Rozlytrek 100 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rozlytrek 100 mg hard capsules

Rozlytrek 200 mg hard capsules

entrectinib

This medicine is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4. Please read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. See section 4.
• This leaflet has been written as if the person taking the medicine is reading it.

If you are giving this medicine to your child, replace "you" with "your child" throughout.

Contents of the leaflet

1. What Rozlytrek is and what it is used for
2. What you need to know before taking Rozlytrek
3. How to take Rozlytrek
4. Possible side effects
5. How to store Rozlytrek
6. Contents of the pack and other information
7. Instructions for use

1. What Rozlytrek is and what it is used for

What Rozlytrek is

Rozlytrek is an anticancer medicine that contains the active substance entrectinib.

What Rozlytrek is used for

Rozlytrek is used to treat:

• adolescents and adults, and children over 1 month of age, who have solid tumours (cancer) in various parts of the body caused by a change in a gene called neurotrophic tyrosine receptor kinase (NTRK)
• adults who have a type of lung cancer called “non-small cell lung cancer” (NSCLC), caused by a change in the ROS1 gene.

This medicine is used for solid tumours when:

• a test has shown that your cancer cells have a change in genes called "NTRK" (see "How Rozlytrek works" below), and
• your cancer has spread within the affected organ or to other parts of your body, or if surgery to remove the cancer is likely to cause serious complications, and
• you have not previously been treated with medicines called 'NTRK inhibitors'
• other treatments have not worked or are not suitable for you.

This medicine is used for non-small cell lung cancer (NSCLC) when:

• it is 'ROS1-positive', meaning that your cancer cells have a change in a gene called 'ROS1' (see "How Rozlytrek works" below),
• it is advanced – for example, it has spread to other parts of your body (i.e., it is metastatic), and
• you have not previously received treatment with medicines called 'ROS1 inhibitors'.

How Rozlytrek works

Rozlytrek works by blocking the action of certain defective proteins. These defective proteins are caused by a change in the genes that produce them, called NTRK or ROS1. These defective proteins stimulate the growth of cancer cells.

Rozlytrek may slow down or stop the growth of cancer. It may also help shrink it.

2. What you need to know before starting Rozlytrek

Do not take Rozlytrek:

• if you are allergic to entrectinib or to any of the other ingredients of this medicine (listed in section 6).

If you are unsure, consult your doctor, pharmacist, or nurse before taking Rozlytrek.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Rozlytrek if:

• you have recently experienced memory loss, confusion, hallucinations, or changes in mental status
• you have had bone fractures or conditions that may increase your risk of bone fractures, known as 'osteoporosis' or 'osteopenia'
• you are taking medication to lower uric acid levels in the blood
• you have heart failure (when your heart has difficulty pumping blood to supply oxygen to the rest of the body) – signs may include cough, difficulty breathing, and swelling in the arms and legs
• you have ever had heart problems or an electrical conduction disorder of the heart called 'prolonged QTc interval' – this may be seen on an electrocardiogram (ECG) or due to low levels of electrolytes in the blood
• you have a hereditary condition called "galactose intolerance", "congenital lactase deficiency", or "glucose-galactose malabsorption"

If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking Rozlytrek.

Other medicines and Rozlytrek

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Rozlytrek may affect how other medicines work. Likewise, other medicines may affect how Rozlytrek works.

In particular, consult your doctor or pharmacist if you are taking any of the following medicines:

