Ropivacaine hydrochloride Bioindustria L.I.M.: detailed information

Package leaflet: Information for the user

ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 2 mg/ml injectable solution, 2 mg/ml infusion solution, 7.5 mg/ml injectable solution, 10 mg/ml injectable solution

ropivacaine hydrochloride
Generic medicine
Please read all of this leaflet carefully before you start using this medicine as 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 nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

What ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is and what it is used for
What you need to know before being given ROPIVACAINA CLORIDRATO Bioindustria L.I.M.
How ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is administered
Possible side effects
How to store ROPIVACAINA CLORIDRATO Bioindustria L.I.M.
Contents of the pack and other information

1. What ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is and what it is used for

ROPIVACAINA CLORIDRATO Bioindustria L.I.M. contains the active substance ropivacaine hydrochloride, which belongs to a group of medicines called local anaesthetics used to numb a part of the body. It will be administered to you either as an injection or as an infusion, depending on how it is to be used.
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 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 can be used for:

anaesthetizing parts of the body during surgical procedures, including caesarean section.
relieving pain during childbirth, after surgery, or after an injury.

ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 2 mg/ml is used in adults and children of all ages for the treatment of acute pain. It numbs (anaesthetizes) parts of the body, for example after surgery.

2. What you should know before using ROPIVACAINA CLORIDRATO Bioindustria L.I.M.

ROPIVACAINA CLORIDRATO Bioindustria L.I.M. must not be administered to you if:

you are allergic (hypersensitive) to ropivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
you are allergic to any other local anaesthetic of the same class (e.g. lidocaine or bupivacaine);
you have low 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 ROPIVACAINA CLORIDRATO Bioindustria L.I.M.

Warnings and precautions
Talk to your doctor or nurse before using ROPIVACAINA CLORIDRATO Bioindustria L.I.M.
Inform your doctor before treatment:

about any pre-existing diseases or medical conditions;
if you have heart, liver or kidney problems, as your doctor may need to adjust the dose of ROPIVACAINA CLORIDRATO Bioindustria L.I.M.;
if you or a family member has a rare blood disorder called "porphyria"; in this case, your doctor may choose to administer a different anaesthetic. Special precautions must be taken to avoid injecting this medicine directly into a vein or into the spinal canal (subarachnoid injection) in order to prevent immediate toxic effects. Injections must not be performed in inflamed areas. Prolonged administration of ropivacaine should be avoided in patients concurrently treated with medicines such as fluvoxamine and enoxacin (see section "Other medicines and ROPIVACAINA CLORIDRATO Bioindustria L.I.M.").
Children
Exercise particular caution with ROPIVACAINA CLORIDRATO Bioindustria L.I.M.:
- in newborn infants, as they are more sensitive to ROPIVACAINA CLORIDRATO Bioindustria L.I.M.;
- in children up to and including 12 years of age, as certain injections to numb body areas have not been evaluated in younger children;
- in children up to and including 12 years of age, as the use of injections of this medicine at concentrations of 7.5 mg/ml and 10 mg/ml to numb body areas has not been evaluated. Doses of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. at 2 mg/ml and 5 mg/ml may be more suitable.

Other medicines and ROPIVACAINA CLORIDRATO Bioindustria L.I.M.
Inform your doctor if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription and herbal medicines. ROPIVACAINA CLORIDRATO Bioindustria L.I.M. may affect how other medicines work, and some medicines may affect ROPIVACAINA CLORIDRATO Bioindustria L.I.M.
In particular, inform your doctor if you are taking any of the following medicines so that the correct dose of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. can be determined:

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 lidocaine, mexiletine, and amiodarone.

Also 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). The body takes longer to eliminate ROPIVACAINA CLORIDRATO Bioindustria L.I.M. when these medicines are taken. If you are taking any of these medicines, prolonged use of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. should be avoided.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine. It is not known whether ropivacaine hydrochloride affects pregnancy.
It is not known whether ropivacaine is excreted in breast milk or whether it could harm breastfed infants.
If this medicine is administered during pregnancy, it may reduce the baby's heart rate (known as fetal heart rate), so your doctor will monitor the fetal heart rate.

Driving and using machines
After receiving ROPIVACAINA CLORIDRATO BIOINDUSTRIA L.I.M., you must not drive or operate tools or machinery until the following day. ROPIVACAINA CLORIDRATO Bioindustria L.I.M. may cause drowsiness and affect reaction speed.

