Albumin Diluent For Reconstitution Of Pharmalgen Bee And Wasp Venom
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.