• fungal infections (antifungals) – such as ketoconazole, itraconazole, voriconazole, posaconazole
• HIV/AIDS infection – such as ritonavir or saquinavir
• depression – such as paroxetine, fluvoxamine, or the herbal remedy for depression – St. John's wort
• seizures or fits – such as phenytoin, carbamazepine, or phenobarbital
• tuberculosis – such as rifampicin, rifabutin
• solid tumors and blood cancers – topotecan, lapatinib, mitoxantrone, apalutamide, or methotrexate
• joint inflammation or autoimmune joint diseases (rheumatoid arthritis) – methotrexate
• migraines – ergotamine
• severe pain – fentanyl
• mental illness (psychosis) or Tourette syndrome – pimozide
• irregular heartbeat – quinidine
• prevention of blood clots – warfarin or dabigatran etexilate
• gastric reflux (heartburn) – cisapride or omeprazole
• lowering cholesterol in the blood – atorvastatin, pravastatin, or rosuvastatin
• suppressing your immune system or preventing rejection of a transplanted organ – sirolimus, tacrolimus, or ciclosporin
• lowering blood sugar levels – repaglinide or tolbutamide
• high blood pressure – bosentan, felodipine, nifedipine, or verapamil
• inflammation or nausea – dexamethasone

If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking Rozlytrek.

Taking Rozlytrek with food or drinks

Do not drink grapefruit juice or eat grapefruit or bitter oranges during treatment with this medicine. This may increase the amount of medicine in your blood to harmful levels.

Pregnancy, breastfeeding, and fertility

Women and contraception

You must avoid becoming pregnant while taking this medicine, as it could harm the unborn baby. If you are able to become pregnant, you must use a highly effective method of contraception:

• during treatment, and
• for at least 5 weeks after stopping treatment.

It is not known whether Rozlytrek may reduce the effectiveness of birth control medicines (contraceptive pills or implanted hormonal contraceptives). You should use another reliable method of contraception such as a barrier method (e.g., condom).

Consult your doctor about suitable contraceptive methods for you and your partner.

Men and contraception

Your partner must avoid becoming pregnant while you are taking this medicine, as it could harm the unborn baby. If your partner is able to become pregnant, you must use a highly effective method of contraception:

• during treatment, and
• for at least 3 months after stopping treatment.

Consult your doctor about suitable contraceptive methods for you and your partner.

Pregnancy

• Do not take Rozlytrek if you are pregnant, as it could harm the unborn baby.
• If you become pregnant while taking this medicine or within 5 weeks after your last dose, inform your doctor immediately.

Breastfeeding

You must not breastfeed while taking this medicine. It is unknown whether Rozlytrek passes into breast milk and could therefore harm your baby.

Driving and using machines

Rozlytrek may affect your ability to drive, ride a bicycle, or operate machinery. The following side effects may occur while taking Rozlytrek:

• blurred vision
• feeling tired, dizzy, or faint
• changes in mental status, confusion, or seeing things that are not there (hallucinations)

If this happens, do not drive, ride a bicycle, or operate heavy machinery until you feel better. Ask your doctor or pharmacist whether you can drive, ride a bicycle, or use machines.

Rozlytrek contains:

• lactose – a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
• orange-yellow FCF (E-110) only in 200mg hard capsules. This is a colouring agent that may cause allergic-type reactions.

3. How to take Rozlytrek

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

Adults

• The recommended dose is 3 capsules of 200 mg once daily (this corresponds to a total daily dose of 600 mg).
• If you do not feel well, your doctor may reduce your dose, temporarily interrupt your treatment, or completely discontinue therapy.

Adolescents and children over 1 month of age:

• Your doctor will calculate the correct dose based on the child's height and weight.
• Your doctor will review the dose and adjust it as necessary.

Rozlytrek is also available as film-coated granules in sachets for patients who cannot swallow capsules but can consume soft foods.

How to take it

Rozlytrek can be taken with or without food.

There are two ways your doctor may instruct you to take Rozlytrek capsules:

• Swallow each capsule whole. Do not crush or chew the capsules.
• Take it prepared as an oral suspension (using a syringe) or, if necessary, through a feeding tube.

Read the 'Instructions for Use' at the end of the leaflet.

Carefully read and follow the 'Instructions for Use' at the end of this leaflet on how to take and administer Rozlytrek. Detailed information is provided on how to prepare, measure, take, or administer Rozlytrek when prepared as an oral suspension:

• by mouth, or
• through a feeding tube (such as a gastric or nasogastric tube).

If you vomit after taking Rozlytrek

Capsules

If you vomit immediately after taking a dose of Rozlytrek, take another dose.

