Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Contains no excipients.

6.2 Incompatibilities
Vancomycin solutions are acid, and must remain so to prevent precipitates from forming. They must therefore not be mixed with alkaline solutions.
It has been demonstrated that vancomycin solutions and beta-lactam antibiotic solutions are physically incompatible. The likelihood of precipitates forming increases with higher concentrations of vancomycin.
Each parenteral solution should be checked visually for precipitations and discolouration prior to use. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3
Intravenous routes should be washed carefully between administrations of these antibiotics. It is also recommended that vancomycin solutions be diluted to a concentration of 5 mg/ml or lower.

Although intravitreous injection is not an authorised administration route for vancomycin, there have been reports of the formation of precipitates after intravitreous injection of vancomycin and ceftadizime for the treatment of endophthalmitis using different syringes and needles. The precipitates dissolved gradually with complete clearance of the vitreous cavity over two months and improved visual acuity.

6.3 Shelf life
Prior to reconstitution:
The expiry date of the product is indicated on the packaging materials.

After reconstitution:
Chemical and physical stability for use has been demonstrated for 14 days at 2°C-8°C and for 8 hours at below 250C if the solvent is 5% dextrose or 0.9% sodium chloride 
From the microbiological point of view, the product should be administered immediately. If this is not the case, times and conditions of storage for use before administration shall be no more than 24 hours at 2°C - 8ºC unless reconstitution and dilution have been carried out in controlled and validated aseptic conditions.

6.4 Special precautions for storage
Protect from light.
Before reconstitution: do not store above 25 °C.
After reconstitution: store between 2 °C and 8 ºC (in the fridge).

6.5 Nature and contents of container
Type I glass vial with rubber stopper sealed with aluminium cap.
6.6 Instructions for use and handling
For intravenous administration
VancoAvenir 500 mg, powder for solution for injection:
1. Reconstitution: at moment of use, add 10 ml water for injection to the vial containing 500 mg vancomycin; in this way a concentration of 50 mg/ml is obtained.
2. Dilution: immediately following reconstitution, dilute the reconstituted solution by adding 100 ml solvent.
The required dose diluted in this manner can be administered intravenously over a period of not less than 60 minutes.

VancoAvenir 1 g, powder for solution for injection:
1. Reconstitution: at moment of use, add 20 ml water for injection to the vial containing 1 g vancomycin; in this way a concentration of 50 mg/ml is obtained.
2. Dilution: immediately following reconstitution, dilute the reconstituted solution by adding 200 ml solvent.
The required dose diluted in this manner can be administered intravenously over a period of not less than 60 minutes.

For oral administration
Intravenous vancomycin hydrochloride can be administered orally for antibiotic-related pseudomembranous colitis caused by C. difficile and for treatment of staphylococcal enterocolitis. It is not effective p.o. for other types of infection. The normal total daily dose for adults is 500 mg to 2 g given in 3 or 4 divided doses for a period of 7 to 10 days. The normal total daily dose for children is 40 mg/kg body weight given in 3 or 4 divided doses over a period of 7 to 10 days. The total daily dose must not exceed 2 g. The appropriate dose can be diluted in 30 ml water and given to the patient to drink. Common flavouring syrups may be added to the solution to make it more palatable. The diluted solution may be administered via 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.

7. PRODUCTS' REGISTRATION NUMBERS
VancoAvenir 500 mg - 153-17-34018-00
VancoAvenir 1 g - 153-18-34020-00