Description
A highly precise, easy-to-use and convenient drug delivery device that allows Puregon to be injected safely and effectively. Puregon can be administered in prescribed doses, from 50 to 450 International Units (IU), with pre-set 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 audible clicks, which help to set the correct dose. Any setting errors can be easily corrected without loss of medicine.

Instructions for 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 pen body completely 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 treatment, you may be prescribed cartridges with different doses. Always ensure that the cartridge dose matches the dose prescribed by your doctor. Remove the cartridge from its packaging. Do not use the Puregon cartridge if the medicine contains particles or is cloudy. Before use, ensure the medicine is at room temperature. 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 must press against the rubber plunger on the cartridge. Screw the pen body fully onto the cartridge holder. Ensure there is no gap between the pen body and the cartridge holder. The arrow on the cartridge holder must point to the center of the yellow alignment mark on the blue pen body.
Before checking the medicine flow (point 12) and again before administering the set 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 should never be reused. Insert a new needle after ensuring that a Puregon cartridge is present 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 uncapped 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 on all the way. Place Puregon Pen with the needle inserted on a flat, clean, dry surface.
8. The most suitable area for injection is the abdomen, i.e., the portion of the belly just below the navel, or the thigh. Your doctor can indicate other areas where Puregon can be injected. To reduce the possibility of a skin reaction, it is advisable to slightly change the exact injection site each time.
9. To remove bacteria from the skin surface, clean the injection area with an alcohol swab. Clean an area of about 4-5 cm around the chosen injection site. Allow the alcohol to dry on the skin for at least one minute before proceeding with the injection.
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 upwards. It will be reused later to safely remove the needle after injection (See NEEDLE EXTRACTION AND DISPOSAL FOR BD MICRO-FINE PEN).
10. Carefully remove the inner needle cap and discard it. When the needle is uncapped, it should not be touched and should not come into contact with any surface.
12. Hold Puregon Pen with the needle pointing upwards. Gently tap the cartridge holder with a finger to move air bubbles towards the tip of the needle. The presence of a small air bubble does not affect the amount of medicine administered. When loading Puregon Pen with a new, unused cartridge, always follow these procedures:
a. turn the dosage knob until you hear a click. With the needle pointing upwards, press the injection button;
b. a droplet of liquid will emerge from the tip of the needle;
c. if no droplet is seen, repeat procedure a. (see above) until a droplet emerges. It is important to ensure that a droplet of medicine emerges, as otherwise an incorrect amount of medicine may be injected.
If the Puregon cartridge has already been used previously for self-injection of Puregon, you only need to insert a new needle and ensure a droplet emerges from the tip of the needle. If the droplet emerges, proceed to point 13; otherwise, follow procedures a, b, and c described above.
- Procedures a, b, and c must be performed each time Puregon Pen is loaded with a new, unused cartridge. - Always check the medicine flow as indicated in point 12. This ensures that the correct dose of Puregon is injected. If the medicine flow is not checked, the amount of medicine administered may be less than the set amount.
13. The Puregon cartridge will contain one of the following color-coded doses: 300 IU (silver), 600 IU (gold), 900 IU (blue). The contents of the Puregon cartridge must be recorded in the Puregon Pen treatment diary (for more information see CHECKING MEDICINE LEVEL). This will allow you to calculate the amount of Puregon remaining in each cartridge before each injection. If there is not enough medicine in the cartridge to cover the full dose, see the section below, IF THE PUREGON SOLUTION IN THE CARTRIDGE IS INSUFFICIENT. For doses between 50 IU and 450 IU, rotate the dosage knob until the correct dose aligns with the dosage mark on either side of the dosage window.
14. If a dose that is too high has been set by mistake, do not try to turn the dosage knob backward to correct the error. Instead, continue to turn the dosage knob in the same direction as far as possible beyond the mark corresponding to 450 IU. The dosage scale should now move freely. Press the injection button completely. Reset the correct dose starting from 0.
Following these instructions ensures that no part of the prescribed Puregon dose is lost.
15. After disinfecting the area, form a small skin fold between two fingers. With the other hand, insert the needle fully into the skin. Press the injection button completely to perform the entire injection. Wait 5 seconds before withdrawing the needle from the skin.
16. Withdraw the needle and press firmly on the injection site with an alcohol swab. The needle should only be used once. If administering the injection to another person, the needle must be withdrawn from the skin with extreme care. Accidental needle sticks with used needles can transmit potentially serious or severe infections.
17. These instructions must be followed carefully. Place the outer needle cap on a table with the opening facing upwards. The opening of the outer needle cap is the larger, rimmed end. Without resting on the outer needle cap, carefully insert the needle (attached to Puregon Pen) into the center of the outer needle cap opening and press firmly, as shown in the figure. The outer needle cap should be secured to the cartridge holder and completely cover the needle.
18. Ensure 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 care must be taken when holding the outer needle cap firmly and unscrewing the needle from the cartridge holder. You can ask your doctor where to find a suitable container for needle disposal. Immediately discard the outer cap with the used needle into a suitable container.
19. Before removing the empty Puregon cartridge from Puregon Pen, unscrew the needle by following the procedures described in points 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 discard the empty Puregon cartridge into the same suitable container used for the needle. At the end of the treatment cycle, your doctor will advise you on how to properly dispose of the container.