Capsules administered as oral suspension

If you experience vomiting or total or partial regurgitation immediately after taking the dose, consult your doctor or pharmacist regarding the next steps.

If you take more Rozlytrek than you should

If you take more Rozlytrek than you should, inform a doctor immediately or go to the hospital. Take the medicine packaging and this leaflet with you.

If you forget to take Rozlytrek

• If there are more than 12 hours until your next scheduled dose, take the missed dose as soon as you remember.
• If there are less than 12 hours until your next scheduled dose, do not take the missed dose. Take your next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Rozlytrek

Do not stop treatment with this medicine without first consulting your doctor. It is important that you take this medicine every day for the duration prescribed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine.

Serious adverse effects

Inform your doctor immediately if you experience any of the following serious adverse effects. Your doctor may reduce your dose, interrupt your treatment for a short period of time, or completely stop the treatment if:

• you have cough, difficulty breathing, or swelling in the arms or legs (fluid retention) – these may be signs of heart problems (congestive heart failure)
• you feel confused, have mood changes, memory problems, or see things that are not there (hallucinations)
• you feel dizzy or lightheaded, or feel that your heart is beating irregularly and rapidly – this may be a symptom of abnormal heart rhythm
• you notice any joint pain, bone pain, deformities, or changes in your ability to move, as these may be signs of fractures
• you have kidney problems or arthritis – you may have high levels of uric acid in the blood

Inform your doctor immediately if you notice any of the above adverse effects.

Other adverse effects
Inform your doctor, pharmacist, or nurse if you experience any of the following adverse effects:

Very common: may affect more than 1 in 10 people:

• tiredness
• altered taste
• feeling unsteady or dizziness
• blurred vision
• swelling
• diarrhoea or constipation
• feeling or being unwell
• difficulty swallowing
• abnormal sense of touch, numbness, itching, tingling, or burning sensation
• skin rash
• difficulty breathing
• cough or fever
• headache
• weight gain
• vomiting
• muscle pain or weakness
• pain, including back, neck, musculoskeletal, or limb pain
• stomach pain
• joint pain
• unpleasant abnormal sensation in arms or legs
• loss of muscle control, unsteadiness when walking
• changes in normal sleep patterns
• lung infection
• urinary tract infection
• inability to empty the bladder completely
• loss of appetite
• low blood pressure
• decrease in the number of a type of white blood cells called neutrophils
• decrease in the number of red blood cells (anaemia)
• increased levels of certain liver enzymes (AST/ALT) in blood
• increased levels of creatinine in blood (a substance normally removed in urine by the kidneys)

Common: may affect up to 1 in 10 people:

• mood alterations
• dehydration
• fluid in the lungs
• fainting
• skin sensitivity to sunlight

Uncommon: may affect less than 1 in 100 people:

• changes in certain chemical components in your blood due to rapid breakdown of tumour cells – this may cause organ damage, including to the kidneys, heart, and liver
• inflammation of the heart muscle

Inform your doctor, pharmacist, or nurse if you experience any of the above adverse effects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V.* By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rozlytrek

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and bottle after EXP. The expiry date refers to the last day of the month indicated.
• Store the capsules in the original packaging and keep the bottle tightly closed to protect from moisture.
• After preparing the oral suspension, store at a temperature below 30 °C and use within 2 hours of preparation.
• Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rozlytrek

The active substance is entrectinib.

Rozlytrek 100 mg: each capsule contains 100 mg of entrectinib.
Rozlytrek 200 mg: each capsule contains 200 mg of entrectinib.

The other components are:

• Capsule contents: tartaric acid (E334), lactose (see section 2 “Rozlytrek contains lactose”), hypromellose (E464), crospovidone (E1202), microcrystalline cellulose (E460), anhydrous colloidal silica (E551), magnesium stearate (E470b).
• Capsule coating: hypromellose (E464), titanium dioxide (E171), iron oxide yellow (E172; for Rozlytrek 100 mg capsule), orange yellow FCF (E110; for Rozlytrek 200 mg capsule. See section 2 “Rozlytrek contains orange yellow FCF (E110)”).
• Printing ink: shellac, propylene glycol, aluminium indigo carmine lake (E132).

