INFLECTRA 100 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Inflectra100mg powder for concentrate for solution for infusion

infliximab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• Your doctor will give you a patient information card, which contains important safety information that you need to know before and during your treatment with Inflectra.
• When you start a new card, keep this card as a reference for 4 months after your last dose of Inflectra.

• If you have any further questions, ask your doctor.

• This medicine has been prescribed for you only, do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Inflectra and what is it used for
2. What you need to know before you use Inflectra
3. How Inflectra will be given to you
4. Possible side effects
5. Storing Inflectra
6. Contents of the pack and other information

1. What is Inflectra and what is it used for

Inflectra contains the active substance infliximab, which is of human and mouse origin. Infliximab is a monoclonal antibody, a type of protein that binds to a specific target in the body called TNF (tumor necrosis factor) alpha.

Inflectra belongs to a group of medicines called ‘TNF blockers’. It is used in adults for the following inflammatory diseases:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis (Bechterew's disease)
• Psoriasis.

Inflectra is also used in adults and children from 6 years of age for:

• Crohn's disease
• Ulcerative colitis.

Inflectra works by selectively binding to TNF alpha (tumor necrosis factor alpha) and blocking its action. TNF alpha is involved in the inflammatory process of the body and its blockade can reduce inflammation in your body.

Rheumatoid Arthritis

Rheumatoid arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis, you will first be given other medicines. If these medicines do not work well enough, you will be given Inflectra in combination with another medicine called methotrexate to:

• reduce the signs and symptoms of your disease,
• slow down the damage to your joints,
• improve your physical function.

Psoriatic Arthritis

Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medicines. If these medicines do not work well enough, you will be given Inflectra to:

• reduce the signs and symptoms of your disease,
• reduce the damage to your joints,
• improve your physical function.

Ankylosing Spondylitis (Bechterew's Disease)

Ankylosing spondylitis is an inflammatory disease of the spine. If you have ankylosing spondylitis, you will first be given other medicines. If these medicines do not work well enough, you will be given Inflectra to:

• reduce the signs and symptoms of your disease,
• improve your physical function.

Psoriasis

Psoriasis is an inflammatory disease of the skin. If you have moderate to severe plaque psoriasis, you will first be given other medicines or other treatments such as phototherapy. If these medicines or treatments do not work well enough, you will be given Inflectra to reduce the signs and symptoms of your disease.

Ulcerative Colitis

Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will first be given other medicines. If these medicines do not work well enough, you will be given Inflectra to treat your disease.

Crohn's Disease

Crohn's disease is an inflammatory disease of the intestine. If you have Crohn's disease, you will first be given other medicines. If these medicines do not work well enough, you will be given Inflectra to:

• treat active Crohn's disease,
• reduce the number of abnormal channels (fistulas) between your intestine and your skin, that have not been controlled by other medicines or surgery.

2. What you need to know before you start using Inflectra

Inflectra must not be given to you if:

• you are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6),

• you are allergic (hypersensitive) to proteins that come from mice,
• you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (serious bacterial infection of the blood),
• you have moderate or severe heart failure.

If any of the above applies to you, do not use Inflectra. If you are not sure, consult your doctor before you are given Inflectra.

Warnings and precautions

Consult your doctor before or during treatment with Inflectra if:

You have previously received treatment with any medicine that contains infliximab

• Tell your doctor if you have received treatment with medicines that contain infliximab in the past and are now starting a new treatment with Inflectra.

• If you interrupt treatment with infliximab for more than 16 weeks, there is a greater risk of allergic reactions when you start treatment again.

Infections

• Tell your doctor if you have an infection, even if it is mild, before you are given Inflectra.
• Tell your doctor if you have ever lived or traveled in a place where infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common before you are given Inflectra. These infections are caused by certain types of fungi and can affect the lungs or other parts of your body.
• You may be more likely to get an infection when you are being treated with Inflectra. If you are 65 years of age or older, you have a greater risk.
• These infections can be serious and include tuberculosis, infections caused by viruses, fungi, bacteria, or other organisms in the environment, and sepsis, which can be life-threatening.

