Package leaflet: Information for the patient

Adtralza 150 mg solution for injection in pre-filled syringe

tralokinumab
Please read this entire leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Adtralza is and what it is used for
What you need to know before using Adtralza
How to use Adtralza
Possible side effects
How to store Adtralza
Contents of the pack and other information

1. What Adtralza is and what it is used for

Adtralza contains the active substance tralokinumab.
Tralokinumab is a monoclonal antibody (a type of protein) that blocks the action of a protein called IL-13. IL-13 plays an important role in causing the symptoms of atopic dermatitis.
Adtralza is used to treat adult and adolescent patients aged 12 years and older with moderate to severe atopic dermatitis, also known as atopic eczema. Adtralza can be used together with topical eczema medications applied to the skin or may be used alone.
The use of Adtralza in atopic dermatitis may improve eczema and reduce associated itching and skin pain.

2. What you need to know before using Adtralza

Do not use Adtralza:

if you are allergic to tralokinumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, or are unsure, ask your doctor, pharmacist, or nurse for advice before using Adtralza.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Adtralza.
Allergic reactions
Very rarely, medicines can cause allergic reactions (hypersensitivity) and severe allergic reactions known as anaphylaxis. While using Adtralza, you should monitor for signs of these reactions (such as breathing difficulties, swelling of the face, mouth, and tongue, fainting, dizziness, mental lightheadedness (due to low blood pressure), hives, itching, and skin rash).
If you notice any signs of an allergic reaction, stop using Adtralza and inform your doctor or seek immediate medical help. These signs are listed at the beginning of section 4.
Intestinal parasitic infection
Adtralza may reduce resistance to infections caused by parasites. Any parasitic infection should be treated before starting treatment with Adtralza. Inform your doctor if you have diarrhoea, gas, stomach upset, fatty stools, or dehydration, which could be signs of a parasitic infection. If you live in an area where such infections are common, or if you travel to such areas, inform your doctor.
Eye problems
Talk to your doctor if you develop new eye problems or worsening of existing ones, including eye pain or changes in vision.
Children
Do not give this medicine to children under 12 years of age, as the safety and benefit of Adtralza have not been established in this population.
Other medicines and Adtralza
Inform your doctor or pharmacist

if you are taking, have recently taken, or might take any other medicines
if you have recently received or are due to receive any vaccination.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before using this medicine. The effects of Adtralza in pregnant women are unknown; therefore, it is preferable to avoid using this medicine during pregnancy unless advised by your doctor.
If applicable, you and your doctor will decide whether to breastfeed or use Adtralza. You should not do both.
Driving and using machines
It is unlikely that Adtralza will affect your ability to drive or operate machinery.
Adtralza contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 150 mg, i.e. essentially ‘sodium-free’.
Adtralza contains polysorbate (E 433)
This medicine contains 0.1 mg of polysorbate 80 in each pre-filled syringe, equivalent to 0.1 mg/ml.
Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Adtralza

Use this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

Each pre-filled syringe contains 150 mg of tralokinumab.

Dose and duration of Adtralza treatment

Your doctor will decide how much Adtralza you should receive and for how long.
The recommended starting dose is 600 mg (four injections of 150 mg), followed by 300 mg (two injections of 150 mg) administered every 2 weeks. Depending on how well the medicine is working, your doctor may decide to administer the dose every 4 weeks.

Adtralza is given by injection under the skin (subcutaneous injection). You and your doctor or nurse must decide whether you can self-inject Adtralza.
Only self-inject Adtralza after being properly trained by your doctor or nurse. Adtralza may also be administered by a caregiver after appropriate training.

Do not shake the syringe.
Before administering Adtralza, read the “Instructions for use”.

If you use more Adtralza than you should
If you use more medicine than you should, or if the dose was administered too soon, contact your doctor, pharmacist, or nurse.

If you forget to use Adtralza
If you forget to administer a dose at the correct time, administer Adtralza as soon as possible. The next dose should be given at the normally scheduled time.

If you stop using Adtralza
Do not stop treatment with Adtralza without first talking to your doctor.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adtralza may cause serious side effects, including allergic reactions (hypersensitivity) such as anaphylaxis, the signs of which may include:

breathing problems
swelling of the face, mouth and tongue
fainting, dizziness, feeling mentally lightheaded (low blood pressure)
hives
itching
skin rash

Stop using Adtralza and contact your doctor or seek immediate medical help if you notice any signs of an allergic reaction.

