NANOFIX

500 International Unit Pdr+Solv for Soln for Inj

Octapharma LimitedPA0521/018/001

SPC: Special precautions for disposal and other handling

Please read all the instructions and follow them carefully!

Do not use NanoFIX after expiry date given on the label and carton.

During the procedure described below, sterility must be maintained!

The solution in the syringe should be clear or slightly pearly shimmery. Do not inject solutions that are cloudy or have deposits.

Use the prepared solution immediately, to prevent microbial contamination.

Only use the injection set provided. The use of other injection/infusion equipment can cause additional risks and treatment failure.


Instructions for preparing the solution:

1. Do not use the product directly from the refrigerator. Allow the solvent and the powder in the closed vials to reach room temperature.

2. Remove the flip off caps from both vials and clean the rubber stoppers with one of the provided alcohol swabs

3. The Mix2vial™ is depicted in Fig. 1. Place the solvent vial on an even surface and hold it firmly. Take the Mix2Vial™ and turn it upside down. Place the blue part of the Mix2Vial™ on top of the solvent vial and press firmly down until it snaps (Fig. 2 + 3).

4. Place the powder vial on an even surface and hold it firmly. Take the solvent vial with the attached Mix2Vial™ and turn it upside down. Place the transparent part on top of the powder vial and press firmly down until it snaps (Fig. 4). The solvent flows automatically into the powder vial.

5. With both vials still attached, gently swirl the powder vial until the product is dissolved.

The dissolving is completed in less than 10 minutes at room temperature. Slight foaming might occur during preparation. Unscrew the Mix2Vial™ into two parts (Fig. 5). Foaming will disappear.
Dispose the empty solvent vial with the blue part of the Mix2Vial™.

Instructions for injection:

As a precaution, your pulse rate should be taken before and during the injection. If a marked increase in your pulse rate occurs, reduce the injection speed or interrupt the administration for a short time.

1. Attach the syringe to the transparent part of the Mix2Vial™. Turn the vial upside down and draw the solution into the syringe (Fig. 6).

The solution in the syringe should be clear or slightly pearly shimmery.

Once the solution has been transferred, firmly hold the plunger of the syringe (keeping it facing down) and remove the syringe from the Mix2Vial™ (Fig. 7). Dispose the Mix2Vial™ and the empty vial.

2. Clean the chosen injection site with one of the provided alcohol swabs.

3. Attach the provided injection needle to the syringe.

4. Insert the injection needle into the chosen vein. If you have used a tourniquet to make the vein easier to see, this tourniquet should be released before you start injecting NanoFIX.

No blood must flow into the syringe due to the risk of formation of fibrin clots.

5. Inject the solution into the vein at a slow speed, not faster than 2-3 ml per minute.

If you use more than one vial of NanoFIX powder for one treatment, you may use the same injection needle and syringe again. The Mix2Vial™ is for single use only.

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

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Latest Changes to Medicine Info & SPC


Please note changes to the medicine information and summary of product characteristics are only available from the 19/05/2015 onwards. Changes made before this date aren't available online.