Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Glycine
Sodium chloride
L-Histidine monohydrochloride
L-Histidine
Polysorbate 80
Water for injection

6.2   Incompatibilities

Cyramza should not be administered or mixed with dextrose solutions.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

Unopened vial
The expiry date of the product is indicated on the packaging material.

After dilution

When prepared as directed, infusion solutions of Cyramza contain no antimicrobial preservatives.
Chemical and physical in-use stability of Cyramza in sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for 24 hours at 2 ºC to 8 ºC or for 4 hours at room temperature (below 30ºC). From a microbiological point of view, the product should be used immediately.

6.4   Special precautions for storage

Store in a refrigerator (2 ºC to 8 ºC ).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.



6.5   Nature and contents of container

10 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap.
50 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap.

Pack of 1 vial of 10 ml.
Pack of 1 vial of 50 ml.

6.6   Special precautions for disposal and other handling
Do not shake the vial.

Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution.

Each vial is intended for single use only. Inspect the content of the vials for particulate matter and discoloration (the concentrate for solution for infusion should be clear to slightly opalescent and colorless to slightly yellow without visible particles) prior to dilution. If particulate matter or discoloration is identified, discard the vial.

Calculate the dose and volume of ramucirumab needed to prepare the infusion solution. Vials contain either 100 mg or 500 mg as a 10 mg/ml solution of ramucirumab. Only use sodium chloride 9 mg/ml (0.9%) solution for injection as a diluent.

In case of pre-filled intravenous infusion container usage

Based on the calculated volume of ramucirumab, remove the corresponding volume of sodium chloride 9 mg/ml (0.9%) solution for injection from the pre-filled 250 ml intravenous container.
Aseptically transfer the calculated volume of ramucirumab to the intravenous container. The final total volume in the container should be 250 ml. The container should be gently inverted to ensure adequate mixing. Do not freeze or shake the infusion solution. Do not dilute with other solutions or co-infuse with other electrolytes or medicinal products.

In case of empty intravenous infusion container usage

Aseptically transfer the calculated volume of ramucirumab into an empty intravenous infusion container. Add a sufficient quantity of sodium chloride 9 mg/ml (0.9%) solution for injection to the container to make the total volume 250 ml. The container should be gently inverted to ensure adequate mixing. Do not freeze or shake the infusion solution. Do not dilute with other solutions or co-infuse with other electrolytes or medicinal products.

Parenteral medicinal products should be inspected visually for particulate matter prior to administration. If particulate matter is identified, discard the infusion solution.

Discard any unused portion of ramucirumab left in a vial, as the product contains no antimicrobial preservatives.

Administer via infusion pump. A separate infusion line with a protein sparing 0.22 micron filter must be used for the infusion and the line must be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection at the end of the infusion.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.    LICENSE HOLDER
Eli Lilly Israel Ltd.
4 HaSheizaf Street, POB 4246 Ra’anana 4366411, Israel