ROPIVACAINA CLORIDRATO Bioindustria L.I.M. contains sodium
2 mg/ml:
This medicine contains 33.83 mg of sodium (the main component of table salt) per 10 ml vial/solution.
This corresponds to 1.69% of the maximum daily dietary intake recommended for an adult.
This medicine contains 338.3 mg of sodium (the main component of table salt) per 100 ml bottle/solution.
This corresponds to 16.93% of the maximum daily dietary intake recommended for an adult.
7.5 mg/ml:
This medicine contains 33.83 mg of sodium (the main component of table salt) per 10 ml vial.
This corresponds to 1.69% of the maximum daily dietary intake recommended for an adult.
10 mg/ml:
This medicine contains 33.83 mg of sodium (the main component of table salt) per 10 ml vial.
This corresponds to 1.69% of the maximum daily dietary intake recommended for an adult.

3. How is ROPIVACAINA CLORIDRATO Bioindustria L.I.M. administered?

ROPIVACAINA CLORIDRATO Bioindustria L.I.M. will be administered by a doctor or another healthcare professional via injection or infusion. The dose given by the doctor will depend on the type of pain relief required. The doctor will adjust the dose according to your individual needs and taking into account your age, body weight, and general health condition. The doctor knows the correct way to administer this medicine.
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. will be administered as an injection or infusion.
The part of the body where the medicine is administered will depend on the reason for which ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is being given.
The doctor will administer ROPIVACAINA CLORIDRATO Bioindustria L.I.M. at one of the following sites:

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 distant from the part of the body that needs to be anesthetized. This occurs when an epidural or infusion injection is performed (into an area around the spinal cord). When ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 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 knows the correct method of administering this medicine.

If you receive more ROPIVACAINA CLORIDRATO Bioindustria L.I.M. than you should
This medicine will be administered by a doctor, so overdose is unlikely. However, if you think you have been given too much of this medicine, inform your doctor immediately.
Serious adverse effects resulting from an overdose of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. require special treatment, and your doctor is able to manage these situations.
The first signs of overdose include: feeling dizzy or lightheaded, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, ringing in the ears (tinnitus), vision disturbances, mild euphoria, altered sensation in the limbs.
At the first sign of overdose, the doctor will immediately stop the treatment and initiate the most appropriate therapy depending on the severity of symptoms. This means that, if any of the above situations occur, or if you think you have received too much ROPIVACAINA CLORIDRATO Bioindustria L.I.M., you must inform your doctor immediately.
More severe adverse effects include difficulty speaking, muscle spasms, tremors, brief and rapid muscle contractions, epileptic seizures (fits), loss of consciousness, breathing difficulties (apnea).
In the most severe cases, cardiac toxicity may also occur, leading to low blood pressure (hypotension), slow heart rate (bradycardia), changes in heart rhythm (arrhythmia), and potentially cardiac arrest.

4. Possible side effects

Like all medicines, ROPIVACAINA CLORIDRATO Bioindustria L.I.M. can cause side effects, although not everyone gets them.

Important side effects to be aware of:
Sudden, life-threatening allergic reactions (such as anaphylaxis, including anaphylactic shock) are rare, affecting between 1 and 10 out of 10,000 patients. Possible symptoms include sudden onset of skin rash, itching or rash with swelling (urticaria); swelling of the face, lips, tongue or other body parts; shortness of breath, wheezing or difficulty breathing; feeling faint or loss of consciousness.

If you think ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is causing an allergic reaction, inform your doctor immediately.

The following side effects may also occur:

Very common (affects more than 1 in 10 people)

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

Common (affects between 1 and 10 out of 100 people)

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

Uncommon (affects between 1 and 10 out of 1,000 people)

anxiety;
reduced sensitivity to touch (hypoesthesia);
feeling faint (syncope);
difficulty breathing (dyspnoea);
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 ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 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 disturbances, visual disturbances, speech difficulties, muscle stiffness and tremor.

Rare (affects between 1 and 10 out of 10,000 people)

heart attack (cardiac arrest);
irregular heartbeat (arrhythmia);
allergic reactions, even severe ones (anaphylactic reactions), rapid swelling of the neck and face (angioneurotic oedema), urticaria.

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

Horner’s syndrome

Other side effects may also occur:

numbness due to nerve irritation caused by the needle or injection. This is usually temporary;
involuntary muscle movements (dyskinesia).

