Package leaflet: Information for the patient

Ordspono 2 mg concentrate for solution for infusion, 80 mg concentrate for solution for infusion, 320 mg concentrate for solution for infusion

odronextamab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully 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 provide you with a Patient Card. Read it carefully and follow all instructions contained therein. Always carry this Patient Card with you.
Always show the Patient Card to your doctor or nurse when you see them, or if you go to hospital.
If you have any questions, ask your doctor, pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Ordspono is and what it is used for
What you need to know before you are given Ordspono
How Ordspono is administered
Possible side effects
How to store Ordspono
Contents of the pack and other information

1. What Ordspono is and what it is used for

Ordspono is a type of antibody and belongs to a class of anticancer medicines. 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 cell that protects against infections, called “B-cells”, becomes malignant. The abnormal B-cells do not function properly and grow too quickly. These cancerous B-cells replace normal B-cells in the bone marrow and lymph nodes.
Ordspono is administered to patients who have already received at least two prior treatments for FL or DLBCL, when the cancer has not responded (refractory) or has returned (relapsed).

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

Odronextamab binds to a target molecule present on B-cells, including cancerous B-cells, and to another target present on “T-cells”, a different type of white blood cell.
T-cells are another component of the body’s immune defenses capable of destroying abnormal or invading cells.
By linking T-cells and B-cells together, forming a bridge, Ordspono activates the T-cells to destroy the cancerous B-cells.
This helps control FL and DLBCL and prevents their spread.

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

Do not receive Ordspono

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

If you think you are allergic or are unsure, consult your doctor or nurse before receiving
Ordspono.
Warnings and precautions
Talk to your doctor or nurse before receiving Ordspono if:

you have ever had heart, lung, liver, or kidney problems
you have an infection or have had a past infection that lasted a long time or keeps recurring. Any infection must be treated before you receive Ordspono.
you have recently received a vaccine or are due to receive a vaccine in the near future. Some vaccines should not be given during treatment with Ordspono.

If any of the above apply to you, or if you have any doubts, speak to your doctor or
nurse before you are given Ordspono.
Immediately inform your doctor if you experience 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 and symptoms of each side effect are
listed in section 4 under “Serious side effects”.

Cytokine release syndrome (CRS): a condition that can occur with medicines that stimulate T-cells. CRS can be potentially life-threatening.
- Signs and symptoms of CRS may include fever, dizziness or feeling lightheaded, and difficulty breathing.
- Before or after certain infusions, you may be given medicines to help reduce the possible side effects of CRS.
- Your doctor will monitor how your treatment is working and will ask you to stay near a certified healthcare facility for at least 24 hours after each dose during the Ordspono dose escalation schedule and after the first full dose.
Infections: you may develop signs or symptoms of infection (e.g., fever, chills, cough, or pain when urinating), including potentially life-threatening infections that could be fatal.
- Signs and symptoms of infections may vary depending on where in the body the infection is located.
- While taking Ordspono, your doctor may prescribe another medicine to help prevent certain types of infections.
Effects on the nervous system: you may experience signs or symptoms such as confusion or problems with speech.
Tumour lysis syndrome: some people may develop unusually high levels of certain salts (such as potassium and uric acid) in the blood, due to the rapid breakdown of tumour cells during treatment.
- Your doctor or pharmacist will perform blood tests to check for this condition.
- Before each Ordspono infusion, you must be well hydrated and may be given medicines to help reduce high levels of uric acid.
- These measures may help reduce possible side effects of tumour lysis syndrome.
Lung inflammation (pneumonitis/lung interstitial disease): you may experience signs or symptoms such as new or worsening cough, shortness of breath

