Leaflet: information for the user
Ropsine2 mg/ml injectable solution EFG
Ropivacaine hydrochloride
Read this leaflet carefully before you start using the medicine.
1. What isRopsineand what it is used for
2. What you need to know before starting to useRopsine
3. How to useRopsine
4. Possible side effects
5. Storage ofRopsine
6. Contents of the pack and additional information
Ropsinecontains the active ingredient ropivacaine hydrochloride, which belongs to a class of medications known as local anesthetics.
Ropsine2 mg/ml injectable solution 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.
No useRopsine
Warnings and precautions
Consult your doctor or pharmacist before starting to useRopsine
Special care must be taken toavoid any injectionofRopsinedirectly into a blood vesselto prevent any immediate toxic effects. The injection should not be made in an inflamed area.
Inform your doctor:
Inform your doctor if you have any of these problems as your doctor will need to adjust yourRopsinedosage.
Inform your doctor:
Inform your doctor if you or a family member suffers from porphyrin as your doctor may need to use another anesthetic.
Use ofRopsinewith other medicines
Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.
Caution should be exercised if you are receiving:
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. The effect of ropivacaine hydrochloride on pregnancy or passage into breast milk is unknown.
Driving and operating machinery
Ropsinemay cause drowsiness and affect your reaction time. Do not drive or use tools or machinery after takingRopsine, until the next day.
Consult your doctor or pharmacist if you have any doubts.
Important information about some of the components ofRopsine
This medicine contains 3.39 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.2% of the maximum daily sodium intake recommended for an adult.
Ropsinewill be administered by your doctor. It will be administered via injection.
Dose
The recommended dose will depend on what it is being used for and also on your health, age, and weight.
The smallest dose that can produce a sensory block (anesthesia) of the required area should be used.
Usual Dose
Treatment Duration
The administration of ropivacaine hydrochlorideusuallylastsbetween2 and 10 hoursin the caseofanesthesiabefore certain surgeries and may takeup to 72 hoursin the case ofpain reliefduring or after surgery.
If moreRopsineis administered than it should
The first symptoms of having received more ropivacaine hydrochloride than you should, are usually related to:
These symptoms may precede a cardiac arrest, respiratory arrest, or severe seizures.
If you experience any of these symptoms or think you may have received too muchRopsine, inform your doctor or healthcare personnel immediately.
In the 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 product, ask your doctor or pharmacist.
Like all medicines,Ropsinecan cause side effects, although not everyone will experience them.
Important side effects to be aware of:
Sudden and potentially life-threatening allergic reactions (e.g., anaphylaxis, including anaphylactic shock) are rare and affect 1 to 10 people out of every 10,000. Possible symptoms include:
If you thinkRopsineis causing an allergic reaction, inform your doctor or healthcare professional immediately.
Other possible side effects:
Very common(may affect more than 1 in 10 people)
Common(may affect up to 1 in 10 people)
Rare(may affect up to 1 in 100 people)
Very rare(may affect up to 1 in 1000 people)
Possible side effects observed with other local anesthetics that may also be produced byRopsineinclude:
Additional side effects in children
In children,side effects are the same as in adults except for low blood pressure, which is less common in children(affects fewer than 1 in 10 children) and feeling unwell, which are more common in children(affects more than 1 in 10 children).
If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, 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 the Vigilance of Medicinal Products 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 this medication out of the sight and reach of children.
Do not useRopsineafter the expiration date that appears on the vial or box. The expiration date is the last day of the month indicated.
Do not freeze.
Do not useRopsineif you observe any precipitation in the injection solution.
Normally, your doctor or the hospital will storeRopsineand are responsible for the product quality if once opened it is not used immediately. They are also responsible for disposing of all unusedRopsinecorrectly.
Medicines should not be thrown down the drains, nor in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.
Composition ofRopsine
Each 20 ml polypropylene ampoule contains 40 mg of ropivacaine (as hydrochloride).