Other side effects
Very common (may affect more than 1 in 10 people)

upper respiratory tract infections (such as common cold and sore throat)

Common (may affect up to 1 in 10 people)

eye redness and itching
eye infection
reactions at the injection site (such as redness, swelling)

Uncommon (may affect up to 1 in 100 people)

eye inflammation, which may cause eye pain or reduced vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Adtralza

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton after Scad./EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
If necessary, Adtralza can be stored at room temperature up to 30 °C in the original packaging for a maximum of 14 days. Do not store above 30 °C. Discard Adtralza if not used within 14 days of storage at room temperature.
If the carton is permanently removed from the refrigerator, write on the carton the date it was removed and use Adtralza within 14 days. Adtralza must not be returned to the refrigerator during this period.
Do not use this medicine if it appears cloudy, contains particles, or if there is any change in colour.
Do not dispose of medicines via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Adtralza contains

The active substance is tralokinumab.
Each pre-filled syringe contains 150 mg of tralokinumab in 1 mL of injectable solution.
The other components are sodium acetate trihydrate (E 262), acetic acid (E 260), sodium chloride, polysorbate 80 (E 433) and water for injections.

Description of the appearance of Adtralza and contents of the pack
Adtralza is a solution that ranges from clear to opalescent and from colourless to pale yellow, supplied in a glass pre-filled syringe with a needle shield.
Adtralza is available in packs containing 2 pre-filled syringes or in multiple packs containing 4 (2 packs of 2) or 12 (6 packs of 2) pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

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

België/Belgique/Belgien Lietuva
LEO Pharma N.V./S.A LEO Pharma A/S
Tél/Tel: +32 3 740 7868 Tel: +45 44 94 58 88

България Luxembourg/Luxemburg
LEO Pharma A/S LEO Pharma N.V./S.A
Teл.: +45 44 94 58 88 Tél/Tel: +32 3 740 7868

Česká republika Magyarország
LEO Pharma s.r.o. LEO Pharma A/S
Tel: +420 734 575 982 Tel: +45 44 94 58 88

Danmark Malta
LEO Pharma AB LEO Pharma A/S
Tlf: +45 70 22 49 11 Tel: +45 44 94 58 88

Deutschland Nederland
LEO Pharma GmbH LEO Pharma B.V.
Tel: +49 6102 2010 Tel: +31 205104141

Eesti Norge
LEO Pharma A/S LEO Pharma AS
Tel: +45 44 94 58 88 Tlf: +47 22514900

Ελλάδα Österreich
LEO Pharmaceutical Hellas S.A. LEO Pharma GmbH
Τηλ: +30 212 222 5000 Tel: +43 1 503 6979

España Polska
Laboratorios LEO Pharma, S.A. LEO Pharma Sp. z o.o.
Tel: +34 93 221 3366 Tel.: +48 22 244 18 40

France Portugal
Laboratoires LEO LEO Farmacêuticos Lda.
Tél: +33 1 3014 4000 Tel: +351 21 711 0760

Hrvatska România
LEO Pharma A/S LEO Pharma A/S
Tel: +45 44 94 58 88 Tel: +45 44 94 58 88

Ireland Slovenija
LEO Laboratories Ltd LEO Pharma A/S
Tel: +353 (0) 1 490 8924 Tel. +45 44 94 58 88

Ísland Slovenská republika
Vistor hf. LEO Pharma s.r.o.
Sími: +354 535 7000 Tel: +420 734 575 982

Italia Suomi/Finland
LEO Pharma S.p.A LEO Pharma Oy
Tel: +39 06 52625500 Puh/Tel: +358 20 721 8440

Κύπρος Sverige
LEO Pharma AB
The Star Medicines Importers Co. Ltd.
Τηλ: +357 2537 1056 Tel: +46 40 3522 00

Latvija
LEO Pharma A/S
Tel: +45 44 94 58 88

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

Instructions for use, providing information on how to inject Adtralza, are printed on the other side of this leaflet.

Instructions for use:

Adtralza

tralokinumab
Injectable solution in prefilled syringe
Read these instructions before starting to use Adtralza prefilled syringes and each time you receive a new package, as they may contain new information. Consult your doctor regarding your medical condition or treatment.
Keep these instructions for use to refer to them again if necessary.
Each prefilled syringe contains 150 mg of tralokinumab.
Adtralza prefilled syringes are for single use only.