Possible side effects observed with other local anaesthetics, which could also be caused by ROPIVACAINA CLORIDRATO Bioindustria L.I.M., are:

nerve damage. Rarely (affects between 1 and 10 out of 10,000 people), which may lead to permanent problems (e.g. anterior spinal artery syndrome, arachnoiditis, cauda equina syndrome);
if an excessive dose of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is administered into the spinal fluid, it may cause numbness (anaesthesia) throughout the entire body;
total spinal block following accidental administration into the cranial cavity (intrathecal);
receiving an epidural injection (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 occasionally result in a condition called Horner’s syndrome. This is characterised by reduced pupil size, drooping of the upper eyelid, and inability of the sweat glands to produce sweat. It will resolve spontaneously once treatment is discontinued.

Children
In children, side effects are the same as in adults, except that low blood pressure occurs less frequently in children (affects between 1 and 10 out of 100 children), while vomiting occurs more frequently in children (affects more than 1 in 10 children).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at the following website:
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 Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C. Do not freeze.
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is normally stored by the physician or hospital, who are responsible for maintaining the product's quality if it is not used immediately after opening. They are also responsible for the proper disposal of any unused ROPIVACAINA CLORIDRATO Bioindustria L.I.M.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 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 dosage.
The other excipients are: sodium chloride, hydrochloric acid and/or sodium hydroxide, and water for injections.

Description of the appearance of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. and contents of the
packaging
Clear, colourless solution for injection or infusion.
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 2 mg/ml, 7.5 mg/ml and 10 mg/ml solution for injection
is available in: pack containing 10 glass vials of 10 ml of solution for injection.
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 2 mg/ml solution for infusion is available in:
Packs of 5 and 25 infusion bottles of 100 ml or 200 ml of solution for infusion.
Marketing Authorisation Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A.
(Bioindustria L.I.M. S.p.A.)
Via De Ambrosiis 2, 15067 Novi Ligure (AL) - Italy
This summary of product characteristics was last approved on:
The following information is intended exclusively for medical professionals and healthcare operators.
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 2 - 7.5 - 10 mg/ml solution for injection
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 2 mg/ml solution for infusion
Preparation
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. must not be diluted or mixed with other
solutions.
Precipitation may occur in alkaline solutions, as ropivacaine is poorly soluble at pH above 6.0.
This medicinal product is preservative-free and for single use only. Any unused solution must be
discarded.
Warnings and precautions
Cervical and head level blocks
Certain local anaesthetic procedures, such as injections into the head and neck regions, may be
associated with a higher frequency of serious adverse reactions, regardless of the local anaesthetic
used.
Peripheral major nerve blocks
Blocking major peripheral nerves may require administration of a larger volume of local anaesthetic
into a highly vascularized area, often near large blood vessels, where there is an increased risk of
intravascular injection and/or rapid systemic absorption, potentially leading to high plasma
concentrations.
The medicine contains sodium, which should be taken into account in patients on a sodium-restricted diet.
Validity after first opening
From a microbiological standpoint, the product should be used immediately. If not used immediately,
the conditions and duration of storage 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 adolescents over 12 years of age
The table below provides guidance on recommended dosages for the most common types of block.
The administered dose should be the lowest required to achieve effective block. The dose should also
be selected based on the physician's experience and knowledge of the patient's clinical condition.

	Conc. mg/ml	Volume ml	Dose mg	Onset of action minutes	Duration hours
SURGICAL ANESTHESIA Lumbar epidural administration
Surgery	7.5 10.0	15–25 15–20	113–188 150–200	10–20 10–20	3–5 4–6
Cesarean section	7.5	15–20	113–150¹⁾	10–20	3–5
Thoracic epidural administration
Block for postoperative pain control	7.5	5–15 (depends on injection level)	38–113	10–20	n/a²⁾
Major nerve block*Brachial plexus block	7.5	30–40	225–300³⁾	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 Lumbar epidural 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.: - labor and delivery analgesia - postoperative pain control	2.0 2.0	6–10 ml/h 6–14 ml/h	12–20 mg/h 12–28 mg/h	n/a²⁾ n/a²⁾	n/a²⁾ n/a²⁾
Thoracic epidural administration
Continuous infusion (postoperative pain control)	2.0	6–14 ml/h	12–28 mg/h	n/a²⁾	n/a²⁾
Surgical field block (e.g.: minor nerve block and infiltration)	2.0	1–100	2.0–200	1–5	2–6
Peripheral nerve block (femoral or interscalene block) Continuous infusion or intermittent injections (e.g.: postoperative pain treatment)	2.0	5–10 ml/h	10–20 mg/h	n/a²⁾	n/a²⁾

The doses reported in the table are those considered appropriate to produce adequate block and should be regarded as a guide for use in adults. However, individual variations may occur with respect to onset time and duration. The "dose" column reports the average dose ranges required. Reference texts should be consulted both regarding factors influencing specific block techniques and individual patient requirements.