• Tell your doctor immediately if you have signs of infection during treatment with Inflectra, such as fever, cough, flu-like symptoms, general feeling of being unwell, redness or feeling of warmth on the skin, wounds, or dental problems. Your doctor may temporarily stop your treatment with Inflectra.

Tuberculosis (TB)

• It is very important that you tell your doctor if you have ever had TB or if you have been in close contact with someone who has had or has TB.
• Your doctor will do a test to see if you have TB. Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for TB. Your doctor will record the results of these tests on your patient information card.
• If your doctor thinks you are at risk of TB, you will need to be treated with medicines for TB before you are given Inflectra.

• Tell your doctor immediately if you notice symptoms of TB during treatment with Inflectra. The symptoms are persistent cough, weight loss, tiredness, fever, night sweats.

Hepatitis B virus

• Tell your doctor if you are a carrier or have ever had hepatitis B before you are given Inflectra.
• Tell your doctor if you think you may be at risk of getting hepatitis B.
• Your doctor will do tests for the hepatitis B virus.
• Treatment with TNF blockers such as Inflectra may cause the hepatitis B virus to become active again in people who carry this virus, which in some cases can be life-threatening.
• If you have a recurrence of hepatitis B, your doctor may need to stop your treatment and may give you medicines such as antiviral therapy with supportive treatment.

Heart problems

• Tell your doctor if you have any heart problems, such as mild heart failure.
• Your doctor will want to keep a close eye on your heart.

• Tell your doctor immediately if you notice new symptoms or worsening of heart failure during treatment with Inflectra. The symptoms include difficulty breathing or swelling of the feet.

Cancer and lymphoma

• Tell your doctor if you have or have had lymphoma (a type of blood cancer) or any other type of cancer before you are given Inflectra.
• Patients with severe rheumatoid arthritis who have had the disease for a long time may have a higher risk of developing lymphoma.
• Children and adults treated with Inflectra may have a higher risk of developing lymphoma or other types of cancer.
• Some patients who have received TNF blockers, including infliximab, have developed a rare type of cancer called hepatosplenic T-cell lymphoma. Most of these patients were male adolescents or young adults, and most had Crohn's disease or ulcerative colitis. This type of cancer is usually fatal. Almost all of these patients had also received other medicines such as azathioprine or mercaptopurine, in addition to TNF blockers.
• Some patients treated with infliximab have developed certain types of skin cancer. Tell your doctor if you notice any changes in the appearance of your skin or an abnormal growth of the skin during or after treatment.
• Some women treated with infliximab for rheumatoid arthritis have developed cervical cancer. Women treated with Inflectra, even those over 60 years of age, may be recommended regular cervical cancer screening by their doctor.

Lung disease or heavy smoking

• Tell your doctor if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker before you are given Inflectra.
• Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with treatment with Inflectra.

Nervous system disease

• Tell your doctor if you have or have had any problems that affect your nervous system before you are given Inflectra. This includes multiple sclerosis, Guillain-Barré syndrome, if you have had seizures or have been diagnosed with "optic neuritis".

Tell your doctor immediately if you notice symptoms of nervous system disease during treatment with Inflectra. The symptoms can be changes in vision, weakness in the arms or legs, numbness or tingling in any part of the body.

Abnormal skin openings

• Tell your doctor if you have any abnormal skin ulcers (fistulas) before you are given Inflectra.

Vaccines

• Tell your doctor if you have recently had or are scheduled to have a vaccine.
• Before starting treatment with Inflectra, you should receive all recommended vaccines. You can receive some vaccines during treatment with Inflectra, but you should not receive live vaccines (vaccines that contain a weakened live infectious agent) while you are using Inflectra because they may cause infections.

