Ropivacaine Altan 7.5 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ropivacaine Altan 7.5 mg/ml solution for injection EFG

ropivacaine hydrochloride

Read the entire 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, pharmacist or nurse.
• 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 could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Ropivacaína Altan is and what it is used for

Ropivacaína Altan contains ropivacaine hydrochloride, which belongs to a group of medicines called amide-type local anesthetics.

Ropivacaína Altan is indicated in adults and children over 12 years of age to numb (anesthetize) specific parts of the body. It is used to block pain or provide pain relief. It can be used for:

• Numbing parts of the body during surgery, including cesarean deliveries.
• Relieving pain during labor, after surgery, or after an injury.

2. What you need to know before using Ropivacaine Altan

Do not use Ropivacaine Altan

• If you are allergic to ropivacaine, to other amide-type local anesthetics (such as lidocaine or bupivacaine), or to any of the other ingredients of this medicine (listed in section 6).
• For intravenous regional anesthesia (injection into a blood vessel to numb a specific area of your body) or obstetric paracervical anesthesia (injection into the cervix to relieve pain during childbirth).
• If you have reduced blood volume (hypovolemia), as you may develop a drop in blood pressure.

If you are unsure whether any of the above apply to you, consult your doctor before being administered Ropivacaine Altan.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Ropivacaine Altan:

• If you have heart, liver, or kidney problems. Your doctor may need to adjust the dose of Ropivacaine Altan.

• If you or a family member has ever been diagnosed with a rare blood pigment disorder called "porphyria." Your doctor may need to administer a different anesthetic.

• About any medical condition or health problem you have.

Children and adolescents

The use of Ropivacaine Altan has not been studied in premature infants.

Use extra caution with Ropivacaine Altan:

In children up to and including 12 years of age, as certain injections to numb body parts have not been established in young children. Other concentrations (2 mg/ml) may be more appropriate.

Use of Ropivacaine Altan with other medicines

Inform your doctor if you are currently using, have recently used, or might need to use any other medicines, including over-the-counter medications and herbal products. This is because Ropivacaine Altan may affect how some medicines work, and some medicines may affect Ropivacaine Altan.

In particular, inform your doctor if you are taking any of the following medicines:

• Other local anesthetics
• Strong painkillers such as morphine or codeine
• Medicines used to treat irregular heartbeat (arrhythmia), such as lidocaine and mexiletine

Your doctor needs to know if you are taking these medicines in order to calculate the correct dose of Ropivacaine Altan.

Also inform your doctor if you are taking any of the following medicines:

• Medicines used to treat depression (such as fluvoxamine)
• Antibiotics used to treat bacterial infections (such as enoxacin)

This is because your body eliminates Ropivacaine Altan more slowly when taking these medicines. If you are taking any of these medicines, prolonged use of Ropivacaine Altan should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or nurse before being administered this medicine.

Ropivacaine Altan should not be used during pregnancy or breastfeeding unless clearly necessary, as determined by your doctor.

It is unknown whether ropivacaine hydrochloride affects pregnancy or passes into breast milk.

Driving and using machines

Ropivacaine Altan may cause drowsiness and affect your reaction speed. Do not drive or operate tools or machinery after receiving Ropivacaine Altan until the following day.

Ropivacaine Altan contains sodium

This medicine contains 3.15 mg of sodium (the main component of table/cooking salt) per ml. This corresponds to 0.16% of the maximum daily recommended sodium intake for an adult.

3. How to use Ropivacaine Altan

Method of administration

Ropivacaine Altan must be administered by a physician or, occasionally, by a nurse under the supervision of a physician.

Dosage

The dose your doctor administers will depend on the type of pain relief you require. It will also depend on your physical build, age, and general health condition.

Ropivacaine Altan will be given to you as an injection. The part of the body where it will be administered depends on the reason for which Ropivacaine Altan is being used. Your doctor will administer Ropivacaine Altan in one of the following sites:

• The part of the body that needs to be numbed.
• Near the part of the body that needs to be numbed.
• In an area distant from the part of the body that needs to be numbed. This is the case when you receive an epidural injection or infusion (into the area surrounding the spinal cord).

When Ropivacaine Altan is administered in any of these ways, it prevents nerves from transmitting pain signals to the brain. You will no longer feel pain, heat, or cold in the treated area, but you may still perceive other sensations such as pressure or touch.

Your doctor will determine the most appropriate method for administering this medicine.

If you are given more Ropivacaine Altan than you should

Serious side effects resulting from receiving too much Ropivacaine Altan require special treatment, and your doctor is trained to manage such situations.

The first signs that too much Ropivacaine Altan has been administered are usually:

• Dizziness or lightheadedness.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing disturbances.
• Vision problems.

Your doctor will stop administering Ropivacaine Altan as soon as these signs appear to reduce the risk of serious adverse effects. If you experience any of these symptoms, or think you have received too much Ropivacaine Altan, inform your doctor immediately.

More serious adverse effects from receiving excessive amounts of Ropivacaine Altan include speech difficulties, muscle spasms, tremors, seizures, fits, and loss of consciousness.

If you experience any of these symptoms or suspect you may have received too much Ropivacaine Altan, inform your doctor or healthcare professional immediately. In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20.

