Product Information for the Patient

Ngenla 2424 mg pre-filled injectable solution

somatropin

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you or the child in your care, and you must not give it to others even if they have the same symptoms as you or the child in your care, as it may harm them.
• If you or the child in your care experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

Ngenla contains the active ingredient somatropin, a modified pharmaceutical form of human growth hormone. Natural human growth hormone is necessary for bones and muscles to grow. It also helps to develop fat and muscle tissues in the appropriate amounts. Ngenla is used to treat children and adolescents from 3 years old who do not have enough growth hormone and are not growing at a normal rate.

The active ingredient of Ngenla is produced using "recombinant DNA technology". This means that it is created in cells that have been modified in the laboratory to produce it.

No use Ngenla

-If you or the child in your care are allergic to somatropin(see “Warnings and precautions”) or to any of the other components of this medication (listed in section6).

• If you or the child in your care have an active tumor (cancer). Inform your doctor if you or the child in your care have or have had an active tumor. Tumors must be inactive and you or the child in your care must have completed their antitumor treatment before starting treatment with Ngenla.
• If you or the child in your care have stopped growing due to the closure of growth plates (epiphyses closed), meaning that your doctor has told you or the child in your care that their bones have stopped growing.
• If you or the child in your care are severely ill (for example, suffer complications after open-heart surgery, abdominal surgery, acute respiratory failure, multiple accidental injuries or similar conditions). If you or the child in your care are about to undergo or have undergone major surgery, or are going to the hospital for any reason, inform your doctor and remind other doctors treating you or the child in your care that they are receiving growth hormone.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Ngenla:

• If you or the child in your care experience a severe allergic reaction, stop using Ngenla and consult your doctor immediately. In some cases, severe allergic reactions such as hypersensitivity, including anaphylaxis or angioedema (difficulty breathing or swallowing, or swelling of the face, lips, throat or tongue) have occurred. If you or the child in your care experience any of the following symptoms of a severe allergic reaction:
• • Respiratory problems.
  • Swelling of the face, mouth and tongue.
  • Hives (urticaria, bumps that rise under the skin).
  • Rash.
  • Fever.
• If you or the child in your care are receiving corticosteroid replacement therapy (glucocorticoids), you must consult your doctor regularly, as you or the child in your care may need to adjust your glucocorticoid dose.
• Your doctor must check from time to time if the thyroid gland is functioning correctly in you or the child in your care and, if necessary, may prescribe treatment or adjust the existing treatment dose, as this may be necessary for Ngenla to work correctly.
• If you or the child in your care have Prader-Willi syndrome, you or the child should not be treated with Ngenla unless you or the child have growth hormone deficiency.
• Your doctor must monitor the occurrence in you or the child in your care of high blood sugar levels (hyperglycemia) during treatment with Ngenla. If you or the child in your care are receiving insulin or other diabetes medications, your doctor may need to adjust the insulin dose. If you or the child in your care have diabetes and a severe or worsening eye disease, you or the child should not receive treatment with Ngenla.
• If you or the child in your care have ever had any type of tumor(cancer).
• If you or the child in your care experience changes in vision, severe or frequent headaches, related to nausea, vomiting, or experience lack of muscle control or voluntary movement coordination, such as walking or grasping objects, difficulty speaking, eye movement ordifficultyswallowing, especially at the beginning of treatment, inform your doctor immediately. These may be signs of a temporary increase in intracranial pressure (hypertension intracranial).
• If you or the child in your care are severely ill (for example, suffer complications after open-heart surgery, abdominal surgery, acute respiratory failure, multiple accidental injuries or similar conditions). Ifyou or the child in your careare about to undergo or have undergone major surgery, or are going to the hospital for any reason, inform your doctor and remind other doctors treating you or the child in your care that you or the child in your care are receiving growth hormone.
• If you or the child in your care experience intense stomach pain during treatment with Ngenla, as it could be a symptom of pancreatitis inflammation.
• If you or the child in your care notice a lateral curvature in your spine (scoliosis), you or the child in your care should be examined frequently by your doctor.
• If during growth, you or the child in your care experience limpness or pain in the hip or knee, you or the child in your care must consult your doctor immediately. These may be symptoms of bone disorders in the hip, as this can occur during periods of rapid growth.
• If you or the child in your care are taking or stopping oral contraceptives or hormone replacement therapy with estrogens, your doctor may recommend adjusting the Ngenla dose.

