ROPIVACAINE ALTAN 2 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Ropivacaína Altan 2 mg/ml solution for infusion EFG

ropivacaína, hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

Contents of the package leaflet:

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

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

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

Ropivacaína Altan 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 you use Ropivacaína Altan

Do not use Ropivacaína Altan

• If you are allergic to ropivacaína, to other local anesthetics of the amide type (such as lidocaína or bupivacaína) or to any of the other ingredients of this medicine (listed in section 6).
• In case of regional intravenous 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 a decreased blood volume (hypovolemia) as you may develop a decrease in blood pressure.

If you are not sure if any of the above applies to you, consult your doctor before you are given Ropivacaína Altan.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before you start using Ropivacaína Altan:

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

• if you have been informed that you or a family member has a rare blood pigment disorder called "porphyria". Your doctor may need to administer a different anesthetic medicine.
• about any illness or medical condition you have.

Children and adolescents

The use of Ropivacaína Altan has not been studied in premature children.

Be particularly 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 parts of the body are not established in younger children.

Using Ropivacaína Altan with other medicines

Tell your doctor if you are using, have recently used, or might use any other medicines, including those obtained without a prescription and herbal remedies. This is because Ropivacaína Altan may affect the way some medicines work and some medicines may have an effect on Ropivacaína Altan.

In particular, tell 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 lidocaína and mexiletina.

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

Tell 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 enoxacina).

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before you are given this medicine.

Ropivacaína Altan should not be used during pregnancy and breastfeeding unless your doctor considers it essential.

It is not known if ropivacaína hydrochloride affects pregnancy or if it passes into breast milk.

Driving and using machines

Ropivacaína Altan may cause drowsiness and affect your reaction speed. Do not drive or use tools or machines after you have been given Ropivacaína Altan until the next day.

Ropivacaína Altan contains sodium

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

3. How to use Ropivacaína Altan

Method of administration

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

Dose

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

You will be given Ropivacaína Altan as an infusion. The part of the body where it will be used will depend on the reason why you are being given Ropivacaína Altan. Your doctor will administer Ropivacaína Altan in one of the following places:

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

When Ropivacaína Altan is administered in one of these ways, it prevents the nerves from transmitting pain messages to the brain. You will stop feeling pain, heat, or cold in the area where it is used, but you may still feel other sensations such as pressure or touch.

Your doctor will decide the most correct way to administer this medicine to you.

If you are given more Ropivacaína Altan than you should

Serious side effects as a result of receiving too much Ropivacaína Altan require special treatment, and your doctor is trained to act in these situations. The first signs that you have been given too much Ropivacaína Altan are usually:

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

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

More serious side effects from receiving too much Ropivacaína Altan include speech problems, muscle spasms, tremors, convulsions, seizures, and loss of consciousness.

If you experience any of these symptoms or think you may have received too much Ropivacaína Altan, tell your doctor or healthcare staff immediately.In case of overdose or accidental ingestion, consult the Toxicology Information Service Telephone 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 further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects to look out for:

Sudden and potentially life-threatening allergic reactions (e.g., anaphylaxis, including anaphylactic shock) are rare and affect 1 to 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 loss of consciousness. If you think Ropivacaína Altan is causing an allergic reaction, tell 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).

Other possible side effects observed with other local anesthetics that may also be caused 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 disruption of a nerve pathway that goes from the brain to the head and neck, especially in pregnant women, which can sometimes lead to a condition called Horner's syndrome. It is characterized by a decrease in pupil size, drooping of the upper eyelid, and inability of the sweat glands to produce sweat. It will resolve on its own when treatment is stopped.

Children

In children, the 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 sick, which is more common in children (affects more than 1 in 10 children).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ropivacaína Altan

Keep out of the sight and reach of children.

Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

From a microbiological point of view, unless the opening method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

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

6. Package Contents and Additional Information

Composition of Ropivacaína Altan

• The active ingredient is ropivacaína hydrochloride.

