Leaflet: information for the user

Ropsine2 mg/ml solution for EFG infusion

Ropivacaine hydrochloride

Read this leaflet carefully before you start using the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• 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 pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isRopsineand what it is used for

2. What you need to know before starting to useRopsine

3. Howto useRopsine

4. Possible side effects

5. Storage ofRopsine

6. Contents of the pack and additional information

Ropsinecontains the active ingredient ropivacaine hydrochloride, which belongs to a class of medications known as local anesthetics.

Ropsine2 mg/ml solution for infusion is used in adults and children of all ages for the treatment of acute pain. It numbs (anesthetizes) a part of the body, for example, after surgery.

No useRopsine

• if you areallergic(hypersensitive)to ropivacaine hydrochloride, to any other amide-type anesthetic or to any of the other components ofRopsine(listed in section 6),
• if you have adecreased blood volume(hypovolemia). This will be measured by healthcare personnel,
• toinject it into a blood vesselto numb a specific area of your body,
• toinject it into the cervixto relieve pain during childbirth.

Warnings and precautions

Consult your doctor or pharmacist before starting to useRopsine

• In newborns, as they are more susceptible toRopsine.
• In children under 12 years old,since the use ofRopsineinjections to numb a body part has not been established.

Special care must be taken toavoid any injectionofRopsinedirectly into a blood vesselto prevent any immediate toxic effect. The injection should not be made in an inflamed area.

Inform your doctor:

• if you have apoor general conditiondue to age or other factors,
• if you haveheart problems(partial or complete heart block),
• if you have anadvanced liver problem,
• if you havesevere kidney problems.

Inform your doctor if you have any of these problems, as your doctor will need to adjust yourRopsinedosage.

Inform your doctor:

• if you suffer fromacute porphyria(problems with the generation of red blood pigment, sometimes resulting in neurological symptoms).

Inform your doctor if you or a family member suffers from porphyria, as your doctor may need to use another anesthetic.

Use ofRopsinewith other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Caution should be exercised if you are receiving:

• Other local anesthetics(e.g., lidocaine) or structurally related agents, such as certain medications used to treat irregular heartbeats (arrhythmia), such as mexiletine or amiodarone,
• General anestheticsoropioids, such as morphine or codeine,
• Medications used to treatdepression(e.g., fluvoxamine),
• Certain antibiotics(e.g., enoxacina).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. The effect of ropivacaine hydrochloride on pregnancy or passage into breast milk is unknown.

Driving and operating machinery

Ropsinemay cause drowsiness and affect your reaction time. Do not drive or use tools or machines after takingRopsine, until the next day.

Consult your doctor or pharmacist if you have any doubts.

Important information about some of the components ofRopsine

This medication contains 3.39 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.2% of the maximum daily sodium intake recommended for an adult.

Administration Method

Ropsinewill be administered by your doctor. It will be administered via injection.

Dose

The recommended dose will depend on what it is being used for and also on your health, age, and weight.

The smallest dose that can produce an anesthetic effect in the required area should be used.

Usual Dose

• foradultsand adolescents over 12 years oldis between2 mg and 200 mgof ropivacaine hydrochloride.
• ininfantsand children(from 0 to 12 years old, inclusive)is between1-2 mg per kilogramof body weight.

Treatment Duration

The administration of ropivacaine hydrochlorideusuallylastsbetween0.5 and 6 hoursbutmay takeup to 72 hoursin case ofpain reliefduring or after surgery.

If moreRopsineis administered than it should be

The first symptoms of having received more ropivacaine hydrochloride than necessary are usually related to:

• hearing and vision,
• numbness around the mouth,
• dizziness or fainting,
• tingling,
• speech disorder characterized by poor articulation (dysarthria),
• muscle stiffness, muscle spasms, seizures,
• low blood pressure,
• slow or irregular heart rate.

These symptoms may precede a cardiac arrest, respiratory arrest, or severe seizures.

If you experience any of these symptoms or think you may have received too muchRopsine, inform your doctor or healthcare personnel immediately.

In case of acute toxicity, the appropriate corrective measures will be taken immediately by healthcare personnel.

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

Like all medicines,Ropsinecan cause side effects, although not everyone will experience them.

Important side effects to be aware of:

Severe and potentially life-threatening allergic reactions (such as anaphylaxis, including anaphylactic shock) are rare and affect 1 to 10 people per 10,000. Possible symptoms include:

• rapid onset of rash,itching or hives (urticaria);
• swelling of the face, lips, tongue, or other parts of the body;
• shortness of breath, wheezing, or difficulty breathing;
• and a feeling of loss of consciousness.

If you thinkRopsineis causing an allergic reaction, inform your doctor or healthcare professional immediately.

Other possible side effects:

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

• Low blood pressure(hypotension).This could make you feel dizzy or lightheaded.
• Feeling unwell(nausea).

