Medine.co.uk

Out of date information, search another

Diluent For Glucagen 1mg (Water For Injections 1ml)

Out of date information, search another

1.    NAME OF THE MEDICINAL PRODUCT

Diluent for GlucaGen lmg.

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient : Water for injections 1.1ml.

3.    PHARMACEUTICAL FORM

Sterile liquid, for reconstitution for GlucaGen 1mg.

4.    CLINICAL PARTICULARS

4.1    Therapeutic Indications

Not applicable.

4.2    Posology and Method of Administration

Not applicable.

4.3    Contra-Indications

Not applicable.

4.4    Special Warnings and Special 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    Effect 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.

5.2    Pharmacokinetic Properties

Not applicable.

5.3    Pre-clinical Safety Data

Not applicable.

6.    PHARMACEUTICAL PARTICULARS

6.1    List of Excipients

Not applicable.

6.2    Incompatibilities

Not applicable.

6.3    Shelf-Life

Prior to reconstitution, the shelf-life is 36 months when stored at 2 to 8°C.

The reconstituted solution should be prepared immediately prior to use and any portion of the solution remaining after use should be discarded.

6.4    Special Precautions for Storage

6.5


6.6


7.


8.


9.


Packs carried for use may be kept at ambient temperature (max 25°C) for up to 18 months, provided the expiry date is not exceeded.


Nature and Content of Container

Syringe made of glass type 1, Ph. Eur., and closed with a bromobutyl plunger.


Instructions for Use, Handling and Disposal

GlucaGen lmg is reconstituted with diluent before use. Each carton contains a patient information leaflet with instructions for reconstitution.


MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S Novo Alle DK-2880 Bagsvaerd Denmark


MARKETING AUTHORISATION NUMBER(S) PL 04668/0028


DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

30 September 1991 / 15 October 2001


DATE OF (PARTIAL) REVISION OF THE TEXT.

June 2002 Legal Category


POM


10.