Ropivacaine hydrochloride S.A.L.F.: detailed information

Package leaflet: Information for the patient

ROPIVACAINA CLORIDRATO S.A.L.F. 2 mg/ml solution for injection, 2 mg/ml solution for infusion, 7.5 mg/ml solution for injection, 10 mg/ml solution for injection

ROPIVACAINA CLORIDRATO
Generic medicine
Please read all of this leaflet carefully before you are given this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ROPIVACAINA CLORIDRATO S.A.L.F. is and what it is used for
What you need to know before using ROPIVACAINA CLORIDRATO S.A.L.F.
How to use ROPIVACAINA CLORIDRATO S.A.L.F.
Possible side effects
How to store ROPIVACAINA CLORIDRATO S.A.L.F.
Package contents and other information

1. What ROPIVACAINA CLORIDRATO S.A.L.F. is and what it is used for

Ropivacaina Cloridrato S.A.L.F. contains the active substance ropivacaine hydrochloride, which belongs to a group of medicines called local anaesthetics used to numb a part of the body. Ropivacaina Cloridrato S.A.L.F. will be administered either as an injection or as an infusion, depending on how it is to be used.

Ropivacaina Cloridrato S.A.L.F. 7.5 mg/ml and 10 mg/ml is used in adults and children over 12 years of age to numb (anaesthetize) parts of the body. It is used to prevent the onset of pain or to provide pain relief. It may be used for:

anaesthetizing parts of the body during surgical procedures, including caesarean section;
relieving pain during or after childbirth, after surgery, or following trauma.

Ropivacaina Cloridrato S.A.L.F. 2 mg/ml is used in adults and children of all ages for the treatment of acute pain, for example after surgery.

2. What you need to know before using ROPIVACAINA CLORIDRATO S.A.L.F.

Do not use ROPIVACAINA CLORIDRATO S.A.L.F.

if you are allergic (hypersensitive) to ropivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to any other local anaesthetic of the same class (e.g. lidocaine or bupivacaine);
if you have been told that you have reduced blood volume (hypovolemia). This medicine must not be administered into a blood vessel to anaesthetize a specific area of the body or into the cervix to relieve pain during childbirth. If you are unsure whether any of the above apply to you, consult your doctor before receiving

Ropivacaine Hydrochloride S.A.L.F.
Warnings and precautions
Talk to your doctor or pharmacist before using Ropivacaine Hydrochloride S.A.L.F. This
medicine should be administered with caution in the following cases:

if you have heart, liver or kidney problems, or if you are elderly, as your doctor may need to adjust the dose of Ropivacaine Hydrochloride S.A.L.F.;
if you or a family member has a rare blood disorder called “porphyria”, in which case your doctor may administer a different anaesthetic. Inform your doctor before treatment of any previous medical conditions or disorders.

Children
This medicine should be administered with caution in newborns, as they are more sensitive to
ropivacaine.
Great care must be taken when using this medicine in children under 12 years of age, as the safety and
efficacy of the medicine have not been established in younger children.
In children up to and including 12 years of age, the use of injections of Ropivacaine Hydrochloride S.A.L.F. 7.5 mg/ml
and 10 mg/ml to numb areas of the body has not been evaluated. For this patient group, the 2 mg/ml strength may be more suitable.
Particular attention should be paid to newborns due to the increased toxicity of the medicine in
this age group.
Methaemoglobinaemia:
Methaemoglobinaemia has been reported with the use of local anaesthetics; the risk may be increased
in patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methaemoglobinaemia, cardiac or pulmonary impairment, infants under 6 months of age, and concomitant exposure to oxidizing agents or their metabolites, and other drugs associated with methaemoglobinaemia. If use is required in at-risk patients, medical supervision is recommended.
Other medicines and ROPIVACAINA CLORIDRATO S.A.L.F.
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, inform your doctor if you are taking any of the following medicines:

