Ropivacaine Altan 2 mg/ml solution for infusion EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 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 adverse effects
- 5. Storage of Ropivacaine Altan
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Ropivacaine Altan 2 mg/ml solution for infusion 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, ask 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 may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Ropivacaine Altan is and what it is used for
- What you need to know before using Ropivacaine Altan
- How to use Ropivacaine Altan
- Possible adverse effects
- How to store Ropivacaine Altan
- Contents of the pack and other information
1. What Ropivacaine Altan is and what it is used for
Ropivacaine Altan contains ropivacaine hydrochloride, which belongs to a group of medicines called amide-type local anesthetics.
Ropivacaine 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 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 low 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:
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if you have heart, liver, or kidney problems. Your doctor may need to adjust the dose of Ropivacaine Altan.
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if you have ever been told that you or a family member has a rare blood pigment disorder called "porphyria." Your doctor may need to administer a different anesthetic medicine.
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about any medical conditions or health problems you may have.
Children and adolescents
The use of Ropivacaine Altan has not been studied in premature children.
Take special care with Ropivacaine Altan:
- in newborn infants, as they are more sensitive to ropivacaine.
- in children up to and including 12 years of age, as certain injections to numb parts of the body have not been established in younger children.
Use of Ropivacaine Altan with other medicines
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal remedies. 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 takes longer to eliminate Ropivacaine Altan if you are 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 may 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 and 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 times. Do not drive or operate tools or machinery after receiving Ropivacaine Altan until the following day.
Ropivacaine Altan contains sodium
This medicine contains 3.34 mg of sodium (a main component of table/cooking salt) per ml. This corresponds to 0.17% 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 body build, age, and physical condition.
Ropivacaine Altan will be administered to you as an infusion. The part of the body where it will be administered depends on the reason for which you are receiving Ropivacaine Altan. Your doctor will administer Ropivacaine Altan at 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 one 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 problems.
- Vision problems.
Your doctor will stop administering Ropivacaine Altan as soon as these signs appear, in order 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 severe adverse effects from receiving excessive amounts of Ropivacaine Altan include speech difficulties, muscle spasms, tremors, convulsions, seizures, 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 personnel 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 professionals.
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 can produce 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 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 Ropivacaine Altan is causing you an allergic reaction, inform your doctor immediately.
Other possible adverse effects:
Very common (affect more than 1 in 10 patients) |
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Common: (affect 1 to 10 in 100 patients) |
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Uncommon (affect 1 to 10 in 1,000 patients) |
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Rare (affect 1 to 10 in 10,000 patients) |
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Frequency not known (cannot be estimated from the available data) |
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Other possible adverse effects include:
- Numbness, due to nerve irritation caused by the needle or the injection. This is usually short-lived.
- Involuntary muscle movements (dyskinesia).
Possible adverse effects observed with other local anaesthetics that could also occur with Ropivacaine Altan include:
- Nerve damage. Rarely (affects 1 to 10 users in 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 disrupt a nerve pathway from the brain to the head and neck, particularly in pregnant women, which may sometimes lead to a condition known as Horner's syndrome. This is characterized by decreased pupil size, drooping of the upper eyelid, and inability of the sweat glands to produce sweat. This will resolve on its own once treatment is discontinued.
Children
In children, adverse effects are the same as in adults, except for low blood pressure, which is less frequent in children (affects 1 to 10 children in 100), and feelings of discomfort, which are more frequent in children (affects more than 1 in 10 children).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 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 Ropivacaine Altan
Keep out of the 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 refers to the last day of the month indicated.
From a microbiological standpoint, unless the method of opening 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 been in contact with it must comply with local regulations.
6. Contents of the pack and other information
Composition of Ropivacaine Altan
- The active substance is ropivacaine hydrochloride.
Each 100 ml bag contains 200 mg of ropivacaine hydrochloride.
Each 200 ml bag contains 400 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 solution for infusion. Each pack contains 5 bags of 100 ml or 5 bags of 200 ml with non-sterile outer surface.
Although the solution is sterile, procedures related to the use of the product should take into account that the outer surface of the bag is non-sterile within its overwrap. The removable overwrap provides photoprotection and ensures mechanical and physical protection of the sterile solution.
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
Edificio Prisma
28230 Las Rozas (Madrid)
Spain
Manufacturer
Altan Pharmaceuticals S.A.
Polígono Industrial de Bernedo s/n
01118 Bernedo (Álava)
Spain
Date of the most recent review of this leaflet: 06/2024
This information is intended for healthcare professionals only:
Posology
Adults and adolescents over 12 years of age:
The table below provides recommendations 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.