Appearance of Rozlytrek and contents of the pack
Rozlytrek 100 mg: opaque yellow hard capsules printed with "ENT 100" in blue ink on the body.

Rozlytrek 200 mg: opaque orange hard capsules printed with "ENT 200" in blue ink on the body.

The capsules are supplied in bottles containing:

• 30 hard capsules of Rozlytrek 100 mg, or
• 90 hard capsules of Rozlytrek 200 mg.

Marketing Authorization Holder

Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Manufacturer

Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

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

Denmark Roche Pharmaceuticals A/S  Tel: +45 - 36 39 99 99	Netherlands Roche Nederland B.V. Tel: +31 (0) 348 438050
Germany Roche Pharma AG Tel: +49 (0) 7624 140	Norway Roche Norge AS Tel: +47 - 22 78 90 00
Estonia Roche Eesti OÜ Tel: + 372 - 6 177 380	Austria Roche Austria GmbH Tel: +43 (0) 1 27739
Greece Roche (Hellas) A.E. Tel: +30 210 61 66 100	Poland Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 88
Spain Roche Farma S.A. Tel: +34 - 91 324 81 00	Portugal Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00
France Roche Tel: +33 (0) 1 47 61 40 00	Romania Roche România S.R.L. Tel: +40 21 206 47 01
Croatia Roche d.o.o. Tel: +385 1 4722 333 Ireland Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700	Slovenia Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00
Iceland Roche Pharmaceuticals A/S c/o Icepharma hf Tel: +354 540 8000	Slovakia Roche Slovensko, s.r.o. Tel: +421 - 2 52638201
Italy Roche S.p.A. Tel: +39 - 039 2471	Finland Roche Oy Puh/Tel: +358 (0) 10 554 500
Sweden Roche AB Tel: +46 (0) 8 726 1200

Date of the most recent review of this leaflet

This medicinal product has been authorised under a "conditional approval". This type of approval means that further information on this medicinal product is expected.

The European Medicines Agency will review new information on this medicinal product at least once a year, and this leaflet will be updated as necessary.

Other sources of information

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

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7. Instructions for use

Rozlytrek

(entrectinib)

Capsules for oral use

(administered as whole capsules or as an oral suspension)

These instructions for use contain information on how to prepare, take, and administer Rozlytrek capsules.

Rozlytrek capsules may be swallowed whole or prepared as an oral suspension and taken or administered orally or via a gastric or nasogastric tube.

Before you begin

• Read these Instructions for Use before taking or administering Rozlytrek capsules.

• Ask your doctor to show you how to use Rozlytrek before starting treatment.

• If you have any questions about how to use Rozlytrek, ask your doctor.

Important information you need to know before preparing, taking, or administering Rozlytrek

• Your doctor should teach you how to properly prepare and take or administer a dose of Rozlytrek capsules. Follow exactly the administration instructions for Rozlytrek provided by your doctor.

• Do not take or administer Rozlytrek to another person unless you have been shown how to properly prepare and take or administer Rozlytrek.

• Wash your hands before and after using Rozlytrek. Do not touch your eyes, nose, or mouth during the preparation of the oral suspension.

• Check the expiry date and for any signs of damage to the product before use. Do not use if it has expired or is damaged.

• For whole capsules, if you vomit immediately after taking a dose of Rozlytrek, take another dose.

• For capsules administered as oral suspension, if you vomit or experience partial or complete regurgitation immediately after administration of a dose, consult your doctor or pharmacist for further instructions.

• The oral suspension must be administered within 2 hours of preparation.

Administration of Rozlytrek capsules orally

Your doctor will determine the correct daily dose of Rozlytrek for you or your child.

• Swallow the capsules whole, with or without food, with a glass of water, as directed by your doctor.
• Do not crush or chew the capsules.

Administration of Rozlytrek as a liquid suspension – orally or via a gastric/nasogastric tube

If you or your child cannot swallow the capsules whole, Rozlytrek capsules can be prepared as a suspension (in water or milk) and administered orally or via a feeding tube.

