Dexamethasone Medochemie 4 mg/ml solution for injection/infusion - 2ml ampoule

Country: Մալթա

language: անգլերեն

source: Medicines Authority

MAH:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC_code:

H02AB02

INN:

DEXAMETHASONE SODIUM PHOSPHATE 4 mg/ml

pharmaceutical_form:

SOLUTION FOR INJECTION/INFUSION

composition:

DEXAMETHASONE SODIUM PHOSPHATE 4 mg/ml

prescription_type:

POM

therapeutic_area:

CORTICOSTEROIDS FOR SYSTEMIC USE

leaflet_short:

Licence number in the source country: NOT APPLICAPABLE

authorization_status:

Authorised

authorization_date:

2023-02-13

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXAMETHASONE MEDOCHEMIE 4 MG/ML SOLUTION FOR INJECTION/INFUSION
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 Medochemie is and what it is used for
2.
What you need to know before you are given Dexamethasone Medochemie
3.
How Dexamethasone Medochemie is given
4.
Possible side effects
5.
How to store Dexamethasone Medochemie
6.
Contents of the pack and other information
1.
WHAT DEXAMETHASONE MEDOCHEMIE IS AND WHAT IT IS USED FOR
DEXAMETHASONE IS A SYNTHETIC GLUCOCORTICOID
(adrenocortical hormone) with an effect on
metabolism, electrolyte balance and tissue functions.
DEXAMETHASONE MEDOCHEMIE IS USED IN
Diseases requiring treatment with glucocorticoids. Depending on the
type and severity, these include:
SYSTEMIC USE:
-
Swelling of the brain caused by brain tumours, brain surgery, brain
abscess, bacterial
inflammation of the lining of the brain.
-
States of shock after severe injuries, for prophylactic treatment of
shock lung.
-
Severe acute asthma attack.
-
Initial treatment of extensive acute severe skin diseases such as
erythroderma, pemphigus vulgaris,
acute eczema.
-
Treatment of systemic rheumatic diseases (rheumatic diseases that can
affect internal organs) such
as systemic lupus erythematosus.
-
Active rheumatic inflammation of joints (rheumatoid arthritis) with a
severe progressive course,
e.g. forms rapidly leading to joint destruction, and/or where tissue
outside the joints is affected.
-
Severe infectious diseases with poisoning-like conditions (e.g. in
tuberculosis, typhoid,
brucellosis); only in addition to appropriate anti-infectious

SPC

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dexamethasone Medochemie 4 mg/ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 1 ml contains 4 mg dexamethasone phosphate (as
dexamethasone sodium
phosphate).
Each ampoule of 2 ml contains 8 mg dexamethasone phosphate (as
dexamethasone sodium
phosphate).
Excipient with known effect: sodium.
Each ampoule of 1 ml contains 3.12 mg sodium.
Each ampoule of 2 ml contains 6.24 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion
Clear, colourless to slightly yellowish solution, pH 7.0 to 8.5.
Osmolality: 160 to 230 mOsm/Kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Systemic use
-
Cerebral oedema associated with cerebral tumour, neurosurgical
procedures, cerebral abscess,
bacterial meningitis
-
Polytraumatic shock/prophylaxis of post-traumatic shock-lung syndrome
-
Severe, acute asthma attack
-
Initial parenteral treatment of extensive, acute, severe skin diseases
like erythroderma, pemphigus
vulgaris, acute eczema
-
Initial parenteral treatment of autoimmune diseases like systemic
lupus erythematosus (especially
visceral forms)
-
Active rheumatoid arthritis with a severe, progressive course, e.g.
fast proceeding destructive
forms and/or with extra-articular manifestations
-
Severe infectious diseases with toxic conditions (e.g. tuberculosis,
typhoid, brucellosis) only with
simultaneous anti-infectious therapy
-
Palliative therapy of malignant tumours
-
Prophylaxis and treatment of post-operative or cytostatic-induced
vomiting as part of anti-emetic
regimens.
-
Dexamethasone Medochemie 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.
Local application
-
_Intraarticular injection_
: persistent inflammation of one or a few joints after general
management
of chronic inflammatory joint dise