Leaflet: information for the user

Fentanilo Kalceks 50 micrograms/ml injectable solution EFG

fentanilo

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

1. What isFentanilo Kalceksand what is it used for

2. What you need to know beforeyou are given Fentanilo Kalceks

3. Howyou will be given Fentanilo Kalceks

4. Possible side effects

5. Storage ofFentanilo Kalceks

6. Contents of the pack and additional information

Fentanilo Kalceks 50micrograms/ml, injectable solution is a liquid that is injected. Fentanilo is a substance that reduces pain and is responsible for the action of this medication. Fentanilo belongs to a group of potent narcotic analgesics, which are also known as opioid analgesics.

This medication will be administered to you during the surgical procedure to ensure that you do not feel pain.

You should not be givenFentaniloKalceks

• if you are allergic to fentanilo or any of the other components of this medication (listed in section6). Additionally, if you are hypersensitive to other potent analgesics (narcotics), you should not receive this medication.
• if your lungs do not function normally (without mechanical ventilation).

Warnings and precautions

After administration of this medication, your breathing may become excessively slow or weak. It is essential to inform your doctor immediately if this occurs. This can also happen during the postoperative period, so you will be under observation during this time.

Before Fentanilo Kalceks is administered to you,consult your doctor or nurseif:

• you have liver, kidney, or thyroid insufficiency;
• you have lung or respiratory disease;
• you use alcohol or drugs;
• you have any muscle disorder (myasthenia gravis);
• you are using certain medications for depression (see «Other medications and Fentanilo Kalceks»);
• in elderly or debilitated patients and in children (see section3);
• you or a family member has ever abused or been dependent on alcohol, prescription medications, or illegal drugs («addiction»);
• you are a smoker;
• you have ever had mood problems (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for another mental illness.

Inform your doctor if any of these warnings apply to you. You may require close medical monitoring when receiving this medication. You may also need a dose adjustment.

The repeated use of opioid analgesics can make the medication less effective (you become accustomed to it). It can also lead to dependence and abuse that may cause a potentially fatal overdose. If you are concerned about the possibility of becoming dependent on Fentanilo Kalceks, it is essential to consult your doctor.

If treatment is interrupted, withdrawal symptoms may occur. Inform your doctor or nurse if you believe you are experiencing this (see also section4. Possible adverse effects).

Children

There is no experience with the use of this medication in children under 2years. Therefore, it is not recommended to administer this medication to children under 2years.

Other medications and Fentanilo Kalceks

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication, including those obtained without a prescription.

It is especially important for the medications listed below, as it may be necessary to adjust the dose of this or other medications, or close monitoring may be required.

Inform your doctor if you are using or have used recently:

• certain medications for treating depression:

• selective serotonin reuptake inhibitors (SSRIs);
• serotonin and norepinephrine reuptake inhibitors (SNRIs);
• monoamine oxidase inhibitors (MAOIs).

When used together, they may produce changes in mood (e.g., agitation, hallucinations [perceiving things that are not there], coma), elevated body temperature above 38°C, rapid heart rate, unstable blood pressure, and hyperactive reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Your doctor will determine if this medication is suitable for you.

If you are using an MAOI, your doctor will suspend treatment with these medications at least 2 weeks before administering this medication.

• long-term potent analgesics;
• some analgesics for neuropathic pain (gabapentin and pregabalin);
• medications for treating psychosis or Parkinson's disease;

• sleeping pills;
• tranquilizers;
• antiepileptic medications (e.g., carbamazepine or phenytoin);
• medications for reducing anxiety;
• medications for certain mental illnesses;
• medications for fungal infections (e.g., fluconazole or voriconazole);

• ritonavir (medication for treating HIV infection). If you receive a single dose of fentanilo, your doctor will be especially vigilant and may prescribe a lower dose for prolonged use.

Fentanilo Kalceks with alcohol

Inform your doctor if you are using or have used recently alcohol or drugs.

