Dexamethasone Phosphate 4 mg/ml solution for injection

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Dexamethasone sodium phosphate

Beszerezhető a:

hameln pharma gmbh

ATC-kód:

H02AB02

INN (nemzetközi neve):

Dexamethasone sodium phosphate

Adagolás:

4 milligram(s)/millilitre

Gyógyszerészeti forma:

Solution for injection

Terápiás terület:

dexamethasone

Engedély dátuma:

2021-08-24

Betegtájékoztató

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXAMETHASONE PHOSPHATE 4 MG/ML SOLUTION FOR INJECTION
Dexamethasone phosphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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,
pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Dexamethasone phosphate 4 mg/ml solution
for injection, which will
be referred to as Dexamethasone Injection throughout this leaflet.
WHAT IS IN THIS
LEAFLET
1. What Dexamethasone Injection is and what it is used
for
2. What you need to know before you are given Dexamethasone Injection
3. How Dexamethasone Injection is given
4. Possible side
effects
5. How to store Dexamethasone Injection
6. Contents of the pack and other
information
1.
WHAT DEXAMETHASONE INJECTION IS AND WHAT
IT
IS USED
FOR
Dexamethasone Injection is a synthetic glucocorticoid
(adrenocortical hormone) with an effect on
metabolism, electrolyte balance, and tissue functions.
Dexamethasone Injection is used to treat diseases that require
treatment with glucocorticoids.
Depending on their nature and severity these include:
VIA SYSTEMIC USE

Brain swelling, caused by brain tumour, neurosurgical operations,
brain abscess, bacterial
meningitis.

Shock following severe injuries, to prevent acute respiratory distress
syndrome (ARDS).

Treatment of coronavirus disease 2019 (COVID-19) in adult and
adolescent patients (aged 12
years and older with body weight at least 40 kg) with difficulty in
breathing and need of
oxygen therapy.

Severe acute asthma attack.

Initial treatment of extensive acute severe skin diseases, such as
erythroderma, pemphigus
vulgaris, acute eczema.

Systemic rheumatic diseases (rheumatic diseases that can affect
internal organs), such as
systemic lupus erythematosus

Termékjellemzők

Health Products Regulatory Authority
07 March 2022
CRN00CS3P
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone Phosphate 4 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 millilitre (ml) of solution for injection contains 3.32 mg of
dexamethasone base (as dexamethasone sodium phosphate)
which is equivalent to 4.00 mg of dexamethasone phosphate or 4.37 mg
dexamethasone sodium phosphate.
Each 2 millilitres (ml) of solution for injection contains 6.64 mg of
dexamethasone base (as dexamethasone sodium phosphate)
which is equivalent to 8.00 mg of dexamethasone phosphate or 8.74 mg
dexamethasone sodium phosphate.
Excipients with known effect:
This medicine contains 20 mg of propylene glycol per 1 ml – see
sections 4.2, 4.4, 4.6 and 4.8.
This medicine contains 0.42 mg of sodium per 1 ml - see section 4.4.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection)
Clear and colourless solution, free of visible particles.
pH 7.5 – 8.7
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION
Dexamethasone phosphate 4 mg/ml solution for injection is recommended
for systemic administration by intravenous or
intramuscular injection when oral therapy is not feasible or desirable
in the following conditions:

_Cerebral oedema caused by cerebral tumour, neurosurgical
interventions, cerebral abscess, bacterial meningitis_

_Posttraumatic shock_ and prevention of _posttraumatic acute
respiratory distress syndrome_ (ARDS)

_Coronavirus disease 2019 (COVID-19) Treatment of coronavirus disease
2019 (COVID-19) in adult and adolescent _
_patients (aged 12 years and older with body weight at least 40 kg)
who require supplemental oxygen therapy._

_Anaphylactic shock _(following initial epinephrine injection)

Severe acute _asthma attack_

_Initial parenteral treatment of extensive, acute, severe skin
diseases, such as erythroderma, pemphigus vulgaris, acute