Your doctor will inform you of the number of capsules to use, the exact volume of liquid (water or milk) to mix with the contents of the required capsule(s) to prepare the suspension, and the exact volume (ml) of suspension to withdraw to achieve the prescribed dose of Rozlytrek to be taken or administered.

Table 1 shows the prescribed dose, the number and strength of capsules required, the volume of water or milk to mix with the capsule contents to prepare the suspension, and the volume of suspension to withdraw to achieve the prescribed dose to be taken or administered.

You may need to measure a volume of suspension smaller than the total volume prepared in order to take or administer the correct prescribed dose of Rozlytrek.

Table 1. Preparation of Rozlytrek capsules as a suspension
Prescribed Rozlytrek dose to administer	Number of 100 mg or 200 mg capsules required	Amount of water or milk to be mixed with the capsule(s) content for suspension preparation	Volume of suspension to be withdrawn to achieve the prescribed dose
20 mg	One 100 mg capsule	5 ml	1 ml
30 mg	One 100 mg capsule	5 ml	1.5 ml
40 mg	One 100 mg capsule	5 ml	2 ml
50 mg	One 100 mg capsule	5 ml	2.5 ml
60 mg	One 100 mg capsule	5 ml	3 ml
70 mg	One 100 mg capsule	5 ml	3.5 ml
80 mg	One 100 mg capsule	5 ml	4 ml
90 mg	One 100 mg capsule	5 ml	4.5 ml
100 mg	One 100 mg capsule	5 ml	5 ml
110 mg	One 200 mg capsule	10 ml	5.5 ml
120 mg	One 200 mg capsule	10 ml	6 ml
130 mg	One 200 mg capsule	10 ml	6.5 ml
140 mg	One 200 mg capsule	10 ml	7 ml
150 mg	One 200 mg capsule	10 ml	7.5 ml
200 mg	One 200 mg capsule	10 ml	10 ml
300 mg	Three 100 mg capsules	15 ml	15 ml
400 mg	Two 200 mg capsules	20 ml	20 ml
600 mg	Three 200 mg capsules	30 ml	30 ml

To prepare the suspension, you will need:

• The number of capsules indicated by your doctor
• A clean, empty glass (not included in the package)
• A glass of drinking water or milk at room temperature (below 30°C)
• An oral syringe (provided by your pharmacist) graduated in 0.5 ml increments
• A paper towel

Preparation of Rozlytrek suspension

Step 1. Wash your hands.
Step 2. Count the number of capsules indicated by your doctor to prepare the suspension.
Step 3. Place a clean, empty glass on a paper towel.	Figure A
Step 4. Gently tap the capsule to loosen the contents inside.
Step 5. Hold the capsule over the clean, empty glass to avoid spills.
Step 6. Open the capsule by gently pressing on it and carefully twisting both ends apart. Pour the contents into the clean glass (Figure A).
Step 7. Gently tap both sides of the capsule and check that all the contents have fallen into the glass. If the capsule contents spill outside the glass, discard the contents in the glass and use another capsule. Go to Step C1 for cleaning instructions and restart at Step 1.
Step 8. Push the syringe plunger fully to remove air from the syringe (Figure B).	Figure B
Step 9. Take a glass of water or milk at room temperature (below 30°C). Using the syringe, draw up the exact volume of drinking water or milk* at room temperature from the glass (Figure C). *Your doctor will tell you the amount of liquid to use. Do not use any other type of liquid.	Figure C
Step 10. Add the drinking water or milk from the syringe to the glass containing the capsule contents (Figure D).	Figure D
Step 11. Let the suspension stand for 15 minutes (Figure E). Note: This step is important to achieve a uniform suspension; otherwise, you may not receive the correct dose.	Figure E
Step 12. Stir the suspension several times to mix the medication evenly with the liquid (Figure F). Note: The suspension may appear cloudy if water was used.	Figure F
Step 13. Push the syringe plunger fully to remove air from the syringe (Figure G).	Figure G
Step 14. Swirl the glass again before placing the syringe into the glass (Figure H).	Figure H
Step 15. Immediately place the syringe into the glass and slowly pull back the plunger to draw up the exact amount of suspension needed to achieve the prescribed dose of Rozlytrek (Figure I). Your doctor will tell you how much suspension to draw up for the prescribed dose. Do not delay drawing up the suspension. If left standing too long, the medication may settle at the bottom, and you may not receive the correct dose.	Figure I
Step 16. Check the amount in the syringe (Figure J). With the tip of the syringe pointing upward, verify that: the correct volume of suspension has been drawn up there are no large air bubbles Note: If the correct volume has not been drawn or if there are large air bubbles: reinsert the syringe into the glass expel the medication back into the glass then withdraw the medication again (return to Step 15) Shake the syringe gently. Administer Rozlytrek immediately after drawing it into the syringe. If not taken within 2 hours, discard the medication in the syringe. Go to Step C1 for cleaning instructions and restart with Step 2 to prepare a new dose.	Figure J