IMPORTANT INFORMATION
Important information you should know before injecting Adtralza

Before injecting Adtralza for the first time, a healthcare professional will show you how to prepare and inject Adtralza using the prefilled syringes.
Do not inject Adtralza until you have been shown how to administer it correctly.
Contact your healthcare professional if you have any questions about how to inject Adtralza correctly.
To receive the full dose, you must administer 2 injections of Adtralza (1 set of injections). It is recommended to use a different injection site for each new set of injections.
Adtralza prefilled syringes are equipped with a needle shield that automatically covers the needle after injection.
Do not remove the needle cap until immediately before performing the injection.
Do not share or reuse Adtralza prefilled syringes.

Parts of the Adtralza prefilled syringe:

Technical drawing of two pre-filled syringes with needles, one with the barrel filled with liquid and the

Before use After use
How to store Adtralza

Keep this medicine out of the sight and reach of children.
Store Adtralza prefilled syringes in a refrigerator at a temperature between 2 °C and 8 °C.
Keep Adtralza prefilled syringes in their original packaging to protect the medicine from light until ready to use.
Do not freeze Adtralza prefilled syringes. Do not use them if they have been frozen.
Adtralza can be stored in its original packaging at room temperature up to 30 °C for a maximum of 14 days. If the box is permanently removed from the refrigerator,
write on the box the date it was removed. Discard the syringes if they have been left outside the refrigerator for more than 14 days.

Step 1: Preparing the Adtralza injection

Schematic drawing of two syringes ready for

1a. Gather the materials needed for the injection
For each dose of Adtralza, you will need:

a flat, clean, well-lit surface, such as a table
the Adtralza box containing 2 Adtralza prefilled syringes
an alcohol swab (not included in the box)
clean cotton balls or gauze pads (not included in the box)
a puncture-resistant sharps disposal container (not included in the box)

Linear drawing of a hand holding a rectangular box with technical text and a black arrow on the top side

1b. Remove the box of Adtralza prefilled syringes from the refrigerator

Check the expiration date (Exp.) on the box. Do not use if the expiration date printed on the box has passed.
Check that the seal on the Adtralza box is intact. Do not use the prefilled syringes if the seal on the box is broken or missing.

Do not use Adtralza prefilled syringes if they have been stored at room temperature for more than 14 days.

Stylized circular icon with black border and internal vertical division between a white half and a gray half on a light background

min
Waiting time
1c. Allow Adtralza prefilled syringes to reach room temperature
Place the Adtralza box on the flat surface and wait 30 minutes before injecting the medicine, allowing the prefilled syringes to reach room temperature (20 ºC–30 ºC). This will make the Adtralza injection more comfortable.

Do not heat the prefilled syringes in any way.
Do not shake the syringes.
Do not remove the needle cap from the prefilled syringes until Step 3, when you are ready to administer the injection.
Do not return the syringes to the refrigerator after they have reached room temperature.

A hand holding a pre-filled syringe above an open box containing two similar medical devices

1d. Remove the Adtralza prefilled syringes from the box
Remove the 2 Adtralza prefilled syringes from the box one at a time, holding them by the barrel (not by the plunger rod).

Do not touch the needle shield clips to avoid premature activation of the safety device (needle shield).
Do not remove the needle cap from the prefilled syringes until Step 3, when you are ready to administer the injection.

Technical drawing of a hand holding an injection pen with markings LOT and EXP, and a second pen labeled Adtralza

1e. Inspect the 2 Adtralza prefilled syringes

Check that the labels show the correct medicine name, Adtralza.
Check the expiration date on the syringes.
Inspect the medicine through the inspection windows. The medicine should be from clear to opalescent, colorless to pale yellow.
Do not use the Adtralza prefilled syringes if:
o the expiration date on the syringes has passed
o the medicine is cloudy, contains particles, or has changed color
o the prefilled syringes appear damaged or have been dropped

If you cannot use the syringes, dispose of them in a puncture-resistant container and use new syringes.

You may notice small air bubbles in the liquid. This is normal. No action is required.

Step 2. Choosing and preparing the injection site

Human body diagram showing gray areas on the arms, a black circle divided into four parts on the abdomen, and two black areas on the thighs

2a. Choose the injection sites

Injections can be administered:
o in the stomach area (abdomen)
o in the thighs
o in the upper arm. Injections in the upper arm must be administered by a caregiver.
Do not inject in areas where the skin is tender, bruised, flaky, scarred, hardened, or affected by eczema.
Do not inject within 5 cm of the navel.