other local anaesthetics, such as lidocaine;
certain strong painkillers used to relieve pain, such as morphine or codeine;
certain medicines used to treat irregular heartbeat (arrhythmia), such as mexiletine and lidocaine. Your doctor must be informed of the use of these medicines in order to determine the correct dose of Ropivacaine Hydrochloride S.A.L.F. Inform your doctor if you are taking any of the following medicines:
medicines used for depression (such as fluvoxamine);
antibiotics used to treat bacterial infections (such as enoxacin).
Epidural anaesthesia (and unintentional intrathecal administration) can lead to hypotension and bradycardia. Hypotension should be promptly treated with an intravenous vasopressor and adequate vascular volume replacement. The body takes longer to eliminate Ropivacaine Hydrochloride S.A.L.F. when these medicines are taken. If you are taking any of these medicines, prolonged use of Ropivacaine Hydrochloride should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before using this medicine.
It is not known whether ropivacaine hydrochloride affects pregnancy or passes into breast milk.
If this medicine is administered during pregnancy, it may reduce the baby's heart rate (known as fetal heart rate), therefore your doctor will monitor the fetal heart rate.
Use of this medicine should be avoided if you are breastfeeding, as there are no data available on the excretion of the medicine in breast milk.
There are no available data regarding fertility.
Driving and using machines
Avoid driving or operating machinery after administration of this medicine.
Ropivacaine Hydrochloride S.A.L.F. may cause drowsiness and affect reaction speed.
ROPIVACAINA CLORIDRATO S.A.L.F. contains sodium
Ropivacaine Hydrochloride S.A.L.F. 2 mg/ml injectable solution, 10 ml vial
This medicine contains 34 mg of sodium (main component of table salt) per 10 ml.
This corresponds to 1.7% of the maximum daily intake recommended in an adult's diet.
Ropivacaine Hydrochloride S.A.L.F. 2 mg/ml injectable solution, 20 ml vial
This medicine contains 68 mg of sodium (main component of table salt) per 20 ml.
This corresponds to 3.4% of the maximum daily intake recommended in an adult's diet.
Ropivacaine Hydrochloride S.A.L.F. 2 mg/ml injectable solution, 100 ml bag
This medicine contains 340 mg of sodium (main component of table salt) per 100 ml.
This corresponds to 17% of the maximum daily intake recommended in an adult's diet.
Ropivacaine Hydrochloride S.A.L.F. 2 mg/ml injectable solution, 200 ml bag
This medicine contains 680 mg of sodium (main component of table salt) per 200 ml.
This corresponds to 31% of the maximum daily intake recommended in an adult's diet.
Ropivacaine Hydrochloride S.A.L.F. 7.5 mg/ml injectable solution, 10 ml vial
This medicine contains 29.9 mg of sodium (main component of table salt) per 10 ml.
This corresponds to 1.5% of the maximum daily intake recommended in an adult's diet.
Ropivacaine Hydrochloride S.A.L.F. 7.5 mg/ml injectable solution, 20 ml vial
This medicine contains 59.8 mg of sodium (main component of table salt) per 20 ml.
This corresponds to 3% of the maximum daily intake recommended in an adult's diet.
Ropivacaine Hydrochloride S.A.L.F. 10 mg/ml injectable solution, 10 ml vial
This medicine contains 28 mg of sodium (main component of table salt) per 10 ml.
This corresponds to 1.4% of the maximum daily intake recommended in an adult's diet.
Ropivacaine Hydrochloride S.A.L.F. 10 mg/ml injectable solution, 20 ml vial
This medicine contains 56 mg of sodium (main component of table salt) per 20 ml.
This corresponds to 2.8% of the maximum daily intake recommended in an adult's diet.

3. How to use ROPIVACAINA CLORIDRATO S.A.L.F.

Ropivacaine Hydrochloride S.A.L.F. will be administered to you by a doctor or other healthcare professional as an injection or infusion. Care must be taken to avoid direct injection into a vein. The part of the body where the medicine will be administered depends on the reason for which Ropivacaine Hydrochloride S.A.L.F. is being given. The doctor will adjust the dose according to your needs and taking into account your age, body weight, and general health condition. The dose administered by the doctor will depend on the type of pain relief required. The dose used should be the lowest necessary to achieve effective anaesthesia.

