GENOTROPIN GOQUICK 5.3 mg/mL

Powder and Solvent for Solution for Injection in a Pre-filled Pen

INSTRUCTIONS FOR USE

1. Before Use

• Read these instructions carefully before using GENOTROPIN GOQUICK.

• Use this medicine only as prescribed by your doctor.

• If you are unsure how to use the pre-filled pen, ask your doctor, nurse, pharmacist, or another healthcare professional for assistance.

• Do not change your prescribed dose without consulting your doctor.

Here's the English translation:

2. About GENOTROPIN GOQUICK

GENOTROPIN GOQUICK is a pre-filled injection pen containing a powder and a solvent that are mixed to prepare a solution for injection.

The medicine contains the growth hormone somatropin and is used to treat conditions that require growth hormone therapy.

Each pre-filled pen contains:

• A cartridge with the powder

• A cartridge with the solvent

After mixing, the contents form a solution that is ready for subcutaneous injection.

The required dose and frequency of injections are determined by your doctor.

3. Components of the Pre-filled Pen

Pre-filled Pen

The pre-filled pen consists of:

• Pen cap

• Cartridge holder

• Mixing button

• Mixing indicator

• Dose window

• Dose indicator line

• Dose selector

• Dose adjustment button

• Injection button

Needle

Not included with the pen

The needle consists of:

• Outer needle cap

• Inner needle cap

• Needle

• Protective seal

Use a new sterile needle for every injection.

Needle Removal Device

Not included with the pen

The needle removal device is used for the safe removal and disposal of the needle.

It consists of:

• Black cap

• Needle removal device

• Gray cap

• Disposal opening

PART I. INITIAL PREPARATION

4. Checking the Pre-filled Pen

Before using the pen for the first time:

• Check the product name on the label.

• Make sure you are using the correct GENOTROPIN GOQUICK pen.

• Check the expiration date.

• Do not use the medicine after the expiration date.

• Ensure that the pre-filled pen and cartridge are not damaged.

• If the pen has been dropped, make sure it is functioning properly before use.

5. Mixing the Powder and Solvent

• Remove the cap from the pre-filled pen.

• Mix the powder and solvent according to the instructions and illustrations provided in the original User Guide.

• Do not shake the pen vigorously.

• After mixing, inspect the solution carefully.

The solution should be:

• Clear

• Colorless

• Free of visible particles

Do not use the solution if it is:

• Cloudy

• Discolored

• Contains visible particles

6. Attaching a New Needle

• Wipe the rubber membrane with an alcohol swab.

• Remove the protective seal from a new sterile needle.

• Hold the needle straight.

• Screw the needle onto the pre-filled pen by turning it clockwise.

• Tighten the needle securely, but do not overtighten.

• Remove the outer needle cap and keep it for later use.

• Remove the inner needle cap.

Do not touch the needle with your hands.

7. Needle Guard

When using a needle guard:

• Remove the protective component according to the illustrations in the official Instructions for Use.

• Pull it straight off.

• Do not twist the protective component.

• Do not touch the needle itself.

8. Priming the Pen and Checking the Flow

Before the first injection, make sure that the solution flows properly through the needle.

• Hold the pre-filled pen with the needle pointing upward.

• Gently tap the cartridge holder with your finger to allow any air bubbles to rise to the top.

• Set the dose selector to the flow check (priming) position as indicated in the original Instructions for Use.

• Press the injection button all the way down.

• Keep the button fully pressed until a drop of solution appears at the tip of the needle.

A drop of solution at the tip of the needle indicates that the pre-filled pen is ready for use.

If No Drop Appears

• Repeat the flow check.

• Gently tap the cartridge again.

• Press the injection button all the way down.

• Repeat the procedure the number of times specified in the official Instructions for Use, if necessary.

• If the solution still does not appear, replace the needle and repeat the flow check.

If no drop of solution appears after replacing the needle, do not use the pre-filled pen. Contact your healthcare professional or the manufacturer's customer support.

PART II. DAILY USE

9. Preparing for Each Injection

Before each injection:

• Wash and dry your hands thoroughly.

• Remove the cap from the pre-filled pen.

• Check the product name on the label.

• Verify the expiration date.

• Inspect the solution through the cartridge window.

• Make sure the solution is clear, colorless, and free of visible particles.

• Attach a new sterile needle.

• Perform a flow check (priming), if necessary.

Do not use the pre-filled pen if the solution is cloudy, discolored, or contains visible particles.

10. Setting the Dose

• Turn the dose selector until your prescribed dose appears in the dose window.

• The dose is displayed in milligrams (mg).

• Make sure the value shown in the dose window exactly matches the dose prescribed by your doctor.

• You may adjust the dose by turning the selector forward or backward until the correct dose is set, before administering the injection.

