Ropivacaina altan 7,5 mg/ml solucion inyectable efg
Introduction
Leaflet: Information for the user
Ropivacaína Altan 7.5 mg/ml injectable solution 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, even if they are not listed in this leaflet. See section 4.
1. What is Ropivacaína Altan and what it is used for
2. What you need to know before starting to use 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
1. What is Ropivacaína Altan and what is it used for
Ropivacaína Altan contains hydrochloride of ropivacaine which belongs to a group of medications called amide-type local anesthetics.
Ropivacaína Altan is indicated in adults and children over 12 years of age to anesthetize (numb) specific parts of the body. It is used to stop pain or provide relief from pain. It can be used for:
- To anesthetize parts of the body during surgery, including cesarean deliveries.
- To relieve pain during childbirth, after surgery, or after an accident.
2. What you need to know before starting to 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 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 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 medication.
- About any medical condition or problem you have.
Children and adolescents
Ropivacaína Altan has not been studied in premature infants.
Be especially careful with Ropivacaína Altan:
In children up to 12 years old, as some injections to numb body parts are not established in young children. Other concentrations (2 mg/ml) may be more suitable.
Use of Ropivacaína Altan with other 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 remedies. This is because Ropivacaína Altan may affect how some medications work and some medications may affect 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 bacterial infections (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, avoid prolonged use of Ropivacaína Altan.
Pregnancy, breastfeeding and 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 its passage into breast milk are unknown.
Driving and operating machinery
Ropivacaína Altan may cause drowsiness and affect your reaction time. Do not drive or use tools or machinery after Ropivacaína Altan is administered to you until the next day.
Ropivacaína Altan contains sodium
3. How to Use Ropivacaine Altan
Administration Method
Ropivacaína Altan should be administered by a doctor or, occasionally, by a nurse under the supervision of a doctor.
Dose
Ropivacaína Altan will be administered to you in the form of an injection. 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 distant area from the part of the body that needs to be numbed. This is the case if you are administered an epidural or infusion injection (in an area around the spinal cord).
When Ropivacaína Altan is administered in this way, it prevents 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
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 (sight).
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 personnel 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 healthcare personnel.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Important side effects to be aware of:
Sudden and potentially life-threatening allergic reactions (such as anaphylaxis, including anaphylactic shock) are rare and affect 1 to 10 people out of every 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 Ropivacaina Altan is causing an allergic reaction, inform your doctor immediately.
Other possible side effects:
Very common (affects more than 1 in 10 patients) |
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Common: (affects 1 to 10 in 100 patients) |
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Rare: (affects 1 to 10 in 1,000 patients) |
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Rare: (affects 1 to 10 in 10,000 patients) |
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Frequency not known (cannot be estimated from available data) |
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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 Ropivacaina Altan include:
- Nerve damage. Rarely(affects 1 to 10 users in every 10,000), it may cause permanent problems.
- If too much Ropivacaina 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 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 a decrease in pupil size, drooping of the upper 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 occurs less frequently in children (affects 1 to 10 children in 100) and nausea occurs more frequently in children (affects more than 1 child in 10).
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.
5. Conservation of Ropivacaína Altan
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.
6. Contents of the packaging and additional information
Composition of Ropivacaine Altan
- The active principle is ropivacaine hydrochloride. Each ampoule of 10 ml 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 injectable preparations.
Aspect of the product and content of the package
Ropivacaine Altan is presented in the form of a transparent and colorless injectable solution. Each package contains 5 ampoules of 10 ml.
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, 1st Floor
Edificio Prisma.
28230 Las Rozas (Madrid) - Spain
Responsible for manufacturing
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
Last review date of this leaflet:06/2024
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This information is intended solely for healthcare professionals:
Ropivacaine Altan is used in several ways:
- injection of the solution into the tissue where the surgery will be performed.
- injection around a nerve or group of nerves that conduct to the area of the body where the surgery will be performed; for example, an injection in the axilla before surgery on the forearm or hand.
- injection in the lower part of the spine when it is necessary to anesthetize the legs or lower parts of the body.
Dosage
Adults and adolescents over 12 years of age:
The table below is a guide to the most commonly used doses for different types of blocks.Use the smallest dose required to produce an effective block. Clinical experience and knowledge of the patient's clinical condition are important factors in deciding the dose.
