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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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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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