PUREGON PEN PEN FOR ADMINISTRATION OF PUREGON MEDICATION

Description
Extremely precise, easy and convenient to use drug delivery device that allows you to inject Puregon safely and effectively. Puregon can be administered at prescribed doses, from 50 to 450 International Units (IU), in preset increments of 25 IU (Puregon Pen complies with the precision requirements of ISO International Standard 11608-1). The dosage scale on the pen has clearly visible numbers and produces clearly audible clicks, which help to set the correct dose. Any setting errors can be easily corrected, without causing any loss of medicine.

How to use
Before each use of Puregon Pen, wash your hands thoroughly with antibacterial soap and water.
1. Holding the pen body firmly in one hand, remove the protective cap with the other hand. Place the cap on a clean, dry surface.
2. Unscrew the entire pen body from the cartridge holder. Place the cartridge holder and pen body on a clean, dry surface.
3. Puregon cartridges are available in different doses and during the course of treatment you may be prescribed cartridges with different doses. You should always make sure that the dose in the cartridge corresponds to the dose prescribed by your doctor. Remove the cartridge from the packaging. Do not use the Puregon cartridge if the medicine contains particles or is cloudy. Make sure the medicine is at room temperature before use. Clean the rubber stopper of the cartridge with an alcohol swab. Take the cartridge holder and place the cartridge in it. Insert the metal cap first.
4. Insert the pen body into the cartridge holder. The black plunger should press against the rubber plunger on the cartridge. Screw the pen body completely onto the cartridge holder. Make sure there is no free space between the pen body and the cartridge holder. The tip of the arrow on the cartridge holder should point to the center of the yellow alignment mark on the blue pen body.
Before checking the flow of the medicine (point 12) and again before administering the prescribed dose (points 15-16), always check that the arrow on the cartridge holder and the alignment mark on the pen body are still aligned. 5. A new needle must be used for each new injection. Needles must never be reused. Attach a new needle after making sure that there is a Puregon cartridge in the cartridge holder. Clean the open end of the cartridge holder with an alcohol swab.
6. Remove the needle from the outer cap. Remove the protective paper seal. Do not touch the needle or place an open needle on any surface.
7. Hold the outer needle cap firmly in one hand and the cartridge holder in the other. Push the end of the cartridge holder into the needle cap. Screw them all the way in. Place the Puregon Pen with the needle inserted on a flat, clean and dry surface.
8. The most suitable area for the injection is the abdomen, that is, the part of the belly located just below the navel, or the thigh. The doctor may indicate other areas where Puregon can be injected. To reduce the possibility of a skin reaction, it is advisable to change the exact injection site a little each time.
9. To remove bacteria from the skin surface, clean the injection area with an alcohol swab. Clean an area approximately 4-5 cm around the intended injection site. Allow the alcohol to dry on the skin for at least one minute before injecting.
Gently remove the outer needle cap, leaving the inner needle cap in place (covering the needle, which is now inserted into the pen): place the outer needle cap on the table, keeping the open end facing up. You will need to reuse it later to safely remove the needle after the injection (See "REMOVING AND DISPOSING THE BD MICRO-FINE PEN NEEDLE").
10. Carefully remove the inner needle cap and throw it away. When the needle is removed from the cap, it should not be touched or come into contact with any surface.
12. Hold Puregon Pen with the needle pointing upwards. Gently tap the cartridge holder with your finger to make any air bubbles rise to the needle tip. A small air bubble does not affect the amount of medicine administered. When loading Puregon Pen with a new, unused cartridge, always follow these steps:
a. turn the dosage knob until you hear a "click". With the needle pointing up, press the injection button;
b. a droplet of liquid comes out of the tip of the needle;
c. if no drop is seen, repeat procedure a. (see above) until a droplet appears. Make sure that a droplet of medicine appears, otherwise the wrong amount of medicine may be injected.
If the Puregon cartridge has been used previously to self-inject Puregon, simply attach a new needle and check that a droplet emerges from the needle tip. If a droplet emerges, go to step 13; otherwise, follow steps a, b and c above.
- Procedures a, b and c must be performed each time you load Puregon Pen with a new, unused cartridge. - Always check the medicine flow according to step 12. This will ensure that you inject the correct dose of Puregon. If you do not check the medicine flow, you may receive less medicine than you set.
13. The Puregon cartridge will contain one of the following colour-coded doses: 300 IU (silver), 600 IU (gold), 900 IU (blue). The contents of the Puregon cartridge should be recorded in the Puregon Pen treatment diary (see “CHECKING THE MEDICATION LEVEL” for further information). This will allow you to calculate the amount of Puregon in each cartridge before each injection. If there is not enough medicine in the cartridge to cover the full dose, see “IF THERE IS NOT ENOUGH PUREGON SOLUTION IN THE CARTRIDGE” below. For doses between 50 IU and 450 IU, turn the dosing knob until the correct dose lines up with the dosage mark on each side of the dosing window.
14. If you have mistakenly set a dose that is too high, do not try to turn the dosage knob backwards to correct the error. Instead, continue to turn the dosage knob in the same direction as far as possible beyond the 450 IU mark. The dosage scale should now move freely. Press the injection button fully down. Reset the correct dose starting from "0".
Following these instructions will ensure that you do not miss even a part of your prescribed dose of Puregon.
15. After disinfecting the area, form a small fold of skin between two fingers. With the other hand, insert the needle completely into the skin. Press the injection button completely, so as to perform the entire injection. Wait 5 seconds before removing the needle from the skin.
16. Remove the needle and press firmly on the injection site with an alcohol swab. The needle should be used only once. If you are giving the injection to another person, you must remove the needle from the skin with extreme caution. Accidental needle sticks with used needles can transmit potentially serious or life-threatening infections.
17. These instructions must be followed carefully. Place the outer needle cap on a table with the opening facing up. The opening of the outer needle cap is the larger, beaded end. Without leaning on the outer needle cap, carefully insert the needle (attached to the Puregon Pen) into the center of the opening of the outer needle cap and press firmly, as shown in the figure. The outer needle cap should be attached to the cartridge holder and should completely cover the needle.
18. Make sure that the outer needle cap completely covers the entire needle. Then hold the outer needle cap firmly and use it to unscrew the needle from the cartridge holder. Extreme caution must be used when holding the outer needle cap firmly and unscrewing the needle from the cartridge holder. Ask your doctor where to find a suitable container for needle disposal. Immediately throw away the outer needle cap with the used needle in a suitable container.
19. Before removing the empty Puregon cartridge from the Puregon Pen, unscrew the needle following the procedures described in steps 17 and 18. Unscrew the pen body from the cartridge holder.
20. Place the pen body on a clean, dry surface and remove the empty Puregon cartridge from the cartridge holder. Immediately throw away the empty Puregon cartridge in the same suitable container used for the needle. At the end of the treatment cycle, your doctor will indicate how to properly dispose of the container.

