) which is equivalent to 8 mg of
dexamethasone phosphate or 8.74 mg dexamethasone sodium phosphate.
Excipient with known effect
Each ml of solution contains about 3 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution free from visible particles.
pH of solution between 7.0 – 8.5
Osmolality 270-310 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_1. Systemic use_
Dexamethasone phosphate solution for injection/infusion is often used
following emergency treatment initiated at high dose:

Treatment and prophylaxis of cerebral oedema in brain tumours
(postoperatively and after X‑ray radiation) and
after spinal cord trauma.

State of anaphylactic shock (e.g. contrast medium reaction) in
combination with adrenaline, antihistamines and
appropriate volume replacement (caution: mixed syringes).

Polytraumatic shock / prophylaxis of post-traumatic shock lung.

Severe exacerbations of asthma (only with concomitant
sympathomimetics).

Acute severe dermatosis (e.g. pemphigus vulgaris, erythroderma).

Severe blood diseases (e.g. acute thrombocytopenic purpura, haemolytic
anaemia, as concomitant medication as
part of leukaemia treatments).

As second‑line treatment for acute adrenocortical insufficiency
(Addisonian crisis).
Dexamethasone phosphate is indicated in the treatment of coronavirus
disease 2019 (COVID-19) in adult and adolescent
patients (aged 12 years and older with body weight a