Dexamethasone (base) 3.3mg/1ml solution for injection ampoules

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Dexamethasone sodium phosphate

Prieinama:

base) 3.3mg/1ml solution for injection ampoules (hameln pharma Ltd

ATC kodas:

H02AB02

INN (Tarptautinis Pavadinimas):

Dexamethasone sodium phosphate

Dozė:

3.3mg/1ml

Vaisto forma:

Solution for injection

Vartojimo būdas:

Subcutaneous; Intralesional; Intravenous; Intramuscular; Intrabursal; Intraarticular

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 06030200; GTIN: 5016386100796

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXAMETHASONE 3.3 MG/ML INJECTION
Dexamethasone sodium phosphate
HAMELN
1. What Dexamethasone Injection is and what it
is used for
Dexamethasone belongs to a group of medicines
called STEROIDS.
Dexamethasone 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
• Sometimes,
the
injection
is
given
into
the
PAINFUL
AREA
ITSELF
e.g.
inflammation
of
the
joints (rheumatoid arthritis and osteoarthritis)
Dexamethasone can sometimes also be given
by
injection
under
the
skin
(subcutaneously)
to
relieve
certain
symptoms
including
pain,
tiredness, weight loss and feeling and being sick.
2. What you need to know before you are given
Dexamethasone Injection
YOU SHOULD NOT BE GIVEN DEXAMETHASONE
INJECTION IF YOU:
• are SENSITIVE or ALLERGIC to Dexamethasone
or any of the other ingredients in this injection
(listed in section 6).
• have a FUNGAL infection that has spread to
involve the WHOLE body.
• have any other WIDESPREAD INFECTION which is
not currently being treated.
• are to be VACCINATED with live virus vaccines.
PLEASE TELL YOUR DOCTOR OR NURSE BEFORE BEING
GIVEN THE INJECTION IF:
• YOU HAVE EVER HAD SEVERE DEPRESSION or
manic-depression
(bipolar
disorder).
This
includes having had depression before while
taking steroid medicines like dexamethasone.
• ANY
OF
YOUR
CLOSE
FAMILY
has
had
these
illnesses. If either of these applies to you, TALK
TO A DOCTOR BEFORE RECEIVING DEXAMETHASONE.
MENTAL
HEALTH
PROBLEMS
WHILE
TAKING
DEXAMETHASONE
MENTAL HEALTH problems can happen while taking
steroids like dexamethasone (see also sec

Prekės savybės

OBJECT 1
DEXAMETHASONE 3.3 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 28-Feb-2017 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Dexamethasone 3.3 mg/ml solution for injection
2. Qualitative and quantitative composition
3.32 mg of dexamethasone (dexamethasone base) in 1 ml solution for
injection
6.64 mg of dexamethasone (dexamethasone base) in 2 ml solution for
injection
Each ml of solution for injection contains 4.00 mg of dexamethasone
phosphate (as 4.37 mg
dexamethasone sodium phosphate) equivalent to 3.32 mg of dexamethasone
base.
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
Clear and colourless solution
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 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.
_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 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
_Gastrointestinal_
Crohn's disease and ulcerative colitis
_Infection (with appropriate chemotherapy)_
Miliary tuberculosis and endotoxic shock
_Neurological disorders_
Raised intracranial pressure secondary to cerebral tumours and
infantile spasms
_Respiratory_
Bronchial asthma and aspiration pneumonitis
_Skin disorders_
Toxic epidermal necrolysis
_Shock_
Adjunctive treatment where high pharmacological doses are