Alcohol may increase certain effects of this medication. This medication also affects the effect of alcohol. For these reasons, do not drink alcohol before receiving this medication or the day after receiving this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

There is not enough knowledge about whether the use of this medication is harmful if you are pregnant. Fentanilo should not be used during delivery, including during cesarean section, as it may cause respiratory problems in the newborn.

Breastfeeding

The substance responsible for the effect of this medication passes into breast milk. Therefore, it is not recommended to breastfeed during the first 24 hours after administration of this medication. Do not use expressed breast milk during the 24 hours after administration of this medication. Consult your doctor.

Driving and operating machinery

Do not drive a car or any other vehicle and do not use machines or tools for at least 24 hours after receiving this medication, as it may affect your alertness and ability to drive. Your doctor will decide when you can drive again or operate hazardous machinery after receiving this medication.

Use in athletes

It is reported to athletes that this medication contains a component that may result in a positive analytical result in doping control.

Fentanilo Kalceks contains sodium

This medication contains less than 23 mg of sodium (1mmol) per 2ml ampoule; this is, essentially »sodium-free«.

This medication contains 35.41mg of sodium (main component of table salt) per 10ml ampoule. This corresponds to 1.78% of the maximum recommended daily sodium intake in the diet for an adult.

This medication is administered by injection into a vein.

Dosage

It is essential that you receive the correct amount of this medication. The dose may vary depending on age, body weight, physical condition, underlying diseases, other medications taken simultaneously, and the type of anesthesia and surgical intervention. Your doctor will determine the correct dose for you.

Adults

Typically, 4-12ml of this medication are administered just before the surgical intervention. If the doctor considers it necessary, an additional dose may be administered later.

Elderly and debilitated patients

The dose administered to elderly patients (65 years or older) or debilitated patients just before the surgical intervention is less than that indicated for other adults. If the doctor considers it necessary, an additional dose may be administered later.

Children 2 years of age and older

The dose administered to children just before the surgical intervention depends on the child's weight. If the doctor considers it necessary, an additional dose may be administered later.

Adolescents aged 12 to 17 years receive the same dose as adults.

Children under 2 years of age

There is no experience with the use of this medication in children under 2years. Therefore, it is not recommended to administer this medication in this age range.

Patients with renal problems

The doctor may decide to reduce the dose administered to patients with renal problems.

Obese patients

The dose administered to obese patients just before the surgical intervention may be lower than that indicated for other adults. If the doctor considers it necessary, an additional dose may be administered later.

If you use more Fentanilo Kalceks than you should

Since this medication will be administered by a healthcare professional, it is unlikely that you will receive too much. However, inform your doctor or nurse immediately if you experience shallow or slow breathing, or if your breathing stops temporarily.

A overdose may result in a brain disorder (known as toxic leukoencephalopathy).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects may be serious. If you have any of the side effects listed below, your doctor must decide whether your treatment should be stopped immediately:

Unknown frequency (cannot be estimated from available data):

• anaphylactic shock (severe allergic reaction to certain substances, characterized by the following as a result of sudden and severe dilation of blood vessels: sudden drop in blood pressure, pallor, restlessness, weak and rapid pulse, moist skin, and loss of consciousness);
• serotonin syndrome (syndrome with characteristics such as restlessness, hallucinations, coma, heart palpitations, unstable blood pressure, elevated body temperature, increased response to stimuli, poor coordination, stiffness, nausea, vomiting, and diarrhea).

Other side effects. Inform your doctor or nurse if any of the side effects worsen:

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

• nausea, vomiting;
• muscle stiffness.

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

• involuntary movements, drowsiness, dizziness;
• visual disturbances;
• slow heart rate, rapid heart rate, cardiac arrhythmias;
• low blood pressure, high blood pressure, vein pain;
• voice cord spasms, difficulty breathing due to spasms of the respiratory tract muscles, shallow or interrupted breathing;
• allergic skin inflammation;
• confusion after surgery, neurological disturbances due to anesthesia.

