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SYRUP BP

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Syrup B.P.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
(no active ingredients)

3

PHARMACEUTICAL FORM
Syrup.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
To be used as a diluent for oral products.

4.2

Posology and method of administration
To be used as a diluent for oral products.

4.3

Contraindications
Hypersensitivity to any of the ingredient

4.4

Special warnings and precautions for use
Not applicable.

4.5

Interaction with other medicinal products and other forms of interaction
Refer to information supplied with product to be diluted.

4.6

Fertility, Pregnancy and lactation
Not applicable.

4.7

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable effects
Not applicable.

4.9

Overdose
Not applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Not applicable for B.P. formulation.

5.2

Pharmacokinetic properties
Not applicable for B.P. formulation.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sucrose B.P.
Water B.P.
Preservative: Nipasept Sodium.

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
2 Years.

6.4

Special precautions for storage
None.

6.5

Nature and contents of container
Nature:
Plastic jerrycan with plastic cap - 2 litre.

6.6

Special precautions for disposal
None stated

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0075

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25/02/91 - 21/08/96

10

DATE OF REVISION OF THE TEXT
24/01/2012

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