Isotonic Saline Solution 0.9% Containing Benzyl Alcohol 0.9%
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isotonic saline solution (0.9%) containing benzyl alcohol (0.9%)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium chloride 0.9%
Benzyl alcohol 0.9%
Water for injection to 100%
3. PHARMACEUTICAL FORM
Sterile solution for reconstitution of an injectable preparation
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
This diluent is supplied for the reconstitution of an injectable preparation.
4.2. Posology and Method of Administration
For administration according to the instructions on the product to be reconstituted.
Route of administration: sub-cutaneous
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. Interactions 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.
Pre-clinical Safety Data
5.3.
Not Applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Benzyl alcohol Water for injections
6.2. Incompatibilities
As for the product to be reconstituted.
6.3. Shelf life
Shel life of the unopened ampoule is 36 months.
6.4. Special Precautions for Storage
The diluent is supplied in a combined pack for the reconstitution of an injectable preparation. The storage precautions on the pack will be those for the product to be reconstituted.
6.5. Nature and Contents of Container
Type 1 Borosilicate glass ampoule with a ceramic ring break. 5ml ampoule containing
3.5ml or 5ml sterile solution.
6.6 Special precautions for disposal
Reconstitution
Two concentrations can be prepared: 3.3 mg/ml for use with the ZomaJet 2 Vision, Ferring-Pen or conventional syringes and 1.3 mg/ml for conventional syringes only.
The 3.3 mg/ml solution is prepared by reconstituting the Zomacton powder with 1.3 ml benzyl alcohol preserved saline solvent using a graduated disposable syringe, when the 1.3 mg/ml solution is prepared with 3.2 ml of solvent.
After reconstitution the solvent forms a clear and colorless solution for injection.
To prevent foaming of the solution, the stream of solvent should be aimed against the side of the vial. The vial must then be swirled with a gentle rotary motion until the contents are completely dissolved and a clear, colorless solution is produced. Since Zomacton is a protein, shaking or vigorous mixing is not recommended. If after mixing, the solution is cloudy or contains particulate matter, the contents must be discarded. In the case of cloudiness after refrigeration, the product should be allowed to warm to room temperature. If cloudiness persists or coloration appears, discard the vial and its contents.
Administration
The required Zomacton dose is administered by using the ZomaJet 2 Vision (a needle free device), the Ferring-Pen (a needle device) or alternatively a conventional syringe.
Specific instructions for use of the ZomaJet 2 Vision and the Ferring-Pen are given in a brochure supplied with the device.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Ferring Pharmaceuticals Limited The Courtyard Waterside Drive Langley
Berkshire SL3 6EZ
8. MARKETING AUTHORIZATION NUMBER
PL 03194/0054.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
17 March 1995
10
DATE OF REVISION OF THE TEXT
28/10/2009