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DILUENT FOR MONONINE (WATER FOR INJECTIONS PH EUR)

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
®

Diluent for Mononine (Water for Injections Eur. Phar.)

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Quantity

Reference

Water for Injections

2.5

ml

Ph. Eur

Water for Injections

5.0

ml

Ph. Eur

Water for Injections

3

Units

10.0

ml

Ph. Eur

PHARMACEUTICAL FORM
Solution for injection.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
As a diluent for Mononine®

4.2

Posology and method of administration
Not applicable

4.3

Contraindications
Not applicable

4.4

Special warnings and precautions for use
Not applicable

4.5

Interaction with other medicinal products and other forms of interaction
Not applicable

4.6

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
Solvent and diluting agent

5.2

Pharmacokinetic properties
Not applicable

5.3

Preclinical safety data
Not applicable

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Not applicable

6.2

Incompatibilities
Not applicable

6.3

Shelf life
36 months in the unopened container.

6.4

Special precautions for storage
Refrigeration is not essential. Once opened, the diluent should be used within
3 hours.

6.5

Nature and contents of container
1 vial with 2.5ml, 5ml or 10ml sterile water for injections.
Type I clear glass vial (complying with Ph. Eur.) sealed with grey butyl rubber
infusion stopper, aluminium seal and plastic flip-off cap.

6.6

Special precautions for disposal
Do not use after expiry date given on the pack and container.
Do not use solutions which are cloudy or contain residues (deposits/particles).

Reconstitution and withdrawal must be carried out under aseptic conditions.
After administration, any unused solution and the administration equipment
must be discarded appropriately.

7

MARKETING AUTHORISATION HOLDER
CSL Behring UK Limited
Hayworth House
Market Place
Haywards Heath
West Sussex
RH16 1DB
United Kingdom

8

MARKETING AUTHORISATION NUMBER
PL 00231/0100

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/06/2003

10

DATE OF REVISION OF THE TEXT
02/08/2007

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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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