РОПИВАКАИНА 2 мг/мл Инъекционный раствор

Содержание инструкции

1. ROPIVACAINA CLORIDRATO S.A.L.F. 2 mg/ml injectable solution, 2 mg/ml infusion solution, 7.5 mg/ml injectable solution, 10 mg/ml injectable solution
   1. What is ROPIVACAINA CLORIDRATO S.A.L.F. and what is it used for?
   2. What you need to know before using ROPIVACAINA CLORIDRATO S.A.L.F.
   3. How to use ROPIVACAINA CLORIDRATO S.A.L.F.
   4. Possible side effects
   5. How to store ROPIVACAINA CLORIDRATO S.A.L.F.
   6. Package Contents and Other Information What ROPIVACAINA contains
2. Ropivacaine Hydrochloride S.A.L.F./morphine sulfate and Ropivacaine Hydrochloride S.A.L.F./clonidine

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

ROPIVACAINA CLORIDRATO

Generic medicine
Read 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ROPIVACAINA CLORIDRATO S.A.L.F. is and what it is used for
• 2. What you need to know before you are given ROPIVACAINA CLORIDRATO S.A.L.F.
• 3. How to use ROPIVACAINA CLORIDRATO S.A.L.F.
• 4. Possible side effects
• 5. How to store ROPIVACAINA CLORIDRATO S.A.L.F.
• 6. Contents of the pack and other information

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

Ropivacaina Cloridrato S.A.L.F. contains the active ingredient ropivacaine hydrochloride which belongs
to a group of medicines called local anesthetics used to make a part of the
body insensitive. Ropivacaina Cloridrato S.A.L.F. will be administered to you either as an injection or as an infusion,
depending on how it will be used.
Ropivacaina Cloridrato S.A.L.F. 7.5 mg/ml and 10 mg/ml is used in adults and children over the age of
12 years to make parts of the body insensitive (anesthetize). It is used to prevent the onset
of pain or to provide pain relief. It can be used for:

• anesthetizing parts of the body during a surgical procedure, including cesarean section;
• relieving pain during or after childbirth, after surgery, or after an injury. 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 a surgical procedure.

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 any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to any other local anesthetic of the same class (e.g. lidocaine or bupivacaine);
• if you have been told that you have a reduced blood volume (hypovolemia). This medicine should not be administered into a blood vessel to anesthetize a specific area of the body or into the cervix to relieve pain during childbirth. If you are not sure if you fall into any of the above cases, consult your doctor before receiving

Ropivacaina Cloridrato S.A.L.F.

Warnings and precautions
Consult your doctor or pharmacist before using ROPIVACAINA hydrochloride S.A.L.F. This
medicine should be administered to you with caution in the following cases:

• if you have heart, liver or kidney problems and if you are elderly, because it may be necessary for the doctor to adjust the dose of Ropivacaina Cloridrato S.A.L.F.;
• if you or a family member has a rare blood disease called “porphyria”, in this case the doctor may administer a different anesthetic. Inform your doctor, before treatment, of all previous illnesses or medical conditions.

Children
This medicine should be administered with caution in newborns because they are more sensitive to
ropivacaine.
Great care should be taken when using in children under 12 years of age, as the safety and
efficacy of the medicine have not been defined in younger children.
In children up to and including 12 years of age, the use of injections of Ropivacaina Cloridrato S.A.L.F. 7.5 mg/ml
and 10 mg/ml to numb areas of the body have not been evaluated. For this group of
patients, the 2 mg/ml dosage may be more suitable.
Particular attention should be paid to newborns due to the increased toxicity of the medicine in
this age group.
Methemoglobinemia:
Methemoglobinemia has been reported with the use of local anesthetics; an increase
in risk may occur in patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary impairment, infants under 6 months of age, and
concurrent exposure to oxidizing agents or their metabolites and other drugs associated with
methemoglobinemia. If use is required in at-risk patients, medical supervision is recommended.