• If you received treatment with Inflectra during pregnancy, your baby may also have a higher risk of getting an infection as a result of receiving a live vaccine during the first year of life. It is important that you inform pediatricians and other healthcare professionals about your treatment with Inflectra so that they can decide when your baby can be vaccinated, including live vaccines, such as the BCG vaccine (used to prevent tuberculosis).
• If you are breastfeeding, it is important that you inform pediatricians and other healthcare professionals about your treatment with Inflectra before your baby is vaccinated. You should not give your baby live vaccines while you are breastfeeding, unless your pediatrician recommends otherwise. For more information, see the section on Pregnancy and breastfeeding.

Therapeutic infectious agents

• Tell your doctor if you have recently received or are scheduled to receive treatment with infectious agents (such as BCG instillation used for cancer treatment)

Surgical or dental procedures

• Tell your doctor if you are going to have any surgical or dental procedure.
• Tell your surgeon or dentist that you are being treated with Inflectra and show them your patient information card.

Liver problems

• Some patients who received infliximab have developed serious liver problems.
• Tell your doctor immediately if you notice symptoms of liver problems during treatment with Inflectra. The symptoms can be yellowing of the skin and eyes, dark brown urine, pain or swelling in the upper right side of the stomach, joint pain, skin rash, or fever.

Low blood cell counts

• In some patients who receive infliximab, the body cannot produce enough blood cells that help fight infections or help stop bleeding.
• Tell your doctor immediately if you notice symptoms of low blood cell counts during treatment with Inflectra. The symptoms can be persistent fever, bleeding or bruising easily, small red or purple spots caused by bleeding under the skin, or paleness.

Immune system disorder

• Some patients who received infliximab have developed symptoms of an immune system disorder called lupus.
• Tell your doctor immediately if you have symptoms of lupus during treatment with Inflectra. The symptoms can be joint pain or a rash on the cheeks or arms due to sun sensitivity.

Children and adolescents

The above information also applies to children and adolescents. Additionally:

• Some children and adolescents treated with TNF blockers like infliximab have developed cancers, some of which are rare and have led to death.
• More children treated with infliximab have developed infections compared to adults.
• Children should receive all recommended vaccines before starting treatment with Inflectra. Children can receive some vaccines during treatment with Inflectra, but they should not receive live vaccines while they are using Inflectra.

Inflectra should only be used in children if they are being treated for Crohn's disease or ulcerative colitis. These children must be 6 years of age or older.

If you are not sure if any of the above applies to you, consult your doctor before you are given Inflectra.

Other medicines and Inflectra

Patients with inflammatory diseases are taking medicines to treat their condition. These medicines may cause side effects. Your doctor will advise you which other medicines you should continue to use while you are being treated with Inflectra.

Tell your doctor if you are using, have recently used, or could be using any other medicine, including any other medicine for the treatment of Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, or other medicines that you can buy without a prescription, such as vitamins or herbal remedies.

In particular, tell your doctor if you are using any of the following medicines:

• Medicines that affect your immune system.
• Kineret (which contains anakinra). Inflectra and Kineret must not be used at the same time.
• Orencia (which contains abatacept). Inflectra and Orencia must not be used at the same time.

You must not receive live vaccines while you are using Inflectra. If you were using Inflectra during pregnancy or if you are receiving Inflectra during breastfeeding, tell the pediatrician and other healthcare professionals looking after your baby about your treatment with Inflectra before your baby receives any vaccine.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before you start using Inflectra.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Inflectra should only be used during pregnancy or breastfeeding if your doctor thinks it is necessary for you.
• You should avoid becoming pregnant while you are being treated with Inflectra and for 6 months after you finish treatment. Discuss the use of birth control measures during this time with your doctor.
• If you received treatment with Inflectra during pregnancy, your baby may have a higher risk of getting an infection.
• It is important that you inform pediatricians and other healthcare professionals about your treatment with Inflectra before your baby is vaccinated. If you received Inflectra while you were pregnant, the administration of the BCG vaccine (used to prevent tuberculosis) to your baby within 12 months after birth may cause infections with serious complications, including death. You should not give your baby live vaccines, such as the BCG vaccine, within 12 months after birth, unless your pediatrician recommends otherwise. For more information, see the section on Vaccines.
• If you are breastfeeding, it is important that you inform pediatricians and other healthcare professionals about your treatment with Inflectra before your baby is vaccinated. You should not give your baby live vaccines while you are breastfeeding, unless your pediatrician recommends otherwise.
• In children born to women treated with infliximab during pregnancy, a serious decrease in the number of white blood cells in the blood has been reported. If your baby has fevers or infections, contact your pediatrician immediately.

