InfoCons Consumer Protection informs you – Ordspono – Package Leaflet

Before anything else

Read all of this leaflet c arefully before you are given 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 Card. Read it carefully and follow the instructions on it.

Keep this Pati ent Card with you at all times. − Always show the Patient Card to the doctor or nurse when you see them or if you go to hospital. − If you have any further questions, ask your doctor, pharmacist, or nurse. − If you get any side effects, talk to your doctor, pha rmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Ordspono is and what it is used for

Ordspono is a type of antibody tha t is a cancer medicine. Ordspono contains the active substance odronextamab.

Ordspono is used in adults to treat the following blood cancers:

• Follicular lymphoma (FL)
• Diffuse large B -cell lymphoma (DLBCL) In FL and DLBCL, a type of white blood cells tha t protect you from infection called ‘B cells’ become cancerous. The abnormal B cells do not work properly and grow too quickly. These cancerous B cells crowd out the normal B cells in the bone marrow and lymph nodes.

Ordspono is given to patients who have already tried at least two previous treatments for FL or DLBCL, when either the cancer has not responded to them (refractory), or it has come back again (relapsed).

How Ordspono works

The active substance in Ordspono , odronextamab, is a bispecific monoclonal antibody. This is a type of protein that attaches to two specific targets in the body.

• Odronextamab attaches to a target substance found on B cells, including the cancerous ‘B cells,’ and another target found on ‘T cells’, a different type of white blood cell.
• T cells are another part of the body’s defences that can destroy invading cells.
• By attaching T cells and B cells together like a bridge, Ordspono encourages the T cells to destroy the cancerous B cells.
• This helps control the FL and DLBCL and prevent their spread.

⚠️ 2. What you need to know before you are given Ordspono

You must not be given Ordspono

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

If you think you may be allergic, or you are not sure, talk to your doctor or nurse before you are given Ordspono.

Warnings and precautions

Talk to your doctor or nurse before you are given Ordspono if you:

• have ever had heart, lung, liver, or kidney problems
• have an infection or have had an infection in the past that lasted a long time or keeps coming back.

An infection should be treated before you receive Ordspono.

• recently had a vaccine or are due to have a vaccine in the near future. Certain vaccines should not be given while you are receiving treatment with Ordspono.

If any of the above apply to you, or you are not sure, talk to your doctor or nurse before you are given Ordspono.

Tell your doctor straight away if you get signs or symptoms of any of the side effects listed below during or after treatment with Ordspono. You may need immediate medical treatment. The most common signs or symptoms of each side e ffect are listed in section 4 under ‘Serious side effects.’

• Cytokine release syndrome (CRS) – a condition that can happen with medicines that stimulate T cells. CRS can be life-threatening.

− Signs or symptoms of CRS may include fever, feeling dizzy or lig htheaded, and difficulty breathing. − You may be given medicines that help reduce possible side effects of CRS before or after certain infusions. − Your doctor will monitor how your treatment is working and ask you to remain within proximity of a qualified he althcare facility for at least 24 hours after administration of each dose within the Ordspono step-up dosing regimen and after the first full dose.

• Infections – you may get signs or symptoms of infection (for example, a fever, chills, cough, or pain in uri nation), including life -threatening infections that may lead to death.

− The signs and symptoms of infections can vary depending on where in the body the infection is. − Your doctor may prescribe another medicine to prevent certain types of infection while you are receiving Ordspono.

• Effects on your nervous system – you may get signs or symptoms that can include confusion or problems with the use of language.
• Tumour lysis syndrome –some people may get unusual levels of some salts (such as potassium and uric acid) in the blood – caused by the fast breakdown of cancer cells during treatment.

− Your doctor or nurse will do blood tests to check for this condition. − Before each infusion with Ordspono, you should be well -hydrated and may be given medicines that can help reduce high levels of uric acid.

47 − These measures may help reduce possible side effects of tumour lysis syndrome.