Other medicines and ROPIVACAINA CLORIDRATO S.A.L.F.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor if you are taking any of the following medicines:

• other local anesthetics, such as lidocaine;
• some strong painkillers, used to relieve pain such as morphine or codeine;
• some medicines used to treat irregular heartbeat (arrhythmia) such as mexiletine and lidocaine. The doctor must be informed of the intake of these medicines in order to establish the correct dose of Ropivacaina Cloridrato S.A.L.F. Tell your doctor if you are taking any of the following medicines:
• medicines used for depression (such as fluvoxamine);
• antibiotics to treat infections caused by bacteria (such as enoxacin).
• Epidural anesthesia (and accidental intrathecal anesthesia) can lead to hypotension and bradycardia. Hypotension should be treated promptly with an intravenous vasopressor and with adequate vascular filling. The body takes longer to eliminate Ropivacaina Cloridrato S.A.L.F. if you are taking these medicines. If you are taking one of these medicines, prolonged use of Ropivacaina Cloridrato should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
It is not known whether ropivacaine hydrochloride affects pregnancy or passes into breast milk.
If this medicine is administered to you during pregnancy, it may reduce the baby's heart rate (known as fetal heart rate) therefore the doctor will monitor the
fetal heart rate.
The use of this medicine should be avoided if you are breastfeeding, because there is no data
available on the excretion of the medicine in breast milk.
No data are available in relation to fertility.

Driving and operating machinery
Avoid driving vehicles or using machinery after the administration of this medicine.
Ropivacaina Cloridrato 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 (the main component of table salt) per 10 ml.
This is equivalent to 1.7% of the recommended daily maximum intake with the diet of an adult.
Ropivacaine hydrochloride S.A.L.F. 2 mg/ml injectable solution, 20 ml vial
This medicine contains 68 mg of sodium (the main component of table salt) per 20 ml.
This is equivalent to 3.4% of the recommended daily maximum intake with the diet of an adult.
Ropivacaine hydrochloride S.A.L.F. 2 mg/ml injectable solution, 100 ml bag
This medicine contains 340 mg of sodium (the main component of table salt) per 100 ml.
This is equivalent to 17% of the recommended daily maximum intake with the diet of an adult.
Ropivacaine hydrochloride S.A.L.F. 2 mg/ml injectable solution, 200 ml bag
This medicine contains 680 mg of sodium (the main component of table salt) per 200 ml.
This is equivalent to 31% of the recommended daily maximum intake with the diet of an adult.
Ropivacaine hydrochloride S.A.L.F. 7.5 mg/ml injectable solution, 10 ml vial
This medicine contains 29.9 mg of sodium (the main component of table salt) per 10 ml.
This is equivalent to 1.5% of the recommended daily maximum intake with the diet of an adult.
Ropivacaine hydrochloride S.A.L.F. 7.5 mg/ml injectable solution, 20 ml vial
This medicine contains 59.8 mg of sodium (the main component of table salt) per 20 ml.
This is equivalent to 3% of the recommended daily maximum intake with the diet of an adult.
Ropivacaine hydrochloride S.A.L.F. 10 mg/ml injectable solution, 10 ml vial
This medicine contains 28 mg of sodium (the main component of table salt) per 10 ml.
This is equivalent to 1.4% of the recommended daily maximum intake with the diet of an adult.
Ropivacaine hydrochloride S.A.L.F. 10 mg/ml injectable solution, 20 ml vial
This medicine contains 56 mg of sodium (the main component of table salt) per 20 ml.
This is equivalent to 2.8% of the recommended daily maximum intake with the diet of an adult.

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

Ropivacaina Cloridrato S.A.L.F. will be administered to you by a doctor or another healthcare professional
as an injection or infusion. Care must be taken to avoid direct injection into a
vein. The part of the body where it will be administered depends on the reason why Ropivacaina Cloridrato S.A.L.F. is being administered. The doctor will adjust the dose to be administered based
on your needs, taking into account age, body weight and your health conditions. The
dose administered by the doctor will depend on the type of pain relief needed. The dose to be
used should be the lowest required to achieve effective anesthesia.
The doctor will administer Ropivacaina Cloridrato S.A.L.F. in one of the following areas:

• The part of the body that needs to be anesthetized.
• The area near the part of the body that needs to be anesthetized.
• An area away from the part of the body that needs to be anesthetized. This occurs in the case of an epidural or infusion injection (in an area around the spinal cord). When Ropivacaina Cloridrato S.A.L.F. is used in one of the ways described above, it prevents nerves from transmitting pain messages to the brain. You will not feel the sensation of pain, heat or cold, but you may have other sensations such as pressure or touch. The doctor will know the correct way to administer the medicine.

