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ISOTONIC SALINE SOLUTION 0.9% CONTAINING BENZYL ALCOHOL 0.9%

Active substance(s): BENZYL ALCOHOL / SODIUM CHLORIDE

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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
Benzyl alcohol
Water for injection

3.

to

0.9%
0.9%
100%

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.

5.3.

Pre-clinical Safety Data
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

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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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