Concentration | Volume | Dose | Onset of action | Duration | |
mg/ml | ml | mg | minutes | hours | |
ANESTHESIA IN SURGERY | |||||
Administration of epidural lumbar | |||||
Surgery | 7.5 | 15-25 | 113-188 | 10-20 | 3-5 |
Cesarean section | 7.5 | 15-20 | 113-150(1) | 10-20 | 3-5 |
Administration of epidural thoracic | |||||
Establishing a block for postoperative pain relief | 7.5 | 5-15 (depending on the level of injection) | 38-113 | 10-20 | n/p(2) |
Block of nerve trunks* | |||||
Brachial plexus block | 7.5 | 30-40 | 225-300(3) | 10-25 | 6-10 |
Peripheral block | |||||
For example, block of small nerves and infiltration | 7.5 | 1-30 | 7.5-225 | 1-15 | 2-6 |
The doses shown in the table are those considered necessary to produce an effective block and should be considered as recommendations for use in adults. There are individual variations in the onset and duration of action. The figures in the "Dose" column reflect the expected average dose range. Consult relevant literature for factors affecting specific block techniques and patient requirements. * With regard to nerve trunk block, only a posological recommendation can be given for the brachial plexus. For other nerve trunk blocks, lower doses may be required. However, there is currently no experience for specific dose recommendations for other blocks. (1)Should be administered in a gradual manner. The initial dose of 100 mg (97.5 mg = 13 ml; 105 mg = 14 ml) should be administered over 3-5 minutes, and additional doses may be administered as needed, up to a total of 50 mg additional. (2)n/p = not applicable (3)The dose used for nerve trunk block should be adjusted according to the site of administration and the patient's condition. Interscalene and supraclavicular plexus blocks may be associated with a higher frequency of severe adverse reactions, regardless of the local anesthetic used (see section 4.4). |
Generally, anesthesia in surgery (e.g. epidural administration) requires the use of higher concentrations and doses. For surgical procedures requiring deep motor block, it is recommended to use the 10 mg/ml formulation for epidural anesthesia. For analgesia (e.g. epidural administration for acute pain), lower concentrations and doses are recommended.
Administration form
Epidural and perineural administration.
Before and during injection, it is recommended to perform careful aspiration to prevent intravascular injection. When a higher dose is to be administered, it is advisable to perform a test dose of 3-5 ml of lidocaine (lignocaine) with adrenaline (epinephrine). An accidental intravascular injection may be recognized by a temporary increase in heart rate, and an accidental subarachnoid injection may be recognized by signs of spinal block with apnea or hypotension.
Aspiration should be performed before and during administration of the main dose, which should be administered slowly or in a gradual manner, at a rate of 25-50 mg/minute, while constantly monitoring the patient's vital functions and maintaining verbal contact with the patient. If toxic symptoms appear, administration of the drug should be stopped immediately.
In epidural anesthesia for surgery, doses of up to 250 mg of ropivacaine have been used, which were well tolerated.
In a limited number of patients, a single dose of 300 mg has been used for brachial plexus block, which was well tolerated.
When prolonged blocks are required, through continuous perfusion or repeated bolus administration, the risks of achieving a toxic plasma concentration or inducing local neural damage should be considered. Accumulated 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 continuous epidural postoperative 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, a 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 moderate to severe postoperative pain. The maximum duration of the epidural block is 3 days. However, close monitoring of analgesic effect should be performed to remove the catheter as soon as possible. With this technique, a significant reduction in the need for opioids has been observed.
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 interscalene block with 225 mg of Ropivacaine 7.5 mg/ml, respectively, before surgery, and analgesia was 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.
Concentrations above 7.5 mg/ml of Ropivacaine Altan have not been studied in cesarean section interventions.
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.
Ropivacaine has not been documented in premature infants.
Incompatibilities
In the absence of compatibility studies, this medication should not be mixed with others.
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 not used unless the solution is transparent and colorless and the package is intact.
The intact package should not be re-introduced into the autoclave.
Other presentations:
Ropivacaine Altan 2 mg/ml injectable solution: 10 ml ampoules
Ropivacaine Altan 10 mg/ml injectable solution: 10 ml ampoules
Ropivacaine Altan 2 mg/ml perfusion solution: 100 ml bags with a removable overwrap
Ropivacaine Altan 2 mg/ml perfusion solution: 200 ml bags with a removable overwrap
More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.
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