A hand gripping a small white rectangular object above a light curved surface with the number 6 on the right

2b. Wash hands thoroughly and prepare the skin

Wash your hands with soap and water.
Clean the injection sites for both injections using an alcohol swab with a circular motion.
o Allow the area to dry completely.
o Do not blow on or touch the cleaned area before administering the injection.

Step 3. Injecting Adtralza

Two hands moving a syringe with needle toward a rectangular container indicated by a black arrow pointing to the left

3a. Remove the Adtralza needle cap
Hold the barrel of the Adtralza prefilled syringe in one hand and use the other hand to remove the needle cap. Dispose of the cap in the puncture-resistant container.

Do not attempt to recap the Adtralza prefilled syringes.
Do not hold the plunger rod or plunger head while removing the needle cap.
You may see a drop of liquid at the tip of the needle. This is normal.
Do not touch the needle or let it come into contact with any surface.

Technical drawing showing a hand holding a medical device at a 45 or 90 degree angle relative to the skin of the arm

3b. Insert the needle
With one hand, gently pinch and lift a fold of skin at the cleaned injection site. With the other hand, insert the needle fully into the skin at an angle of 45–90 degrees.

Black and white drawing showing a hand pressing a medical device against the skin of the arm with a black arrow pointing downward

3c. Inject the medicine
Use your thumb to firmly push the plunger head all the way down. The medicine will be fully injected when the plunger head can no longer be pushed.

Technical drawing of hands holding a spring-loaded medical device with a black arrow indicating a pulling motion toward the

3d. Release and remove
Remove your thumb from the plunger head. The needle will automatically retract into the syringe body and lock in place.

Press a cotton ball or gauze pad over the injection site for a few seconds. Do not rub the injection site. If needed, cover the injection site with a small bandage.
You may see a small amount of blood or liquid at the injection site. This is normal. Dispose of the used Adtralza prefilled syringe in a puncture-resistant container. See Step 5 “Disposal of Adtralza”.

Step 4. Injection with the second syringe

Stylized black icon on a light gray background depicting a curved arrow rotating clockwise forming a complete circle

repeat
To receive the full prescribed dose, a second injection must be administered.
Take a new Adtralza prefilled syringe and repeat Steps 3 and 5.
Note
Ensure that the second injection is administered in the same body area but at least 3 cm away from the first injection.

Step 5. Disposal of Adtralza

A hand holds a spring-loaded medical device above a sharps disposal container with small components scattered around

Immediately after use, place used Adtralza prefilled syringes into a puncture-resistant sharps disposal container.
o Do not dispose of Adtralza prefilled syringes in household waste.
If you do not have a puncture-resistant container, you may use a household container that:
o is made of heavy-duty plastic,
o can be closed with a tight-fitting, puncture-resistant lid that prevents leakage of sharp objects,
o remains upright and stable during use,
o is leak-proof, and
o is properly labeled to warn that the contents are hazardous waste.
When the puncture-resistant container is nearly full, follow local guidelines for proper disposal.
Do not recycle the used sharps container.

Package leaflet: information for the patient

Adtralza 300 mg solution for injection in pre-filled pen

tralokinumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Adtralza is and what it is used for
What you need to know before using Adtralza
How to use Adtralza
Possible side effects
How to store Adtralza
Contents of the pack and other information

1. What Adtralza is and what it is used for

Adtralza contains the active substance tralokinumab.
Tralokinumab is a monoclonal antibody (a type of protein) that blocks the action of a protein called IL-13. IL-13 plays an important role in causing the symptoms of atopic dermatitis.
Adtralza is used to treat adult and adolescent patients aged 12 years and older with moderate to severe atopic dermatitis, also known as atopic eczema. Adtralza can be used together with topical eczema treatments applied to the skin, or it can be used alone.
The use of Adtralza for atopic dermatitis may improve eczema and reduce associated itching and skin pain.