Children and adolescents
Ordspono must not be used in children and adolescents under 18 years of age, as
Ordspono has not been studied in this age group.
Other medicines and Ordspono
Inform your doctor if you are taking, have recently taken, or might take any other
medicines. This includes medicines purchased without a prescription and herbal medicines.
Pregnancy
Contraception
Women of childbearing potential must use an effective method of contraception during treatment and for 6 months after the last dose of Ordspono.
Breast-feeding
You must not breast-feed during treatment and for at least 6 months after the last treatment with Ordspono.
This is because it is not known whether Ordspono passes into breast milk and could therefore harm the baby.
Driving and using machines
Ordspono has a minor influence on your ability to drive vehicles, ride a bicycle, or use tools or machines. Some people may experience fatigue, dizziness, lightheadedness, or confusion while taking Ordspono. If you experience any symptoms that could affect your ability to drive, do not drive or operate tools or machinery until the symptoms have resolved. See section 4 for further information on side effects.
Ordspono contains polysorbate 80
The 2 mg vial of odronextamab contains 1 mg of polysorbate 80 in each 1 ml vial, equivalent to 1 mg/ml.
The 80 mg vial of odronextamab contains 4 mg of polysorbate 80 in each 4 ml vial, equivalent to 1 mg/ml.
The 320 mg vial of odronextamab contains 16 mg of polysorbate 80 in each 16 ml vial, equivalent to 1 mg/ml.
Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to administer Ordspono

Ordspono is administered under the supervision of a physician experienced in the administration of
such treatments. Follow the treatment schedule explained to you by your doctor. If in doubt, consult your doctor.
How to administer Ordspono
Ordspono is administered into a vein as an intravenous infusion (IV infusion).

For Cycles 1, 2, 3, and 4, each treatment cycle lasts 21 days.
Ordspono is administered over 4 hours on Day 1 of Cycle 1 and Cycle 2.
Subsequent doses may be administered over 1 hour if side effects are not too severe.
After Cycle 4, you will receive a maintenance dose every 2 weeks.

Medications administered before and after Ordspono treatment
You will be given other medications before and after Ordspono treatment on Days 1 and 8 of
Cycle 1 and Cycle 2. These medications help reduce the risk of serum sickness reactions (SSR) and infusion-related reactions (IRR). These medications may include:

Corticosteroids, including dexamethasone
Paracetamol
An antihistamine, such as diphenhydramine

After Day 8 of Cycle 2, your doctor will decide whether you should continue taking other medications to help reduce the side effects of Ordspono during subsequent cycles.
Dose of Ordspono administered
For the treatment of follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL), a
treatment cycle with Ordspono from Cycles 1, 2, 3, and 4 lasts 21 days.
In Cycle 1, you will receive 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 receive a dose on Days 1, 8, and 15:

for follicular lymphoma: 80 mg
for diffuse large B-cell lymphoma: 160 mg

If your Ordspono dose is delayed for any reason, you may need to restart treatment from Cycle 1.
One week after completion of Cycle 4, you will receive 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 tumor has remained in remission for at least 9 months, your doctor may decide to reduce the frequency of administration from every 2 weeks to every 4 weeks.
Your doctor may continue treatment for as long as you continue to respond to Ordspono,
or until side effects become too severe. Your doctor may delay or permanently discontinue your treatment with Ordspono if you experience certain side effects.
If you miss an appointment
If you miss an appointment, reschedule immediately. To ensure full effectiveness of treatment, it is very important not to miss a dose.
If Ordspono administration is stopped
Treatment with Ordspono should not be interrupted unless discussed with your doctor.
This is because stopping treatment may worsen your condition.
If you have any questions about the use of this medicine, consult 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 occur at any time during or even after treatment has ended.

Serious side effects
Contact your doctor immediately if you notice any of the following serious side effects. You may experience only one or some of these symptoms.