Appearance of the product and contents of the pack
Ropsine injectable solution is a transparent, colourless, sterile, isotonic, isobaric aqueous solution.
Ropsine 2 mg/ml injectable solution EFG is available in 10 ml and 20 ml transparent polypropylene ampoules.
Pack size:
10 sterile ampoules in a plastic blister.
Marketing authorisation holder and responsible person for manufacturing
Marketing authorisation holder:
Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany
Responsible person for manufacturing:
Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany
Last review date of this leaflet: September 2018
The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.
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This information is intended solely for doctors or healthcare professionals:
Handling
Ropsine should be used by, or under the supervision of, experienced medical professionals in regional anesthesia (see section 3)
Twist the top of the ampoule sharply to open it.
The ampoules fit both Luerfit and LuerLock syringes.
Validity period prior to opening
3 years
Validity period after opening
From a microbiological point of view, the product should be used immediately. If not used immediately, storage during use and conditions before use are the responsibility of the user and generally should not exceed 24 hours at 2-8°C.
Ropsine medicines are products without preservatives and are intended for single use. Discard any unused solution.
The medicine should be visually inspected before use. The solution should only be used if the solution is transparent, practically free of particles, and the container is intact.
The intact container should not be re-introduced into the autoclave.
Dosage
Adults and adolescents over 12 years of age
The following table is a guide to the most commonly used doses for different types of block.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.
Indication | Concentration mg/ml | Volume ml | Dose mg | Onset of action minutes | Duration hours |
Thoracic epidural administration | |||||
Bolus | 2,0 | 10-20 | 20-40 | 10-15 | 0,5-1,5 |
Intermittent injections (top-up) (e.g. pain relief during childbirth) | 2,0 | 10-15 (minimum interval 30 minutes) | 20-30 | -- | -- |
Continuous infusion (e.g. pain relief during childbirth) | 2,0 | 6-10 ml/h | 12-20 mg/h | -- | -- |
Post-operative pain relief | 2,0 | 6-14ml/h | 12-28 mg/h | -- | -- |
Lumbar epidural administration | |||||
Continuous infusion (post-operative pain relief) | 2,0 | 6-14 ml/h | 12-28 mg/h | -- | -- |
Peripheral block | |||||
(e.g. block of minor nerves and infiltration) | 2,0 | 1-100 | 2,0-200 | 1-5 | 2-6 |
Peripheral nerve block (Femoral or inter-scalene block) | |||||
Continuous infusion or intermittent injections (e.g. post-operative pain relief) | 2,0 | 5-10 ml/h | 10-20 mg/h | -- | -- |
The doses shown in the table are considered necessary to produce an effective block and should be considered as guidelines 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. |
Generally, surgical anesthesia (e.g. epidural administration) requires the use of higher concentrations and doses. For surgical procedures requiring deep motor block, epidural anesthesia using the Ropsine 10 mg/ml formulation is recommended. For analgesia (e.g. epidural administration for acute pain relief), lower concentrations and doses are advised.
Administration route
Perineural and epidural administration by injection.
Before and during injection, careful aspiration is recommended to prevent intravascular injection. When administering a higher dose, a 3-5 ml dose of 2% lidocaine (lignocaine) with adrenaline (epinephrine) 1:200,000 is recommended as a test dose. Accidental intravascular injection may be recognized by a temporary 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 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.
Doses of up to 250 mg of ropivacaine hydrochloride have been used for epidural block in surgery and were well tolerated.
A single dose of 300 mg has been used for brachial plexus block in a limited number of patients and was well tolerated.
When prolonged peripheral nerve blocks are applied, either through continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations or inducing local neural damage should be considered. Accumulated doses of up to 675 mg of ropivacaine hydrochloride for surgery and post-operative analgesia administered over 24 hours were well tolerated in adults, as well as continuous epidural infusions post-operatively at rates of up to 28 mg/hour for 72 hours. In a limited number of patients, doses up to 800 mg/day have been administered with relatively few adverse reactions.