If you use more ROPIVACAINA cloridrato S.A.L.F. than you should
If you think you have been given too much of this medicine, immediately inform your
doctor 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, numbness of the tongue, hearing problems, ringing in the ears, vision problems.
The most serious side effects include speech problems, muscle spasms, tremors,
shaking, generalized seizures and loss of consciousness.
The doctor, at the first sign of overdose, will immediately stop therapy and establish the
most appropriate therapy based on the severity of the symptoms.

4. Possible side effects

Like all medicines, Ropivacaina Cloridrato S.A.L.F. can cause side effects, although
not everyone gets them.

Important side effects to check for:
Sudden, life-threatening allergic reactions (such as anaphylaxis, including anaphylactic shock)
are rare, affecting between 1 and 10 users out of 10,000. Possible symptoms include sudden onset
of skin rash, itching or rash with swelling (urticaria);
swelling of the face, lips, tongue or other parts of the body (angioedema); and shortness of breath, wheezing or
difficulty breathing; feeling of loss of consciousness.
If you think Ropivacaina Cloridrato S.A.L.F. is causing an allergic reaction, tell your
doctor immediately.
The following side effects may also occur:

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

• low blood pressure (hypotension); this can cause dizziness or confusion
• feeling sick (nausea).

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

• tingling in the extremities (paresthesia);
• dizziness, headache;
• slowed or accelerated 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 of fainting (syncope);
• difficulty breathing (dyspnea);
• low body temperature (hypothermia);
• overdose symptoms, which can occur after accidental injection into a blood vessel or administration of an excessive dose (see the paragraph “If you use more Ropivacaina Cloridrato S.A.L.F. than you should”). These include seizures (convulsions), dizziness or confusion, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems (vision impairment), speech problems, 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 available data)

• Horner's syndrome;
• fetal bradycardia;
• methaemoglobinemia;
• malignant hyperthermia.

Other side effects may also occur:

• numbness, due to irritation of the nerves 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 may also be caused
by Ropivacaina Cloridrato S.A.L.F,are:

• nerve damage that can cause permanent problems. Rarely (affects 1 to 10 patients out of 10,000);
• if an excessive dose of Ropivacaina Cloridrato S.A.L.F. is administered into the spinal fluid, it is possible for the whole body to become numb (anesthetized).
• receiving an epidural injection (injection into the space around the spinal nerves) can cause disruption of a nerve pathway that goes from the brain to the head and neck, especially in pregnant women, which can sometimes cause a condition called Horner's syndrome. This is characterized by a reduction in the size of the pupil, drooping of the upper eyelid and inability of the sweat glands to produce sweat. It will resolve spontaneously when treatment is stopped.

Additional effects in children
In children, the side effects are the same as in adults, except for low blood pressure, which occurs less frequently in children (affects 1 to 10 children out of 100) and
vomiting, which occurs more frequently in children (affects more than 1 child in 10).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging 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 any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information What ROPIVACAINA contains

ROPIVACAINE HYDROCHLORIDE S.A.L.F.