Other medications and Ngenla

Inform your doctor, pharmacist or nurse if you or the child in your care are using, have recently used or may need to use any other medication.

• Ifyou or the child in your care receivecorticosteroid replacement therapy (glucocorticoids), as these may reduce the effect of Ngenla on growth. You or the child in your care must consult your doctor regularly, as you or the child in your care may need to adjust your glucocorticoid dose.
• If you or the child in your care are receiving insulin or other diabetes medications, you must consult your doctor, as it may be necessary to adjust the insulin dose.
• If you or the child in your care are receiving thyroid hormone replacement therapy, your doctor may need to adjust the dose.
• If you or the child in your care are receiving oral estrogens, you must consult your doctor, as you or the child in your care may need to adjust your Ngenla dose.
• If you or the child in your care are receiving ciclosporin (a medication that weakens the immune system after a transplant), you must consult your doctor, as your doctor may need to adjust the dose.
• If you or the child in your care are receiving anticonvulsants (medications to control epilepsy), you must consult your doctor, as your doctor may need to adjust the dose.

Pregnancy and breastfeeding

If you or the girl in your care are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Ngenla has not been tested in pregnant women and it is not known if this medication can harm the fetus. Therefore, it is preferable to avoid Ngenla during pregnancy.If you can become pregnant, do not use Ngenla unless you are also using a reliable contraceptive method.

The effect of somatropin on breast milk is unknown. Inform your doctor or the child's doctor if you or the child in your care are breastfeeding or plan to do so. Your doctor will help you decide whether you or the child in your care should stop breastfeeding or stop receiving Ngenla, taking into account the benefits of breastfeeding for the baby and the benefits of Ngenla for you or the child in your care.

Driving and operating machines

Ngenla does not affect the ability to drive and operate machines.

Ngenla contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose; this is, essentially “sodium-free”.

Ngenla contains metacresol

Ngenla contains a preservative called metacresol. In rare cases, the presence of metacresol may cause inflammation (swelling) in the muscles. If you or the child in your care experience muscle pain or pain at the injection site, inform your doctor.

This medication can only be prescribed by a doctor with experience in growth hormone treatment and who has confirmed the diagnosis or that of the child under their care.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse again.

Your doctor will decide the dose ofNgenlathat must be injected.

How much to use

Your doctor will calculate your dose of Ngenla from your body weight in kilograms. The recommended dose is 0.66mg per kilogram of body weight and is administered once a week. If you or the child under your care have been previously treated with daily injections of growth hormone, your doctor will instruct you to wait before receiving the first dose of Ngenla until the day after your last daily injection and then continue with Ngenla once a week.

Do not change your dose unless your doctor tells you to.

How to administer Ngenla

• Ngenla is available as a pre-filled pen in 2different sizes(Ngenla 24mg and Ngenla 60mg). According to the recommended dose, your doctor or the doctor of the child under your care will prescribe the most suitable pen size (see section6 “Contents of the package and additional information”).
• Before you or the child under your care use the pen for the first time, your doctor or nurse will teach you how to use it. Ngenla is administered by a subcutaneous injection using a pre-filled pen. Do not inject it into a vein or muscle.
• The best area to administer Ngenla is the abdomen (stomach), thighs, buttocks, and upper arms. Injections in the upper arms and buttocks must be administered by a caregiver.
• Change the injection site on your body or the body of the child under your care each time a dose is administered.
• If more than one injection is required to administer a complete dose, each one must be administered in a different injection site.

The detailed usage instructions for the pre-filled pen are found at the end of this prospectus.

When to use Ngenla

You or the child under your care must use this medication once a week on the same day of each week.

You or the child under your care must record which day of the week you useNgenlato help you remember to inject this medication once a week.

If necessary, you or the child under your care can change the day of your weekly injection as long as at least 3days have passed since you or the child under your care received the last injection.After selecting a new administration day, continueadministering the injection to yourself or the child under your care on that day every week.

