DEXAMETHASONE PANPHARMA 3.3 mg/ml, solution for injection (1.8ml amp)

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

DEXAMETHASONE SODIUM, PHOSPHATE

Διαθέσιμο από:

Panpharma Z.I. DU CLAIRAY, 35133 LUITRE, France

Φαρμακολογική κατηγορία (ATC):

H02AB02

INN (Διεθνής Όνομα):

DEXAMETHASONE SODIUM PHOSPHATE 6 mg

Φαρμακοτεχνική μορφή:

SOLUTION FOR INJECTION

Σύνθεση:

DEXAMETHASONE SODIUM PHOSPHATE 6 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

CORTICOSTEROIDS FOR SYSTEMIC USE

Περίληψη προϊόντος:

Licence number in the source country: NOT APPLICAPABLE

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2021-05-11

Φύλλο οδηγιών χρήσης

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXAMETHASONE PANPHARMA 3.3 MG/ML, SOLUTION FOR INJECTION
Dexamethasone (as sodium 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.
•
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 PANPHARMA is and what it is used for
2.
What you need to know before you use Dexamethasone PANPHARMA
3.
How to use Dexamethasone PANPHARMA
4.
Possible side effects
5.
How to store Dexamethasone PANPHARMA
6.
Contents of the pack and other information
1.
WHAT DEXAMETHASONE PANPHARMA IS AND WHAT IT IS USED FOR
Dexamethasone PANPHARMA 3.3 mg/ml, solution for injection contains the
active substance
dexamethasone (as sodium phosphate), which belongs to a group of
medicines called steroids
(specifically
known
as
corticosteroids).
Dexamethasone
is
a
synthetic
glucocorticoid
(adrenocortical hormone).
Corticosteroids occur naturally in the body and help to maintain
health and well-being. Synthetic
steroids such as dexamethasone work by mimicking some of their actions
to treat disease.
Corticosteroids are given to patients for a variety of conditions
where their abilities to reduce
inflammation and suppress the immune system are valuable. These
conditions may include Crohn’s
disease, asthma, shock, anaphylaxis, tuberculosis, arthritis,
osteoarthritis, and skin disorders
including acne.
Dexamethasone PANPHARMA 3.3 mg/ml 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DEXAMETHASONE PANPHARMA
DO NOT USE DEXAMETHASON

Αρχείο Π.Χ.Π.

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
DEXAMETHASONE PANPHARMA 3.3 mg/ml, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 3,3 mg dexamethasone (as sodium
phosphate) which is equivalent to 4 mg
dexamethasone phosphate or 4,37 mg dexamethasone sodium phosphate.
Each 1,8 ml contains 6 mg of dexamethasone (as sodium phosphate) which
is equivalent to 7,27 mg
dexamethasone phosphate or 7,94 mg dexamethasone sodium phosphate.
Each 2 ml contains 6,6 mg dexamethasone (as sodium phosphate) which is
equivalent to 8 mg
dexamethasone phosphate or 8,74 mg dexamethasone sodium phosphate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Corticosteroid.
For use in certain endocrine and non-endocrine disorders responsive to
corticosteroid therapy.
_Systemic administration: _
DEXAMETHASONE PANPHARMA 3.3 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.
Dexamethasone PANPHARMA 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.
_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
infancy,
mineralocorticoid supplementation is particularly important).
_Non-endocrine disorders _
DEXAMETHASONE PANPHARMA 3.3 mg/ml, solution for injection may be used
in the treatment of
non-endocrine corticosteroid- responsive conditions, including:
_Allergy and anaphylaxis: _
Angioneurotic oedema and anaphylaxis.
_Gastro-intestinal: _
Crohn's disease and ulcerative colitis.
_Infection (with appropriate chemotherapy)