• Lung inflammation (pneumonitis/interst itial lung disease) – you may get signs or symptoms that can include new or worsening cough, being short of breath

Children and adolescents

Ordspono should not be used in children and adolescents below 18 years of age because Ordspono has not been studi ed in this age group.

Other medicines and Ordspono

Tell your doctor if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Pregnancy

It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant. Ordspono is not recommended during pregnancy and in women who can get pregnant and are not using contraception. Ordspono may harm your unborn baby.

Contraception Women who could become pregnant must use effective contraception during treatment – and for 6 months after the last dose of Ordspono.

Breast -feeding You must not breast -feed during and for at least 6 months after your last treatment with Ordspono.

This is because it is not known whether any Ordspono passes into breast milk and could therefore harm the baby.

Driving and using machines

Ordspono has minor influence on your ability to drive, cycle or use any tools or machines. Some people may feel tired, dizzy, light-headed, or confused while taking Ordspono. If you feel any symptoms that may affect your ability to drive, do not drive or use tools or machines until your symptoms go away. See section 4 for more information about side effects.

Ordspono contains polysorbate 80

The 2 mg vial of odronextamab contains 1 mg of polysorbate 80 in each 1 mL vial which is equivalent to 1 mg/mL.

The 80 mg vial of odronextamab contains 4 mg of polysorbate 80 in ea ch 4 mL vial which is equivalent to 1 mg/mL.

The 320 mg vial of odronextamab contains 16 mg of polysorbate 80 in each 16 mL vial which is equivalent to 1 mg/mL.

Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

💊 3. How Ordspono is given

Ordspono is given under the supervision of a doctor experienced in giving such treatments. Follow the treatment schedule explained to you by your doctor. Check with your doctor if you are not sure.

48 How Ordspono is given Ordspono is given into a vein, as a drip ( intravenous infusion).

• For Cycles 1, 2, 3, and 4, a treatment cycle is 21 days.
• Ordspono is given over 4 hours during Cycle 1 and on Cycle 2, Day 1.
• The next doses may be given over 1 hour if side effects are not too severe.
• After Cycle 4, you will get a maintenance dose every 2 weeks.

Medicines given before and after treatment with Ordspono You will be given other medicines before and after treatment with Ordspono in Cycle 1 and Cycle 2, Days 1 and 8. These medicines help reduce the risk of CRS and inf usion-related reactions (IRR).

These medicines may include:

• Corticosteroids – such as dexamethasone
• Paracetamol
• An antihistamine – such as diphenhydramine After Cycle 2 Day 8, your doctor will decide if you need to continue to take other medicines to help reduce side effects from Ordspono during future cycles.

How much Ordspono is given For the treatment of follicular lymphoma (FL) and diffuse large B -cell lymphoma (DLBCL), a treatment cycle of Ordspono from Cycles 1, 2, 3, and 4 is 21 days.

In Cycle 1, you will be given increasing doses of Ordspono to treat FL or DLBCL on the following days:

• Day 1: 0.2 mg
• Day 2: 0.5 mg
• Day 8: 2 mg
• Day 9: 2 mg
• Day 15: 10 mg
• Day 16: 10 mg In Cycles 2, 3, and 4, you will be given a dose on Days 1, 8, and 15:
• for follicular lymphoma: 80 mg
• for diffuse large B-cell lymphoma: 160 mg If your dose of Ordspono is delayed for any reason, you may need to restart treatment from Cycle 1.

One week after the end of Cycle 4, you will be given a maintenance dose every 2 weeks.

The maintenance doses are as follows:

• for follicular lymphoma: 160 mg
• for diffuse large B-cell lymphoma: 320 mg If your cancer has been in remission for at least 9 months, your doctor may decide to reduce your dosing frequency from every 2 weeks to every 4 weeks.

Your doctor may continue your treatment for as long as you continue to respond to Ordspono or for as long as side effects are not too severe. Your doctor may delay or completely stop your treatment with Ordspono if you have certain side effects. If you miss an appointment 49 If you miss an appointment, make another one straight away. For the treatment to be fully effective, it is very important not t o miss a dose.

