Betnesol 4mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betamethasone sodium phosphate

Available from:

Focus Pharmaceuticals Ltd

ATC code:

H02AB01

INN (International Name):

Betamethasone sodium phosphate

Dosage:

4mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Subconjunctival; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200; GTIN: 5015313010238

Patient Information leaflet

Focus Pharmaceuticals Limited,
Capital House, 1st Floor, 85 King William Street,
London EC4N 7BL, UK.
06/2015.
06/2015.
If this leaflet is difficult to see
or read or you would like it in
a different format, please contact
Focus Pharmaceuticals Limited,
Unit 5, Faraday Court,
First Avenue, Centrum 100,
Burton upon Trent,
Staffordshire, DE14 2WX, UK.
TEL:
01283 495280
FAX:
01283 495290
APPROVED
FOR
PRINT
SIGNATURE: (PROOF READER)
FOCUS CONTACT:
PRODUCT DESCRIPTION/COMPONENT:
BETNESOL 4MG/ML SOLUTION FOR
INJECTION - PIL
SUPPLIER / MANUFACTURER:
XXXXX
BARCODE:
REASON FOR NEW VERSION:
KEYS:
V1 - CHANGE TO FOCUS MA FROM RECIPHARM. V2 - CORRECTION OF BATCH
RELEASE SITE/
MANUFACTURER. V3 - MAH ADDRESS CHANGED.
MARKET:
UK / ENGLISH
FILE NAME:
BETNESOL_4MGML_SOLINJ_PIL
CUTTER REF:
-
PL 20046/0281
DIMENSIONS:
144(H) X 437.5(W)MM
MINIMUM POINT SIZE:
8PT
PART NO/COMPONENT CODE:
-
SUBSTRATE:
SA PAPER
PRINTER / REPRO:
XXXXX
SOFTWARE PACKAGE:
ADOBE ILLUSTRATOR CS3
PL NO.:
DATE:
DATE:
SIGNATURE: (REGULATORY)
SIGNATURE: (MARKETING)
SIGNATURE: (BRAILLE)
CLEARLY MARK ANY AMENDMENTS
AND RESUBMIT
CLEARLY MARK ANY AMENDMENTS
AND RESUBMIT
AMEND
&
RESUBMIT
DATE:
DATE:
PANTONE/
PROCESS COLS USED:
pharmaceuticals ltd
VERSION
3
CAUTION! We cannot accept responsibility for any errors in this proof
after approval. The artwork received has been significantly
adjusted, revised or reset by us from disk or hard copy. Whilst we
take extreme care at all times to ensure accuracy, the final
responsibility must be taken by our customer. If you sign this proof
you are signifying full approval of design and text.
01/06/2015
Black
Wasserburger Arzneimittelwerk GmbH,
Herderstraße 2, D-83512 Wasserburg, Germany
25
uch as:
ulcers, diverticulitis (inflammation of

Summary of Product characteristics

OBJECT 1
BETNESOL 4MG/ML INJECTION
Summary of Product Characteristics Updated 17-May-2017 | Concordia
International- formerly Focus
Pharmaceuticals Ltd
1. Name of the medicinal product
Betnesol 4mg/ml Solution for Injection
Betamethasone 4mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each ampoule contains 5.3mg of betamethasone sodium phosphate
equivalent to 4mg betamethasone in
1ml of sterile aqueous solution.
Excipients with known effect
Sodium Metabisulphite contains 0.100 %w/v
Also contains approximately 0.678mg sodium per ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection
1ml ampoules containing a clear colourless or pale yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
Betamethasone is a glucocorticosteroid which is about eight to ten
times as active as prednisolone on a
weight-for-weight basis. It may be indicated in the following
conditions:
Status asthmaticus and acute allergic reactions, including
anaphylactic reactions to drugs. Betnesol
Injection/Betamethasone Injection supplements the action of
adrenaline.
Severe shock arising from surgical or accidental trauma or
overwhelming infection.
Acute adrenal crisis caused by abnormal stress in Addison's disease,
Simmonds' disease, hypopituitarism
following adrenalectomy, and when adrenocortical function has been
suppressed by prolonged
corticosteroid therapy.
Soft tissue lesions such as tennis elbow, tenosynovitis and bursitis.
NB. Betnesol Injection/Betamethasone Injection does not replace other
forms of therapy for the treatment
of shock and status asthmaticus.
4.2 Posology and method of administration
Posology:
_Systemic therapy in adults_
4 to 20mg betamethasone (1 to 5ml) administered by slow intravenous
injection over half to one minute.
This dose can be repeated three or four times in 24 hours, or as
required, depending upon the condition
being treated and the patient's response.
Alternatively, Betnesol Injection/Betamethasone Injection may be given
by int