The doctor will administer Ropivacaine Hydrochloride S.A.L.F. at one of the following sites:

The part of the body that needs to be anaesthetized.
The area near the part of the body that needs to be anaesthetized.
An area distant from the part of the body that needs to be anaesthetized. This occurs when an epidural or infusion administration is performed (into the area surrounding the spinal cord). When Ropivacaine Hydrochloride S.A.L.F. is used in one of the ways described above, it prevents nerves from transmitting pain signals to the brain. You will not feel pain, heat, or cold sensations, but you may still perceive other sensations such as pressure or touch. The doctor will know the correct method of administering the medicine.

If you are given more Ropivacaine Hydrochloride S.A.L.F. than you should
If you think you have been given too much of this medicine, inform your doctor immediately or go to the nearest hospital.
The first signs of an overdose are: feeling dizzy or lightheaded, numbness of the lips and around the mouth, tongue numbness, hearing problems, ringing in the ears, vision problems.
More serious adverse effects include difficulty speaking, muscle spasms, tremors, shaking, generalized seizures, and loss of consciousness.
At the first sign of overdose, the doctor will immediately stop the treatment and initiate the most appropriate therapy depending on the severity of the symptoms.

4. Possible side effects

Like all medicines, Ropivacaine Hydrochloride S.A.L.F. can cause side effects, although
not everyone will experience them.
Important side effects to monitor:
Life-threatening, sudden allergic reactions (such as anaphylaxis, including anaphylactic shock)
are rare, affecting between 1 and 10 out of 10,000 users. Possible symptoms include sudden onset of
skin rash, itching or raised rash (urticaria); swelling of the face, lips, tongue or other body parts (angioedema);
shortness of breath, wheezing or difficulty breathing; and feeling faint or losing consciousness.
If you think Ropivacaine Hydrochloride S.A.L.F. is causing an allergic reaction, inform your doctor
immediately.
The following side effects may also occur:

Very common (may affect more than 1 in 10 people):

low blood pressure (hypotension); may cause dizziness or mental confusion
feeling unwell (nausea)

Common (may affect up to 1 in 10 people):

tingling in the extremities (paresthesia)
dizziness, headache
slow or fast heartbeat (bradycardia, tachycardia), high blood pressure (hypertension)
vomiting, difficulty urinating (urinary retention)
increased body temperature (fever), chills
back pain

Uncommon (may affect up to 1 in 100 people):

anxiety, reduced sensitivity to touch (hypoesthesia)
feeling faint (syncope)
difficulty breathing (dyspnea)
low body temperature (hypothermia)
symptoms of overdose, which may occur following accidental injection into a blood vessel or administration of an excessive dose (see section “If you use more Ropivacaine Hydrochloride S.A.L.F. than you should”). These include epileptic seizures (fits), dizziness or mental confusion, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems, speech difficulties, muscle stiffness and tremor.

Rare (may affect up to 1 in 1,000 people):

heart attack (cardiac arrest)
irregular heartbeat (arrhythmia)

Not known (frequency cannot be estimated from the available data):

Horner’s syndrome
fetal bradycardia
methemoglobinemia
malignant hyperthermia

Other side effects may also occur:

numbness due to nerve irritation caused by the needle or injection. This usually does not last long
involuntary muscle movements (dyskinesia)

Possible side effects observed with other local anesthetics, which could also be caused by
Ropivacaine Hydrochloride S.A.L.F., include:

nerve damage that may cause permanent problems. Rarely (affects between 1 and 10 out of 10,000 patients)
if an excessive dose of Ropivacaine Hydrochloride S.A.L.F. is administered into the spinal fluid, the entire body may become numb (anesthetized)
receiving an epidural injection (an injection into the space around the spinal nerves) may interrupt a nerve pathway from the brain to the head and neck, particularly in pregnant women, which may sometimes lead to a condition called Horner’s syndrome. This is characterized by reduced pupil size, drooping of the upper eyelid, and inability of sweat glands to produce sweat. It will resolve spontaneously once treatment is discontinued.