If you use more Ngenla than you should

Ifyou or the child under your carehave injected more Ngenla than you should, contact your doctor immediately, as it may be necessary to control your blood sugar levels.

If you forgot to use Ngenla

Ifyou or the child under your careforgot to inject a dose and:

• Have passed 3days or less sinceyou or the child under your careshould have used Ngenla, use it as soon as you remember. Then, inject your next dose on the usual injection day.
• Have passed more than 3days sinceyou or the child under your careshould have used Ngenla, skip the missed dose. Then, inject your next dose as usual on the next scheduled day. A regular administration day must be maintained.

Do not use a double dose to compensate for the missed dose.

If you interrupt treatment with Ngenla

Do not stop using this medication without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Very common: may affect more than 1 in 10 peoplepeople

• Headache
• Bleeding, inflammation, itching, pain, redness, discomfort, stinging, sensitivity, or heat at the injection site (injection site reactions)
• Fever (pyrexia)

Common: may affect up to 1 in 10 peoplepeople

-Decreased number of red blood cells in the blood (anemia)

-Increased number of eosinophils in the blood (eosinophilia)

-Decreased blood level of thyroid hormone (hypothyroidism)

-Allergic inflammation of the conjunctiva, the transparent layer covering the outer eye (allergic conjunctivitis)

-Joint pain (arthralgia)

-Pain in arms or legs

Rare: may affect up to1 in 100 peoplepeople

-The adrenal glands do not produce enough steroid hormones (adrenal insufficiency)

-Rash

Other possible side effectsnot observed withNgenlabut that have beenreportedwith other growth hormone treatments may include the following:

• Tissue growth (non-cancerous or cancerous)
• Type 2 diabetes
• Increased intracranial pressure (which causes symptoms such as severe headache, visual disturbances, or vomiting)
• Numbness or tingling
• Joint or muscle pain
• Enlargement of breasts in children and men
• Skin rash, redness, and itching
• Water retention (manifesting as swollen fingers or ankles)
• Facial swelling
• Pancreatitis (causing symptoms of stomach pain, nausea, vomiting, or diarrhea)

In rare cases, the presence of metacresol may cause inflammation (swelling) in the muscles. If you or the child under your care experience muscle pain or pain at the injection site, inform your doctor.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the reach and sight of children.

Do not use this medication after the expiration date that appears on the pen label orin thebox after “EXP”. The expiration date is the last day of the month indicated.

The preloaded pen should not be used more than 28days after the first use.

Before the first use ofNgenla

• Store in the refrigerator (between 2°C and 8°C).
• Keep Ngenla in the outer packaging to protect it from light.
• Remove Ngenla from the refrigerator before use. Ngenla can be stored at room temperature (up to a maximum of 32°C) for a maximum of 4hours.
• Do not use this medication if you observe that the solution is cloudy or dark yellow in color. Do not use the medication if it has flakes or particles.
• Do not shake the pen. Shaking it may damage the medication.

After the first use ofNgenla

• Use it within 28days after the first use. Store in the refrigerator (between 2°C and 8°C). Do not freeze.

• Keep Ngenla with the pen cap on to protect it from light.
• Do not store the preloaded pen with the needle attached.
• Dispose of the pen after the last dose, even if it contains unused medication.
• Ngenlacan be stored at room temperature (up to a maximum of32°C) for a maximum of 4hours with each injection, up to a maximum of 5times. ReturnNgenlato the refrigerator after each use.
• Do not leave it at room temperature for more than 4hours with each use.
• Do not place the pen in any location where the temperature exceeds 32°C.

-If more than 28days have passed since the first use of the pen, dispose of it even if it contains unused medication. If your pen or the pen of the child under your care have been exposed to temperatures above 32°C, have been removed from the refrigerator for more than 4hours with each use, or have been used a total of 5times, dispose of them even if they contain unused medication.

To help you remember when to dispose of your pen, you can write the date of the first use on the pen label.

It may be possible that a small amount of medication remains in the pen after all the doses have been administered correctly. Do not attempt to use the remaining medication. After administering the last dose, the pen should be disposed of properly.