Common(may affect up to 1 in 10 people)

• Headache, tingling (paresthesias), feeling of dizziness.
• Slow or rapid heartbeat(bradycardia, tachycardia).
• High blood pressure(hypertension).
• Feeling unwell(vomiting).
• Difficulty urinating(urinary retention).
• Back pain, high temperature, muscle stiffness.

Uncommon(may affect up to 1 in 100 people)

• Anxiety.
• Some symptoms may occur if the injection was administered by mistake into a blood vessel, or if you have been given too muchRopsine(see also section 3 “If you have been given too muchRopsine” earlier). These include seizures (convulsions, crisis), feeling of dizziness or lightheadedness,numbness of the lips and around the mouth,numbness of thetongue,hearing problems, vision problems (vision), speech problems (dysarthria), muscle stiffness and tremor, decreased sense of touch (hypoesthesia).
• Fainting (syncope).

• Difficulty breathing(dyspnea).
• Low body temperature.

Rare(may affect up to 1 in 1000 people)

• Heart attack, irregular heartbeat(arrhythmias).

Possible side effects observed with other local anesthetics that may also be produced byRopsineinclude:

• Numbness, due to nerve irritation caused by the needle or injection. This usually does not last long.
• Damage to nerves. Rarely,it may cause permanent problems.
• If too muchRopsineis administered into the spinal fluid, it may numb the entire body (anesthetized).

Additional side effects in children

In children,side effects are the same as in adults except for low blood pressure, which is less common in children(affects fewer than 1 in 10 children) and feeling unwell, which are more common in children(affects more than 1 in 10 children).

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://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.

Do not useRopsineafter the expiration date that appears on the package. The expiration date is the last day of the month indicated.

Do not freeze.

Do not useRopsineif you observe any precipitation in the injection solution.

Normally, your doctor or the hospital will storeRopsineand are responsible for the product quality if once opened it is not used immediately. They are also responsible for disposing of all unusedRopsinecorrectly.

Medicines should not be thrown down the drains, nor in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Composition of Ropsine

• The active principle is ropivacaine hydrochloride 2 mg/ml.

Each 100 ml polypropylene bag contains 200 mg of ropivacaine (as hydrochloride).

Each 200 ml polypropylene bag contains 400 mg of ropivacaine (as hydrochloride).

Each 250 ml polypropylene bag contains 500 mg of ropivacaine (as hydrochloride).

Each 500 ml polypropylene bag contains 1000 mg of ropivacaine (as hydrochloride).

• The other components are sodium chloride, sodium hydroxide (for pH adjustment), and water for injection preparations.

Appearance of the product and contents of the package

Ropsine solution for infusion is a transparent, colorless, sterile, isotonic, isobaric aqueous solution for infusion.

Ropsine 2 mg/ml solution for infusion is available in 100 ml, 200 ml, 250 ml, and 500 ml polypropylene bags.

Package size:

5 bags

10 bags

20 bags

Not all package sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder:

Sintetica GmbH

Albersloher Weg 11

48155 Münster

Germany

Responsible person for manufacturing:

Sintetica GmbH

Albersloher Weg 11

48155 Münster

Germany

Only for UK (NI):

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Last review date of this leaflet: January 2024.

The detailed and updated information on this medicine is available on 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 solely for medical professionals or healthcare professionals:

Handling

Ropsine should be used by, or under the supervision of, experienced anesthesiologists in regional anesthesia (see section 3).

Shelf life

Shelf life before opening

3 years

Shelf life after opening

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage during use and the conditions before use are the responsibility of the user and generally should not exceed 24 hours at 2-8°C.

Ropsine is a product without preservatives and is intended for single use. Discard any unused solution.

The medicine should be visually inspected before use. The solution should only be used if the solution is transparent, practically free of particles, and the package is intact.

The intact package should not be re-introduced into the autoclave.

Dosage

Adults and adolescents over 12 years of age

The table below is a guide to the most commonly used doses for the different types of blockage. Use the smallest dose required to produce an effective blockage. Clinical experience and knowledge of the patient's clinical condition are important factors in deciding the dose.

Administration route

Administration by perineural and epidural injection.

Before and during administration, careful aspiration is recommended to prevent intravascular administration. When a higher dose is to be administered, a test dose of 3-5 ml of lidocaine 2% (lignocaine) with adrenaline (epinephrine) 1:200,000 is recommended. Accidental intravascular injection can be recognized by a temporary increase in heart rate and accidental intrathecal injection by signs of spinal block.

Aspiration should be performed before and during administration of the main dose, which should be administered slowly or in incremental doses at a rate of 25-50 mg/minute, while constantly monitoring the patient's vital functions and maintaining verbal contact with the patient. If toxic symptoms appear, administration of the drug should be stopped immediately.

In epidural anesthesia for surgery, doses of up to 250 mg of ropivacaine hydrochloride have been well tolerated.