Warnings
1. Puregon Pen is a precision device. It is very important to read and follow all instructions for its use. It is also important to read the patient leaflet attached to the Puregon cartridge. As with all injection devices, any errors could result in the administration of an incorrect dose.
2. The Puregon Pen should only be used with Puregon cartridges. Keep this information and read it carefully before starting to use Puregon with the Puregon Pen and every time the cartridge needs to be replaced.
3. If the medicine is injected cold, it may cause some discomfort. It is therefore recommended to allow the medicine to reach room temperature before injecting it. The needle should be inserted into the pen just before the injection.
4. When inserting the needle under the skin, always press the injection button completely for 5 seconds. During these 5 seconds, the needle must be left in the skin to ensure the administration of the entire Puregon dose.
5. The Puregon Pen is for personal use and should not be shared with others.
6. The BD Micro-Fine pen needle should only be used with the Puregon Pen. The BD Micro-Fine pen needle is for single use. The needle must be handled with extreme care. If administering the injection to another person, accidental needle sticks with used needles can transmit potentially serious or severe infections.
7. The use of the Puregon Pen is not recommended for blind or visually impaired patients unless assisted by a sighted person who has been instructed on the correct use of this device.
8. Record each injection performed with a Puregon cartridge. This will allow you to calculate the daily amount of medicine remaining in the cartridge, by subtracting the injected quantity from the quantity indicated on the cartridge label (300 IU, 600 IU, or 900 IU).
9. Your doctor will determine the dose of Puregon to be administered. This dose may then be increased or decreased during treatment depending on the type of individual therapy. If you have used gonadotropins previously, the dose of Puregon may be different. Your doctor will always determine the dosage based on your medical history.
10. Some statements in this booklet are specifically addressed to most users on a daily treatment regimen. If your doctor has given you other instructions on your treatment regimen, always follow their 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 the correct administration of the prescribed Puregon® dose, carefully follow the instructions in this booklet. o Some statements in this booklet are specifically addressed to most users on a daily treatment regimen. If your doctor has given you other instructions on your treatment regimen, always follow their instructions. - Do not share your Puregon Pen with others.
- The use of the Puregon Pen is not recommended for blind or visually impaired patients unless assisted by a sighted person who has been instructed on the correct use of this device.
- The Puregon Pen should only be used with a Puregon cartridge prescribed for subcutaneous administration.
- Insert the needle only when you are ready for the injection (see points 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 points 17 and 18 for the correct handling of a used needle.
- The needle is sterile. To avoid contaminating the needle after opening, do not rest it on any surface or touch its exposed parts.
- Before attempting to replace a Puregon cartridge, ensure that no needle is inserted in Puregon Pen.
- Never set the dose or try to correct a setting error after inserting the needle into the skin. This operation could be dangerous and result in the administration of an incorrect dose of medicine.
- Proper procedures must be followed for the disposal of used needles (inserted in their outer cap), empty cartridges, and residual medicine. Consult your doctor about the correct disposal procedures.
- The Puregon Pen is intended for self-injection of Puregon. If administering the injection to another person, the needle must be withdrawn from the skin with extreme care. Follow points 17 and 18 for the correct handling of a used needle. Accidental needle sticks with used needles can transmit infectious diseases.

Storage
If enough Puregon remains 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 a temperature equal to or below 25°C. Never store Puregon Pen with a needle inserted.
Shelf life unopened: 24 months.
Shelf life after opening: 28 days at 2-25°C.

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