Driving and using machines

It is unlikely that Inflectra will affect your ability to drive or use tools or machines. If you feel tired, dizzy, or unwell after you are given Inflectra, do not drive or use tools or machines.

Inflectra contains sodium

Inflectra contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free". However, before you are given Inflectra, it is mixed with a solution that contains sodium. Tell your doctor if you are on a low-salt diet.

3. How Inflectra will be given to you

How much Inflectra will you be given

• Your doctor will decide your dose and how often you will be given Inflectra. This will depend on your disease, weight, and how you respond to Inflectra.
• The following table shows how often you will normally be given this medicine after your first dose.

Rheumatoid arthritis

The recommended dose is 3 mg per kilogram of body weight.

Psoriatic arthritis, ankylosing spondylitis (Bechterew's disease), psoriasis, ulcerative colitis, and Crohn's disease

The recommended dose is 5 mg per kilogram of body weight.

How Inflectra will be given to you

• Inflectra will be given to you by your doctor or nurse, in a hospital or clinic.
• Your doctor or nurse will prepare the medicine for infusion.
• The medicine will be given as an intravenous infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor will decide if you will be given the dose of Inflectra over 1 hour.
• You will be monitored while you are given Inflectra and for 1 or 2 hours after.

Use in children and adolescents

In children (6 years of age or older) treated for Crohn's disease or ulcerative colitis, the recommended dose is the same as for adults.

If you are given too much Inflectra

As this medicine is given by your doctor or nurse, it is unlikely that you will be given too much Inflectra. The effects of overdose of Inflectra are not known.

If you miss or do not attend your Inflectra infusion

If you miss or do not attend a scheduled infusion of Inflectra, make an appointment as soon as possible.

If you have any other questions about the use of this medicine, ask your doctor.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Most adverse effects are mild to moderate. However, some patients may experience serious adverse effects and may require treatment. Adverse effects may occur after your treatment with Inflectra has ended.

Tell your doctor immediately if you notice any of the following:

• Signs of an allergic reactionsuch as swelling of the face, lips, mouth, or throat, which can cause difficulty swallowing or breathing, skin rash, hives, swelling of the hands, feet, or ankles. Some of these reactions can be severe or potentially life-threatening. The allergic reaction can occur within 2 hours after infusion or later. More signs of allergic adverse effects may occur up to 12 days after your infusion, such as muscle pain, fever, joint pain or jaw pain, sore throat, or headache.

• Signs of a heart problemsuch as discomfort or pain in the chest, pain in the arm, stomach pain, difficulty breathing, anxiety, dizziness, fainting, sweating, nausea (feeling of discomfort), vomiting, palpitations or pounding in the chest, rapid or slow heartbeat, and swelling of the feet.
• Signs of infection (including TB)such as fever, fatigue, persistent cough, difficulty breathing, flu-like symptoms, weight loss, night sweats, diarrhea, wounds, accumulation of pus in the abdomen or around the anus (abscess), dental problems, or a burning sensation when urinating.

• Possible signs of cancerthat include, but are not limited to, inflammation of the lymph nodes, weight loss, fever, rare skin nodules, changes in moles or skin color, or rare vaginal bleeding.