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

fever (temperature equal to or greater than 38°C)
feeling dizzy or lightheaded
rapid or irregular heartbeat
difficulty breathing
chills or shaking
headache

Infections (very common: may affect more than 1 in 10 people)
Signs and symptoms may include:

fever (temperature equal to or greater than 38°C)
chills or shaking
cough or shortness of breath
sore throat
pain during urination

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

COVID-19
lung infection (pneumonia)
cytomegalovirus infection, which can cause serious complications in people with weakened immune systems
infection of the nose and throat (upper respiratory tract infection)
infection of the parts of the body involved in collecting and passing urine (urinary tract infection)
herpes virus infection

Common infections (may affect up to 1 in 10 people):

respiratory tract infection
fungal infection
inflammation of the sinuses (sinusitis)
blood infection (sepsis)
bacteria in the blood (bacteremia)

Nervous system effects (uncommon: may affect up to 1 in 100 people)
Signs and symptoms may include:

headache
dizziness
reduced brain function, such as difficulty thinking
feeling anxious
feeling confused

Tumour lysis syndrome (uncommon: may affect up to 1 in 100 people)
Signs and symptoms may include:

weakness
shortness of breath
feeling confused
irregular heartbeat
muscle cramps

Lung inflammation (pneumonitis/lung interstitial disease) (common: may affect up to 1 in 10 people)
Signs and symptoms may include:

shortness of breath
new or worsening cough

If you experience any of these signs or symptoms during or after treatment with Ordspono, inform your doctor immediately. You may require medical treatment.

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

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

Fever (pyrexia)
Muscle or bone pain (musculoskeletal pain)
Feeling of tiredness (fatigue)
Diarrhoea
Rash
Cough
Swelling of hands, ankles or feet (oedema)
Feeling unwell (nausea)
Stomach pain (abdominal pain)
Constipation
Infusion-related reactions (IRR)
Reduced feeling of hunger (decreased appetite)
Difficulty sleeping (insomnia)
Low blood pressure (hypotension)
Headache
Feeling short of breath at rest or during physical activity (dyspnoea)
Vomiting

What may be observed in blood tests:

Low number of red blood cells (anaemia), which may cause tiredness or shortness of breath
Low levels of certain types of white blood cells (neutropenia, leucopenia, lymphopenia), which may increase the risk of infection
Low platelet count (thrombocytopenia), which may increase the likelihood of bruising or bleeding
Low levels of potassium, sodium or phosphate (hypokalaemia, hyponatraemia or hypophosphataemia)
High blood sugar levels (hyperglycaemia)
Elevated levels of alanine aminotransferase or aspartate aminotransferase in the blood

Common (may affect up to 1 in 10 people):

Rapid or irregular heartbeat (tachycardia)
Weakness, numbness, and pain, usually affecting hands and feet (peripheral neuropathy)
Confusion, disorientation, drowsiness (changes in mental status)
A condition that may cause inflammation of lung tissue and affect your ability to breathe (interstitial lung disease)
Fever due to low levels of neutrophils (a type of white blood cell)

What may be observed in blood tests:

Elevated levels of gamma-glutamyl transferase, an enzyme found mainly in the liver
Low levels of magnesium (hypomagnesaemia)
Low levels of albumin (hypoalbuminaemia)
Increased levels of bilirubin, which may cause yellowing of the skin or eyes and dark-coloured urine

Uncommon (may affect up to 1 in 100 people):

Difficulty speaking (aphasia)
Rapid breakdown of tumour cells called tumour lysis syndrome. This may cause chemical changes in the blood and organ damage, including to the kidneys, heart, and liver
Effects on the nervous system with symptoms that may include confusion or reduced attention (immune effector cell-associated neurotoxicity syndrome or neurotoxicity)

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

5. How to store Ordspono

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 packaging and on the 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 intended for their use.
Unopened vial
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Diluted solution
The chemical and physical in-use stability has been demonstrated for diluted Ordspono infusion solution as follows:

in a refrigerator (from 2°C to 8°C) for all doses up to 24 hours.
at room temperature (from 20°C to 25°C) for a maximum of 6 hours for the 0.2 mg dose with albumin (human).
at room temperature (from 20°C to 25°C) for a maximum of 12 hours for doses of 0.5 mg or higher.