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

• agitation or euphoric mood;
• headache;
• superficial vein inflammation, fluctuations in blood pressure;
• hyperventilation, hiccups;
• difficulty swallowing;
• chills, low body temperature;
• respiratory problems due to anesthesia, agitation after surgery, complications resulting from the procedure.

Unknown frequency (cannot be estimated from available data):

• hypersensitivity (including skin rash with itching and extensive urticaria; hypersensitivity to the medication may cause a severe reaction in which blood vessels suddenly dilate, causing a drop in blood pressure and a rapid but weak heartbeat, characterized by pallor, restlessness, and moist skin);
• delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not there, sleep disturbances, nightmares);
• seizures, loss of consciousness, sudden muscle contraction (myoclonia);
• cardiac arrest;
• decreased respiratory force, depth, or frequency;
• itching;
• symptoms of withdrawal syndrome (may manifest as the appearance of the following side effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating).

Cases of serotonin syndrome have been reported when fentanyl was used with certain antidepressant medications (see section "Other Medications and Fentanil Kalceks").

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging to protect it from light. Do not freeze.

Do not use this medication after the expiration date that appears on the outer packaging or on the ampule after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Fentanyl Kalceks

• The active ingredient is fentanyl (as fentanyl citrate).

Each milliliter of solution contains 50 micrograms of fentanyl (as fentanyl citrate).

Each ampoule of 2 ml contains 100 micrograms of fentanyl (as fentanyl citrate).

Each ampoule of 10 ml contains 500 micrograms of fentanyl (as fentanyl citrate).

• The other components are sodium chloride, sodium hydroxide (for pH adjustment), and water for injection. This medication does not contain preservatives.

Appearance of Fentanyl Kalceks and packaging contents

Transparent and colorless injectable solution, without visible particles.

10 glass ampoules of 2 ml

10 glass ampoules of 10 ml

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

AS KALCEKS

Krustpils iela 71E, Riga, LV-1057, Latvia

Phone: +371 67083320

Email:[email protected]

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

EVER Pharma Therapeutics Spain SL

c/ Toledo 170

28005 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

NetherlandsFentanyl Kalceks 0.05 mg/ml oplossing voor injectie

AustriaFentanyl Kalceks 50Mikrogramm/ml Injektionslösung

BulgariaFentanyl Kalceks 50??????????/ml ??????????? ???????

CroatiaFentanil Kalceks

DenmarkFentanyl Kalceks

EstoniaFentanyl Kalceks

FinlandFentanyl Kalceks

GermanyFentanyl Kalceks 50 Mikrogramm/ml Injektionslösung

GreeceFENTANYL/KALCEKS

HungaryFentanyl Kalceks 50mikrogramm/ml oldatos injekció

IrelandFentanyl 50micrograms/ml solution for injection

ItalyFentanil Kalceks

NorwayFentanyl Kalceks

RomaniaFentanil Kalceks 50micrograme/ml solutie injectabila

SlovakiaFentanyl Kalceks 50mikrogramov/ml injekcný roztok

SloveniaFentanil Kalceks 50 mikrogramov/ml raztopina za injiciranje

SpainFentanilo Kalceks 50microgramos/ml solución inyectable EFG

SwedenFentanyl Kalceks

United Kingdom(Northern Ireland)Fentanyl 50micrograms/ml solutionfor injection

Last review date of this leaflet: March 2024

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended for healthcare professionals only:

Consult the Summary of Product Characteristics or Product Information for a complete description and other information.

Therapeutic indications

Fentanyl Kalceks 50micrograms/ml is an analgesic and anesthetic:

• for use as an opioid analgesic adjunct in general or local anesthesia;
• for administration with a neuroléptico.

Dosage and administration

Fentanyl Kalceks50micrograms/mlshould only be administered in an environment where it is possible to control the airways and by professionals who can monitor the airways (see the Summary of Product Characteristics section4.4).