• Signs of lung problemssuch as cough, difficulty breathing, or chest tightness.
• Signs of a nervous system problem (including eye problems)such as signs of a stroke (sudden numbness or weakness of your face, arms, or legs, especially on one side of your body; sudden confusion, difficulty speaking or understanding; difficulty seeing with one or both eyes, difficulty walking, dizziness, loss of balance or coordination, or a severe headache), seizures, numbness/tingling in any part of the body, or weakness in arms or legs, vision changes such as double vision or other eye problems.
• Signs of liver problems(including hepatitis B infection, when you have had hepatitis B before) such as yellowing of the skin or eyes, dark brown urine, pain or swelling in the upper right part of the stomach, joint pain, skin rash, or fever.
• Signs of immune system diseasesuch as joint pain, sun-sensitive rash on the cheeks or arms (lupus), or cough, difficulty breathing, fever, or skin rash (sarcoidosis).
• Signs of low blood cell countssuch as persistent fever, bleeding, or easy bruising, small red or purple spots caused by bleeding under the skin, or paleness.
• Signs of severe skin problemssuch as red or circular spots on the skin, often with central blisters on the trunk, large areas of peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes, or small pus-filled bumps that can spread across the body. These skin reactions can be accompanied by fever.

Tell your doctor immediately if you observe any of the above.

The following adverse effects have been observed with Inflectra:

Very common: may affect more than 1 in 10 people

• Stomach pain, nausea.
• Viral infections such as herpes or flu.
• Upper respiratory tract infections such as sinusitis.
• Headache.
• Infusion-related adverse effect.
• Pain.

Common: may affect up to 1 in 10 people

• Changes in liver function, increased liver enzymes (shown in blood tests).
• Lung or chest infections, such as bronchitis or pneumonia.
• Difficulty or pain breathing, chest pain.
• Bleeding in the stomach or intestines, diarrhea, indigestion, heartburn, constipation.
• Rash (hives), itchy skin rash, or dry skin.
• Balance or dizziness problems.
• Fever, increased sweating.
• Circulation problems such as low or high blood pressure.
• Bruising, flushing, or nosebleeds, feeling of heat or redness of the skin (flushing).
• Feeling of tiredness or weakness.
• Bacterial infections such as septicemia, abscess, or skin infection (cellulitis).
• Fungal skin infection.
• Blood problems such as anemia or low white blood cell count.
• Lymph node inflammation.
• Depression, sleep disturbances.
• Eye problems including red eyes and infections.
• Fast heartbeats (tachycardia) or palpitations.
• Joint, muscle, or back pain.
• Urinary tract infection.
• Psoriasis, skin problems such as eczema, and hair loss.
• Injection site reactions such as pain, swelling, redness, or itching.
• Chills, fluid accumulation under the skin that causes swelling.
• Feeling of numbness or tingling.

Uncommon: may affect up to 1 in 100 people

• Lack of blood flow, vein swelling.
• Blood accumulation outside the blood vessels (hematoma) or bruising.
• Skin problems such as blisters, warts, abnormal skin color or pigmentation, swollen lips, thickened skin, or red, scaly, and peeling skin.
• Severe allergic reactions (e.g., anaphylaxis), immune system disease called lupus, allergic reactions to foreign proteins.
• Slow-healing wounds.
• Liver inflammation (hepatitis) or bile duct inflammation, liver damage.
• Feeling forgetful, irritable, confused, or nervous.
• Eye problems including blurred or reduced vision, swollen or inflamed eyes.
• Heart malfunction or worsening, decreased heartbeat.
• Fainting.
• Seizures, nerve problems.
• Intestinal ulcer or obstruction, stomach pain or cramps.
• Pancreas inflammation (pancreatitis).
• Fungal infections such as Candida or fungal nail infection.
• Lung disorders (such as edema).
• Fluid around the lungs (pleural effusion).

• Narrowing of the airways in the lungs, causing difficulty breathing.
• Inflammation of the membrane that protects the lung, causing severe chest pain that worsens with breathing (pleurisy).
• Tuberculosis.

• Kidney infections.
• Low platelet count, too many white blood cells in the blood.
• Vaginal infections.
• Blood test result showing "antibodies" against your own body.
• Changes in cholesterol and fat levels in the blood.
• Weight gain (for most patients, the weight gain was small).

