Dexamethasone Thame 2mg/5ml Oral Solution

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

DEXAMETHASONE

Доступна з:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

Код атс:

H02AB02

ІПН (Міжнародна Ім'я):

DEXAMETHASONE 2 mg

Фармацевтична форма:

ORAL SOLUTION

Склад:

DEXAMETHASONE 2 mg

Тип рецепту:

POM

Терапевтична области:

CORTICOSTEROIDS FOR SYSTEMIC USE

Статус Авторизація:

Authorised

Дата Авторизація:

2019-06-05

інформаційний буклет

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXAMETHASONE THAME 2MG/5ML ORAL SOLUTION
Dexamethasone
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.

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 pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Dexamethasone Thame 2mg/5ml Oral Solution
but it will be referred
to as ‘Dexamethasone’ throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Dexamethasone is and what it is used for
2.
What you need to know before you take Dexamethasone
3.
How to take Dexamethasone
4.
Possible side effects
5.
How to store Dexamethasone
6.
Contents of the pack and other information
1.
WHAT DEXAMETHASONE IS AND WHAT IT IS USED FOR
The name of your medicine is Dexamethasone. Dexamethasone is a
synthetic glucocorticoid
(adrenocortical hormone).
Corticosteroids are hormones that are found naturally in your body
that help to keep you healthy
and well. Taking extra corticosteroids, such as Dexamethasone, is used
to treat various illnesses
involving inflammation in the body.
Dexamethasone lowers inflammation, which could otherwise go on making
your condition worse.
You must take this medicine regularly to get maximum benefit from it.
Dexamethasone can be used to:
•
Reduce inflammation
•
Treat a number of different diseases of the immune system including:

Rheumatism (pain, stiffness or limitation of motion in the joints,
muscles and tendons)

Inflammations including inflammation of the joints and tissue around
the joint
(rheumatoid arthritis), inflammation of the skin (such as contact
dermatitis), the eye,
blood vessels and other parts of

Характеристики продукта

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dexamethasone Thame 2mg/5ml Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral solution contains 2mg of dexamethasone
(as dexamethasone sodium
phosphate)
Excipients with known effect:
Each 5ml of oral solution contains 182.2mg propylene glycol, 1375mg
liquid maltitol, 3mg
benzoic acid and 700mg liquid sorbitol.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral Solution
A clear colourless to faint yellow solution with mint odour
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dexamethasone
Oral
Solution
is
used
for
the
treatment
of
various
inflammatory
and
autoimmune diseases e.g.:
RHEUMATISM
, as pain, stiffness or limitation of motion, especially in the joints
and related
structures, including muscles, bursae, tendons, fibrous tissue;
COLLAGEN DISEASE
, as lupus erythematosus, dermatomyositis, polyarteritis nodosa,
thrombotic
purpura and rheumatoid arthritis;
ALLERGIES
, as status asthmaticus, bronchial asthma, contact dermatitis,
inflammatory processes
of
the
eye
and
its
adnexa,
severe
hypersensitivity
reactions
to
drugs
or
insect
stings,
anaphylactic shock, impending allograft rejection;
PRIMARY OR SECONDARY ADRENOCORTICAL INSUFFICIENCY
, and
ADRENOGENITAL SYNDROMES
.
Besides Dexamethasone is used as an adjunct in the control of
CEREBRAL OEDEMA
(not in those
cases where the oedema is caused by head injury), for treatment of
LYMPHOCYTIC LEUKAEMIA
,
as
ANTI-EMETIC
in antineoplastic regimens and for palliative treatment in terminal
stages of
NEOPLASTIC DISEASE.
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Dexamethasone 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The
DOSAGE OF DEXAMETHASONE ORAL SOLUTION
depends on the severity of the condition and the
response of the patient. Undesirable effects, such as su