Medications should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Ngenla

• The active ingredient is somatotropin.

Ngenla 24mg pre-filled syringe

One ml of solution contains 20mg of somatotropin.

Each pre-filled syringe contains 24mg of somatotropin in 1.2ml of solution. Each pre-filled syringe provides doses of 0.2mg to 12mg in a single injection in increments of 0.2mg.

Ngenla 60mg pre-filled syringe

One ml of solution contains 50mg of somatotropin.

Each pre-filled syringe contains 60mg of somatotropin in 1.2ml of solution. Each pre-filled syringe provides doses of 0.5mg to 30mg in a single injection in increments of 0.5mg.

• The other components are: citric acid dihydrate, citric acid monohydrate, L-histidine, sodium chloride (see section2 “Ngenla contains sodium”), poloxamer 188, m-Cresol, and water for injection.

Appearance of the product and contents of the pack

Ngenla is a clear, colourless to pale yellowish transparent injectable solution in a pre-filled syringe.

Ngenla 24mg injectable solution is available in a pack containing 1pre-filled syringe. The syringe cap, the dosing button, and the syringe label are purple.

Ngenla 60 mg injectable solution is available in a pack containing 1pre-filled syringe. The syringe cap, the dosing button, and the syringe label are blue.

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Spain

Pfizer S.L.

Phone: +34 91 490 99 00

Last update of the summary of product characteristics 03/2024.

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

Instructions for use

Ngenla 60 mg pre-filled syringe

Inject only for subcutaneous use (under the skin)

Keep this leaflet. These instructions indicate step-by-step

how to prepare and administer a Ngenla injection.

Important information about the Ngenla syringe

• Ngenla injectable is a pre-filled syringe multidose that contains 60mg of medication.
• Ngenla injectable can be administered by a patient, a caregiver, a doctor, a nurse, or a pharmacist.Do notattempt to inject Ngenla yourself until you are shown the correct way to administer injections and read and understand the instructions for use. If your doctor, nurse, or pharmacist decides that you or a caregiver can administer Ngenla injections at home, you must receive training on how to properly prepare and inject Ngenla. It is essential to consult with your doctor, nurse, or pharmacist to ensure that you understand the administration instructions for Ngenla.
• To help you remember when to inject Ngenla, you can mark your calendar in advance. Call your doctor, nurse, or pharmacist if you or your caregiver have any questions about how to properly inject Ngenla.
• Each turn (click) of the dosing button increases the dose by 0.5mg of medication. You can administer doses of 0.5mg to 30mg in a single injection. If your dose is greater than 30mg, you will need to administer more than one injection.
• You may see a small amount of medication remaining in the syringe after all doses have been administered correctly. This is normal. Patients should not attempt to use the remaining solution, but rather dispose of the syringe properly.
• Do notshare your syringe with others, even if the needle has been changed. You can transmit a serious infection to others or contract a serious infection from them.
• Always use a new sterile needle for each injection. This will reduce the risk of contamination, infection, medication loss, and blocked needles that can lead to an incorrect dose.
• Do not shake the syringe. Shaking the syringe can damage the medication.
• Do notrecommend the use of the syringe by people who are blind or have visual impairment without the help of a trained person.

Materials you will need each time you inject

Included in the pack:

• 1Ngenla 60 mg pre-filled syringe.

Not included in the pack:

• 1new sterile needle for each injection.
• Alcohol wipes.
• Cotton balls or gauze pads.
• Adhesive bandage.
• A suitable sharps container for disposing of the syringe and needles.

Ngenla 60 mg pre-filled syringe:

Needles that can be used

The needles provided with the syringeare notincluded. You can use needles for syringes with a diameter of 4mm to 8mm and a gauge of 30G to 32G.

• The following needles have been demonstrated to be compatible with the Ngenla syringe:
• • 32G (Novo Nordisk®, NovoFine® Plus)
  • 31G (Novo Nordisk®, NovoFine®)
  • 31G (Becton Dickinson and Company, BDUltra-Fine™ or BD Micro-Fine™)
• The following safety needles have been demonstrated to be compatible with the Ngenla syringe:
• • 30G (Becton Dickinson and Company, AutoShield Duo™)
  • 30G (Novo Nordisk®, NovoFine® AutoCover®)
• Consult your doctor, nurse, or pharmacist about the suitable needle for you.