* With regard to major nerve blocks, a dose is only provided 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 blocks.

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, up to two additional doses of 50 mg each may be used, for a maximum total of 50 mg additional.
n/a = not applicable.
The dose for major nerve blocks must 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 local anesthetic used (see section “Special Warnings”).
In general, surgical anesthesia (e.g., via epidural administration) requires higher concentrations and dosages. ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 10 mg/ml is recommended for epidural anesthesia in surgical procedures requiring complete motor block. Lower concentrations and dosages are recommended for anesthesia (e.g., epidural administration for management of acute pain).

Method of administration – Adults and adolescents over 12 years of age
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. should be used only by physicians experienced in regional anesthesia or under their supervision.
To avoid intravascular injection, careful aspiration is recommended before and during injection. When a large dose is to be injected, it is recommended to administer a test dose of 3–5 ml of lidocaine with adrenaline (epinephrine). Accidental intravascular injection may be recognized by a transient increase in heart rate, while accidental intrathecal injection may be recognized by signs of spinal block.
Aspiration must be performed before and during drug administration, which should be injected slowly or in fractionated doses at a rate of 25–50 mg/minute, with close monitoring of vital parameters and maintenance of verbal contact. If symptoms of toxicity occur, administration must be immediately discontinued.
In surgical epidural block, single doses of up to 250 mg of ropivacaine have been used and well tolerated.
In brachial plexus block, a single dose of 300 mg has been administered in a limited number of patients and was well tolerated.
When performing prolonged blocks, either by continuous epidural infusion or repeated bolus administration, the potential risk of achieving toxic plasma concentrations and inducing local neurotoxicity must be considered. Cumulative doses of up to 675 mg of ropivacaine administered over 24 hours for surgical anesthesia and postoperative analgesia have been well tolerated in adults, as have continuous epidural infusions of up to 28 mg/h for 72 hours in the postoperative period. In a limited number of patients, higher doses of up to 800 mg/day have been administered with a relatively low incidence of adverse reactions.
For the management of postoperative pain, the following technique is recommended: unless already established before surgery, an epidural block is performed with ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 7.5 mg/ml administered via an epidural catheter. Analgesia is then maintained by infusion of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 2 mg/ml: in most cases of moderate to severe postoperative pain, an infusion rate of 6–14 ml/h (12–28 mg/h) provides adequate analgesia with only mild and non-progressive motor block. The maximum duration of epidural block is 3 days. In any case, careful monitoring of analgesic effect should be performed so that the catheter can be removed as soon as pain intensity allows. With this technique, a significant reduction in the need for opioid use has been observed.
In clinical studies, an epidural infusion of ropivacaine 2 mg/ml, alone or mixed with fentanyl 1–4 micrograms/ml, has been administered for up to 72 hours for postoperative pain control.
The combination of ropivacaine with fentanyl allowed further pain control but caused side effects related to opioid administration.
The combination of ropivacaine and fentanyl has only been studied with ropivacaine 2 mg/ml.
When performing prolonged peripheral nerve blocks, either by continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations or causing local neurotoxicity must be evaluated. In clinical studies, femoral nerve block was achieved with 300 mg of ropivacaine 7.5 mg/ml and interscalene block with 225 mg of ropivacaine 7.5 mg/ml, respectively, prior to surgery. Analgesia was then maintained with ropivacaine 2 mg/ml. Infusion rates or intermittent injections of 10–20 mg/hour for 48 hours provided adequate analgesia and were well tolerated.
The use of ropivacaine at concentrations higher than 7.5 mg/ml has not been documented in cesarean delivery.

