Pharmaceutical particulars : מידע רוקחי

6.         PHARMACEUTICAL PARTICULARS
6.1        List of excipients
Water for Injection
Hydrochloric acid 10%
Trometamol
Sodium calcium edetate
Sodium hydroxide solution, 25%

6.2      Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


6.3      Shelf life
The expiry date of the product is indicated on the packaging materials.
After opening the product is stable for 10 hours.
From a microbial point of view, the ready to use preparation should be used immediately.


6.4      Special precautions for storage

Store below 30°C. Protect from light and X-Rays.

6.5      Nature and contents of container
Injection Vial: glass type I
Bottles: glass type II
Stopper: Chlorinated butyl rubber, 4651/40 Y11.
Flanged cap: aluminum with internal and external lacquer and colored plastic cap made of polypropylene (without product contact).


Ultravist 300
Injection vial of: 1X20 ml
Infusion Bottles of 1X50 ml, 1X75 ml, 1X200 ml, 1X500 ml, 10X100 ml.
Ultravist 370
Infusion Bottles of 1X50 ml, 1X100 ml, 1X200 ml, 1X500 ml, 10X100 ml.

Not all package sizes are marketed.

6.6      Special precautions for disposal and other handling

Ultravist should be warmed to body temperature prior to use (see section 4.2).
6.6.1   Visual inspection

Contrast media should be visually inspected prior to use and cannot be used if severely discoloured, nor in the presence of particles (particularly crystals) or if the packaging is damaged. As Ultravist is a highly concentrated solution, crystallisation (milky/cloudy appearance and/or sediment at the bottom or floating crystals) may occur in very rare cases.

6.6.2 Vials/bottles
The contrast medium solution should not be aspirated into the syringe or the infusion bottle attached to the infusion set until immediately before the examination.
The rubber stopper should never be pierced more than once, to prevent large amounts of microparticles from the stopper from reaching the solution. The use of cannulas with a long tip and a maximum diameter of 18G is recommended for piercing the stopper and aspirating the contrast medium (cannulas with a lateral aperture, e.g. Nocore-Admix cannulas, are particularly suitable).
Any remaining contrast solution not used in the examination for a given patient must be discarded.

6.6.3   Recipients of large amounts (reserved for intravascular administration) 
The following rules apply to the repeated removal of contrast medium from 200 mL and larger containers:

The repeated removal of the contrast medium should be carried out using a device approved for multiple use only.
The rubber stopper of the bottle must never be pierced more than once to avoid large amounts of microparticles from the stopper reaching the solution.
The contrast medium must be administered using an automatic delivery system (automatic injection device), or by another approved procedure that ensures sterility of the contrast medium.
To prevent cross contamination, the tube from the injector to the patient (patient's tube) must be replaced after every patient.
The connecting tubes and all disposable parts of the injector system must be discarded when the infusion bottle is empty or ten hours after first opening the container.
The instructions of the device manufacturer must be followed.
All unused Ultravist product in opened containers must be discarded ten hours after first opening the container.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.      MARKETING AUTHORISATION HOLDER
Bayer Israel Ltd., 36 Hacharash St., Hod Hasharon 4527702