Rare: may affect up to 1 in 1,000 people

• A type of blood cancer (lymphoma).
• Blood not providing enough oxygen to the body, circulation problems such as vein narrowing.
• Inflammation of the membranes that protect the brain (meningitis).
• Infections due to a weakened immune system.
• Hepatitis B infection, when you have had it before.
• Liver inflammation caused by an immune system problem (autoimmune hepatitis).
• Liver problem that causes yellowing of the skin and eyes (jaundice).
• Swelling or abnormal growth of tissues.

• Severe allergic reaction that can cause loss of consciousness and can be life-threatening (anaphylactic shock).

• Inflammation of small blood vessels (vasculitis).
• Immune system disorders that can affect the lungs, skin, and lymph nodes (e.g., sarcoidosis).

• Accumulation of immune cells as a result of an inflammatory response (granulomatous lesions).

• Lack of interest or emotion.
• Severe skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and acute generalized exanthematous pustulosis.
• Other skin problems such as erythema multiforme, blisters, and skin peeling or boils (furunculosis).

• Severe nervous system disorders such as transverse myelitis, multiple sclerosis-like disease, optic neuritis, and Guillain-Barré syndrome.

• Inflammation in the eye that can cause vision changes, including blindness.

• Fluid in the layer that protects the heart (pericardial effusion).
• Severe lung problems (such as interstitial lung disease).
• Melanoma (a type of skin cancer).
• Cervical cancer.
• Low blood count, including a severe decrease in the number of white blood cells in the blood.

• Small red or purple spots caused by bleeding under the skin.
• Lichenoid reactions (itchy reddish-purple skin rash and/or thick grayish-white lines on the mucous membranes).
• Abnormal levels of a blood protein called "complement factor" that is part of the immune system.

Frequency not known: cannot be estimated from the available data

• Cancer in children and adults.
• A rare blood cancer that mainly affects young adolescents or young men (hepatosplenic T-cell lymphoma).
• Liver failure.

• Merkel cell carcinoma (a type of skin cancer).
• Kaposi's sarcoma, a rare cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually occurs more frequently as purple skin lesions.
• Worsening of a disease called dermatomyositis (manifested as a skin rash accompanied by muscle weakness).
• Heart attack.
• Stroke.
• Temporary loss of vision during or after infusion.

• Infection due to a live vaccine because of a weakened immune system.

• Post-procedure problems (including infectious and non-infectious problems).

Other adverse effects in children and adolescents

Children who took infliximab for Crohn's disease showed some differences in adverse effects compared to adults who took infliximab for Crohn's disease. The adverse effects that occurred more in children were: low red blood cell count (anemia), blood in stool, low white blood cell count (leucopenia), facial flushing (flushing), viral infections, low white blood cell count that fights infection (neutropenia), bone fracture, bacterial infection, and allergic reactions in the respiratory tract.

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 can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Inflectra

Inflectra will normally be stored by healthcare professionals in a hospital or clinic. The storage details, if needed, are as follows:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that appears on the label and on the carton after EXP. The expiry date is the last day of the month indicated.

• Store in a refrigerator (between 2°C - 8°C).
• This medicine can also be stored in the original package outside the refrigerator up to a maximum of 25°C for a single period of up to six months, but not beyond the initial expiry date. In this situation, it must not be stored in the refrigerator again. Write the new expiry date on the carton including day/month/year. Discard this medicine if it has not been used by the new expiry date or the expiry date printed on the carton, whichever is earlier.

• It is recommended that when Inflectra is prepared for infusion, it should be used as soon as possible (within 3 hours). However, if the solution is prepared under sterile conditions, it can be stored in a refrigerator between 2°C – 8°C for up to 60 days and for an additional 24 hours at 25°C once removed from the refrigerator.

• Do not use this medicine if the color is altered or if there are any foreign particles.