Each 100 ml bag contains 200 mg of ropivacaína hydrochloride.

Each 200 ml bag contains 400 mg of ropivacaína hydrochloride.

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

Appearance of the Product and Package Contents

Ropivacaína Altan is presented as a clear and colorless solution for infusion. Each package contains 5 bags of 100 ml or 5 bags of 200 ml with a non-sterile surface.

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals S.A.

C/ Cólquide 6, Portal 2, 1ª Planta

Edificio Prisma.

28230 Las Rozas (Madrid)

Spain

Manufacturer

Altan Pharmaceuticals S.A.

Polígono Industrial de Bernedo s/n

01118 Bernedo (Álava)

Spain

Date of Last Revision of this Prospectus: 06/2024

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This information is intended only for healthcare professionals:

Dosage

Adults and adolescents over 12 years of age:

The Table below presents recommendations on the most commonly used dose in different types of blocks. The smallest dose required to produce an effective block should be used. Clinical experience and knowledge of the patient's clinical condition are important factors in deciding the dose.

Method 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 recommended. An accidental intravascular injection can be recognized by a temporary increase in heart rate, and an accidental intrathecal injection by signs of spinal block.

Aspiration should be performed before and during the administration of the main dose, which should be injected 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, the administration of the drug should be interrupted immediately.

When prolonged blocks are required, either through continuous infusion or repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury should be considered. Accumulated doses of up to 675 mg of ropivacaína for surgery and post-operative analgesia administered over 24 hours were well tolerated in adults, as well as continuous post-operative 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 post-operative pain treatment, the following technique is recommended: Unless treatment with ropivacaína is started before the intervention, an epidural block is induced with it at a concentration of 7.5 mg/ml using an epidural catheter. Analgesia is maintained with a Ropivacaína Altan infusion of 2 mg/ml. Infusion 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 moderate to severe post-operative pain. 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 the pain allows. This technique has been observed to significantly reduce the need to use opioids.

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

When prolonged peripheral nerve blocks are applied, either through continuous infusion or repeated injections, the risks of reaching a toxic plasma concentration or inducing local neural injury should be considered. In clinical studies, a femoral nerve block was established with 300 mg of Ropivacaína 7.5 mg/ml and an interscalene block with 225 mg of Ropivacaína 7.5 mg/ml, respectively, before surgery; then, analgesia was maintained with Ropivacaína 2 mg/ml.

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

Epidural Block: Pediatric Patients from 0 to 12 years of age inclusive:

Peripheral Nerve Block: Infants and children between 1-12 years of age

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

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

Method of Administration

Epidural and perineural administration.

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 should be interrupted immediately.

A single epidural caudal injection of 2 mg/ml of ropivacaína produces adequate 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 epidural caudal injection can be adjusted to obtain a different distribution of the sensory block, as recommended in the literature. Doses of up to 3 mg/kg of a ropivacaína concentration of 3 mg/ml have been studied in children over 4 years; however, this concentration is associated with a higher incidence of motor block.

The calculated dose of local anesthetic should be fractionated, regardless of the route of administration.

Incompatibilities

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

Precipitation may occur in alkaline solutions since ropivacaína shows poor solubility at pH > 6.0.

Remove the overwrap immediately before administering the preparation.

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

The solution should be visually inspected before use; it should not be used unless the solution is clear and colorless and the packaging is intact.

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

The Ropivacaína Altan solution for infusion in infusion bags is chemically and physically compatible with the following drugs:

The mixtures are chemically and physically stable for a period of 30 days at temperatures of 20º to 30ºC. 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 normally exceed 24 hours at a temperature of 2º to 8ºC.

Other Presentations:

Ropivacaína Altan 2 mg/ml solution for injection: 10 ml ampoules

Ropivacaína Altan 7.5 mg/ml solution for injection: 10 ml ampoules

Ropivacaína Altan 10 mg/ml solution for injection: 10 ml ampoules

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.