For post-operative pain relief, the following technique is recommended: Unless the treatment with Ropivacaína is initiated before the intervention, a spinal block is induced with this product at a concentration of 7.5 mg/ml using an epidural catheter. Analgesia is maintained with a continuous infusion of Ropsine 2 mg/ml. Infusion rates of 6-14 ml (12-28 mg) per hour provide adequate analgesia with only slight and non-progressive motor block in most cases with post-operative pain of moderate to severe intensity. The maximum duration of 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 opioid use has been observed.
In clinical studies, a continuous epidural infusion of 2 mg/ml ropivacaine hydrochloride alone or mixed with 1-4 μg/ml fentanyl has been administered for post-operative pain relief for up to 72 hours. This combination of ropivacaine hydrochloride and fentanyl provided better pain relief but caused opioid-type side effects; this combination has only been investigated for ropivacaine hydrochloride 2 mg/ml.
When applying prolonged peripheral nerve blocks, either through continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations or inducing local neural damage should be considered. In clinical studies, a femoral nerve block was established with 300 mg of ropivacaine hydrochloride 7.5 mg/ml and an interscalene block with 225 mg of ropivacaine hydrochloride 7.5 mg/ml, respectively, before surgery; analgesia was then maintained with ropivacaine hydrochloride 2 mg/ml. Infusion rates or intermittent injections of 10-20 mg per hour for 48 hours resulted in adequate analgesia and were well tolerated.
Children from 0 to 12 years of age
Indication | Concentration mg/ml | Volume ml/kg | Dose mg/kg |
Single caudal epidural block | 2,0 | 1 | 2 |
Lower blocks below T12, in children weighing up to25 kg | |||
Continuous epidural infusion | |||
0 to 6 months | |||
Bolus dosea | 2,0 | 0,5-1 | 1-2 |
Infusion for up to 72 hours | 2,0 | 0,1 ml/kg/h | 0,2 mg/kg/h |
6 to 12 months | |||
Bolus dosea | 2,0 | 0,5-1 | 1-2 |
Infusion for up to 72 hours | 2,0 | 0,2 ml/kg/h | 0,4 mg/kg/h |
1 to 12 years | |||
Bolus doseb | 2,0 | 1 | 2 |
Infusion for up to 72 hours | 2,0 | 0,2 ml/kg/h | 0,4 mg/kg/h |
The doses included in the table should be considered as guidelines for use in pediatrics. There are individual variations. In children with a high body weight, a gradual reduction in dose is often necessary, based on the ideal body weight. The volume for the caudal epidural block and the volume for the epidural bolus doses should not exceed 25 ml in any patient. Consult relevant literature for factors affecting specific block techniques and individual patient requirements. |
Infants from 1 year and children up to 12 years:
The proposed doses of ropivacaine hydrochloride for peripheral block in infants and children provide guidelines for use in children without serious illness.Prior to administering the drug to children with serious illness, a more conservative dose and close monitoring are recommended.
Single injections for peripheral nerve block (e.g. ilioinguinal nerve block, brachial plexus block) should not exceed 2.5-3.0 mg/kg.
Continuous infusion for peripheral nerve block is recommended at 0.2-0.6 mg/kg/h (0.1-0.3 ml/kg/h) for up to 72 hours.
The use of ropivacaine hydrochloride in premature infants has not been documented.
Administration route
Epidural administration by injection.
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 caudal epidural injection of 2 mg/ml ropivacaine hydrochloride produces adequate post-operative 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 caudal epidural 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 3 mg/ml concentration of ropivacaine hydrochloride 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 dose of local anesthetic, regardless of the administration route.
When recommending the infusion of ropivacaine hydrochloride, Ropsine injectable solution may be used.
Incompatibilities
There are no compatibility studies with other solutions, so this medicine should not be mixed with other medications.
Precipitation may occur in alkaline solutions, as ropivacaine hydrochloride has low solubility at pH > 6.0.
Elimination
The unused medicine and all materials that have come into contact with it will be disposed of in accordance with local regulations.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.