Leaflet: Information for the user

Ropivacaína Altan 2 mg/ml solution for infusion EFG

ropivacaína, hydrochloride

Read this 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 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, pharmacist or nurse,evenifthey are not listed in this leaflet. See section 4.

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

2. What you need to know before you start using Ropivacaína Altan

3. How to use Ropivacaína Altan

4. Possible side effects

5. Storage of Ropivacaína Altan

6. Contents of the pack and additional information

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

Ropivacaína Altanis used in adults and children of all ages for the treatment of acute pain. It numbs (anesthesia) a part of the body, for example, after surgery.

No use Ropivacaína Altan

- If you are allergic to ropivacaine, other local anesthetic amides (such as lidocaine or bupivacaine) or any of the other components of this medication (listed in section 6).

- In case of regional intravenous anesthesia (injection into a blood vessel to numb a specific area of your body) or paracervical obstetric anesthesia (injection into the cervix of the uterus to relieve pain during childbirth).

- If you have a decreased blood volume (hypovolemia) as you may develop a decrease in blood pressure.

If you are unsure if any of the above applies to you, consult your doctor before Ropivacaína Altan is administered to you.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Ropivacaína Altan:

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

• if you have ever been told that you or a family member suffers from a rare blood pigment disorder called "porphyria". Your doctor may need to administer a different type of anesthetic.
• about any medical condition or problem you have.

Children and adolescents

Ropivacaína Altan has not been studied in premature children.

Be especially careful with Ropivacaína Altan:

• in newborns as they are more susceptible to Ropivacaína Altan.
• in children up to 12 years old, as some injections to numb body parts are not established in younger children.

Use ofRopivacaína Altan withother medications

Inform your doctor if you are using, have used recently or may need to use any other medication, including those purchased without a prescription and herbal medicines. This is because Ropivacaína Altan may affect how some medications work and some medications may have an effect on Ropivacaína Altan.

In particular, inform your doctor if you are taking any of the following medications.

• Other local anesthetics
• Strong pain medications, such as morphine or codeine.
• Medications used to treat irregular heartbeat (arrhythmia), such as lidocaine and mexiletine.

Your doctor needs to know if you are using these medications to calculate the correct dose of Ropivacaína Altan.

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

• Medications used to treat depression (such as fluvoxamine)
• Antibiotics used to treat infections caused by bacteria (such as enoxacina).

This is because your body takes longer to eliminate Ropivacaína Altan if you are taking these medications. If you are taking any of these medications, you should avoid prolonged use of Ropivacaína Altan.

Pregnancy, breastfeedingand fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor, pharmacist or nurse before this medication is administered to you.

Ropivacaína Altan should not be used during pregnancy and breastfeeding unless your doctor deems it clearly necessary.

The effects of hydrochloride ropivacaine on pregnancy or passage into breast milk are unknown.

Driving and operating machines

Ropivacaína Altan may cause drowsiness and affect your reaction time. Do not drive or use tools or machines after Ropivacaína Altan is administered to you until the next day.

Ropivacaína Altancontains sodium

This medication contains 3.34 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.17% of the recommended daily maximum sodium intake for an adult.

Administration Method

Ropivacaína Altan should be administered by a doctor or, occasionally, by a nurse under the supervision of a doctor.

Dose

The dose administered by your doctor will depend on the type of pain relief you need. It will also depend on your build, age, and physical condition.

Ropivacaína Altan will be administered to you in the form of an infusion. The part of the body where it will be used will depend on the reason for administering Ropivacaína Altan. Your doctor will administer Ropivacaína Altan in one of the following locations:

• The part of the body that needs to be numbed.
• Near the part of the body that needs to be numbed.
• In a location away from the part of the body that needs to be numbed. This is the case if you are administered an epidural injection or infusion (in an area around the spinal cord).

When Ropivacaína Altan is administered in this way, it prevents the nerves from transmitting pain messages to the brain. You will no longer feel pain, heat, or cold in the area where it is used, but you may still feel other sensations such as pressure or contact.

Your doctor will decide the best way to administer this medication to you.

If you are administered more Ropivacaína Altan than you should

Severe side effects resulting from receiving too much Ropivacaína Altan require special treatment, and your doctor is trained to act in these situations. The first signs of having received too much Ropivacaína Altan are usually:

• Dizziness or vertigo.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Problems with hearing.
• Problems with vision.

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

More severe side effects resulting from receiving too much Ropivacaína Altan include problems with speech, muscle spasms, tremors, seizures, attacks, and loss of consciousness.

If you experience any of these symptoms or think you may have received too much Ropivacaína Altan, inform your doctor or healthcare staff immediately.In case of overdose or accidental ingestion, contact the Toxicological Information Service at Teléfono 91 562 04 20.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.This medicinemay 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.

The 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 loss of consciousness. If you think Ropivacaína Altan iscausingan allergic reaction, inform your doctor immediately.

