Dexamethasone 10mg/5ml oral solution sugar free

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Dexamethasone sodium phosphate

Tilgængelig fra:

Rosemont Pharmaceuticals Ltd

ATC-kode:

H02AB02

INN (International Name):

Dexamethasone sodium phosphate

Dosering:

2mg/1ml

Lægemiddelform:

Oral solution

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 06030200; GTIN: 5016119181894

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JOB SPECIFICATION
MAIN BODY TEXT
Univers Roman
UNIVERS BOLD
10mg/5ml
BLACK
7474
PANTONE
PANTONE
265
KEYLINE
BRAILLE
UKL413
393
150 x 500mm
N/A
150 x 33mm
1
8pt
(horizontally
condensed to 85%)
Yes
30ml/150ml
30ml/150ml
N/A
D1P83RBJ3
D1P83RBJ2
N/A
1 of 2
Dexamthasone 10mg/5ml Oral Solution
16/03/18
-
DH
-
3
-
APPROVALS
THIRD PARTY APPROVAL REQUIRED
Name:
Name:
Signature:
Signature:
Date:
Date:
AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
YES
NO
N/A
TICK APPLICABLE BOX
TICK APPLICABLE BOX
IMPORTANT INFORMATION ABOUT THIS MEDICINE
n
DEXAMETHASONE IS A STEROID MEDICINE, prescribed for many different
conditions, including serious illnesses
n
YOU NEED TO TAKE IT REGULARLY to get the maximum benefit
n
DON’T STOP TAKING THIS MEDICINE without talking to your doctor –
you may need to reduce the dose gradually
n
DEXAMETHASONE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read section 4:
Possible side effects). Some problems such as
mood changes (feeling depressed or ‘high’) or stomach problems can
happen straight away. If you feel unwell, in any
way, keep taking your medicine, BUT SEE YOUR DOCTOR STRAIGHT AWAY
n
SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS. These
include weakness of arms and legs or developing a rounder face
(read section 4 for more information)
n
IF YOU TAKE THIS MEDICINE FOR MORE THAN 3 WEEKS, IN THE UK, YOU
WILL GET A BLUE ‘STEROID CARD’: always keep it with you and show
it
to any doctor or nurse treating you
n
KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN-POX, SHINGLES OR
MEASLES, if you have never had them. They could affect you
severely. If you do come into contact with anyone, SEE YOUR
DOCTOR STRAIGHT AWAY.

Produktets egenskaber

OBJECT 1
DEXAMETHASONE 10MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 21-Mar-2018 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Dexamethasone 10mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml contains 10mg Dexamethasone (as dexamethasone sodium
phosphate)
1ml contains 2mg Dexamethasone (as dexamethasone sodium phosphate)
Excipients with known effect:
Liquid maltitol 1375mg/5ml (275mg/ml)
Sorbitol liquid (non crystallising) 700mg/5ml (140mg/ml)
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral Solution
A colourless to faint yellow solution.
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 pulm