Ropsine 7.5 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ropsine 7.5 mg/ml injection solution EFG

Ropivacaine, hydrochloride

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this 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 side 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 anaesthetics.

Ropsine 7.5 mg/ml injection solution EFG is used in adults and adolescents over 12 years of age to numb (anaesthetize) parts of the body. It is used to stop or relieve pain. It can be used for:

• Numbing a part of the body during surgery, including during caesarean section.
• Relieving pain during childbirth, after surgery, or after an injury.

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

Consult your doctor or pharmacist before using Ropsine.

In children up to and including 12 years of age, other concentrations (2 mg/ml, 5 mg/ml) may be more appropriate.

Special care must be taken to avoid any injection of Ropsine directly into a blood vessel to prevent any immediate toxic effects. The injection should 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, sometimes causing neurological symptoms).

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

Use of Ropsine with other medicines

Inform 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 plan 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 use of 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 mg of sodium (a main component of table/cooking salt) per ml. This corresponds to 0.15% of the maximum daily recommended sodium intake 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 produces adequate regional numbing (anesthesia) should be used.

The usual dose

• for adults and adolescents over 12 years of age is between 2 mg and 300 mg of ropivacaine hydrochloride.
• for infants and children (from 0 to 12 years of age, inclusive) is between 1–3 mg per kilogram of body weight.

Duration of treatment

Administration of ropivacaine hydrochloride usually lasts between 2 and 10 hours in the case of anesthesia prior to certain surgeries, and may last up to 72 hours when used for pain relief during or after surgery.

If you are given more Ropsine than you should

The first symptoms of receiving 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 cases 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 will experience 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 parts of the body;
• 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 was 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 (visual disturbances), speech difficulties (dysarthria), muscle stiffness and tremor, reduced sense of touch (hypoesthesia).
• Fainting (syncope).
• Difficulty breathing (dyspnoea).
• 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 nerve irritation from the needle or injection. This is usually temporary.
• 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 (anaesthetised).

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 ampoule or carton. 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 injection solution.

Normally, your doctor or hospital will store Ropsine and are responsible for maintaining the product 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 containers 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 7.5 mg/ml. Each polypropylene ampoule of 10 ml contains 75 mg of ropivacaine (as hydrochloride).

Each 20 ml polypropylene ampoule contains 150 mg of ropivacaine (as hydrochloride).

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

Appearance of the product and contents of the pack

Ropsine solution for injection is a sterile, isotonic, isobaric, clear, colorless, aqueous injectable solution.

Ropsine 7.5 mg/ml solution for injection EFG is available in clear polypropylene ampoules of 10 ml and 20 ml.

Pack size:

10 sterile ampoules in a plastic blister.

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

Date of the most recent revision of this leaflet: September 2023.

Detailed and up-to-date information on this medicinal product 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).

1. Hold the ampoule in an upright position and twist the neck to remove any residual solution.

Open by sharply twisting off the top portion of the ampoule.

2. The ampoule can be directly connected to a syringe as shown in Fig. 2.

The ampoules are compatible with both Luerfit and LuerLock syringes.

3. Hold the syringe with the ampoule upright. Without squeezing the ampoule, withdraw the solution. Maintain downward pressure on the syringe plunger after withdrawal of the solution and until the empty ampoule is discarded.

Shelf-life before first opening

3 years

Shelf-life after first opening

From a microbiological standpoint, 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 generally should not exceed 24 hours at 2–8°C.

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

The medicine 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.

The 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
Anesthesia in surgery
Lumbar epidural administration
Surgery	7.5	15–25	113–188	10–20	3–5
	10.0	15–20	150–200	10–20	4–6
Cesarean section	7.5	15–20	113–1501)	10–20	3–5
Thoracic epidural administration
Establish a block for postoperative pain relief	7.5	5–15 (depending on the level of injection)	38–113	10–20	--
Nerve trunk block*
Brachial plexus block	7.5	30–40	225–3002)	10–25	6–10
Peripheral block
For example, minor nerve blocks and infiltration	7.5	1–30	7.5–225	1–15	2–6
The doses listed in the table are those considered necessary to achieve an adequate block 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 required. Appropriate literature should be consulted regarding factors affecting specific block techniques and individual patient requirements.

• With regard to nerve trunk blocks, dosing recommendations can only be provided for the brachial plexus. For other nerve blocks, lower doses may be required. However, there is currently no experience to support specific dose recommendations for other blocks.
  1. The dose should be administered incrementally. An initial dose of approximately 100 mg (97.5 mg = 13 mL; 105 mg = 14 mL) should be administered over 3–5 minutes, and if necessary, two additional doses may be given, up to a total of 50 mg extra.
  2. The dose used for nerve trunk blocks must be adjusted according to the site of administration and the patient's condition. Interscalene and supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used (see section 4.4).

Generally, anesthesia for surgery (e.g., epidural administration) requires higher concentrations and doses. For surgical procedures requiring deep motor block, epidural anesthesia using Ropsine 10 mg/mL formulation is recommended. For analgesia (e.g., epidural administration for acute pain management), lower concentrations and doses are advised (2 mg/mL).

Method of administration

Perineural and epidural injection.

Careful aspiration is recommended before and during injection to prevent intravascular injection. When a higher dose is to be administered, 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 incrementally 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.

Single doses of up to 250 mg of ropivacaine hydrochloride have been used for epidural anesthesia in surgery 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 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 postoperative pain management, the following technique is recommended: Unless treatment with ropivacaine is initiated before surgery, an epidural block is induced with ropivacaine at a concentration of 7.5 mg/mL using an epidural catheter. Analgesia is maintained with a Ropsine 2 mg/mL infusion. 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 of moderate to severe postoperative pain. The maximum duration of epidural block is 3 days. However, close monitoring of analgesic effect is required to allow catheter removal as soon as pain permits. With this technique, a significant reduction in opioid requirements has been observed.

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

When prolonged peripheral nerve blocks are applied, 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, before 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.

Concentrations above 7.5 mg/mL of ropivacaine hydrochloride have not been studied in cesarean section procedures.

Pediatric population from 0 to 12 years of age inclusive

The use of Ropsine 7.5 mg/mL may be associated with systemic and central toxic events in children. Lower concentrations (2 mg/mL, 5 mg/mL) are more suitable for administration in this population.

The use of ropivacaine hydrochloride in premature neonates has not been studied for any route of administration.

Method of administration

Epidural 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 stopped immediately.

A single caudal epidural injection of 2 mg/mL ropivacaine hydrochloride at a dose of 2 mg/kg in a volume of 1 mL/kg provides ideal postoperative analgesia below T12 in most patients. The volume of the caudal epidural injection may be adjusted to achieve different sensory block distributions, as recommended in the literature. Doses of up to 3 mg/kg of a 3 mg/mL ropivacaine 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 fractionate the calculated local anesthetic dose, regardless of the route of administration.

If ropivacaine hydrochloride infusion is recommended, 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, as ropivacaine hydrochloride has low solubility at pH > 6.0.

Elimination

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