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 medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Important adverse effects to be aware of:

Sudden, potentially life-threatening allergic reactions (e.g. anaphylaxis, including anaphylactic shock) are rare and affect between 1 and 10 people in 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 fainting. If you think Ropivacaine Altan is causing you an allergic reaction, inform your doctor immediately.

Other possible adverse effects:

Other possible side effects include:

• Numbness, due to nerve irritation caused by the needle or injection. This is usually not long-lasting.
• Involuntary muscle movements (dyskinesia).

Possible adverse reactions observed with other local anaesthetics that could also occur with Ropivacaine Altan include:

• Nerve damage. Rarely (affects 1 to 10 users out of 10,000), it may cause permanent problems.
• If too much Ropivacaine Altan is administered into the spinal fluid, it may numb the entire body (anaesthetized).
• Receiving an epidural injection (injection into the space surrounding the spinal nerves) may cause disruption of a nerve pathway from the brain to the head and neck, especially in pregnant women, which may sometimes lead to a condition called Horner's syndrome. It is characterized by decreased pupil size, drooping of the upper eyelid, and inability of sweat glands to produce sweat. This will resolve on its own once treatment is stopped.

Children

In children, adverse reactions are the same as in adults, except for low blood pressure, which occurs less frequently in children (affects 1 to 10 children out of 100), and feeling unwell, which occurs more frequently in children (affects more than 1 child out of 10).

Reporting of adverse reactions

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

5. Storage of Ropivacaine Altan

Keep out of sight and reach of children.

Do not freeze.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

From a microbiological standpoint, unless the opening method excludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.

Medicines must not be disposed of via wastewater or household waste. Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.

6. Contents of the pack and other information

Composition of Ropivacaine Altan

• The active substance is ropivacaine hydrochloride. Each 10 ml vial contains 75 mg of ropivacaine hydrochloride.
• The other components (excipients) are: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

Appearance of the product and contents of the pack

Ropivacaine Altan is presented as a clear, colourless injectable solution. Each pack contains 5 vials of 10 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals S.A.

C/ Cólquide 6, Portal 2, 1st floor, office F, Edificio Prisma

28231 Las Rozas (Madrid), Spain

Manufacturer

Altan Pharmaceuticals S.A.

Poligono Industrial de Bernedo s/n

01118 Bernedo (Álava), Spain

Or

Altan Pharmaceuticals, S.A.

Avda. de la Constitución, 198 – 199, Polígono Industrial Monte Boyal

Casarrubios del Monte, 45950 Toledo, Spain

Date of the most recent revision of this summary: 06/2024

This information is intended exclusively for healthcare professionals:

Ropivacaine Altan is used in several ways:

• Injection of the solution into the tissue where surgery will be performed.
• Injection around a nerve or group of nerves leading to the area of the body where surgery will be performed; for example, an injection in the axilla prior to forearm or hand surgery.
• Injection in the lower region of the spine when anesthesia of the legs or lower parts of the body is required.

Dosing

Adults and adolescents over 12 years of age:

The table shown below is a guide to 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.

Generally, anesthesia in surgery (e.g., epidural administration) requires the use of higher concentrations and doses. For surgical procedures requiring deep motor block, epidural anesthesia using the 10 mg/ml formulation is recommended. For analgesia (e.g., epidural administration in the treatment of acute pain), lower concentrations and doses are recommended.

Route of administration

Epidural and perineural administration.

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 lidocaine (lignocaine) with adrenaline (epinephrine) is advised. Accidental intravascular injection may be recognized by a transient increase in heart rate, and accidental subarachnoid injection by signs of spinal block with apnea or hypotension.

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, administration of the drug must be stopped immediately.

Single doses of up to 250 mg of ropivacaine have been used in epidural blockade for 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 found to be 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 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 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 2 mg/ml ropivacaine Altan 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 the analgesic effect should be performed so that the catheter can be removed as soon as pain allows. With this technique, a significant reduction in opioid requirements has been observed.

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 7.5 mg/ml and an interescalene block with 225 mg of ropivacaine 7.5 mg/ml, respectively, before surgery; analgesia was then maintained with ropivacaine 2 mg/ml. Infusion rates or intermittent injections of 10–20 mg per hour for 48 hours provided adequate analgesia and were adequately tolerated.

Concentrations above 7.5 mg/ml of Ropivacaine Altan have not been studied in cesarean section procedures.

Pediatric patients from 0 to 12 years of age inclusive

The use of ropivacaine 7.5 and 10 mg/ml may be associated with systemic and central toxic events in children. Lower concentrations (2 mg/ml) are more appropriate for administration to this population.

The use of ropivacaine in premature infants has not been documented.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Ropivacaine Altan contains no preservatives and is intended for single use only. Any unused solution must be discarded.

The solution should be inspected visually prior to use; do not use unless the solution is clear, colorless, and the container is intact.

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

Other presentations:

Ropivacaine Altan 2 mg/ml solution for injection: 10 ml vials
Ropivacaine Altan 10 mg/ml solution for injection: 10 ml vials
Ropivacaine Altan 2 mg/ml solution for infusion: 100 ml bags with removable overwrap
Ropivacaine Altan 2 mg/ml solution for infusion: 200 ml bags with removable overwrap

Detailed 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/.