Other possible side effects:

Other possible side effects include:

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

Side effects observed with other local anesthetics that may also be produced by Ropivacaína Altan include::

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

Children

In children, side effects are the same as in adults, except for low blood pressure, which is less common in children (affects 1 to 10 children in 100) and feeling unwell, which are more common in children (affects more than 1 in 10 children).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Pharmacovigilance of Medicines 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 out of sight and reach of children.

Do not freeze.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration 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 must be used immediately. If not used immediately, storage times for use and conditions are the responsibility of the user.

Medicines should not be disposed of through drains or in the trash. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Composition of Ropivacaine Altan

- The active ingredient is ropivacaine hydrochloride.

Cada bolsa de 100 ml contiene 200 mg de hidrocloruro de ropivacaína.

Cada bolsa de 200 ml contiene 400 mg de hidrocloruro de ropivacaína.

- The other components (excipients) are: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injection.

Aspect of the product and contents of the package

Ropivacaine Altan is presented in the form of a transparent and colorless solution for perfusion. Each package contains 5 bags of 100 ml or 5 bags of 200 ml with non-sterile surface.

Although the solution is sterile, the protocols related to the use of the product should take into account that the exterior of the bag is not sterile in its overwrap. The removable overwrap provides photoprotection and allows physical and mechanical protection of the sterile solution.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Altan Pharmaceuticals S.A.

C/ Cólquide 6, Portal 2, 1ª Planta

Edificio Prisma.

28230 Las Rozas (Madrid)

Spain

Responsible for manufacturing

Altan Pharmaceuticals S.A.

Polígono Industrial de Bernedo s/n

01118 Bernedo (Álava)

Spain

Last review date of this leaflet: 06/2024

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This information is intended solely for healthcare professionals:

Dosage

Adults and adolescents over 12 years of age:

The following table shows some recommendations on the most commonly used dose for different types of blockage. The smallest dose required to produce an effective blockage should be used. Clinical experience and knowledge of the patient's clinical condition are important factors in deciding the dose.

Administration

Administration by epidural and perineural routes.

Before and during injection, careful aspiration is recommended to prevent intravascular injection. When a higher dose is to be administered, a test dose of 3-5 ml of lidocaine (lignocaine) with adrenaline (epinephrine) is recommended. An accidental intravascular injection may be recognized by a temporary increase in heart rate, and an accidental intrathecal injection by signs of spinal blockage.

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

When prolonged nerve blocks are required, either through continuous perfusion or repeated injections, the risks of achieving a toxic plasma concentration or inducing local neural damage should be considered. Doses of up to 675 mg of ropivacaine for surgery and postoperative analgesia administered over 24 hours were well tolerated in adults, as well as postoperative epidural continuous perfusions 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, an epidural block is induced with this drug at a concentration of 7.5 mg/ml using an epidural catheter. Analgesia is maintained with a perfusion of Ropivacaine Altan at 2 mg/ml. Perfusion 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 of postoperative pain of moderate to severe intensity. 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 perfusion of 2 mg/ml of Ropivacaine alone or mixed with 1-4 μg/ml of fentanyl for postoperative pain treatment for a period of up to 72 hours was administered. This combination of Ropivacaine and fentanyl provided better pain relief but caused opioid-related side effects; the combination is only investigated for Ropivacaine 2 mg/ml.

When applying prolonged peripheral nerve blocks, either through continuous perfusion or repeated injections, the risks of achieving a toxic plasma concentration or inducing local neural damage should 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.

Perfusion rates or intermittent injections of 10-20 mg per hour for 48 hours resulted in adequate analgesia and were well tolerated.

Epidural block: Children aged 0 to 12 years inclusive:

Peripheral nerve block: Infants and children aged 1-12 years

The doses for peripheral nerve block in infants and children provide guidelines for use in children without severe disease. For children with severe disease, a more conservative dose and close monitoring are recommended.

Ropivacaine has not been documented in premature children.

Administration

Administration by epidural and perineural routes.

Careful aspiration before and during injection is recommended 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 epidural caudal injection of 2 mg/ml of ropivacaine provides 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 epidural caudal 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 ropivacaine concentration of 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 local anesthetic dose, regardless of the administration route.

Incompatibilities

In the absence of compatibility studies, this medication should not be mixed with others.

Precipitation may occur in alkaline solutions, as ropivacaine has limited solubility at pH > 6.0.

Remove the overwrap immediately before administering the preparation.

Ropivacaine Altan does not contain preservatives and is intended for single use only. Discard any unused solution.

The solution should be visually inspected before use, and only used if the solution is transparent and colorless and the package is intact.

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

The Ropivacaine Altan perfusion solution in bags for perfusion is chemically and physically compatible with the following medications:

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 personnel handling them, and should not be prolonged more than 24 hours at a temperature of 2°C to 8°C.

Other presentations:

Ropivacaine Altan 2 mg/ml injectable solution: 10 ml ampoules

Ropivacaine Altan 7.5 mg/ml injectable solution: 10 ml ampoules

Ropivacaine Altan 10 mg/ml injectable solution: 10 ml ampoules

Further information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.