In a limited number of patients, a single dose of 300 mg has been used for brachial plexus block and was well tolerated.

When prolonged peripheral nerve blocks are applied, either through continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations or inducing local neural damage should be considered. Doses of up to 675 mg of ropivacaine hydrochloride administered over 24 hours were well tolerated in adults, as well as continuous postoperative epidural infusions at rates of up to 28 mg/hour for 72 hours. In a limited number of patients, doses of up to 800 mg/day have been administered with relatively few adverse reactions.

For postoperative pain treatment, the following technique is recommended: Unless treatment with Ropivacaine is initiated before the intervention, a block is induced with Ropivacaine at a concentration of 7.5 mg/ml using an epidural catheter. Analgesia is maintained with a continuous infusion of Ropsine 2 mg/ml. Infusion rates of 6-14 ml (12-28 mg) per hour provide adequate analgesia with only a slight and non-progressive motor block in most cases with moderate to severe postoperative pain. The maximum duration of the epidural block is 3 days. However, close monitoring of the analgesic effect should be performed to remove the catheter as soon as possible. With this technique, a significant reduction in the need for opioid use has been observed.

In clinical studies, a continuous epidural infusion of 2 mg/ml of ropivacaine hydrochloride alone or mixed with 1-4 μg/ml of fentanyl has been administered for postoperative pain treatment for up to 72 hours. This combination of ropivacaine hydrochloride and fentanyl provided better pain relief but caused opioid-type side effects; this combination has only been investigated for ropivacaine hydrochloride 2 mg/ml.

When applying prolonged peripheral nerve blocks, either through continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations or inducing local neural damage should be considered. In clinical studies, a femoral nerve block was established with 300 mg of ropivacaine hydrochloride 7.5 mg/ml and an interescaleno block with 225 mg of ropivacaine hydrochloride 7.5 mg/ml, respectively, before surgery; then analgesia was maintained with ropivacaine hydrochloride 2 mg/ml. Infusion rates or intermittent injections of 10-20 mg per hour for 48 hours provided adequate analgesia and were well tolerated.

Pediatric patients from 0 to 12 years of age inclusive

1. It is recommended to use the lower limit of the dose range for thoracic epidural blocks, while for lumbar or caudal epidural blocks, it is recommended to administer the upper limit of the dose.
2. Recommended for lumbar epidural block. It is appropriate to reduce the bolus dose for thoracic epidural analgesia.

Lactants from 1 year and children up to 12 years:

The proposed doses of ropivacaine hydrochloride for peripheral block in lactants and children provide guidelines for use in children without serious diseases. More conservative doses and close monitoring are recommended for children with serious diseases.

Single injections for peripheral nerve block (e.g. ilioinguinal nerve block, brachial plexus block) should not exceed 2.5-3.0 mg/kg.

Continuous infusion for peripheral nerve block is recommended at 0.2-0.6 mg/kg/h (0.1-0.3 ml/kg/h) for up to 72 hours.

The use of ropivacaine hydrochloride in premature children has not been documented.

Administration route

Epidural administration by injection.

Careful aspiration is recommended before and during injection to prevent intravascular injection. The patient's vital functions should be closely monitored during injection. If toxic symptoms appear, injection should be stopped immediately.

A single caudal epidural injection of 2 mg/ml of ropivacaine hydrochloride produces adequate postoperative analgesia below T12 in most patients when a dose of 2 mg/kg is used in a volume of 1 ml/kg. The volume of the caudal epidural injection can be adjusted to achieve a different distribution of sensory block, as recommended in the literature. Doses of up to 3 mg/kg of a concentration of ropivacaine hydrochloride 3 mg/ml have been studied in children over 4 years, but this concentration is associated with a higher incidence of motor block.

It is recommended to fractionate the calculated dose of local anesthetic, regardless of the administration route.

In the case of recommending infusion of ropivacaine hydrochloride, Ropsine solution for injection can be used.

Incompatibilities

No compatibility has been investigated with other solutions, so this medication should not be mixed with other medications.

Precipitation may occur in alkaline solutions since ropivacaine hydrochloride has low solubility at pH > 6.0.

Ropivacaine solution for infusion in polypropylene infusion bags is chemically and physically compatible with the following medications:

* The concentration ranges established in the table are wider than those used in clinical practice. Epidural infusions of Ropsine/citrate of sufentanil, Ropsine/sulfate of morphine, and Ropsine/chloride of clonidine have not been evaluated in clinical studies.

The mixtures are chemically and physically stable for a period of 30 days at temperatures of 20°C to 30°C. From a microbiological point of view, the mixtures should be used immediately; if not, the storage times and conditions before use are the responsibility of the person handling them and generally should not be prolonged more than 24 hours at 2°C to 8°C.

Elimination

The unused medication and all materials that have been in contact with it should be disposed of in accordance with local regulations.