Oral administration

Step A1. Position the patient lying flat on their back when administering an oral dose of Rozlytrek (Figure K). Place the syringe into the mouth, with the tip along one of the cheeks. Slowly push the plunger all the way down. Note: If Rozlytrek is administered too quickly, choking may occur.	Figure K
Step A2. Check that no medication remains in the syringe (Figure L). If any suspension remains in the syringe, repeat Step A1.	Figure L
Step A3. Drink a small amount of water immediately after administering the prescribed dose of Rozlytrek. If an unpleasant taste occurs, breastfeeding or giving milk to the child may help.

Administration via gastric or nasogastric tube

You may take or administer the suspension through a nasogastric or gastric tube placed by a healthcare professional. Check the manufacturer's instructions for the size and dimensions of the enteral tube. Ensure the tube size is at least 8 French or larger to prevent tube blockage when administering aliquots (amounts of suspension) of 3 ml or more. To take or administer Rozlytrek at doses of 3 ml or more, divide the dose and administer it in at least 2 parts. Flush the tube with the same volume of water or milk after administering each part. Neonates and children with fluid restrictions may require minimal flush volumes of 1 to 3 ml when administering Rozlytrek. Aliquots should be adjusted accordingly. To take or administer doses of 30 ml of Rozlytrek, divide the dose into at least 3 parts of 10 ml each. Flush the tube with the same volume of water or milk after administering each part. The tube should be flushed with water or milk after administering Rozlytrek. If you have any questions, consult your doctor.
Step B1 Place the tip of the syringe into the nasogastric/gastric tube. Slowly push the plunger fully down to administer the complete dose of Rozlytrek (Figure M1 and M2).	Figure M1	Figure M2
Step B2 Check that no medication remains in the syringe (Figure N).	Figure N
Step B3 Flush the nasogastric/gastric tube with water or milk* immediately after administering the prescribed dose (Figures O1 and O2). *Your doctor will advise you on the amount of water or milk to use for flushing.	Figure O1	Figure O2
Step C1 Wash your hands and all materials used to administer Rozlytrek. Remove the syringe plunger from the syringe barrel. Use only clean water to wash the syringe parts and the glass used to prepare the suspension. Allow all materials to dry before next use. Reinsert the syringe plunger into the syringe barrel once dry. Any unused medicine or materials that have come into contact with it, including leftover (unadministered) suspension, must be disposed of according to local regulations. Leftover (unadministered) suspension must not be disposed of via wastewater. Ask your pharmacist how to properly dispose of medicines you no longer need. Following these steps will help protect the environment.

Storage of Rozlytrek

• Store below 30 °C in the original container and keep the bottle tightly closed to protect it from moisture.
• Discard Rozlytrek if exposed to temperatures above 30 °C, and follow the disposal instructions indicated in step C1 and in section 5 of the package leaflet.
• After preparation of the oral suspension, store below 30 °C and use within 2 hours of preparation.
• Always keep Rozlytrek out of the sight and reach of children.