6. Package contents and additional information

Composition of Inflectra

• The active substance is infliximab. Each vial contains 100 mg of infliximab. After preparation, each ml contains 10 mg of infliximab.
• The other ingredients are sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate, and disodium hydrogen phosphate dihydrate.

Appearance and package contents of the product

Inflectra is presented in a glass vial containing a powder for concentrate for solution for infusion. The powder is white.

Inflectra is available in packs with 1, 2, 3, 4, or 5 vials. Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer Responsible

Hospira Zagreb d.o.o.

Prudnicka cesta 60

10291 Prigorje Brdovecko

Croatia

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Date of last revision of this leaflet:05/2025.

Other sources of information

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

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This information is intended solely for healthcare professionals:

Patient information cards should be given to patients treated with Inflectra.

Instructions for use and handling – storage conditions

Store between 2 °C and 8 °C.

Inflectra can be stored at temperatures up to a maximum of 25 °C for a single period of up to 6 months, but without exceeding the initial expiry date. The new expiry date must be written on the carton. Once removed from refrigerated storage, Inflectra must not be returned to refrigerated storage.

Instructions for use and handling: reconstitution, dilution, and administration

In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product must be clearly recorded.

1. The dose and number of Inflectra vials must be calculated. Each Inflectra vial contains 100 mg of infliximab. The total volume of reconstituted Inflectra solution needed must also be calculated.

1. Under aseptic conditions, each Inflectra vial must be reconstituted with 10 ml of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle. The removable cap of the vial must be removed and the top cleaned with a cotton swab soaked in 70% alcohol. The syringe needle must be inserted into the vial through the center of the rubber stopper and the water for injections directed towards the glass wall of the vial. The solution must be gently rotated by a rotational movement of the vial to dissolve the powder. Prolonged or vigorous agitation must be avoided. THE VIAL MUST NOT BE SHAKEN. Foam may form during reconstitution. The reconstituted solution must stand for 5 minutes. The solution must be colorless to pale yellow and opalescent. Fine, translucent particles may be present in the solution, as infliximab is a protein. The solution must not be used if it contains opaque particles, color alteration, or other foreign particles.

1. The required volume of reconstituted Inflectra solution must be diluted to 250 ml with 9 mg/ml (0.9%) sodium chloride infusion solution. The reconstituted Inflectra solution must not be diluted with any other diluent. This dilution can be performed by removing a volume of the 9 mg/ml (0.9%) sodium chloride infusion solution from the 250 ml glass bottle or infusion bag equal to the volume of reconstituted Inflectra solution. The required volume of reconstituted Inflectra solution must be slowly added to the 250 ml glass bottle or infusion bag and gently mixed. For volumes greater than 250 ml, a larger infusion bag (e.g., 500 ml, 1000 ml) or multiple 250 ml infusion bags must be used to ensure that the concentration of the infusion solution does not exceed 4 mg/ml. If stored refrigerated after reconstitution and dilution, the infusion solution must be allowed to reach room temperature (25 °C) for 3 hours before administration (Step 4). Storage beyond 24 hours at 2 °C-8 °C applies only to the preparation of Inflectra in the infusion bag.

1. The intravenous infusion solution must be administered over a period of no less than the recommended infusion time (see section 3). Only an infusion set with a low protein-binding, non-pyrogenic, and sterile filter (pore size 1.2 micrometers or less) must be used. As it does not contain preservatives, it is recommended that the administration of the intravenous infusion solution begins as soon as possible and within 3 hours of reconstitution and dilution. If not used immediately, the storage times and conditions before use are the responsibility of the user and normally must not exceed 24 hours between 2 °C and 8 °C, unless the reconstitution/dilution has been performed under controlled and validated aseptic conditions. Unused portions of the intravenous infusion solution must not be stored for reuse.

1. Prior to administration, Inflectra must be visually inspected for particles or color alteration. It must not be used if visible opaque particles, color alteration, or other foreign particles are observed.

1. The disposal of unused medicinal products and all materials that have come into contact with them must be carried out in accordance with local regulations.