Paediatric population
Dosage – Epidural block: Paediatric patients from 0 (term neonates) to 12 years of age

	Conc. mg/ml	Volume ml/kg	Dose mg/kg
ACUTE PAIN TREATMENT (peri- and post-operative) Single caudal epidural block Blocks below T12 level in children weighing up to 25 kg Continuous epidural infusion in children weighing up to 25 kg From 0 to 6 months Bolus dosea) Infusion up to 72 hours From 6 to 12 months Bolus dosea) Infusion up to 72 hours From 1 to 12 years Bolus doseb) Infusion up to 72 hours	2.0 2.0 2.0 2.0 2.0 2.0 2.0	1 0.5–1 0.1 ml/kg/h 0.5–1 0.2 ml/kg/h 1 0.2 ml/kg/h	2 1–2 0.2 mg/kg/h 1–2 0.4 mg/kg/h 2 0.4 mg/kg/h

The dose indicated in the table should be considered as a guideline for use in paediatrics. Individual adjustments may be necessary. In paediatric patients with high body weight, a gradual reduction in dosage is often required, based on ideal body weight. The volume for a single caudal epidural block and the volume for epidural bolus doses must not exceed 25 ml for any patient. Reference texts should be consulted regarding factors affecting specific block techniques as well as individual patient requirements.

Within the dose range indicated, lower doses are recommended for thoracic epidural blocks, whereas higher doses are recommended for lumbar or caudal epidural blocks.

Recommended for lumbar epidural blocks. It is good practice to reduce the bolus dose for thoracic epidural analgesia.

The use of ropivacaine 7.5 mg/ml and 10 mg/ml may be associated with systemic and central nervous system toxicity in children. Lower concentrations (2 mg/ml and 5 mg/ml) are more appropriate for administration in this population.

Dosage – Peripheral nerve blocks: Infants and children from 1 to 12 years of age

	Conc. mg/ml	Volume ml/kg	Dose mg/kg
TREATMENT OF ACUTE PAIN (peri- and postoperative)
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 aged 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 guideline for use in paediatrics. Individual variations may be necessary. In paediatric patients with high body weight, a gradual reduction in dosage is often required, based on ideal body weight. Reference texts should be consulted regarding factors affecting specific block techniques as well as individual patient requirements.

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

Doses for peripheral block in infants and children provide guidance for use in children without serious diseases. More conservative doses and careful monitoring are recommended for children with serious diseases.

Method of administration – Paediatric patients aged 0 to 12 years
To avoid intravascular administration, careful aspiration is recommended before and during injection. The patient's vital parameters must be closely monitored during injection. If signs of toxicity occur, administration must be immediately discontinued.

In most patients, a single caudal epidural injection of ropivacaine 2 mg/ml below the T12 level provides adequate postoperative analgesia when a dose of 2 mg/kg is administered in a volume of 1 ml/kg. The volume of the caudal epidural injection may be adjusted to achieve different sensory block distributions, as described in reference texts. In children above 4 years of age, doses up to 3 mg/kg have been evaluated using a ropivacaine concentration of 3 mg/ml. As a consequence, this concentration has been associated with a high incidence of motor block.

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

The use of ropivacaine in premature children has not been documented.

For further information, consult the Summary of Product Characteristics.

Package leaflet: information for the user

ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 5 mg/ml injectable solution for

intrathecal use
ropivacaine hydrochloride
Equivalent medicine
Read this leaflet carefully before using 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 nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

What ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is and what it is used for
What you need to know before being given ROPIVACAINA CLORIDRATO Bioindustria L.I.M.
How ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is administered
Possible side effects
How to store ROPIVACAINA CLORIDRATO Bioindustria L.I.M.
Contents of the pack and other information

1. What is ROPIVACAINA CLORIDRATO Bioindustria L.I.M. and what is it used for

ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 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 Bioindustria L.I.M. 5 mg/ml is used in adults to numb (anaesthetize) parts of the body during surgical procedures. It may be used:

in adults to anaesthetize the area of the body where surgery is to be performed. ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is injected into the lower part of the spine directly into the spinal canal (intrathecal administration). Pain is rapidly eliminated from the waist downwards for a limited period (usually 1 to 2 hours). This is known as a "spinal block";
in children aged 1 to 12 years to numb (anaesthetize) parts of the body and to stop or relieve pain (single peripheral nerve block).

2. What you need to know before taking ROPIVACAINA CLORIDRATO Bioindustria L.I.M.

Do not take ROPIVACAINA CLORIDRATO Bioindustria L.I.M.

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 low 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.

