Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Hydrochloric acid (pH adjustment)

Water for injections
6.2. Incompatibilities
Vancomycin solution has a low pH value. This may lead to chemical or physical instability if mixed with other substances. Therefore, each parenteral solution should be checked visually for precipitations and discolouration prior to use.
Combined treatment
In case of treatment combining vancomycin with other antibiotics/chemotherapy agents, the preparations must be administered separately.
The mixture of vancomycin and beta-lactam antibiotics solutions has been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to thoroughly rinse the infusion lines between the administration of these antibiotics. It is also recommended to dilute the vancomycin solutions to 5 mg/mL or less.
The administration of vancomycin by intravitreal injection is not authorised. Precipitation has been observed following intravitreal injection of vancomycin and ceftazidime using separate syringes and needles for the treatment of endophthalmitis. The precipitate in the vitreous body dissolved completely but slowly over a period of 2 months, during which visual acuity also improved.

6.3. Shelf life
The expiry date of the product is indicated on the label and packaging.

Vancomycin Viatris 500 mg:
Reconstituted solution in water for injections:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.
Diluted solution using 0.9 % NaCl or 5 % glucose solution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.

NOTE: The maximum storage time of the reconstituted and diluted solution is 24 hours.

Vancomycin Viatris 1000 mg:
Reconstituted solution in water for injections:
Chemical and physical in-use stability has been demonstrated for 96 hours at 2°C - 8°C.
Diluted solution using 0.9 % NaCl or 5 % glucose solution:
Chemical and physical in-use stability has been demonstrated for 96 hours at 2°C - 8°C.

NOTE: The maximum storage time of the reconstituted and diluted solution is 96 hours.

From a microbiological point of view, the prepared solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution / dilution (etc) has taken place in controlled and validated aseptic conditions.

Shelf life of the reconstituted solution for oral use: the reconstituted solution should be used immediately.

6.4. Special precautions for storage
To be stored below 25°C.
For the storage conditions after reconstitution, see section 6.3.

6.5. Nature and contents of container
Neutral type II colourless glass vial, with a bromobutyl rubber stopper sealed with aluminium capsule with plastic tear-off cap.
Pack size: 1 vial.

6.6. Special precautions for disposal and other handling
Preparation of the solution for infusion
The product must be reconstituted and the resulting concentrate must then be diluted prior to use.
Vancomycin 500 mg: dissolve the contents of one vial in 10 ml of water for injections.
For Vancomycin1000 mg: dissolve the contents of one vial in 20 ml of water for injections.
The reconstituted solution should be a clear colourless to slightly yellowish solution, without visible particles.

One ml of reconstituted solution contains 50 mg of vancomycin.
For storage conditions of the reconstituted product see section 6.3.

Suitable diluents for further dilution are water for injections, 5% glucose solution or 0.9% sodium chloride solution.
Different dilution is required depending on method of administration.
-        Intermittent infusion:
Vancomycin 500 mg:
Reconstituted solutions containing 500 mg vancomycin must be diluted with at least 100 ml diluent.
The desired dose should be administered by intravenous infusion at a rate of no more than 10 mg/min, over at least 60 minutes.
Vancomycin 1000 mg:
Reconstituted solutions containing 1 g vancomycin must be diluted with at least 200 ml diluent. The desired dose should be administered by intravenous infusion at a rate of no more than 10 mg/min, over at least 60 minutes.

-       Continuous infusion:
This should be used only if treatment with an intermittent infusion is not possible.
1 g or 2 g of vancomycin, corresponding to 2 to 4 vials of reconstituted solution, may be added to a sufficiently large volume of the above suitable diluent to permit the desired daily dose to be infused over twenty-four hours.
For storage conditions of the diluted product see section 6.3.
Before administration, the reconstituted and diluted solutions should be inspected visually for particulate matter and discoloration. Only clear and colourless to pale yellow solution free from particles should be used.


Preparation of the oral solution
After initial reconstitution of the vial, the selected dose may be diluted in 30 ml of water and given to the patient to drink or the diluted material may be administered by a nasogastric tube.


Disposal
Vials are for single use only. Unused medicinal products must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.