Saizen one click pen growth hormone injector

Serono’s one.click auto-injector is to be used exclusively with Serono’s recombinant Human Growth hormone Saizen in accordance with your medical practitioner’s prescription. The one. Click inserts the needle automatically and accurately to the desired depth in the fatty tissue under the skin and administers a pre-selected dose of growth hormone with just one click. Single use disposable sterile needle for the one.  Clicks are supplied separately. Use only one-click needles 0.33 x 12mm – 29G x _” distributed by Serono. The one-Click containing the cartridge of reconstituted Saizen placed in its storage box should be stored at 2-8C / 36-46F (in a refrigerator).  For young children, an adult should supervise the injection process.

Description

One-click Auto Injector Components (numbers 1-9 on diagram).

1. Blue Activation cap
2. Depth adjuster
3. Cartridge cover
4. Cartridge holder (transparent plastic)
5. Plunger rod
6. Main body
7. Yellow one-click button
8. Dose indicator
9. Green dose dial

Cartridge and Needle (numbers 10-15 on diagram).

1. Outer needle cover
2. Blue inner needle cover
3. Needle
4. Sterility seal
5. Cartridge

II. Installing / changing the cartridge

1. Unlock and remove the blue activation cap
2. Unscrew the cartridge cover and then the cartridge holder
3. Remove the empty cartridge from the cartridge holder, if any. NOTE: Clean the empty cartridge holder as recommended in the “CARE OF YOUR one-click section IV of this manual.
4. Insert a new cartridge containing the constituted Saizen into the clean cartridge holder.
5. Screw the cartridge holder with the cartridge back onto the one-click main body.
6. Turn the cartridge holder until the disc on the plunger rod is against the cartridge – a slight ratchet sound is heard. Note: For an accurate injection it is very important that the disc on the plunger rod is properly positioned against the cartridge plunger.
7. Screw the cartridge cover back onto the one-click main body until it cannot be turned further.

III. Setting the injection Depth

Turn the depth adjuster to the position recommended by your doctor. The exposed needle length is approximately as follows:

IV. Injection with one-click

You are now ready to carry out your injection by following the simple steps below:

1. Take the new needle and remove the protective sterility seal Caution: Do not use the needle of the sterility seal is broken or unstuck.
2. Screw the new needle onto the cartridge holder and remove the outer needle cover. Do not remove the inner needle cover.
3. Place the color end of the blue activation cap on a flat, non-slippery surface.
4. Grip the one-click on the cartridge cover and press down until a click is heard.
5. Remove the blue activation cap. It will automatically remove the inner needle shield. Caution: Do not press the yellow one-click button while activating.
6. Remove the inner needle shield from the blue activation cap by placing the clear end on a flat surface. Press down on the table, and the inner needle shield pops out.
7. Turn the green dose dial slowly until the required dose appears in the dose indicator window. When setting the dose, each click represents 20ul. The minimum dose for injection is 1 click, which is equivalent to 20ul or 0.12mg of Saizen. The maximum dose is 29 clicks, which is equivalent to 580ul or 3.38mg of Saizen. Note: Please refer to dose accuracy table for other dose setting. Caution: Never use force when adjusting the dose. If you have any problems setting the dose on your one-click see “Additional Information” in section V of this manual.
8. Prepare the injection site according to the instructions given by your medical practitioner. There is no need to pinch the skin at the injection site.
9. Hold the one-click directly (right angle) against the skin.
10. Press the yellow one-click button for the injection to start. Keep the one-click during approximately 10 seconds in this position until the injection is completed. The green dose dial rewinds to zero.
11. Withdraw the one-click from the skin. After injection, if a drop of blood appears, simply press for a few seconds with the medical wipe.
12. Cover the needle with the outer needle cover and unscrew it. Caution: Remember to discard the used needle safely, in a suitable container as recommended by your medical practitioner.
13. Push and screw the blue activation cap back into the cartridge cover.
14. Place your one-click with cartridge containing the remaining reconstituted solution of Saizen in its storage box and immediately place the box back into the refrigerator (not into the freezer).

V. Additional information

What if I cannot dial my complete dosage?
If you cannot dial your dose, you should inject the indicated dose and then complete the injection with a new cartridge. For example: If you reach a dose value of 14 clicks in the window instead of the desired 20 clicks. You should inject the 14 clicks. Then you should change the cartridge, not forgetting to change the needle. And set your next dose to 6 clicks (20 minus 14) and inject this amount. This will allow you to have the correct dose and not waste any product. Caution: Never force the dose dial if you do not obtain the required dosing amount.

What if I cannot set a dose?
Verify if the cartridge is empty. If so, follow instruction of section II “Installing /Changing the cartridge” of this manual.

What if I have gone too far in dialing the dose?
Turn the green dose dial backwards to correct the dose.

What if the green dose button turns freely?
If the green dose dial turns freely with no clicking, the one-click is probably not activated. Repeat the activation step (point 3,4,5 of section IV) ensuring that the blue activation cap is pushed down far enough into the one-click or that the cartridge cover is screwed on completely.

What if the needle is stuck in the one-click and I cannot remove it?
When the one-click is activated, the needle is hidden. To remove a stuck needle, you need to remove the cartridge cover. Once the cartridge cover is removed you can safely remove the needle by putting the outer cover on and unscrewing it.

What if I cannot place the blue activation cap to activate the one-click?
You should check if an old inner needle shield has not been left in the blue activation cap.

What if I forget to insert the needle?
You will not be able to activate the one-click nor to dial a dose.

What if the disc on the plunger rod is not properly positioned against the cartridge plunger?
Verify that the cartridge holder is properly screwed up into the main body. Turn until a light ratchet sound in heard.

VI. General Instructions

Care of your one-click

Clean the cartridge holder of your one-click each time you change cartridges. Simply soak the empty cartridge holder I warm water for 10 minutes and let if dry in a vertical position.

If your one-click contains a cartridge of reconstituted Saizen it should not be exposed to light or freezing.

Transporting your one-click

Even for short travel distance, your one-click auto-injector containing a cartridge of reconstituted Saizen placed in its storage box should be transported in a cool bag in order to maintain a temperature of 2-8C / 36-46F. You should consult your medical practitioner before traveling long distances.

VII. Guarantee

Every effort has been made to ensure that the one-click will function correctly for at least two years. After two years of operation your one-click should be replaced. A new one-click auto-injector can be obtained through your medical practitioner, nurse or pharmacist.

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