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

Description of the appearance of ROPIVACAINE HYDROCHLORIDE S.A.L.F. and package contents
Ropivacaine Hydrochloride S.A.L.F. 2 mg/ml is available in:

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

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

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

Marketing Authorisation 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:

ROPIVACAINE HYDROCHLORIDE S.A.L.F. 2 - 7.5 - 10 mg/ml injectable solution
ROPIVACAINE HYDROCHLORIDE S.A.L.F. 2 mg/ml solution for infusion
Preparation
The infusion solution of Ropivacaine Hydrochloride S.A.L.F. contained in the PVC free bags is
chemically and physically compatible with the following drugs. Compatibility with other solutions
different from those reported below has not been studied:
Concentration of Ropivacaine Hydrochloride S.A.L.F.: 1-2 mg/ml

DrugConcentration*
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 what is used
in clinical practice. Epidural infusions of Ropivacaine Hydrochloride S.A.L.F./sufentanil citrate,

Ropivacaine Hydrochloride S.A.L.F./morphine sulfate and Ropivacaine Hydrochloride 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 values above 6.0. This medicinal product is preservative-free and for single use only. Any
remaining solution must be discarded.

Instructions for use, handling and disposal
Ropivacaine Hydrochloride S.A.L.F. must only be used by physicians experienced in regional anesthesia
or under their supervision. Ropivacaine Hydrochloride S.A.L.F. is preservative-free and for single use.
Any remaining solution must be discarded.
The intact primary container must not be resterilized.

Validity after first opening
From a microbiological point of view, the product must be used immediately. Otherwise, the storage
conditions and storage times before use are the responsibility of the user and, in any case, 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 is a guide to the recommended dosages for the most common types of block. The dose to
be administered must be the lowest required to achieve an effective block. The dose to
be administered must also be chosen based on the physician's experience and knowledge
of the patient's clinical condition.

Conc.VolumeDose
Onset
activity
Duration
mg/ml ml mg minutes hours

SURGICAL ANESTHESIA
Epidural lumbar administration
Surgery
7.5 15–25 113–188 10–20 3–5
10.0 15–20 150–200 10–20 4–6
Cesarean section 7.5 15–20 113–150 1)10–20 3–5

Epidural thoracic administration
5–15 (depending
on the level
of injection)
To determine the block for
post-operative pain control 7.538–113 10–20 n/a 2)

Major nerve block*
Brachial plexus block
7.5 30–40 225–300 3)10–25 6–10

Surgical field block
(e.g., minor nerve block and
infiltration)
7.5 1–30 7.5–225 1–15 2–6

ACUTE PAIN TREATMENT
Epidural lumbar administration
Bolus 2.0 10–20 20–40 10–15 0.5–1.5
Intermittent injections (top–up)
(e.g., labor and delivery analgesia)
2.0
10–15
(minimum interval 30
min.)
20–30
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

Epidural thoracic administration
Continuous infusion
(post-operative pain control)
2.0 6–14 ml/h 2–28 mg/h n/a n/a

Surgical field block
(e.g., minor nerve block 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 reported in the table are those considered suitable for producing an adequate block and must
be considered as a guide for use in adults. Individual variations may occur
regarding the onset and duration of action. In the "dose" column, the average dose ranges are reported. Reference texts
must be consulted both regarding the aspects that influence specific blocking techniques,
and regarding the individual needs of the patient.
* With reference to major nerve block, a dose is recommended only for brachial plexus block.
Lower doses may be required for other types of major nerve block.
However, at present, there is no experience of specific recommended doses for other types of block.

• 1) Increasing 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 additional can be used.
• 2) n/a = not applicable
• 3) The dose for major nerve block should be adjusted according to the site of administration and the patient's condition. Blocks in the interscalene and supraclavicular brachial plexuses 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., for epidural administration) requires the use of higher concentrations and dosages. The use of Ropivacaine Hydrochloride S.A.L.F. 10 mg/ml is recommended for epidural anesthesias in surgical interventions where complete motor block is required. Lower concentrations and dosages are recommended for anesthesia (e.g., for epidural administration for the treatment of acute pain).