Conc. mg/ml | Volume ml | Dose mg | Onset of action minutes | Duration hours | |
TREATMENT OF ACUTE PAIN | |||||
Lumbar epidural administration Continuous infusion, e.g. labor pain Postoperative pain treatment | 2.0 2.0 | 6–10 ml/h 6–14 ml/h | 12–20 mg/h 12–28 mg/h | n/p(1) n/p(1) | n/p(1) n/p(1) |
Thoracic epidural administration Continuous infusion (postoperative pain treatment) | 2.0 | 6–14 ml/h | 12–28 mg/h | n/p(1) | n/p(1) |
Peripheral nerve block (femoral or interscalene block) | |||||
Continuous infusion or intermittent injections (e.g. post-surgical pain treatment) | 2.0 | 5–10 ml/h | 10–20 mg/h | n/p(1) | n/p(1) |
The doses listed in the table are those considered necessary to achieve 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 range of average required doses. Appropriate literature should be consulted regarding factors affecting specific block techniques and individual patient requirements. (1) n/p = not applicable |
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 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 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, drug administration must be immediately discontinued.
When prolonged blocks are required, either by continuous infusion or repeated bolus administration, the risks of achieving toxic plasma concentrations or of inducing local neural injury must be considered. Cumulative doses of up to 675 mg of ropivacaine for surgery and postoperative analgesia administered within 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 the treatment of postoperative pain, the following technique is recommended: Unless treatment with ropivacaine is initiated before surgery, an epidural block should be induced with a 7.5 mg/ml concentration of ropivacaine using an epidural catheter. Analgesia is maintained with an infusion of Ropivacaína Altan 2 mg/ml. 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, the analgesic effect should be closely monitored so that the catheter can be removed 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 alone or mixed with 1–4 μg/ml of fentanyl has been administered for the treatment of postoperative pain for periods of up to 72 hours. This combination of ropivacaine and fentanyl provided better pain relief but caused opioid-related side effects; this combination has been investigated only for ropivacaine 2 mg/ml.
When prolonged peripheral nerve blocks are applied, either by continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations or of 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 interscalene 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 well tolerated.
Epidural block: Pediatric patients from 0 to 12 years of age inclusive:
Concentration mg/ml | Volume ml/kg | Dose mg/kg | |
TREATMENT OF ACUTE PAIN (peri- and post-surgical) | |||
Continuous epidural infusion | |||
In children with a body weight up to 25 kg | |||
0 to 6 months Infusion for up to 72 hours | 2.0 | 0.1 ml/kg/h | 0.2 mg/kg/h |
6 to 12 months Infusion for up to 72 hours | 2.0 | 0.2 ml/kg/h | 0.4 mg/kg/h |
1 to 12 years Infusion for up to 72 hours | 2.0 | 0.2 ml/kg/h | 0.4 mg/kg/h |
The doses listed in the Table should be considered as guidelines for use in pediatric patients. Individual variations exist. In children with high body weight, a gradual dose reduction is often necessary and should be based on ideal body weight. The volume for single caudal epidural block and the volume for epidural bolus doses must not exceed 25 ml in any patient. Appropriate literature should be consulted regarding factors affecting specific block techniques and individual patient requirements. |
Peripheral nerve block: Infants and children aged 1–12 years**
Concentration mg/ml | Volume ml/kg | Dose mg/kg | |
TREATMENT OF ACUTE PAIN (peri- and postoperative) | |||
Continuous infusion for peripheral nerve block in children aged 1 to 12 years Infusion for up to 72 hours | 2.0 | 0.1–0.3 ml/kg/h | 0.2–0.6 mg/kg/h |
The doses listed in the Table should be considered as guidelines for use in pediatric patients. Individual variations exist. In children with high body weight, a dose reduction is often required, based on ideal body weight. Appropriate literature should be consulted regarding factors affecting specific block techniques and individual patient requirements. |
Doses for peripheral nerve block in infants and children provide guidance for use in children without serious illness. For children with serious illness, a more conservative dose and close monitoring are recommended.
The use of ropivacaine 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. Vital functions of the patient 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 produces adequate postoperative 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 a different distribution of sensory block, as recommended in the literature. Doses up to 3 mg/kg of a ropivacaine concentration of 3 mg/mL 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 divide the calculated dose of local anaesthetic, regardless of the route of administration.
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Precipitation may occur in alkaline solutions, as ropivacaine shows low 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. Any unused solution must be discarded.
The solution should be visually inspected before use; do not use unless the solution is clear, colourless, and the container is intact.
An intact container must not be re-sterilized in an autoclave.
Ropivacaína Altan infusion solution in infusion bags is chemically and physically compatible with the following drugs:
ROPIVACAINE Concentration: 1-2 mg/mL | |
Additive | Concentration* |
Fentanyl citrate Sufentanil citrate Morphine sulfate Clonidine hydrochloride | 1.0–10.0 micrograms/mL 0.4–4.0 micrograms/mL 20.0–100.0 micrograms/mL 5.0–50.0 micrograms/mL |
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The mixtures are chemically and physically stable for a period of 30 days at temperatures of 20º to 30ºC. From a microbiological standpoint, the mixtures should be used immediately; if this is not possible, the responsibility for internal storage times and conditions prior to use lies with the personnel handling them, and storage should normally not exceed 24 hours at a temperature of 2º to 8ºC.
Other presentations:
Ropivacaine Altan 2 mg/ml injectable solution: 10 ml vials
Ropivacaine Altan 7.5 mg/ml injectable solution: 10 ml vials
Ropivacaine Altan 10 mg/ml injectable solution: 10 ml vials
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/.