Dexamethasone phosphate 4 mg/ml solution for injection

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Dexamethasone sodium phosphate

متاح من:

Fresenius Kabi Deutschland GmbH

ATC رمز:

H02AB02

INN (الاسم الدولي):

Dexamethasone sodium phosphate

الشكل الصيدلاني:

Solution for injection

المجال العلاجي:

dexamethasone

الوضع إذن:

Not marketed

تاريخ الترخيص:

2022-07-22

نشرة المعلومات

IE PIL Dexamethasone_V003
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXAMETHASONE PHOSPHATE 4 MG/ML SOLUTION FOR INJECTION
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 nurse.
- 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 nurse. This
includes any possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What is Dexamethasone Phosphate and what it is used for
2. What you need to know before you use Dexamethasone Phosphate
3. How to use Dexamethasone Phosphate
4. Possible side effects
5. How to store Dexamethasone Phosphate
6. Contents of the pack and other information
1. WHAT IS DEXAMETHASONE PHOSPHATE AND WHAT IT IS USED FOR
Dexamethasone is a synthetic glucocorticoid (adrenocortical hormone).
Dexamethasone Phosphate 4 mg/ml solution for injection is indicated in
the following situations:
SYSTEMIC USE
The indications are:
The same as the oral corticosteroids, in situations in which the oral
therapy is unfeasible (vomits, altered
consciousness);
Conditions that require a rapid therapeutic effect:
Haemorrhagic, traumatic, surgical or septic origin shock
Autoimmune inflammatory diseases: Lupus erythematosus,
Dermatomyositis, Polyarthritis nodosa,
Thrombocytopenic purpura, Pemphigus vulgaris, Rheumatoid arthritis
Allergies:
Acute
bronchial
asthma,
severe
angioedema
(in
combination
with
antihistamines),
Anaphylactic shock (in combination with adrenaline), imminent
allograft rejection
Infections:
Severe typhoid fever, especially if associated with altered
consciousness, shock, coma
Laryngitis stridulosa (pseudocroup) in children
Dexamethasone Phosphate is used as a treatment of coronavirus disease
2019 (COVID-19) in adult

خصائص المنتج

Health Products Regulatory Authority
17 November 2023
CRN00DLLT
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone phosphate 4 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 4 mg of dexamethasone phosphate (as 4.37
mg of dexamethasone sodium phosphate, equivalent
to 3.3 mg of dexamethasone base).
Excipient with known effect:
Each 1 ml ampoule contains 3.2 mg of sodium (as trisodium citrate
dihydrate and disodium edetate dihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear and colourless solution, free of visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dexamethasone Phosphate 4 mg/ml solution for injection is indicated in
the following situations:
SYSTEMIC USE
The indications are:
The same as for oral corticosteroids, in situations in which the oral
route is unavailable (vomiting, altered consciousness);
Conditions that require a rapid therapeutic effect:
Shock of haemorrhagic, traumatic, surgical or septic origin
Autoimmune inflammatory diseases: Lupus erythematosus,
Dermatomyositis, Polyarteritis nodosa, Thrombocytopenic purpura,
Pemphigus vulgaris, Rheumatoid arthritis
Allergies: Acute bronchial asthma, Severe angioedema (in combination
with antihistamines), Anaphylactic shock (in association
with adrenaline), Imminent allograft rejection
Infections:
Severe typhoid fever, especially if associated with altered
consciousness, shock, coma
Stridulous laryngitis (pseudocroup) in children.
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 at least 40 kg) who
require supplemental oxygen therapy.
Neurological conditions: Cerebral oedema following tumours, abscesses,
cerebral toxoplasmosis.
ORL: Laryngeal dyspnoea
Oncological conditions:
In combination with other medicines, treatment of symptomatic multiple
myeloma, acute lympho