Method of administration – Adults and children over 12 years of age
To avoid intravascular injection, careful aspiration is recommended before and during
the injection. When a high dose is to be injected, a test dose of 3-5 ml of lidocaine with epinephrine is recommended.
Accidental intravascular injection can be recognized by a temporary increase in heart rate, while accidental
intrathecal injection can be recognized by signs of spinal block.
Aspiration should be performed before and during the administration of the drug, which should
be injected slowly or in fractional doses, at a rate of 25-50 mg/minute, keeping the patient's vital signs under
close observation and maintaining verbal contact. If symptoms of toxicity occur, administration should be stopped immediately.
For the treatment of post-operative pain, the following technique is recommended: unless already induced before surgery, an epidural block with Ropivacaine Chlorhydrate
S.A.L.F. 7.5 mg/ml is performed via an epidural catheter. Analgesia is then maintained
with an infusion of Ropivacaine Hydrochloride S.A.L.F. 2 mg/ml: in most cases of moderate to severe post-operative pain, an infusion of 6-14 ml (12-28 mg/h) maintains adequate analgesia,
with only mild and non-progressive motor block. The maximum duration of the epidural block is 3 days. In any case, careful monitoring of the analgesic effect should be performed in order to remove the catheter as soon as the intensity of the pain allows. With this
technique, a significant reduction in the need for opioids has been observed.
When performing prolonged peripheral nerve blocks, either through continuous infusion or
through repeated injections, the risks of reaching a toxic plasma concentration or causing local neuronal damage must be assessed.
Cumulative doses of up to 675 mg of ropivacaine administered over 24 hours for surgical anesthesia and analgesia in the post-operative period have been well tolerated in adults, as well as
continuous epidural infusions of up to 28 mg/h for 72 hours in the post-operative period. In a limited number of patients, higher doses of up to 800 mg/day have been administered with a relatively low number of adverse reactions. In cesarean delivery, the use of ropivacaine
at concentrations higher than 7.5 mg/ml has not been documented.

Dosage - Pediatric patients from 0(term newborns)to 12 years of age
TREATMENT OF ACUTE PAIN
(peri- and post-operative)
Conc.
mg/ml

Volume
ml/kg

Dose
mg/kg

Single caudal epidural block
Blocks below the T12 level, in children with
body weight up to 25 kg
2.0 1 2

Continuous epidural infusionin children with body weight up to 25 kg

From 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

From 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

From 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 dose indicated in the table should be considered as a guide for use in pediatrics. Individual variations may be
necessary. In pediatric patients with high body weight, a gradual reduction of the dosage is often
necessary, which must be based on ideal body weight. The volume for single caudal epidural block and the volume for bolus epidural doses must not
exceed 25 ml per patient. Reference texts must be consulted both regarding the aspects that influence specific blocking techniques and regarding the individual needs of
the patient.
a) within the dose range reported, 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
TREATMENT OF ACUTE PAIN
(peri- and post-operative)

Volume
ml/kg

Dose
mg/kg

Conc.
mg/ml

Single injection for peripheral nerve block
e.g. ilioinguinal nerve block,
brachial plexus block, iliac fascia 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 from 1 to 12 years
Infusion up to 72 hours
2.0 0.1-0.3 ml/kg/h 0.2-0.6
mg/kg/h
The dose indicated in the table should be considered as a guide for use in pediatrics. Individual variations may be
necessary. In pediatric patients with high body weight, a gradual reduction of the dosage is often
necessary, which must be based on ideal weight. Reference texts must be consulted both regarding the aspects that influence specific blocking techniques, and regarding the individual needs of
the patient.

Method of administration – Pediatric patients from 0 to 12 years of age
To avoid intravascular injection, careful aspiration is recommended before and during
the injection. The patient's vital signs must be closely monitored during
the injection. If symptoms of toxicity occur, administration should be
immediately stopped.
Gradual administration of the calculated dose of local anesthetic 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 block in infants and children provide guidelines for use in
children without serious illness. More conservative doses and careful monitoring are recommended
for children with serious illnesses.
Single injections for peripheral nerve blocks (e.g., ilioinguinal nerve block, brachial plexus block, iliac
fascia compartment block) should not exceed 2.5 – 3.0
mg/kg.
The use of ropivacaine in premature infants has not been documented.
Special populations: debilitated, elderly or seriously ill patients may have a lower tolerance to elevated blood levels; dose adjustment of ropivacaine is recommended.
For further information, see the Summary of Product Characteristics.