Ropsine 2 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ropsine 2 mg/ml solution for infusion EFG

Ropivacaine hydrochloride

Read the entire leaflet carefully before you start using this 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 should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Ropsine is and what it is used for
2. What you need to know before using Ropsine
3. How to use Ropsine
4. Possible adverse effects
5. How to store Ropsine
6. Contents of the pack and other information

1. What Ropsine is and what it is used for

Ropsine contains the active substance ropivacaine hydrochloride, which belongs to a class of medicines called local anesthetics.

Ropsine 2 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.

2. What you need to know before using Ropsine

Do not use Ropsine

• if you are allergic (hypersensitive) to ropivacaine hydrochloride, to any other amide-type local anaesthetic, or to any of the other ingredients of Ropsine (listed in section 6),
• if you have reduced blood volume (hypovolemia). This will be assessed by healthcare personnel,
• to inject into a blood vessel to numb a specific area of your body,
• to inject into the cervix to relieve pain during childbirth.

Warnings and precautions

Talk to your doctor or pharmacist before using Ropsine

• in newborn infants, as they are more sensitive to Ropsine.
• in children under 12 years of age, as the use of Ropsine injections for regional anaesthesia has not been established.

Special care must be taken to avoid any injection of Ropsine directly into a blood vessel to prevent any immediate toxic effects. The injection must not be administered into an inflamed area.

Inform your doctor:

• if you have poor general health due to age or other factors,
• if you have heart problems (partial or complete cardiac conduction block),
• if you have severe liver disease,
• if you have severe kidney problems.

Inform your doctor if you have any of these conditions, as your doctor may need to adjust your dose of Ropsine.

Inform your doctor:

• if you suffer from acute porphyria (a disorder affecting the production of red blood pigments, which sometimes causes neurological symptoms).

Inform your doctor if you or a family member has porphyria, as your doctor may need to use a different anaesthetic.

Using Ropsine with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Caution is required if you are receiving:

• Other local anaesthetics (e.g. lidocaine) or agents structurally related to amide-type local anaesthetics, such as certain medicines used to treat irregular heartbeats (arrhythmias), for example mexiletine or amiodarone,
• General anaesthetics or opioids, such as morphine or codeine,
• Medicines used to treat depression (e.g. fluvoxamine),
• Certain antibiotics (e.g. enoxacin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. It is unknown whether ropivacaine hydrochloride affects pregnancy or passes into breast milk.

Driving and using machines

Ropsine may cause drowsiness and affect your reaction time. Do not drive or operate tools or machinery after taking Ropsine until the following day.

Consult your doctor or pharmacist if you have any doubts.

Important information about some of the ingredients of Ropsine

This medicine contains 3.39 mg of sodium (a main component of table/cooking salt) per ml. This corresponds to 0.2% of the maximum daily recommended intake of sodium for an adult.

3. How to use Ropsine

Method of administration

Ropsine will be administered to you by your doctor. It will be given by injection.

Dosage

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

The smallest dose that can produce numbing (anesthesia) of the required area should be used.

The usual dose

• for adults and adolescents over 12 years of age is between 2 mg and 200 mg of ropivacaine hydrochloride.
• for infants and children (from 0 to 12 years of age, inclusive) is between 1–2 mg per kilogram of body weight.

Duration of treatment

Administration of ropivacaine hydrochloride usually lasts between 0.5 and 6 hours, but may last up to 72 hours in cases of pain relief during or after surgery.

If you are given more Ropsine than you should

The first symptoms of having received too much ropivacaine hydrochloride are usually related to:

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

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

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

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

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

4. Possible adverse effects

Like all medicines, Ropsine can cause adverse effects, although not everyone experiences them.

Important adverse effects to be aware of:

Sudden and potentially life-threatening allergic reactions (e.g., anaphylaxis, including anaphylactic shock) are rare and affect between 1 and 10 people in every 10,000. Possible symptoms include:

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

If you think Ropsine is causing you an allergic reaction, inform your doctor or healthcare professional immediately.