Warnings
1. Puregon Pen is a precision device. It is very important to read and follow all directions for its use. It is also important to read the patient information leaflet included with the Puregon cartridge. As with all injection devices, errors could result in the wrong dose being administered.
2. The Puregon Pen must only be used with Puregon cartridges. Keep this information and read it carefully before you start using Puregon with the Puregon Pen and each time you need to replace the cartridge.
3. If the medicine is injected cold, it may cause some discomfort. It is therefore recommended to let the medicine reach room temperature before injecting. The needle should be inserted into the pen just before the injection.
4. When inserting the needle under the skin, the injection button must always be fully depressed for 5 seconds. During these 5 seconds the needle must be left in the skin to ensure the entire dose of Puregon is administered.
5. The Puregon Pen is intended for personal use and should not be shared with others.
6. The BD Micro-Fine Pen Needle is for use only with the Puregon Pen. The BD Micro-Fine Pen Needle is for single use only. Extreme care should be taken when handling the needle. If you inject someone else, accidental needle sticks from used needles may transmit potentially serious or life-threatening infections.
7. The use of the Puregon Pen is not recommended for blind or partially sighted patients unless assisted by a person with no vision problems and trained in the correct use of this device.
8. Record each injection you make with a Puregon cartridge. This will allow you to calculate the daily amount of medicine remaining in the cartridge by subtracting the amount injected from the amount indicated on the cartridge label (300 IU, 600 IU or 900 IU).
9. Your doctor will decide the dose of Puregon to administer. This dose may then be increased or decreased during treatment depending on the type of individual therapy. If you have used gonadotropins before, the dose of Puregon may be different. Your doctor will always decide the dosage based on your medical history.
10. Some of the wording in this booklet is specifically addressed to most users on a daily treatment regimen. If your doctor has given you other instructions about your treatment regimen, always follow his or her instructions.
Do not touch the needle or leave it inserted without the inner cap; this will keep the needle sterile.
A new sterile needle must be used for each new injection.
o To ensure that you receive the correct dose of Puregon® as prescribed, carefully follow the instructions in this leaflet. o Some of the wording in this leaflet is specifically intended for most users on a daily treatment regimen. If your doctor has given you other instructions about your treatment regimen, always follow his or her instructions. - Do not share your Puregon Pen with anyone else.
- The use of the Puregon Pen is not recommended for blind or partially sighted patients unless assisted by a person with no vision problems and trained in the correct use of this device.
- The Puregon Pen must only be used with a Puregon cartridge prescribed for subcutaneous administration.
- Only attach the needle when you are ready to inject (see steps 5-7). Always remember to remove the needle from Puregon Pen immediately after completing the injection and dispose of it properly in its outer cap. See steps 17 and 18 for proper handling of the used needle.
- The needle is sterile. To avoid contaminating the needle after opening, do not place it on any surface or touch its exposed parts.
- Before attempting to replace a Puregon cartridge, make sure that no needle is inserted into the Puregon Pen.
- Never set the dose or try to correct a setting error after the needle has been inserted into the skin. This could be dangerous and result in the administration of an incorrect dose of medicine.
- To dispose of used needles (inserted in their external cap), "empty" cartridges and medicine residues, it is necessary to follow suitable procedures. Consult your doctor about the correct disposal procedures.
- The Puregon Pen is intended for self-injection of Puregon. If you are injecting someone else, you must remove the needle from the skin with extreme caution. Follow steps 17 and 18 for proper handling of the used needle. Accidental needle sticks with used needles can transmit infectious diseases.

Conservation
If there is enough Puregon left for further injections, replace the cap on the pen body and store Puregon Pen in a safe place in the refrigerator at 2-8°C (do not freeze), or alternatively store at or below 25°C. Never store Puregon Pen with a needle attached.
Validity with intact packaging: 24 months.
Shelf life with intact packaging: 28 days at 2-25°C.

Format
Contains a Puregon Pen in a case and an instruction manual.
Puregon cartridges and BD Micro-Fine needles are sold separately.
For use with Puregon cartridges only.