Dexamethasone 10mg/5ml oral solution sugar free

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Dexamethasone sodium phosphate

Διαθέσιμο από:

Advanz Pharma

Φαρμακολογική κατηγορία (ATC):

H02AB02

INN (Διεθνής Όνομα):

Dexamethasone sodium phosphate

Δοσολογία:

2mg/1ml

Φαρμακοτεχνική μορφή:

Oral solution

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 06030200; GTIN: 5060064792629

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXAMETHASONE 10MG/5ML ORAL SOLUTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING
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.
-
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 take this medicine for more than three weeks,
you will get a blue ‘steroid card’: always keep it with
you and show it to any doctor, dentist, nurse, midwife
or anyone else who is giving you treatment.
-
If you get any side effects talk to your doctor or
pharmacist. This includes any side effects not listed in
this leaflet.
What is in this leaflet:
1. What Dexamethasone Oral Solution is and what it is
used for
2. What you need to know before you take
Dexamethasone Oral Solution
3. How to take Dexamethasone Oral Solution
4. Possible side-effects
5. How to store Dexamethasone Oral Solution
6. Contents of the pack and other information
1.
WHAT DEXAMETHASONE ORAL SOLUTION IS AND
WHAT IT IS USED FOR
Dexamethasone
Oral
Solution
contains
the
active
substance dexamethasone. Dexamethasone belongs
to a group of medicines called steroids (the full name is
corticosteroids). Corticosteroids occur naturally in the
body, and help to maintain health and well-being.
Boosting your body with extra corticosteroid (such as
dexamethasone) is an effective way to treat various
illnesses involving inflammation in the body.
Dexamethasone
Oral
Solution
reduces
this
inflammation, which could otherwise go on making
your
condition
worse.
You
must
take
this
medicine
regularly to get maximum benefit from it.
DEXAMETHASONE ORAL SOLUTION IS USED FOR ONE OF THE
FOLLOWING:
• where your natural corticosteroid levels have been
reduced and you need to replace them
• where swelling of the brain has occurred
• if
you
are
having
tests
for
diseases
which
may
decrease your

Αρχείο Π.Χ.Π.

OBJECT 1
DEXAMETHASONE 10MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 04-May-2018 | Concordia
International- formerly Focus
Pharmaceuticals Ltd
1. Name of the medicinal product
Dexamethasone 10mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml of solution contains 10mg of dexamethasone (as dexamethasone
sodium phosphate).
Excipients with known effect
Each 5ml of solution also contains 1375mg liquid maltitol (E965) and
700mg sorbitol (E420).
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral Solution
A colourless to yellowish solution with a mint odour.
4. Clinical particulars
4.1 Therapeutic indications
Dexamethasone is a corticosteroid. It is designed for use in certain
endocrine and non-endocrine
disorders, in certain cases of cerebral oedema and for diagnostic
testing of adrenocortical hyperfunction.
Endocrine disorders:
Endocrine exophthalmos.
Non-endocrine disorders:
Dexamethasone may be used in the treatment of non-endocrine
corticosteroid responsive conditions
including:
Allergy and anaphylaxis: Anaphylaxis.
Arteritis collagenosis: Polymyalgia rheumatica, polyarteritis nodosa.
Haematological disorders: Haemolytic anaemia (also auto immune),
leukaemia, myeloma, idiopathic
thrombocytopenic purpura in adults, reticulolymphoproliferative
disorders (see also under oncological
disorders).
Gastroenterological disorders: For treatment during the critical stage
in: ulcerative colitis (rectal only);
regional enteritis (Crohn's disease), certain forms of hepatitis.
Muscular disorders: Polymyositis.
Neurological disorders: Raised intra-cranial pressure secondary to
cerebral tumours, acute exacerbations
of multiple sclerosis.
Ocular disorders: Anterior and posterior uveitis, optic neuritis,
chorioretinitis, iridocyclitis, temporal
arteritis, orbital pseudotumour.
Renal disorders: Nephrotic syndrome.
Pulmonary disorders: Chronic bronchial asthma, aspiration pneumonitis,
chronic obstructive pulmonary
disease (COPD), sarcoidosis, allergic pulmonary diseas