If you stop receiving Ordspono Do not stop treatment with Ordspono unless you have discussed this with your doctor. This is because stopping your treatment may make your condition worse.

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

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These side effects may happen any time during treatment or even after your treatment has ended.

Serious side effects

Tell your doctor straight away if you notice any symptoms of the following serious side effects. You may only get one or some of these symptoms.

Cytokine release syndrome (very common: may affect more than 1 in 10 people) Signs and symptoms can include:

• fever (38°C or higher)
• feeling dizzy or lightheaded
• fast or irregular heartbeat
• difficulty breathing
• chills or shaking
• headache Infections (very common: may affect more than 1 in 10 people) Signs and symptoms can include:
• fever ( 38°C or higher)
• chills or shaking
• cough or feeling short of breath
• sore throat
• pain when passing urine Very common infections (may affect more than 1 in 10 people):
• COVID 19
• infection of the lungs (pneumonia)
• cytomegalovirus infection, which can cause serious complications in people whose immune system is compromised
• infection of the nose and throat (upper respiratory tract infection)
• infection of the parts of the body that collect and pass urine (urinary tract infection)
• herpes virus infection Common infections (may affect up to 1 in 10 people):
• airway (respiratory tract) infection
• fungal infection
• inflammation of the sinuses (sinusitis)
• blood poisoning (sepsis)
• bacteria in the blood (bacteraemia) Effects on your nervous system (uncommon : may affect up to 1 in 100 people) 50 Signs and symptoms can include:
• headache
• dizziness
• decreased brain function, such as trouble thinking
• feeling anxious
• feeling confused Tumour lysis syndrome ( uncommon : may affect up to 1 in 100 people) Signs and symptoms can include:
• weakness
• shortness of breath
• feeling confused
• irregular heartbeat
• muscle cramps Lung inflammation (pneumonitis/interstitial lung disease) (common : may affect up to 1 in 10 people) Signs and symptoms can include:
• being short of breath
• new or worsening cough If you have any of these signs or symptoms during or after treatment with Ordspono, tell your doctor straight away. You may need medical treatment.

Other side effects

Other side effects are listed below. Tell your doctor or nurse if you get any of these side effects.

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

• Fever (pyrexia)
• Muscle pain or bone (musculoskeletal) pain
• Feeling tired (fatigue)
• Diarrhoea
• Rash
• Cough
• Swollen hands, ankles, or feet (oedema)
• Feeling sick (nausea)
• Stomach pain (abdominal pain)
• Constipation
• Infusion-related reactions (IRR)
• Feeling less hungry (decreased appetite)
• Difficulty falling or staying asleep (insomnia)
• Low blood pressure (hypotension)
• Headache
• Feeling short of breath at rest or with activity (dyspnoea)
• Vomiting Shown in blood tests
• Low number of red blood cells (anaemia) that can make you feel tired or short of breath
• Low levels of some types of white blood cells (neutropenia, leukopenia, lymphopenia), which can increase the risk for infection
• Low platelet count (thrombocytopenia) that may make you more likely to bruise or bleed 51 • Low level of potassium, sodium, or phosphate (hypokalaemia, hyponatremia, or hypophosphataemia)
• High level of sugar in the blood (hyperglycaemia)
• High level of alanine aminotransferase or aspartate aminotransferase in the blood

Common (may affect up to 1 in 10 people)

• Fast or uneven heartbeat (tachycardia)
• Weakness, numbness, and pain, usually in the hands and feet (neuropathy peripheral)
• Confusion, disorientation, sleepiness (mental status changes)
• condition that can cause inflammation of lung tissue that can affect your ability to breathe (interstitial lung disease)
• fever due to low levels of neutrophils (a type of white blood cell) Shown in blood tests
• High level of gamma -glutamyltransferase, an enzyme found mostly in the liver
• Low level of magnesium (hypomagnesaemia)
• Low level of albumin (hypoalbuminaemia)
• Increased levels of bilirubin, which may cause yellowing of skin or e yes, and dark urine

Uncommon (may affect up to 1 in 100 people)

• Difficulty with speech (aphasia)
• A rapid breakdown of tumour cells called tumour lysis syndrome. This can cause chemical changes in the blood and damage to organs, including the kidneys, hea rt, and liver
• Effects on your nervous system with symptoms that can include feeling confused or less alert (immune effector cell -associated neurotoxicity syndrome or neurotoxicity)

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V .