Not included in the pack:

Example of a new sterile needle:

Important:The instructions for use of the needle manufacturer should be consulted.

Precaution:Never use a bent or damaged needle. Always handle the needles with care to ensure that you do not prick yourself (or anyone else) with the needle.

Preparation for injection

Step1 Preparation

• Wash and dry your hands.
• You can use your syringe directly from the refrigerator. To make the injection more comfortable, let your syringe come to room temperature for a maximum of 30minutes.(See section5 “Storage of Ngenla” of the Ngenla pre-filled syringe 60 mg prospectus).
• Check the name, concentration, and label of the syringe to ensure that it is the medication prescribed by your doctor.
• Check the expiration date on the syringe label.Do notuse it if it has expired.
• Do notuse the syringe if:
• • It has been frozen or exposed to heat (above 32°C) or more than 28days have passed since the first use of the syringe.(See section5 “Storage of Ngenla” of the Ngenla pre-filled syringe 60 mg prospectus).
  • It has fallen.
  • It appears to be broken or damaged.

• Do notremove the syringe cap until you are ready to inject.

Step2 Choose and clean the injection site

• Ngenla can be administered in the abdomen (stomach), thighs, buttocks, or upper arms.

• Choose the best injection site, as recommended by your doctor, nurse, or pharmacist.

• If you need more than 1injection to complete your dose, each injection should be administered in a different injection site.
• Do notinject in areas of bone, bruised, red, painful, or hard skin, or areas with scars or skin conditions.
• Clean the injection site with an alcohol wipe.
• Allow the injection site to dry.
• Do nottouch the injection site after cleaning it.

Step3 Check the medication

• Remove the syringe cap and store it for later use.
• Check the medication inside the syringe barrel.
• Ensure that the medication is clear and colourless to pale yellowish.Do notinject the medication if it is cloudy or dark yellow.
• Ensure that the medication is free of flakes or particles.Do notinject the medication if it has flakes or particles.

Note:It is normal to see one or more bubbles in the medication.

Step4 Place the needle

• Take a new needle and remove the protective cover.
• Align the needle with your syringe, keeping them straight.
• Gently push and then screw the needle onto your syringe.

Do notpress too hard.

Note:Be careful not to place the needle at an angle. This can cause the syringe to leak.

Precaution:The needles have sharp points at both ends. Be careful to ensure that you do not prick yourself (or anyone else) with the needle.

Step5 Remove the outer needle protector

• Remove the outer needle protector.
• Ensure that you keep the outer needle protector. You will need it later.

Note:You should see an inner needle cap after removing the outer needle protector. If you do not see this, try placing the needle back on.

Note:If you are using a safety needle, consult the manufacturer's instructions.

Step6 Remove the inner needle cap

• Remove the inner needle cap carefully to show the needle.
• Dispose of the inner needle cap in a sharps container. You will no longer need it.

Note:If you are using a safety needle, consult the manufacturer's instructions.

(“Yes:Go to syringe configuration” has an arrow indicating “Syringe configuration (priming)” and “No” has an arrow indicating “Adjust your prescribed dose”)

Syringe configuration (priming): only for the first use of a new syringe

You must configure each new syringe before using it for the first time

• The syringe configuration is performed before each new syringe is used for the first time.
• The purpose of configuring a new syringe is to remove air bubbles and ensure that you receive the correct dose.

Important:Skip from StepA to StepC if you have already configured the syringe.

Step‑A: Set the button to1.0

• Turn the dosing button to1.0.

Note:If you turn the dosing button too much, you may go back.

Step‑B: Tap the syringe barrel

• Hold the syringe with the needle pointing upwards so that air bubbles can rise.
• Tapthe syringe barrel gently to make the air bubbles rise to the top.

Important:Follow StepB even if you do not see air bubbles.