Discard the diluted infusion solution if the storage time exceeds these limits.
From a microbiological standpoint, the product should be used immediately. Otherwise, the in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at a temperature between 2°C and 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Your doctor will dispose of any unused medicines appropriately. These measures will help protect the environment.

6. Package contents and other information

What Ordspono contains

The active substance is odronextamab.
Ordspono 2 mg: each vial contains 2 mg of odronextamab (in 1 ml of concentrate) at a concentration of 2 mg/1 ml.
Ordspono 80 mg: each vial contains 80 mg of odronextamab (in 4 ml of concentrate) at a concentration of 20 mg/1 ml.
Ordspono 320 mg: each vial contains 320 mg of odronextamab (in 16 ml of concentrate) at a concentration of 20 mg/1 ml.

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

Description of the appearance of Ordspono and contents of the pack
Ordspono concentrate for solution for infusion (sterile concentrate) is supplied as a solution ranging from transparent to slightly opalescent, colourless to pale yellow, 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

For further information about this medicinal product, 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

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 medicinal product has been granted a marketing authorisation “subject to additional conditions”. This means that further data on this medicinal product must be provided.
The European Medicines Agency will review new information on this medicinal product at least annually, and this package leaflet will be updated as necessary.
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu .

The following information is intended exclusively for healthcare professionals:

Procedures for the proper handling and disposal of antineoplastic medicinal products must be considered.
Instructions for dilution
General precautions
An appropriate aseptic technique must be maintained throughout the entire handling process of this medicinal product. Ordspono does not contain preservatives and is intended for single-dose use only. Any unused portions remaining in the vial must be discarded. Do not shake.
Nature and contents of the container
2 mg concentrate for solution for infusion
1 ml of concentrate for solution for infusion in a 2 ml clear type I glass vial with a grey chlorobutyl stopper, coated and sealed with an aluminium cap with a dark blue flip-off button containing 2 mg of odronextamab.
Packaged in a single vial.
80 mg concentrate for solution for infusion
4 ml of concentrate for solution for infusion in a 10 ml clear type I glass vial with a grey chlorobutyl stopper, coated and sealed with an aluminium cap with a light green flip-off button containing 80 mg of odronextamab.
Packaged in a single vial.
320 mg concentrate for solution for infusion
16 ml of concentrate for solution for infusion in a 20 ml clear type I glass vial with a grey chlorobutyl stopper, coated and sealed with an aluminium cap with a white flip-off button containing 320 mg of odronextamab.
Packaged in a single vial.
Instructions for dilution
Prior to administration, visually inspect the solution for particulate matter and discoloration. Ordspono is a solution ranging from clear to slightly opalescent, colourless to pale yellow. Discard the vial if the solution is cloudy, discoloured, or contains particulate matter.
Preparation of the 0.2 mg dose

Prepare human albumin in 9 mg/ml (0.9%) sodium chloride for injection solution in a 100 ml intravenous infusion bag [polyvinyl chloride (PVC) or polyolefin (PO)] as indicated in Table 1 below.
- Note: Human albumin is required only for the 0.2 mg dose to prevent adsorption of odronextamab to the intravenous filter. When using human albumin, refer to Traceability in section 4.4.
The final concentration of human albumin must be 0.04%.

Table 1: Examples of concentration and volumes of human albumin required for the 0.2 mg dose

Concentration of albumin (human)a	Volume of albumin (human) to be added to 100 ml of sodium chloride 9 mg/ml (0.9%) injection solution, infusion bag
5%	0.8 ml
20%	0.2 ml
25%	0.16 ml
Concentration of albumin (human)a	Volume of albumin (human) to be added to 100 ml of sodium chloride 9 mg/ml (0.9%) injection solution, infusion bag
aAlbumin (human): use the concentration according to local availability. Examples include, but are not limited to, the following concentrations: 5%, 20%, or 25%.