• Do not attempt to inject a dose larger than the amount of medicine remaining in the pre-filled pen.

If the dose selector cannot be turned to your prescribed dose, there may not be enough medicine left in the pen to deliver the full dose.

Do not change your prescribed dose without consulting your doctor.

11. Choosing an Injection Site

GENOTROPIN GOQUICK is administered by subcutaneous injection into the fatty tissue of the:

• Abdomen

• Thigh

• Upper arm

• Buttocks

Rotate the injection site with each injection.

Do not inject into:

• A vein

• A muscle

• Red or swollen skin

• A painful area

• Damaged skin

• Areas with scars or hardened tissue

Repeated injections into the same site may cause changes in the subcutaneous fatty tissue.

12. Preparing the Injection Site

• Clean the injection site with an alcohol swab.

• Allow the skin to dry completely.

• Do not touch the cleaned area before the injection.

13. Administering the Injection

• If necessary, gently pinch the skin to form a fold.

• Insert the needle under the skin as demonstrated by your healthcare professional.

• Press the injection button all the way down.

• Keep the button fully pressed.

• Wait for the amount of time specified in the official Instructions for Use to ensure that the full dose has been delivered.

• Remove the needle from the skin.

• Release the injection button.

If a small drop of blood appears after the injection, gently press the area with a clean swab. Do not rub the skin.

14. Removing and Disposing of the Needle

After every injection:

• Carefully replace the outer needle cap or use a dedicated needle removal device.

• Do not touch the used needle.

• Unscrew the needle from the pre-filled pen.

• Place it in an approved sharps disposal container.

• Do not throw an uncovered needle into ordinary household waste.

• Replace the cap on the pre-filled pen.

Do not store the pre-filled pen with a needle attached.

PART III. STORAGE

15. Before First Use

• Store the medicine in a refrigerator at 2°C–8°C (36°F–46°F).

• Do not freeze.

• Keep the pre-filled pen in the original carton to protect it from light.

• Do not place the pen next to the freezer compartment or a cooling element.

16. After Mixing or First Use

Follow the storage conditions specified in the official Instructions for Use for your specific GENOTROPIN GOQUICK pen.

The original instructions describe two possible storage options:

• Store in a refrigerator at 2°C–8°C (36°F–46°F) for up to 28 days; or

• Store at room temperature up to 25°C (77°F) for up to 28 days.

Do not combine these storage conditions without verifying the official Instructions for Use for your specific pen.

Additional recommendations:

• Do not freeze the prepared solution.

• Protect the pen from light and heat.

• Keep out of the reach of children.

• Dispose of any unused medicine after the permitted storage period has expired.

PART IV. IMPORTANT INFORMATION

17. Safe Use

• Do not share your pre-filled pen with anyone, even after changing the needle.

• Never share needles with another person.

• Use a new sterile needle for every injection.

• Do not reuse needles.

• Do not use a damaged pre-filled pen.

• Do not use a cloudy or discolored solution.

• Do not use a solution containing visible particles.

• Do not inject into a vein or a muscle.

• Do not leave the needle attached to the pen after an injection.

• Do not attempt to disassemble or repair the pre-filled pen.

PART V. FREQUENTLY ASKED QUESTIONS

Can I use the solution if it becomes cloudy?

No. Do not use a solution that is cloudy, discolored, or contains visible particles.

How long can the medicine be stored after mixing?

The storage period and temperature must follow the official Instructions for Use for your specific pre-filled pen. The instructions provided indicate a storage period of up to 28 days.

Why should I rotate injection sites?

Repeated injections into the same area may cause lipodystrophy, a change in the subcutaneous fatty tissue.

Can I use a different needle?

Use only compatible needles recommended for GENOTROPIN GOQUICK. Using an incompatible needle may affect dose accuracy and proper injection.

What should I do if the medicine is accidentally injected into a vein?

Seek medical attention immediately and contact your doctor or another healthcare professional.

What should I do if redness, swelling, or pain occurs?

These may be local injection-site reactions. If symptoms are severe, worsen, or do not go away, contact your doctor.

Can I reuse a needle?

No. Needles are intended for single use only. Reusing a needle increases the risk of infection and may reduce dosing accuracy.

How should I dispose of used needles?

Place used needles in an approved sharps disposal container and dispose of them according to local regulations.

What should I do if I miss a dose?

Do not inject a double dose unless instructed by your doctor. Contact your doctor or nurse for advice.

What should I do if I accidentally inject too much medicine?

Contact your doctor, nurse, or the nearest medical facility immediately.

Should I eat before the injection?

Use the medicine according to your doctor's instructions. Any recommendation regarding injections before or after meals should be confirmed in the official Instructions for Use.

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