Step‑C: Press the button and check if there is liquid

• Pressthe injection button until it cannot move further and “0” appears in the dose window.
• Checkif there is liquid at the needle tip. If liquid appears, your syringe is configured.
• Always ensure that a drop of liquid appears before injection. If no liquid has appeared, repeat from StepA to StepC.
• • If no liquid appears after repeating from StepA to StepC five(5)times, place a new needle and try one(1)more time.

Do notuse the syringe if no liquid appears. Contact your doctor, nurse, or pharmacist and use a new syringe.

Adjust your prescribed dose

Step7 Adjust your dose

Example A:

21.5 mg is shown in the dose window

Example B:

30.0 mg is shown in the dose window

• Turn the dosing button to adjust your dose.
• • The dose can be increased or decreased by turning the dosing button in any direction.
  • The dosing button turns 0.5mg each time.
  • Your syringe contains 60mg of medication, but you can only adjust a dose of up to 30mg for a single injection.
  • The dose window shows the dose in mg. SeeexamplesA andB.
• Always check the dose window to ensure that you have adjusted the correct dose.

Important:Do notpress the injection button while adjusting your dose.

What should I do if I cannot adjust the dose I need?

• If your dose is greater than 30mg, you will need more than one injection.
• You can administer doses of 0.5mg to 30mg in a single injection.
• • If you need help dividing your dose correctly, consult your doctor, nurse, or pharmacist.
  • Use a new needle for each injection(see Step4: Place the needle).
  • If you normally need to administer 2injections to complete your dose, ensure that you administer your second dose.

What should I do if there is not enough medication left in my syringe?

• If your syringe contains less than 30mg of medication, the dosing button will stop with the remaining amount of medication shown in the dose window.
• If there is not enough medication left in your syringe to complete your dose, you can:
• • Inject the remaining amount in your syringe and then prepare a new syringe to complete your dose.

Remember to subtract the dose you have already received. For example, if the dose is 21.5mg and you can only adjust the dosing button by 17mg, you must inject an additional 4.5mg with a new syringe.

Inject your dose

Step8 Insert the needle

• Hold the syringe so that you can see the numbers in the dose window.
• Insert the needle directly into the skin.

Step9 Inject your medication

• Continue holding the needle in the same position in your skin.
• Pressthe injection button until it cannot move further and “0” appears in the dose window.

Step10 Count to10

• Continue pressing the injection button while counting to10. Counting to10 will allow the complete dose of medication to be administered.
• After counting to10, release the injection button and remove the syringe from the injection site slowly by pulling the needleoutwards.

Note:You may see a drop of medication at the needle tip. This is normal and does not affect the dose you have just received.

Step11 Place the outer needle protector

• Put the outer needle protector back over the needle carefully.
• Press the outer needle protector until it is secure.

Precaution:Never attempt to put the inner needle cap back on the needle. You can prick yourself with the needle.

Note:If you are using a safety needle, consult the manufacturer's instructions.

Step12 Remove the needle

• Unscrew the needle from the syringe.
• Pull the needle out slowly.

Note:If the needle is still in place, put the outer needle protector back on and try again. Ensure that you apply pressure when unscrewing the needle.

• Dispose of the used needles in a sharps container according to the instructions of your doctor, nurse, or pharmacist and in accordance with local health and safety regulations. Keep the sharps container out of reach of children.Do notre-use the needles.

Step13 Put the syringe cap back on

• Put the syringe cap back on the syringe.
• Do notput the syringe cap back on with a needle still in place.
• If there is still medication left in your syringe, store it in the refrigerator between uses.(See section5 “Storage of Ngenla” of the Ngenla pre-filled syringe 60 mg prospectus).

Step14 After injection

• Press gently on the injection site with a cotton ball or gauze pad and hold it in place for a few seconds.
• Do notrub the injection site. You may experience a slight bleeding. This is normal.
• You can cover the injection site with a small adhesive bandage, if necessary.
• If the syringe is empty or more than 28dayshave passed since the first use, dispose of it, even if it contains unused medication. Dispose of the syringe in the sharps container.

• To help you remember when to dispose of the syringe, you can write the date of the first use on the syringe label and then:

Date of first use ______ / ______ / ______