By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Ord spono

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

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.

Ordspono will be stored by healthcare professionals at the hospital or clinic. This storage information is for their use.

Unopened vial Store in a refrigerator (2 °C to 8 °C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Diluted solution Chemical and physical in -use stability has been demonstrated for the diluted Ordspono infusion solution as follows:

52 • in a refrigerator (2 °C to 8 °C) for all doses for up to 24 hours.

• at room temperature (20 °C to 25 °C) for up to 6 hours for the 0.2-mg dose with Albumin (Human).
• at room temperature (20 °C to 25 °C) for up to 12 hours for doses of 0.5 mg or greater.

Discard diluted infusion solution if storage time excee ds these limits.

From a microbiological point of view, the product should be used immediately. If not used immediately, in -use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

Your doctor will dispose of any unneeded medicine appropriately. These measures will help protect the environment.

📦 6. Contents of the pack and other informatio n

What Ordspono contains

The active substance is odronextamab.

• Ordspono 2 mg: Each vial contains 2 mg of odronextamab (in 1 mL concentrate) at a concentration of 2 mg/1 mL.
• Ordspono 80 mg: Each vial contains 80 mg of odronextamab (in 4 mL concentrate) at a concentration of 20 mg/1 mL.
• Ordspono 320 mg: Each vial contains 320 mg of odronextamab (in 16 mL concentrate) at a concentration of 20 mg/1 mL.

The other ingredients are L -histidine, L- histidine monohydrochloride monohydrate, sucrose, polysorbate 80 (E433), and water for injections (see “Ordspono contains polysorbate 80” in section 2).

What Ordspono looks like and contents of the pack

Ordspono concentrate for solution (sterile concentrate) for infusion is supplied as a clear to slightl y opalescent, colourless to pale yellow solution provided in a glass vial.

Each pack contains one vial.

Marketing Authorisation Holder

Regeneron Ireland Designated Activity Company (DAC) One Warrington Place Dublin 2, D02 HH27 Ireland

Manufacturer

Regeneron Ireland DAC Raheen Business Park Limerick Ireland 53 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Latvija Regeneron Ireland DAC Regeneron Ireland DAC Tél/Tel: 0800 89383 Tel: 8000 5874 България Lietuva Regeneron Ireland DAC Regeneron Ireland DAC Тел.: 008002100419 Tel: 8 800 33598 Česká republika Luxembourg/Luxemburg Regeneron Ireland DAC Regeneron Ireland DAC Tel: 800 050 148 Tél/Tel: 8007 -9000 Danmark Magyarország Regeneron Ireland DAC Regeneron Ireland DAC Tlf: 80 20 03 57 Tel.: 06 -809-93029 Deutschland Malta Regeneron GmbH Regeneron Ireland DAC Tel.: 0800 330 4267 Tel: 80065169 Eesti Nederland Regeneron Ireland DAC Regeneron Ireland DAC Tel: 800 004 4845 Tel: 0800 020 0943 Ελλάδα Norge Regeneron Ireland DAC Regeneron Ireland DAC Τηλ: 00800 44146336 Tlf: 8003 15 33 España Österreich Regeneron Spain S.L.U. Regeneron Ireland DAC Tel: 900031311 Tel: 01206094094 France Polska Regeneron France SAS Regeneron Ireland DAC Tél: 080 554 3951 Tel.: 800 080 691 Hrvatska Portugal Regeneron Ireland DAC Regeneron Ireland DAC Tel: 0800 787 074 Tel: 800783394 Ireland România Regeneron Ireland DAC Regeneron Ireland DAC Tel: 1800800920 Tel: 0800 400670 Ísland Slovenija Regeneron Ireland DAC Regeneron Ireland DAC Sími: 800 4431 Tel: 0800 83155 Italia Slovenská republika Regeneron Italy S.r.l. Regeneron Ireland DAC Tel: 800180052 Tel: 0800 123 255 54 Κύπρος Suomi/Finland Regeneron Ireland DAC Regeneron Ireland DAC Τηλ: 800 925 47 Puh/Tel: 0800 772223 Sverige Regeneron Ireland DAC Tel: 0201 604786