Additional side effects in 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 out of 100 children), and vomiting, which occurs more frequently in children (affects more than 1 in 10 children).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ROPIVACAINA CLORIDRATO S.A.L.F.

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the pack after "EXP.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light. Do not freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information What ROPIVACAINA CLORIDRATO S.A.L.F. contains

The active substance is ropivacaine hydrochloride. Each ml of solution contains 2 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride depending on the strength. The other components are: sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of ROPIVACAINA CLORIDRATO S.A.L.F. and contents of the
package
Ropivacaine Cloridrato S.A.L.F. 2 mg/ml is available in:

pack containing 5 glass vials of 10 ml or 20 ml of injectable solution;
pack containing 20 infusion bags of 100 ml or 200 ml of infusion solution.

Ropivacaine Cloridrato S.A.L.F. 7.5 mg/ml is available in:

pack of 5 vials of 10 ml or 20 ml of injectable solution.

Ropivacaine Cloridrato S.A.L.F. 10 mg/ml is available in:

pack of 5 vials of 10 ml or 20 ml of injectable solution.

Marketing Authorization Holder
S.A.L.F. S.p.A. Laboratorio Farmacologico Via Marconi, 2 - Cenate Sotto (BG)
Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico Via G. Mazzini, 9 - Cenate Sotto (BG)
The following information is intended exclusively for medical professionals and healthcare operators:
ROPIVACAINA CLORIDRATO S.A.L.F. 2 - 7.5 - 10 mg/ml injectable solution
ROPIVACAINA CLORIDRATO S.A.L.F. 2 mg/ml infusion solution
Preparation
The infusion solution of Ropivacaine cloridrato S.A.L.F. contained in PVC-free bags is chemically and physically compatible with the following medicinal products. Compatibility with other solutions not listed below has not been studied:
Concentration of Ropivacaine cloridrato S.A.L.F.: 1–2 mg/ml
Medicinal product Concentration*
Fentanyl citrate 1.0–10.0 micrograms/ml
Sufentanil citrate 0.4–4.0 micrograms/ml
Morphine sulfate 20.0–100.0 micrograms/ml
Clonidine hydrochloride 5.0–50.0 micrograms/ml
* The concentration range reported in the table is wider than that used in clinical practice. Epidural infusions of Ropivacaine cloridrato S.A.L.F./sufentanil citrate, Ropivacaine cloridrato S.A.L.F./morphine sulfate and Ropivacaine cloridrato S.A.L.F./clonidine hydrochloride have not been evaluated in clinical studies.
Precipitation may occur in alkaline solutions, as ropivacaine is poorly soluble at pH above 6.0. This medicinal product contains no preservatives and is for single use only. Any unused solution must be discarded.

Instructions for Use, Handling, and Disposal

Ropivacaine hydrochloride S.A.L.F. must be used only by physicians experienced in regional anesthesia or under their supervision. Ropivacaine hydrochloride S.A.L.F. is preservative-free and intended for single use only. Any remaining solution must be discarded.
The primary container must not be resterilized if intact.
Validity after first opening
From a microbiological standpoint, the product should be used immediately. If not used immediately, storage conditions and duration prior to use are the responsibility of the user and must not exceed 24 hours at a temperature between 2 and 8°C.

Dosage – Adults and children over 12 years of age
The following table provides guidance on recommended dosages for the most common types of block. The administered dose should be the lowest required to achieve effective blockade. The dose should also be selected based on the physician’s experience and knowledge of the patient’s clinical status.