Other possible adverse effects:

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

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

Common (may affect up to 1 in 10 people)

• Headache, tingling (paraesthesia), dizziness.
• Slow or fast 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 is accidentally administered into a blood vessel, or if you have been given more Ropsine than intended (see also section 3 “If you are given more Ropsine than you should” above). These include seizures (convulsions, fits), dizziness or lightheadedness, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems, speech difficulties (dysarthria), muscle stiffness and tremor, reduced sense of touch (hypoesthesia).
• Fainting (syncope).
• Difficulty breathing (dyspnea).
• Low body temperature.

Rare (may affect up to 1 in 1,000 people)

• Heart attack, irregular heartbeat (arrhythmias).

Possible adverse effects observed with other local anaesthetics that could also be caused by Ropsine include:

• Numbness, due to irritation of nerves caused by the needle or the injection. This usually does not last long.
• Nerve damage. Rarely, this may lead to permanent problems.
• If too much Ropsine is administered into the spinal fluid, it may numb the entire body (anaesthetized).

Additional adverse effects in children

In children, adverse 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 is more common in children (affects more than 1 in 10 children).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ropsine

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

Do not use Ropsine after the expiry date stated on the bag. The expiry date refers to the last day of the month indicated.

Do not freeze.

Do not use Ropsine if you notice any precipitation in the injectable solution.

Ropsine is normally stored by your doctor or hospital, who are responsible for the product's quality if it is not used immediately after opening. They are also responsible for the proper disposal of any unused Ropsine.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ropsine

• The active substance 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 ingredients are sodium chloride, sodium hydroxide (for pH adjustment), and water for injections.

Nature of the product and pack contents

Ropsine infusion solution is a sterile, isotonic, isobaric, clear, colourless aqueous solution for infusion.

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

Pack sizes:

5 bags

10 bags

20 bags

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sintetica GmbH

Albersloher Weg 11

48155 Münster

Germany

Manufacturer:

Sintetica GmbH

Albersloher Weg 11

48155 Münster

Germany

Only for UK (NI):

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Date of the most recent revision of this summary: January 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

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This information is intended for healthcare professionals only:

Handling

Ropsine must be used by, or under the supervision of, physicians experienced in regional anaesthesia (see section 3).

Shelf life

Shelf life before first opening: 3 years

Shelf life after first opening:
From a microbiological point of view, the product should be used immediately. If not used immediately, storage during use and conditions prior to use are the responsibility of the user and should generally not exceed 24 hours at 2–8°C.

Ropsine medicinal products are preservative-free and intended for single use only. Any unused solution should be discarded.

The solution should be inspected visually before use. The solution should only be used if it is clear, practically free of particles, and if the container is intact.

An intact container must not be re-sterilized in an autoclave.

Dosage

Adults and adolescents over 12 years of age

The table below provides guidance on the most commonly used doses for different types of block. The smallest dose required to achieve effective blockade should be used. Clinical experience and knowledge of the patient's clinical condition are important factors in determining the dose.

Indication	Concentration mg/ml	Volume ml	Dose mg	Onset of action minutes	Duration hours
Lumbar epidural administration
Bolus	2.0	10–20	20–40	10–15	0.5–1.5
Intermittent injections (top-up) (e.g., labor pain management)	2.0	10–15 (minimum interval 30 minutes)	20–30	-	-
Continuous infusion (e.g., labor pain)	2.0	6–10 ml/h	12–20 mg/h	-	-
Postoperative pain management	2.0	6–14 ml/h	12–28 mg/h	-	-
Thoracic epidural administration
Continuous infusion (postoperative pain management)	2.0	6–14 ml/h	12–28 mg/h	-	-
Peripheral block
(e.g., minor nerve blocks and infiltration)	2.0	1–100	2.0–200	1–5	2–6
Peripheral nerve block (Femoral or interlaminar block)
Continuous infusion or intermittent injections (e.g., postoperative pain management)	2.0	5–10 ml/h	10–20 mg/h	-	-
The doses listed in the table are those considered necessary to achieve adequate blockade and should be regarded as usage recommendations for adults. Individual variations in onset and duration of action may occur. Figures in the “Dose” column reflect the expected average dose range. Appropriate literature should be consulted regarding factors affecting specific block techniques and individual patient requirements.

Route of administration

Perineural and epidural administration by injection.

