Saizen one.click pen for Anti Aging Treatment

SERONO SAIZEN ONE CLICK HGH PEN MANUAL

Important Saizen one click ® PEN Information

Serono’s one.click hgh auto-injector is to be used exclusively with Serono’s HGH 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 Saizen with just one click. Singe use disposable sterile needle for the one. Clicks are supplied separately. Use only saizen 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 colour 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 dialling 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 travelling 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.

SAIZEN ONE CLICK Anti Aging Treatment INFORMATION 

Formula:
Each ampoule with lyophilised powder contains: Somatropin 8 mg, equivalent to 24 IU, excipient sufficient amount. The cartridge with the diluting agent contains: Metacresol 0.3%, Injectable water – sufficient amount for 1.37 ml To use the “One-Click”® self-injecting device.

PROPERTIES:
The active principle in SAIZEN® is Somatropin, a biosynthetic human growth hormone produced from mammary cells through genetic engineering. It contains 191 amino acids in identical sequence to the natural hormone produced by the pituitary gland. SAIZEN® promotes an increase in the average growth rhythm by somotomedins or by growth factors similar to insulin.

CONTRAINDICATIONS:
Individual hypersensitivity to the active component in the product. Diabetes mellitus should be considered as a relative contraindication. In patients suffering from diabetes mellitus, treatment should be carried out under strict medical and laboratory supervision. SAIZEN® must not be used if there is any evidence of a concomitant cerebral tumour.

ADVERSE EFFECTS:
Pharmacoginetic and toxicological studies carried out with SAIZEN® and pit-hGH have proven that the safety of the recombinant product is similar to that of the natural growth hormone and that the drug itself does not produce adverse effects. Nonetheless, treatment with human proteins may cause reactions due to hypersensitivity (such as redness and itchiness in the area of the injection site, formation of antibodies with or without the attenuating effect of growth, or both). In a small number of patients where short stature is the result of a genetic defect (depletion of the gene complex for hGH), somatropin treatment may stimulate the production of antibodies which attenuate growth in the majority of cases.

PRECAUTIONS:
Treatment must be carried out under strict periodic medical supervision. Patients with a deficiency of the growth hormone secondary to an intracraneal lesion should be examined frequently in order to follow the progression or recurrence of the underlying pathological process in the same area. Administering SAIZEN® subcutaneously in the same site over a prolonged period of time may cause lipoatrophy. Changing the injection site each time can prevent this.

INTERACTIONS:
Concomitant therapy with corticoids may inhibit the growth promoting effect of somatropin.

DIRECTIONS FOR USE:
Before using the “One-Click”® self-injecting device, Avoid shaking since this may bring about a slight darkening of the solution.

ADMINISTRATION METHOD
SAIZEN® is administered subcutaneously using the “One-Click”® self-injecting device and preferably at night. The dosage and method of administering SAIZEN® will vary according to each patient.

DOSAGE:
According to your doctor’s instructions. Store at room temperature, no higher than 25º C. Protect from the light. Do not administer this product if the seal has been broken. Do not use after the expiry date. Once mixed, the product may be refrigerated between 2ºC and 8ºC for up to 28 days.

PRESENTATION:
Box of either one or five sealed packs. Each contains: pre-assembled ampoule with lyophilised powder and cartridge with diluting agent in a “click-easy”® reconstruction kit, and a rod for administration with the “one-click”® self-injecting device. Keep out of the reach of children. Do not use this pharmaceutical product if you are pregnant or breast-feeding. Sold by medical prescription.

SAIZEN® ONE CLICK CARTRIDGE INSTRUCTIONS

How to prepare your Saizen® cartridge for the One-Click® pen.

1. Remove Saizen® cartridge from packaging.
2. Stand on a flat surface. So that the vial containing the distilled water is at the top and the powder at the bottom.A. Gently turn anti-clockwise to Slide cap down.
B. Push plastic cap down, ensuring that the water vial makes contact with the needle and rubber stopper.
C. Lock cap by gently twisting clockwise.
3. Take plastic plunger rod from package.A. Screw into top of distilled water vial.
B. Depress plunger and observe the distilled water filling The HGH chamber Please ensure all the distilled water has Been emptied into the HGH chamber.
4. Invert the cartridge assembly; you now be holding the HGH Cartridge on top and the distilled water vial on the bottom. Rock gently from side to side to reconstitute the HGH. Note: Do not shake.
5. Pull plunger towards you to draw the reconstituted HGH into the distilled water vial. (Pull back as far as the rubber stopper will allow).
6. Unscrew plunger and remove.
7. Unlock plastic cap, by gently twistingA. Anti-clockwise
B. Following the grooves to the Bottom slot
C. Turn clockwise
D. And Pull clear
8. Withdraw glass vial containing HGH mixture.
9. Remove sticker from the vial.
10. Write the date in felt tip pen in the space provided.
11. Your cartridge is now ready for insertion into the One-Click¨HGH pen (for those instructions please refer to the One-Click¨HGH pen manual).
Note: The remaining parts of the assembly can now be discarded.

	minium order of 1 pen@ $20 per IU =$480