The dose ofFentaniloKalceks 50micrograms/ml should be determined individually according to age, body weight, physical condition, underlying pathological condition, use of other drugs, and type of surgical and anesthetic intervention.

Adults

In the induction of anesthesia, 200 to 600micrograms (2.8 to 8.5micrograms/kg) corresponding to 4-12ml are usually injected intravenously. Doses greater than 200micrograms should only be administered with ventilation. Thirty to 45minutes after administration, additional intravenous doses of 50 to 200micrograms (0.7 to 2.8micrograms/kg), corresponding to 1‑4ml, can be administered for the maintenance of analgesia.

Children

Adolescents aged 12 to 17 years

Follow the dose indicated for adults.

Children aged 2 to 11 years

Generally, a dose of 1.25-2.5 micrograms/kg or 0.25‑0.5ml per 10kg of body weight is recommended for the induction of anesthesia in children. For the maintenance of analgesia, additional intravenous doses of 0.25ml per 10kg every 30‑45minutes can be administered.

Children under 2 years of age

There is no experience with the use of fentanyl in children under 2years of age.

Use in children

In children with spontaneous respiration, techniques that include analgesia should only be used as part of a general anesthetic technique or administered as part of a sedation/analgesia technique by experienced personnel and in an environment that allows for the treatment of sudden muscle rigidity (which may require intubation) or apnea (which may require ventilation) (see the Summary of Product Characteristics section4.4).

Use in the elderly

Like other opioids, the initial dose for the elderly (>65years) and debilitated patients should be reduced. The effect of the initial dose should be taken into account when determining additional doses.

Use in patients with renal insufficiency

In patients with renal insufficiency, a reduction in the dose of Fentanyl Kalceks 50micrograms/ml should be considered, and these patients should be closely monitored for signs of fentanyl toxicity (see the Summary of Product Characteristics section5.2).

Use in obese patients

In obese patients, there is a risk of overdose if the dose is calculated based on body weight. The dose for obese patients (BMI >30kg/m2) should be calculated based on estimated lean body mass rather than body weight only. For any subsequent dose adjustment, caution should be exercised based on the effect (see the Summary of Product Characteristics section5.2).

Administration

Administer by slow intravenous injection (over 1to 2minutes).

Contraindications

• Hypersensitivity to the active ingredient or to any of the excipients included in section 6, or to other opioids.
• Respiratory insufficiency without mechanical ventilation, due to the specific respiratory depressant effect of morphine-like drugs.

