Pharmaceutical particulars : מידע רוקחי

6.   PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Water for Injections, Hydrochloric acid, Sodium hydroxide.

6.2. Incompatibilities

Precipitation may occur when Ringer's lactate solution is mixed with solutions containing phosphate or carbonate.

6.3. Shelf life

Shelf life (Unopened):
The expiry date of the product is indicated on the packaging materials.

In-use shelf-life: Additives
From a microbiological point of view, the product should be used immediately after the addition of additives. If it is not administered immediately, the user assumes responsibility for in-use storage times and storage conditions. Normally, the mixture should be stored for no longer than 24 hours at 4-8°C, unless mixing has taken place under controlled and validated aseptic conditions.
6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container
Polyolefin bags (freeflex) of 250ml, 500 mL, 1000 mL with overwrap.
Polyethylene bottles (KabiPac) of 250 mL, 500 mL, 1000 mL.
Not all pack sizes may be marketed.

6.6. Special precautions for disposal

Use only if the solution for infusion is clear and the container undamaged.
Use immediately after opening the container.
After infusion, any unused solution must be discarded.
Please select the container that applies in your case (KabiPac, freeflex).
The following instructions are designed as a guideline for handling the container.
For pharmaceutical preparations, the requirements for aseptic technique in accordance with the relevant guidelines must be observed.

Instructions for handling - KabiPac (PE container)

General preparation
• Make sure that you are using the desired solution for infusion.
• Check the expiry date and whether the liquid is clear and the container undamaged.


• Identify the correct port for the desired procedure: a) Arrow pointing towards the infusion bottle = injection port b) Arrow pointing away from the infusion bottle = infusion port

• The caps can be easily snapped off by pressing them back with the thumb just above the arrows. Immediately after snapping off the cap, no disinfection of the membrane is necessary.


Preparing the infusion
• Identify the infusion port b) (arrow pointing away from the infusion bottle).
• Open the infusion port by pressing back with the thumb just above the arrows.

• Recommended: Use a commercial, non-vented, DIN infusion set.
• Close the air inlet (if present).
• Leave the roller clamp open (as delivered ex-factory).
• Use the spike to pierce the upright infusion bottle. Pierce vertically in the middle of the circle visible on the membrane.
• Recommended: Insert the spike using a slight twisting motion.
• Close the roller clamp.


• Hang the infusion bottle on the infusion stand.
• Fill the drip chamber up to the mark (about half the drip chamber).
• Fill the infusion set.
• Attach the infusion set to the patient's venous access.
• Regulate the flow rate.

Optional: Injecting additional medicines, e.g. drug application via syringe 

• Identify the injection port a) (arrow pointing towards the infusion bottle).
• Open the injection port by pressing back with the thumb just above the arrows.


• Use only injection needles with an 18 to 23-gauge cannula size (19-gauge recommended).
• Insert the injection needle centrally and vertically.
• Administer the medicine into the KabiPac infusion bottle.
• Carefully mix the solution.


Instructions for handling - freeflex
General preparation
• Make sure that you are using the desired solution for infusion.
• Check the expiry date and whether the liquid is clear and the container undamaged.



• Remove the overwrap immediately before use.



• Identify the correct port for the desired procedure: a) Arrow pointing towards the infusion bag = white injection port b) Arrow pointing away from the infusion bag = dark blue infusion port 

Preparing the infusion
• Identify the dark blue infusion port b) (arrow pointing away from the infusion bag).
• Only use the solution if it is clear and the container is undamaged.



• To break off the caps, hold the dark blue infusion port with one hand and snap the cap back with the other hand. Immediately after snapping off the caps, no disinfection of the membrane is necessary.


• Recommended: Use a commercial, non-vented, DIN infusion set.
• Close the air inlet (if present).
• Leave the roller clamp open (as delivered ex-factory).
• Use the spike to pierce the dark blue infusion port of the infusion bag (on its side). Pierce centrally and vertically.
• Close the roller clamp.

• Hang the infusion bag on the infusion stand.
• Fill the drip chamber up to the mark (about half the drip chamber).
• Fill the infusion set.
• Attach the infusion set to the patient's venous access.
• Regulate the flow rate.


Optional: Injecting additional medicines: Drug application via transfer adapter 


• Identify the white injection port a) (arrow pointing towards the bag).



• To break off the caps, hold the white infusion port with one hand and snap the cap back with the other hand. Immediately after snapping off the caps, no disinfection of the membrane is necessary.



• Push the narrower end of the freeflex transfer adapter onto the white injection port until you hear an initial click.
• The needle tip is now inside the sterile chamber, which protects against contamination.



• Prepare the medication vial and attach it onto the freeflex transfer adapter.
• Push the freeflex transfer adapter further in the white injection port until you hear a second click and pierce the inner membrane.



• Hold the medication vial downwards and pump the solution for infusion into the medication vial by squeezing the bag.
• Dissolve the medication by careful shaking.



• Hold the medication vial upright and squeeze air in, so that the solution enters the bag from the medication vial.
• Repeat this process until all the fluid is transferred into the bag from the medication vial and the medication is thoroughly mixed.


• After mixing has taken place, carefully remove the medication vial and transfer adapter from the infusion bag.
• Mark off the white injection port a) after adding the medication by sealing it with a red freeflex cap.
• This will prevent any further addition of medicines and contamination of the injection port.


Optional: Injecting additional medicines, e.g. drug application via syringe



• Identify the white injection port a) (arrow pointing towards the bag).



• To break off the caps, hold the white infusion port with one hand and snap the cap back with the other hand. Immediately after snapping off the caps, no disinfection of the membrane is necessary.

• Recommendation: Prior to injecting, remove the volume of air inside the infusion bag to ensure a pressure-free injection.
• Use only injection needles with an 18 to 23-gauge cannula size (19-gauge recommended).
• Hold the injection port with your fingers behind the finger guard.
• Prepare the syringe and insert it vertically at the center of the white injection port.
• Administer the medicine from the syringe into the freeflex infusion bag.


• After mixing has taken place, remove the syringe from the infusion bag and mix the drug preparation thoroughly.
• Mark off the white injection port a) after adding the medication by sealing it with a red freeflex cap.
• This will prevent any further addition of medicines and contamination of the white injection port.