This leaflet was last revised in

This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Detailed information on this medicine is available on the Eur opean Medicines Agency web site: https://www.ema.europa.eu ————————————————————————————————————————

🩺 Information intended for healthcare professionals only

Procedures for proper handling and disposal of anticancer medicinal products should be considered.

Instructions for dilution General precautions Proper aseptic technique throughout the handling of this medicinal product should be followed.

Ordspono contains no preservative and is intended for single -dose only. Discard any unused portion left in the vial. Do not shake.

Nature and contents of container 2 mg concentrate for solution for infusion 1 mL of concentrate for solution for infusion in a 2 mL Type I clear glass vial with a grey chlorobutyl stopper with coating and an aluminium seal cap with a dark blue flip-off button containing 2 mg o f odronextamab.

Pack of one vial.

80 mg concentrate for solution for infusion 4 mL of concentrate for solution for infusion in a 10 mL Type I clear glass vial with a grey chlorobutyl stopper with coating and an aluminium seal cap with a light green flip-off button containing 80 mg of odronextamab.

Pack of one vial.

320 mg concentrate for solution for infusion 16 mL of concentrate for solution for infusion in a 20 mL Type I clear glass vial with a grey chlorobutyl stopper with coating and an aluminium seal cap with a white flip -off button containing 320 mg of odronextamab.

Pack of one vial.

55 Instructions for dilution Visually inspect for particulate matter and discoloration prior to administration. Ordspono is a clear to slightly opalescent, colourles s to pale yellow solution. Discard the vial if the solution is cloudy, discoloured, or contains particulate matter.

Preparation of 0.2-mg dose

• Prepare Albumin (Human) in sodium chloride 9 mg/mL (0.9%) solution for injection in a 100 -mL intravenous bag [polyvinyl chloride (PVC) or polyolefin (PO)] as per Table 1 below.

− Note: Albumin (Human) is only required for the 0.2 -mg dose to prevent adsorption of odronextamab to the intravenous filter. When Albumin (Human) is used, please see Traceab ility in section 4.4.

• The final Albumin (Human) concentration should be 0.04%.

Table 1: Examples of Albumin (Human) concentration and volumes required for the 0.2 -mg dose Albumin (Human) concentrationa Albumin (Human) volume for addition to a 100 mL sodium chloride 9 mg/mL (0.9%) solution for injection, infusion bag 5% 0.8 mL 20% 0.2 mL 25% 0.16 mL a Albumin (Human): use concentration as per local availability. Examples include but are not restricted to the following strengths: 5%, 20%, or 25%.

• Mix the Albumin (Human) and sodium chloride 9 mg/mL (0.9%) solution for injection by gentle inversion. Do not shake.
• Obtain 1 vial of 2 mg Ordspono .
• Withdraw 0.1 mL from the 2 -mg Ordspono vial using a 1-mL syringe and add into the prepared 100-mL intravenous bag.
• Mix diluted solution by gentle inversion. Do not shake.

Preparation of 0.5-mg dose

• Obtain a 50 -mL intravenous bag (PVC or PO) containing sodium chloride 9 mg/mL (0.9%) solution for injection.
• Obtain 1 vial of 2 mg Ordspono.
• Withdraw 0.25 mL from the 2 -mg Ordspono vial using a 1-mL syringe and add into the 50-mL intravenous bag.
• Mix diluted solution by gentle inversion. Do not shake.