Mix the injectable solution of albumin (human) and sodium chloride 9 mg/ml (0.9%) by gently inverting it. Do not shake.
Obtain 1 vial of Ordspono 2 mg.
Withdraw 0.1 ml from the 2 mg Ordspono vial using a 1 ml syringe and add it to the prepared 100 ml intravenous infusion bag.
Mix the diluted solution by gently inverting it. Do not shake.

Preparation of the 0.5 mg dose

Obtain a 50 ml intravenous bag (PVC or PO) containing sodium chloride 9 mg/ml (0.9%) injectable solution.
Obtain 1 vial of Ordspono 2 mg.
Withdraw 0.25 ml from the 2 mg Ordspono vial using a 1 ml syringe and add it to the 50 ml intravenous bag.
Mix the diluted solution by gently inverting it. Do not shake.

Preparation of the 1 mg or higher dose

Obtain an intravenous bag of 50 or 100 ml (PVC or PO) containing sodium chloride 9 mg/ml (0.9%) injectable solution.
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 adjustments (see section 4.2 of the SmPC).
Add the appropriate volume of Ordspono to the intravenous infusion bag.
Mix the diluted solution by gently inverting it. Do not shake.

Summary tables for dilution prior to administration
Table 2: Volumes of Ordspono to be added to the infusion bag (standard doses)

Dose of Ordspono (mg)	Amount of Ordspono per vial (mg)	Vial concentration (mg/ml)	Total volume of Ordspono to prepare the dose (ml)	Albumin (human) required	Sodium chloride 9 mg/ml (0.9%) injectable solution, infusion bag volume (PO or PVC) (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 volumes of Ordspono to be added to the infusion bag for dose adjustments
of the dose

Dose of Ordspono (mg)	Amount of Ordspono per vial (mg)	Concentration per vial (mg/ml)	Total volume of Ordspono (ml)	Human albumin required	Sodium chloride 9 mg/ml (0.9%) injectable solution, infusion bag volume (PO or PVC) (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 the Storage section below.

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

The first cycle of Ordspono should be administered as a 4-hour infusion. If Ordspono is tolerated, on Day 1 of Cycle 2 the infusion time may be reduced to 1 hour for all subsequent administrations.
Ordspono must not be administered as a rapid intravenous injection or intravenous bolus.
See Table 1 for premedications and post-medications.
For management of doses not tolerated, refer to Tables 4, 5, and 6.

After diluting Ordspono as indicated above, administer as follows:

Connect the prepared intravenous infusion bag containing the final Ordspono solution to an intravenous tubing made of polyvinyl chloride (PVC), PVC coated with polyethylene (PE), or polyurethane (PU). Use of a 0.2 micron or 5 micron polyethersulfone (PES) filter is recommended.
Prime Ordspono to the end of the intravenous tubing.
Do not mix Ordspono with other medicinal products, nor administer other medicinal products through the same intravenous line.
At the end of the Ordspono infusion, flush the infusion line with an adequate volume of 9 mg/ml (0.9%) sodium chloride injection solution to ensure that the entire content of the infusion bag is delivered.

Storage
Unopened vial
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Keep the vial in the outer packaging to protect from light.

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

In a refrigerator (from 2°C to 8°C) for up to 24 hours for all doses.
At room temperature (from 20°C to 25°C) for up to 6 hours for the 0.2 mg dose with albumin (human).
At room temperature (from 20°C to 25°C) for up to 12 hours for doses of 0.5 mg or higher.

Discard the diluted infusion solution if the storage time exceeds these limits.

Disposal
The release of pharmaceutical products into the environment should be minimized. Medicinal products must not be disposed of via wastewater, and disposal through household waste should be avoided.

The following points must be strictly observed for the use and disposal of syringes and other sharp objects:

Needles and syringes must never be reused.
Place all needles and syringes into a sharps container (puncture-resistant disposal container).

Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

ORDSPONO