Special warnings and precautions for use

• Fentanyl should only be administered in an environment where it is possible to control the airways and by professionals who can monitor the airways.
• Like all potent opioids, fentanyl can cause significant respiratory depression that depends on the dose. After administration of fentanyl in doses greater than 200micrograms of fentanyl (4ml), significant respiratory depression will occur. This pharmacological effect can be reversed by naloxone, a specific opioid antagonist. In some cases, it may be necessary to repeat the dose of the opioid antagonist, as respiratory depression may last longer than the action of these antagonists. Deep analgesia is accompanied by manifest respiratory depression that may persist or recur in the postoperative period. Therefore, patients should be closely monitored. Resuscitation equipment and opioid antagonists should be readily available. Hyperventilation during anesthesia may alter the patient's response to CO2, affecting respiration in the postoperative period.
• Rigidity may occur, resulting in respiratory depression. The incidence may be reduced with a slow intravenous injection (which is usually sufficient for low doses). The reaction can be treated with mechanical ventilation, premedication with a benzodiazepine, and, if necessary, administration of muscle relaxants.
• When fentanyl is administered, it should be noted that anaphylactic reactions may occur.
• Myoclonic movements may occur.
• Bradycardia and cardiac failure may occur if the patient receives an insufficient amount of anticholinergic or when combining this medication with non-vagolytic muscle relaxants. Bradycardia can be treated with atropine.
• Opioids can cause hypotension, especially in patients with hypovolemia. Appropriate measures should be taken to maintain stable blood pressure.
• It should be avoided to inject opioids rapidly (in bolus) in patients with altered intracerebral compliance, as a transient reduction in mean arterial pressure has been accompanied by a reduction in cerebral blood flow for a short period.
• Patients receiving chronic treatment with opioids or those with opioid addiction may require higher doses.
• It is recommended to reduce the dose in elderly or debilitated patients. In cases of uncontrolled hypothyroidism, pulmonary disease, respiratory insufficiency, or alcoholism, the dose of opioids and patients with liver insufficiency should be carefully adjusted, as well as in patients with renal insufficiency, due to possible alterations in metabolism. Patients with renal insufficiency should be closely monitored for signs of fentanyl toxicity. The volume of distribution of fentanyl may vary as a result of dialysis, affecting plasma concentrations. These patients should be subjected to postoperative observation for a longer period.
• If this medication is administered with neurolépticos, the healthcare professional should be familiar with the specific properties of each drug, particularly the differences in duration of action. The risk of hypotension is higher when this combination is administered. Neurolépticos may cause extrapyramidal symptoms that can be counteracted with antiparkinsonian drugs, although the combination with these may increase the risk of tardive dyskinesia.
• Like other opioids, due to anticholinergic effects, the administration of fentanyl may cause an increase in biliary pressure and occasional spasms of the Oddi sphincter.
• In patients with myasthenia gravis, the use of certain anticholinergic and neuromuscular blocking agents should be carefully considered before and during the administration of a general anesthetic regimen that includes intravenous fentanyl administration.
• Care should be taken when administering this medication simultaneously with drugs affecting serotoninergic neurotransmitter systems.

Concomitant use of fentanyl with serotoninergic drugs, such as SSRIs and SNRIs, and monoamine oxidase inhibitors (MAOIs) may increase the risk of developing a potentially fatal serotonin syndrome.

The serotonin syndrome may include changes in mental status (e.g., agitation, hallucinations, or coma), autonomic instability (e.g., tachycardia, blood pressure fluctuations, or hyperthermia), neuromuscular changes (e.g., hyperreflexia, lack of coordination, or rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, or diarrhea).

If a serotonin syndrome is suspected, the treatment with this medication should be discontinued as soon as possible.

Tolerance and opioid use disorder (abuse and dependence)

Tolerance, physical and psychological dependence may occur after repeated administration of opioids.

Repeated use of opioids may lead to opioid use disorder (OUD). Intentional misuse or abuse of opioids may cause overdose and/or death. The risk of developing OUD increases in patients with personal or family history (parents or siblings) of substance use disorders (including alcohol use disorder), in active smokers, or in patients with personal history of other mental health disorders (e.g., major depression, anxiety, and personality disorders).

Withdrawal syndrome

Repeated administration at short intervals over prolonged periods may lead to the development of a withdrawal syndrome after treatment interruption, which may manifest as the appearance of the following adverse effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating.

Children

In children with spontaneous respiration, techniques that include analgesia should only be used as part of a general anesthetic technique or administered as part of a sedation/analgesia technique by experienced personnel and in an environment that allows for the treatment of sudden muscle rigidity (which may require intubation) or apnea (which may require ventilation).

Use in athletes

This medication contains fentanyl, which may produce a positive result in doping control tests.

Excipients

This medication contains:

7.08 mg of sodium less than 23 mg of sodium (1 mmol) per 2 ml ampoule, which is essentially "sodium-free."

35.41 mg of sodium per 10 ml ampoule, equivalent to 1.78% of the maximum recommended daily intake by the WHO of 2g of sodium for an adult.