Preparation of 1-mg or above dose

• Obtain a 50 – or 100-mL intravenous bag (PVC or PO) containing sodium chloride 9 mg/mL (0.9%) solution for injection.
• Obtain the required number of vials and withdraw the appropriate volume of Ordspono.

− Refer to Table 2 for the specific volume for the intended dose. − Refer to Table 3 for the specific volume for dose modifications (see section 4.2 of the SmPC).

• Add the appropriate volume of Ordspono to the intravenous bag.
• Mix diluted solution by gentle inversion. Do not shake.

Summary tables for dilution prior to administration 56 Table 2: Ordspono volumes for addition to the infusion bag (standard doses) Ordspono dose (mg) Amount of Ordspono per vial (mg) Concentration of vial (mg/mL) Total volume of Ordspono to prepare dose (mL) Albumin (Human) required Sodium chloride 9 mg/mL (0.9%) solution for injection, infusion bag (PO or PVC) volume (mL) 0.2 2 2 0.1 Yes 100 0.5 2 2 0.25 No 50 2 2 2 1 No 50 or 100 10 2 2 5 No 50 or 100 80 80 20 4 No 50 or 100 160 80 20 8 No 50 or 100 320 320 20 16 No 50 or 100 Table 3: Other Ordspono volumes for addition to the infusion bag for dose modifications Ordspono dose (mg) Amount of Ordspono per vial (mg) Concentration of vial (mg/mL) Total volume of Ordspono (mL) Albumin (Human) required Sodium chloride 9 mg/mL (0.9%) solution for injection, infusion bag (PO or PVC) volume (mL) 1 2 2 0.5 No 50 or 100 5 2 2 2.5 No 50 or 100 40 80 20 2 No 50 or 100 For storage conditions of the diluted solution in infusion bags, see Storage below.

Method of administration Ordspono is for intravenous use after dilution only. Ordspono must be diluted using aseptic technique.

• The first cycle of Ordspono is administered as a 4 -hour infusion. If Ordspono is tolerated on Cycle 2, Day 1, infusion time can be reduced to 1 hour for all subsequent doses.
• Ordspono must not be administered as intravenous push or bolus.
• See Table 1 for premedications and post -medications.
• For doses that are not tolerated, refer to Tables 4, 5, and 6 for management guidance.

After Ordspono has been diluted as instructed above, administer as follows:

• Connect the prepared intravenous infusion bag containing the final Ordspono solution to intravenous tubing constructed of polyvinyl chloride (PVC), polyethylene (PE) -lined PVC, or polyurethane (PU). It is recommended to use a 0.2-micron or 5-micron polyethersulfone (PES) filter.
• Prime with Ordspono to the end of the intravenous tubing.
• Do not mix Ordspono with other medicinal products or concurrently administer other medicinal products through the same intravenous line.

57 • Upon completion of Ordspono infusion, flush the infusion line with adequate volume of sodium chloride 9 mg/mL (0.9%) solution for injection to ensure that the entire contents of the infusion bag are administered.

Storage Unopened vial Store in a refrigerator (2 °C to 8 °C).

Do not freeze.

Keep the vial in the original outer carton in order to protect from light.

Storage of diluted solution Chemical and physical in -use stability has been demonstrated for the diluted Ordspono infusion solution as follows:

• in a refrigerator (2 °C to 8 °C) for all doses for up to 24 hours.
• at room temperature (20 °C to 25 °C) for up to 6 hours for the 0.2-mg dose with Albumin (Human).
• at room temperature (20 °C to 25 °C) for up to 12 hours for doses of 0.5 mg or greater.

Discard diluted infusion solution if storage time exceeds these limits.

Disposal The release of pharmaceuticals into the environment should be minimised. Medicinal products should not be disposed of via wastewater and disposal through household waste should be avoided.

The following points should be strictly adhered to regarding the use and disposal of syringes and other medicinal sharps:

• Needles and syringes should never be reused.
• Place all used needles and syringes into a sharps container (puncture -proof disposable container).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Ordspono (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/24/1843).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.