2. What you need to know before using Adtralza

Do not use Adtralza:

if you are allergic to tralokinumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, or are unsure, ask your doctor, pharmacist, or nurse for advice before using Adtralza.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Adtralza.
Allergic reactions
Very rarely, medicines can cause allergic reactions (hypersensitivity) and severe allergic reactions known as anaphylaxis. While using Adtralza, monitor for signs of these reactions (such as breathing difficulties, swelling of the face, mouth, and tongue, fainting, dizziness, mental lightheadedness (due to low blood pressure), hives, itching, and skin rash).
If you notice any signs of an allergic reaction, stop using Adtralza and inform your doctor or seek immediate medical help. These signs are listed at the beginning of section 4.
Intestinal parasitic infection
Adtralza may reduce resistance to infections caused by parasites. Any parasitic infection should be treated before starting treatment with Adtralza. Inform your doctor if you have diarrhoea, gas, stomach upset, fatty stools, or dehydration, which may be signs of a parasitic infection. If you live in an area where such infections are common, or if you travel to such areas, inform your doctor.
Eye problems
Talk to your doctor if you develop new eye problems or worsening of existing ones, including eye pain or changes in vision.
Children
Do not give this medicine to children under 12 years of age, as the safety and benefit of Adtralza have not yet been established in this population.
Other medicines and Adtralza
Inform your doctor or pharmacist

if you are currently using, have recently used, or might use any other medicines
if you have recently received or are due to receive a vaccination.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine. The effects of Adtralza in pregnant women are unknown; therefore, it is preferable to avoid using this medicine during pregnancy unless advised by your doctor.
If applicable, you and your doctor will decide whether to breastfeed or use Adtralza. You must not do both.
Driving and using machines
It is unlikely that Adtralza will impair your ability to drive or operate machinery.
Adtralza contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 300 mg, i.e. essentially 'sodium-free'.
Adtralza contains polysorbate (E 433)
This medicine contains 0.1 mg of polysorbate 80 in each pre-filled syringe, equivalent to 0.1 mg/ml.
Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Adtralza

Use this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Each pre-filled pen contains 300 mg of tralokinumab.

Dose and duration of Adtralza treatment

Your doctor will decide how much Adtralza you should receive and for how long.
The recommended starting dose is 600 mg (two injections of 300 mg), followed by 300 mg (one injection of 300 mg) administered every 2 weeks. Depending on how well the medicine is working, your doctor may decide to administer the dose every 4 weeks.

Adtralza is given by injection under the skin (subcutaneous injection). You and your doctor or nurse must decide whether you can self-inject Adtralza.
Only self-inject Adtralza after you have been trained by your doctor or nurse. Adtralza may also be administered by a caregiver, after appropriate training.
Do not shake the pen.
Before administering Adtralza, read the “Instructions for Use”.

If you use more Adtralza than you should
If you use more medicine than you should, or if the dose is administered too soon, contact your doctor, pharmacist, or nurse.

If you forget to use Adtralza
If you forget to administer a dose at the correct time, administer Adtralza as soon as possible. The next dose should be given at the normally scheduled time.

If you stop using Adtralza
Do not stop treatment with Adtralza without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Adtralza may cause serious side effects, including allergic reactions (hypersensitivity) such as anaphylaxis, the signs of which may include:

breathing problems
swelling of the face, mouth, and tongue
fainting, dizziness, mental confusion (low blood pressure)
hives
itching
skin rash

Stop using Adtralza and contact your doctor or seek immediate medical help if you notice any sign of an allergic reaction.

Other side effects
Very common (may affect more than 1 in 10 people)

upper respiratory tract infections (such as common cold and sore throat)

Common (may affect up to 1 in 10 people)

eye redness and itching
eye infection
injection site reactions (such as redness, swelling)

Uncommon (may affect up to 1 in 100 people)

eye inflammation, which may cause eye pain or reduced vision

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Adtralza

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after Scad./EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Store in the refrigerator (2 °C – 8 °C). Do not freeze.
If necessary, Adtralza may be stored at room temperature up to 30 °C in the original packaging for a maximum of 14 days. Do not store above 30 °C. Discard Adtralza if not used within 14 days of storage at room temperature.
If the carton is permanently removed from the refrigerator, note the date of removal directly on the carton and use Adtralza within 14 days. During this period, Adtralza must not be returned to the refrigerator.
Do not use this medicine if it appears cloudy, contains particles, or if the colour has changed.
Do not dispose of any medicine via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Adtralza contains

The active substance is tralokinumab.
Each pre-filled pen contains 300 mg of tralokinumab in 2 mL of injectable solution.
The other components are sodium acetate trihydrate (E 262), acetic acid (E 260), sodium chloride, polysorbate 80 (E 433), and water for injections.

Description of the appearance of Adtralza and contents of the pack
Adtralza is a solution that ranges from clear to opalescent and from colourless to pale yellow, supplied in a pre-filled pen.
Adtralza is available in packs containing 2 pre-filled pens or in multiple packs containing 6 (3 packs of 2) pre-filled pens.
Not all pack sizes may be marketed.