| Onset | Conc. | Volume | Dose | Duration | |----------|----------|----------|----------|-------------| | | mg/ml | ml | mg | minutes hours | | SURGICAL ANESTHESIA | | Lumbar epidural administration | | 7.5 | 15–25 | 113–188 | 10–20 | 3–5 | | Surgery | 10.0 | 15–20 | 150–200 | 10–20 | 4–6 | | Caesarean section | 7.5 | 15–20 | 113–150 1) | 10–20 | 3–5 | | Thoracic epidural administration | | 5–15 (depends on the level of injection) | 7.5 | 38–113 | 10–20 | n/a 2) | | For determining block for post-operative pain control | | Major nerve block* | | 7.5 | 30–40 | 225–300 3) | 10–25 | 6–10 | | Brachial plexus block | | Surgical field block | | (e.g., minor nerve blocks and infiltration) | 7.5 | 1–30 | 7.5–225 | 1–15 | 2–6 | | ACUTE PAIN TREATMENT | | Lumbar epidural administration | | Bolus | 2.0 | 10–20 | 20–40 | 10–15 | 0.5–1.5 | | Intermittent injections (top-up) | 2.0 | 20–30 | 10–15 | (interval minimum 30 min.) | | Continuous infusion, e.g.: | | 2.0 | 6–10 ml/h | 12–20 mg/h | n/a | n/a | | labor and delivery analgesia | 2.0 | 6–14 ml/h | 12–28 mg/h | n/a | n/a | | post-operative pain control | | Thoracic epidural administration | | Continuous infusion | 2.0 | 6–14 ml/h | 12–28 mg/h | n/a | n/a | | (post-operative pain control) | | Surgical field block | | (e.g., minor nerve blocks and infiltration) | 2.0 | 1–100 | 2–200 | 1–5 | 2–6 | | Peripheral nerve block | | (femoral or interscalene block) | | Continuous infusion or intermittent injections (e.g., post-operative pain treatment) | 2.0 | 5–10 ml/h | 10–20 mg/h | n/a | n/a |

The doses listed in the table are considered suitable to achieve adequate blockade and should be regarded as guidance for use in adults. Individual variations in onset time and duration may occur.
The "dose" column lists the average dose ranges typically required. Reference texts should be consulted regarding factors influencing specific block techniques and individual patient requirements.

* Regarding major nerve blocks, a recommended dose is provided only for brachial plexus block.
For other types of major nerve blocks, lower doses may be required.
However, at present, there is no experience with specific recommended doses for other types of block.

Incremental doses should be administered, starting with a dose of approximately 100 mg (97.5 mg = 13 ml; 105 mg = 14 ml) over 3–5 minutes. If necessary, two additional doses of up to 50 mg total may be used.
n/a = not applicable
The dose for major nerve blocks should be adjusted according to the site of administration and the patient’s condition.

Interscalene and supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the anesthetic used (see section “Special Warnings”).

In general, surgical anesthesia (e.g., via epidural administration) requires higher concentrations and dosages. Ropivacaine hydrochloride S.A.L.F. 10 mg/ml is recommended for epidural anesthesia in surgical procedures requiring complete motor block. Lower concentrations and dosages are advised for analgesia (e.g., epidural administration for acute pain treatment).

Administration methods – Adults and children over 12 years of age
To avoid intravascular injection, careful aspiration is recommended before and during injection. When a high dose is to be injected, a test dose of 3–5 ml of lidocaine with adrenaline (epinephrine) is recommended. Accidental intravascular injection may be recognized by a transient increase in heart rate, while accidental intrathecal injection may be identified by signs of spinal block.

Aspiration must be performed before and during drug administration, which should be carried out slowly or in fractionated doses at a rate of 25–50 mg/minute, with close monitoring of vital signs and maintenance of verbal contact. If signs of toxicity occur, administration must be immediately discontinued.

For post-operative pain treatment, the following technique is recommended: unless already established before surgery, perform an epidural block with Ropivacaine hydrochloride S.A.L.F. 7.5 mg/ml administered via an epidural catheter. Analgesia is then maintained with continuous infusion of Ropivacaine hydrochloride S.A.L.F. 2 mg/ml: in most cases of moderate to severe post-operative pain, an infusion rate of 6–14 ml/h (12–28 mg/h) provides adequate analgesia with only mild, non-progressive motor block. The maximum duration of epidural block is 3 days. In any case, careful monitoring of analgesic effect should be performed to allow timely catheter removal as soon as pain intensity permits. This technique has been associated with a significant reduction in opioid requirements.

When performing prolonged peripheral nerve blocks, either via continuous infusion or repeated injections, risks of achieving toxic plasma concentrations or causing local neurologic damage must be evaluated.

