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Albumin Diluent For Reconstitution Of Pharmalgen Bee And Wasp Venom

Informations for option: Albumin Diluent For Reconstitution Of Pharmalgen Bee And Wasp Venom, show other option

1.    NAME OF THE MEDICINAL PRODUCT

Albumin Diluent

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Human serum albumin 0.3 mg/ml

3.    PHARMACEUTICAL FORM

Solvent for parenteral use.

4.    CLINICAL PARTICULARS

4.1    Therapeutic Indications

Albumin Diluent is used for reconstitution of an injectable preparation.

4.2    Posology and Method of Administration

Route of administration: Subcutaneous injection.

For administration according to the instructions on the product to be reconstituted.

4.3    Contra-Indications

As for the product to be reconstituted.

4.4    Special Warnings and Special Precautions for Use

As for the product to be reconstituted.

4.5    Interaction with other Medicinal Products and other Forms of Interaction

As for the product to be reconstituted.

4.6    Pregnancy and Lactation

As for the product to be reconstituted.

4.7    Effects on Ability to Drive and use Machines

As for the product to be reconstituted.

4.8    Undesirable Effects

As for the product to be reconstituted.

4.9    Overdose

As for the product to be reconstituted.

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

Phenol, sodium chloride, water for injections.

6.2    Incompatibilities

As for the product to be reconstituted.

6.3    Shelf-Life

3 years.

6.4    Special Precautions for Storage

Store at 2-8°C. Do not freeze.

6.5    Nature and Contents of Container

Albumin Diluent is supplied in glass vials. Each vial is closed with a chlorobutyl rubber stopper and sealed with an aluminium cap.

Albumin Diluent is supplied in a combined pack for reconstitution of an injectable preparation. Albumin Diluent is also available in a package of 10 x 5 ml.

6.6    Instructions for Use, Handling and Disposal

The diluent is supplied for reconstitution of an injectable preparation.

7.    MARKETING AUTHORISATION HOLDER

ALK-Abello A/S Boge Alle 6-8 DK-2970 Horsholm Denmark.

8.    MARKETING AUTHORISATION NUMBER

PL 10085/0005.

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE    AUTHORISATION

Date of first authorisation: 17 March 1995.

Date of renewal of authorisation: 16 March 2000.

10.    DATE OF REVISION OF THE TEXT

November 1999.