Ropsine 10 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ropsine 10 mg/ml solution for injection EFG

Ropivacaine, hydrochloride

Read the entire leaflet carefully before you start using the medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are 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 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 10 mg/ml solution for injection 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 may be used for:

• Numbing a part of the body during surgery, including 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 professionals,
• 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 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. Injection should not be performed in an inflamed area.

Tell 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.

Tell 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 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 needed 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 not known 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 2.8 mg of sodium (a main component of table/cooking salt) per ml. This is equivalent to 0.14% 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 as an 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 anaesthesia (numbing) 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 anaesthesia prior to certain surgeries, and may last up to 72 hours for pain relief during or after surgery.

If you are given more Ropsine than you should

The first signs that you have been given more ropivacaine hydrochloride than intended are usually related to:

• ear and vision problems,
• numbness around the mouth,
• dizziness or fainting,
• tingling,
• speech disturbances 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 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 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 sensations (paresthesia), 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, speech difficulties (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 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 caused by the needle or 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, the 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 the quality of the product 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 10 mg/ml. Each 10 ml polypropylene ampoule contains 100 mg of ropivacaine (as hydrochloride).

Each 20 ml polypropylene ampoule contains 200 mg of ropivacaine (as hydrochloride).

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

Appearance of the product and contents of the pack

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

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

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 review of this leaflet: September 2023.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (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 dislodge any residual solution.

Open by snapping off the top of the ampoule sharply.

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

Ampoules fit both Luerfit and LuerLock syringes.

1. Hold the syringe with the ampoule pointing upwards. Without squeezing the ampoule, withdraw the solution. Maintain downward pressure on the syringe plunger after the solution has been withdrawn and until the empty ampoule is discarded.

Shelf life before first opening:

3 years

Shelf life after opening:

From a microbiological standpoint, the product should be used immediately. If not used immediately, storage 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 from particles, and the container is intact.

The intact container must not be re-sterilised in an autoclave.

Dosage

Adults and adolescents over 12 years of age

The table shown below is a guide to the most commonly used doses in different types of block. The smallest dose required to achieve effective block should be used. Clinical experience and knowledge of the patient's clinical condition are important factors when 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 injection level)	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 produce 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 block, dosage recommendations can only be given 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 block should 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 in 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 treatment of acute pain), lower concentrations and doses are advised.

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 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 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.

In epidural block for surgery, single doses of up to 250 mg of ropivacaine hydrochloride have been used and were well tolerated.

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

When prolonged blocks are required, via continuous infusion or repeated bolus administration, the risks of reaching 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 postoperative pain treatment, the following technique is recommended: Unless treatment with ropivacaine is initiated prior to surgery, an epidural block is induced using a 7.5 mg/ml concentration via 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 with moderate to severe postoperative pain. The maximum duration of epidural block is 3 days. However, close monitoring of analgesic effect is required to remove the catheter as soon as pain allows. 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 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 been studied only with ropivacaine hydrochloride 2 mg/ml.

When prolonged peripheral nerve blocks are applied, either via continuous infusion or repeated injections, the risks of reaching 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.

Pediatric population from 0 to 12 years of age inclusive

The use of Ropsine 10 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 produces ideal post-surgical 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 distributions of sensory block, as recommended in the literature. Doses up to 3 mg/kg of a 3 mg/ml concentration of ropivacaine hydrochloride 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 all materials that have come into contact with it must be carried out in accordance with local regulations.