Cumulative doses of up to 675 mg of ropivacaine administered within 24 hours for surgical anesthesia and post-operative analgesia have been well tolerated in adults, as have continuous epidural infusions of up to 28 mg/h for 72 hours post-operatively. In a limited number of patients, higher doses up to 800 mg/day have been administered with a relatively low incidence of adverse reactions. In caesarean section, use of ropivacaine at concentrations exceeding 7.5 mg/ml has not been documented.

Dosage – Pediatric patients from 0 (term neonates) to 12 years of age
ACUTE PAIN TREATMENT (peri- and post-operative)
| Conc. | Volume | Dose | |----------|----------|----------| | mg/ml | ml/kg | mg/kg | | Single caudal epidural block | | 2.0 | 1 | 2 | | Blocks below T12 level in children weighing up to 25 kg | | Continuous epidural infusion in children weighing up to 25 kg | | 0 to 6 months | | Bolus dose a) | 2.0 | 0.5–1 | 1–2 | | Infusion up to 72 hours | 2.0 | 0.1 ml/kg/h | 0.2 mg/kg/h | | 6 to 12 months | | Bolus dose a) | 2.0 | 0.5–1 | 1–2 | | Infusion up to 72 hours | 2.0 | 0.2 ml/kg/h | 0.4 mg/kg/h | | 1 to 12 years | | Bolus dose b) | 2.0 | 1 | 2 | | Infusion 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 guidance for pediatric use. Individual variations may be necessary. In pediatric patients with high body weight, a gradual dose reduction based on ideal body weight is often required. The volume for a single caudal epidural block and for bolus epidural doses must not exceed 25 ml per patient. Reference texts should be consulted regarding factors influencing specific block techniques and individual patient requirements.

a) Within the dose range listed, lower doses are recommended for thoracic epidural blocks, while higher doses are recommended for lumbar or caudal epidural blocks.
b) Recommended for lumbar epidural blocks. It is good practice to reduce the bolus dose for thoracic epidural analgesia.

Peripheral nerve blocks: Infants and children from 1 to 12 years
ACUTE PAIN TREATMENT (peri- and post-operative)
| Conc. | Volume | Dose | |----------|----------|----------| | mg/ml | ml/kg | mg/kg | | Single injection for peripheral nerve block | | e.g., ilioinguinal nerve block, brachial plexus block, fascia iliaca compartment block | 2.0 | 0.5–0.75 | 1.0–1.5 | | Multiple blocks | 2.0 | 0.5–1.5 | 1.0–3.0 | | Continuous infusion for peripheral nerve block in children 1 to 12 years | 2.0 | 0.1–0.3 ml/kg/h | 0.2–0.6 mg/kg/h | | Infusion up to 72 hours |

The doses listed in the table should be considered as guidance for pediatric use. Individual variations may be necessary. In pediatric patients with high body weight, a gradual dose reduction based on ideal body weight is often required. Reference texts should be consulted regarding factors influencing specific block techniques and individual patient requirements.

Administration method – Pediatric patients from 0 to 12 years of age
To avoid intravascular injection, careful aspiration is recommended before and during injection. Vital signs must be closely monitored during injection. If signs of toxicity occur, administration must be immediately discontinued.

Gradual administration of the calculated local anesthetic dose is recommended, regardless of the route of administration.

The use of ropivacaine 7.5 mg/ml and 10 mg/ml may be associated with systemic and central toxic events in children. Lower concentrations (2 mg/ml and 5 mg/ml) are more appropriate for administration in these populations.

Doses for peripheral blocks in infants and children provide guidance for use in children without serious illness. More conservative dosing and careful monitoring are recommended for children with severe illness.

Single injections for peripheral nerve blocks (e.g., ilioinguinal nerve block, brachial plexus block, fascia iliaca compartment block) must not exceed 2.5–3.0 mg/kg.

The use of ropivacaine in preterm infants has not been documented.

Special populations: debilitated, elderly, or severely ill patients may have reduced tolerance to high blood levels; dose adjustment of ropivacaine is recommended.

For further information, consult the Summary of Product Characteristics.