Interactions with other medicinal products and other forms of interaction

Effect of other drugs on fentanyl

MAO inhibitors and other serotoninergic drugs

The coadministration of fentanyl with MAO inhibitors may produce paroxysmal stimulation of the CNS and hypertension. Simultaneous administration should be avoided, and treatment with MAO inhibitors should be interrupted as soon as possible for at least 2 weeks before starting treatment with this medication.

The concomitant use of fentanyl with serotoninergic drugs, such as SSRIs and SNRIs, and MAOIs may increase the risk of developing a potentially fatal serotonin syndrome.

If simultaneous use of this medication with SSRIs, SNRIs, or MAOIs is unavoidable, the patient's appearance of symptoms of serotonin syndrome should be closely monitored during coadministration.

The concomitant use of barbiturates, benzodiazepines, neurolépticos, halogenated anesthetics, gabapentinoids (gabapentin and pregabalin), and other non-selective CNS depressants (including alcohol) may potentiate the respiratory depression caused by opioids. If patients have received CNS depressants, the usual dose of fentanyl will be lower.

Fentanyl, a high-clearance active ingredient, is rapidly and extensively metabolized by CYP3A4. Itraconazole (a potent CYP3A4 inhibitor) administered at 200mg/day orally for 4 days did not have a significant effect on the pharmacokinetics of intravenous fentanyl. Oral administration of ritonavir (one of the most potent CYP3A4 inhibitors) reduced the clearance of intravenous fentanyl by two-thirds. However, plasma concentration peaks were not affected after a single intravenous dose of fentanyl.

The coadministration of fluconazole or voriconazole and fentanyl may increase fentanyl exposure by approximately 25% to 40%. During concomitant use of fluconazole or voriconazole and fentanyl, patients should be closely monitored, and the dose of fentanyl adjusted as necessary.

When fentanyl is administered orally in a single dose, special attention and observation of the patient are required when using potent CYP3A4 inhibitors, such as ritonavir, simultaneously. With continuous administration, it may be necessary to reduce the dose of fentanyl to avoid its accumulation, which, in some cases, increases the risk of prolonged or delayed respiratory depression.

Inducers of cytochrome P450 3A4 (CYP3A4)

A single injection of fentanyl with the administration of potent CYP3A4 inducers (e.g., carbamazepine or phenytoin) may decrease fentanyl plasma concentrations, reducing its efficacy. The patient should be closely monitored for signs of reduced analgesic effects if fentanyl is used with a strong CYP3A4 inducer. The dose of fentanyl may also be increased if necessary.

Effects of fentanyl on other medicinal products

The concomitant use of other drugs with CNS depressant effects, such as opioids, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antihistamines, and alcohol, may produce additive CNS depressant effects and may result in cases of hyperventilation, hypotension, and deep sedation or coma. Therefore, the use of fentanyl with any of these medications requires special attention and observation of the patient.

The concomitant use of fentanyl with etomidate increased etomidate plasma concentrations by a factor of 2‑3. During simultaneous use, the total plasma clearance and volume of distribution of etomidate decreased by a factor of 2 to 3 without any change in the half-life.

The concomitant administration of fentanyl and midazolam intravenously results in an increase in the terminal half-life and a decrease in the plasma elimination of midazolam. Exposure to midazolam increases approximately by 50%. The mechanism of interaction is competitive inhibition of CYP3A4 (see the Summary of Product Characteristics section5.2). When midazolam is administered concomitantly with fentanyl, the dose of midazolam may need to be reduced.

Incompatibilities

This medication should not be mixed with other medications.

Special precautions for disposal and other manipulations

For single use only. If used only in part, discard the remaining solution.

Protect fingers when opening an ampoule.

After the first opening: the medication should be used immediately.

Instructions for opening the ampoule:

1)Hold the ampoule with the color point upwards. If there is any solution left in the upper part of the ampoule, gently tap with the finger to allow all the solution to flow to the lower part.

2)Use both hands to open it, while holding the lower part of the ampoule with one hand, use the other hand to break the upper part of the ampoule in the opposite direction to the color point (see the images below).

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.