Careful aspiration is recommended before and during administration to prevent intravascular injection. When a higher dose is to be injected, a test dose of 3–5 ml of 2% lidocaine (lignocaine) with adrenaline (epinephrine) 1:200,000 is advised. Accidental intravascular injection may be recognized by a transient 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 injected slowly or in incremental doses at a rate of 25–50 mg/minute, while continuously monitoring the patient's vital functions and maintaining verbal contact. If toxic symptoms occur, drug administration must be stopped immediately.

In epidural block for surgery, single doses of up to 250 mg of ropivacaine hydrochloride have been used and were 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 blocks are required, via continuous infusion or repeated bolus administration, the risks of achieving toxic plasma concentrations or inducing local neural injury must be considered. Cumulative doses of up to 675 mg of ropivacaine hydrochloride for surgery and postoperative analgesia administered over 24 hours were well tolerated in adults, as were continuous postoperative epidural infusions at rates of up to 28 mg/hour for 72 hours. In a limited number of patients, higher doses of up to 800 mg/day have been administered with relatively few adverse reactions.

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

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

When prolonged peripheral nerve blocks are performed, either via continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations or inducing local neural injury must be considered. In clinical studies, a femoral nerve block was established with 300 mg of ropivacaine hydrochloride 7.5 mg/ml and an interscalene block with 225 mg of ropivacaine hydrochloride 7.5 mg/ml, respectively, prior to surgery; analgesia was then maintained with ropivacaine hydrochloride 2 mg/ml. Infusion rates or intermittent injections of 10–20 mg per hour over 48 hours provided adequate analgesia and were well tolerated.

Pediatric patients aged 0 to 12 years inclusive

Indication	Concentration mg/ml	Volume ml/kg	Dose mg/kg
Single caudal epidural block	2.0	1	2
Inferior blocks to T12, in children with a body weight up to 25 kg
Continuous epidural infusion In children with a body weight up to 25 kg
0 to 6 months
Bolus dosea	2.0	0.5–1	1–2
Infusion up to 72 hours	2.0	0.1 ml/kg/h	0.2 mg/kg/h
6 to 12 months
Bolus dosea	2.0	0.5–1	1–2
Infusion up to 72 hours	2.0	0.2 ml/kg/h	0.4 mg/kg/h
1 to 12 years
Bolus doseb	2.0	1	2
Infusion up to 72 hours	2.0	0.2 ml/kg/h	0.4 mg/kg/h
The doses listed in the table should be considered as guidelines for use in pediatric patients. Individual variations exist. In children with higher body weight, a gradual dose reduction is often necessary, based on ideal body weight. The volume for single caudal epidural block and for bolus epidural doses should not exceed 25 ml in any patient. Appropriate literature should be consulted regarding factors affecting specific block techniques and individual patient requirements.

1. Lower end of the dose range is recommended for thoracic epidural blocks, whereas upper end of the dose range is recommended for lumbar or caudal epidural blocks.
2. Recommended for lumbar epidural block. It is appropriate to reduce the bolus dose for thoracic epidural analgesia.

Infants from 1 year to children up to 12 years of age:

The proposed doses of ropivacaine hydrochloride for peripheral nerve block in infants and children provide guidance for use in children without serious underlying 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 infants has not been documented.

Method of administration

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 occur, the injection must be immediately discontinued.

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

It is recommended to divide the calculated local anesthetic dose into fractions, regardless of the route of administration.

If ropivacaine hydrochloride infusion is indicated, Ropsine injectable solution may be used.

Incompatibilities

Compatibility with other solutions has not been investigated; therefore, this medicinal product must not be mixed with other medicinal products.

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 drugs:

Concentration of Ropsine: 1-2 mg/ml
Additive	Concentration*
Fentanyl citrate	1.0 – 10.0 µg/ml
Sufentanil citrate	0.4 – 4.0 µg/ml
Morphine sulfate	20.0 – 100.0 µg/ml
Clonidine hydrochloride	5.0 – 50.0 µg/ml

• The concentration ranges established in the table are broader than those used in clinical practice. Epidural infusions of Ropsine/citrate of sufentanil, Ropsine/morphine sulfate, and Ropsine/clonidine hydrochloride 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 standpoint, the mixtures should be used immediately; if not, the internal storage times and conditions prior to use are the responsibility of the handling personnel and should normally not exceed 24 hours at a temperature of 2°C to 8°C.

Elimination

Disposal of unused medication and of all materials that have been in contact with it should be carried out in accordance with local regulations.