Dexamethasone phosphate Noridem 4 mg/mL Solution for injection

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Dexamethasone sodium phosphate

Предлага се от:

Noridem Enterprises Limited

АТС код:

H02AB02

INN (Международно Name):

Dexamethasone sodium phosphate

дозиране:

4 milligram(s)/millilitre

Лекарствена форма:

Solution for injection

Терапевтична област:

dexamethasone

Статус Оторизация:

Marketed

Дата Оторизация:

2021-05-28

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXAMETHASONE PHOSPHATE NORIDEM 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. WHAT IS IN THIS LEAFLET
1.
What Dexamethasone phosphate Noridem is
and what it is used for
2.
What you need to know before you are given
Dexamethasone phosphate Noridem
3.
How Dexamethasone phosphate Noridem is
given
4.
Possible side effects
5.
How to store Dexamethasone phosphate
Noridem
6.
Contents of the pack and other information
1.
WHAT DEXAMETHASONE PHOSPHATE NORIDEM
IS AND WHAT IT IS USED FOR
Dexamethasone is a synthetic glucocorticoid
(adrenocortical hormone).
Dexamethasone belongs to a group of medicines
called steroids.
This medicine is given by injection to patients
unable to take a tablet form of the medicine.
Dexamethasone reduces inflammation and
suppresses the immune system and is used
normally for patients with:
•
severe allergic reactions causing swelling
of the face and throat, low blood pressure
and collapse (angioneurotic oedema and
anaphylaxis)
•
shock caused by infection or severe
tuberculosis (also with anti-infective treatments
e.g. antibiotics)
•
raised pressure in the skull caused by tumours
or infantile spasms (seizure disorder in babies)
•
Sometimes, the injection is given into the
painful area itself for example inflammation
of the joints (rheumatoid arthritis and
osteoarthritis)
Dexamethasone phosphate Noridem is used as a
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 breathing and need of oxygen therapy.
Dexamethasone can sometimes also be g

Данни за продукта

Health Products Regulatory Authority
28 April 2022
CRN00CV8D
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone phosphate Noridem 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 (as dexamethasone sodium phosphate) which
is equivalent to 4.00 mg of dexamethasone phosphate or 4.37 mg
dexamethasone sodium phosphate.
Each 2 mL of solution for injection contains 6.64 mg of dexamethasone
(as dexamethasone sodium phosphate) which is
equivalent to 8.00 mg of dexamethasone phosphate or 8.74 mg
dexamethasone sodium phosphate.
Each 5 mL of solution for injection contains 16.6 mg of dexamethasone
(as dexamethasone sodium phosphate) which is
equivalent to 20.00 mg of dexamethasone phosphate or 21.85 mg
dexamethasone sodium phosphate.
_ _
Excipients with known effect
Sodium: Each ampoule of 1 mL solution for injection contains 0.575 mg
sodium. Each ampoule of 2 mL solution for injection
contains 1.150 mg sodium. Each ampoule of 5 mL solution for injection
contains 2.875 mg sodium.
Propylene glycol: This medicinal product contains 20 mg propylene
glycol (E 1520) in each mL of solution for injection.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution.
pH: 7.00 – 8.50
Osmalility: approximately 300 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Corticosteroid
For use in certain endocrine and non-endocrine disorders responsive to
corticosteroid therapy.
INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION
Dexamethasone phosphate Noridem is recommended for systemic
administration by intravenous or intramuscular injection
when oral therapy is not feasible or desirable in the following
conditions.
_Endocrine disorders_
_Primary or secondary adrenocortical insufficiency_
(Hydrocortisone or cortisone is the first choice, but synthetic
analogues may be used with mineralocorticoids where applicable
and, in infan