Warnings and precautions
Talk to your doctor or nurse before taking ROPIVACAINA CLORIDRATO Bioindustria L.I.M.
Inform your doctor before treatment:

about any previous medical conditions or disorders;
if you have heart, liver or kidney problems, as your doctor may need to adjust the dose of ROPIVACAINA CLORIDRATO Bioindustria L.I.M.;
if you or a family member has a rare blood disorder called “porphyria”; in this case, your doctor may administer a different anaesthetic.

Prolonged administration of ropivacaine should be avoided in patients being treated concurrently with medicines such as fluvoxamine and enoxacin (see section “Other medicines and ROPIVACAINA CLORIDRATO Bioindustria L.I.M.”).

Children
This medicine is administered with caution:

in children, as the safety and efficacy of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 5 mg/ml injections administered into the spinal canal (intrathecal route) have not been established in this population;
in children under 1 year of age, as the safety and efficacy of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 5 mg/ml injections for anaesthetizing parts of the body (peripheral nerve blocks) have not been established in younger children. Particular attention should be paid to neonates due to increased drug toxicity in this age group.

Other medicines and ROPIVACAINA CLORIDRATO Bioindustria L.I.M.
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal medicines. ROPIVACAINA CLORIDRATO Bioindustria L.I.M. may affect the action of other drugs, and some medicines may affect ROPIVACAINA CLORIDRATO Bioindustria L.I.M.
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 amiodarone.

Also inform your doctor if you are taking any of the following medicines:

those used for depression (such as fluvoxamine);
antibiotics used to treat bacterial infections (such as enoxacin). The body takes longer to eliminate ROPIVACAINA CLORIDRATO Bioindustria L.I.M. when these medicines are taken. If you are taking any of these medicines, prolonged use of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. should be avoided.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before using this medicine.
It is not known whether ropivacaine hydrochloride affects pregnancy or passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
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.

Driving and using machines
After receiving ROPIVACAINA CLORIDRATO Bioindustria L.I.M., you must not drive or operate tools or machinery until the following day. ROPIVACAINA CLORIDRATO Bioindustria L.I.M. may cause drowsiness and affect reaction speed.

ROPIVACAINA CLORIDRATO Bioindustria L.I.M. contains sodium
This medicine contains 33.83 milligrams (mg) of sodium (the main component of table salt) per 10 ml vial.
This corresponds to 1.69% of the maximum daily recommended dietary intake for an adult.

3. How ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is administered to you

ROPIVACAINA CLORIDRATO Bioindustria L.I.M. will be administered to you by a doctor. The dose given by the doctor will depend on the type of pain relief required.
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. will be administered to you in the form of:

an injection into the lower part of the spinal column (intrathecal route).
an injection near the area of the body that needs to be anesthetized.

When ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is injected into the body, 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 adjust the administered dose according to your needs and taking into account your age, body weight, and general health condition.
The doctor knows the correct way to administer this medicine.
If you receive more ROPIVACAINA CLORIDRATO Bioindustria L.I.M. than you should
This medicine will be administered by a doctor, so it is unlikely that an overdose will occur. However, if you think you have been given too much of this medicine, inform your doctor immediately.
Serious adverse effects resulting from an overdose of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. require special treatment, and your doctor is able to manage these situations.
The first signs of overdose include: feeling dizzy or lightheaded, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, ringing in the ears, vision problems, mild euphoria, altered sensation in the limbs.
At the first sign of overdose, the doctor will immediately stop treatment and initiate the most appropriate therapy depending on the severity of symptoms. This means that, if any of the above-mentioned events occur, or if you think you have received too much ROPIVACAINA CLORIDRATO Bioindustria L.I.M., you must inform your doctor immediately.
The most serious adverse effects include speech difficulties, muscle spasms, tremors, brief and rapid muscle contractions, epileptic seizures (fits), loss of consciousness, breathing problems (apnea).
In the most severe cases, cardiac toxicity may also occur, resulting in low blood pressure (hypotension), slow heart rate (bradycardia), changes in heart rhythm (arrhythmia), up to cardiac arrest.

4. Possible side effects

Like all medicines, ROPIVACAINA CLORIDRATO Bioindustria L.I.M. can cause side effects, although not everyone experiences them.
Important side effects to be aware of:
Sudden and life-threatening allergic reactions (such as anaphylaxis, including anaphylactic shock) are rare, affecting between 1 and 10 out of 10,000 patients. 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; shortness of breath, wheezing or difficulty breathing; feeling faint.
If you think ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is causing an allergic reaction, inform your doctor immediately.

The following side effects may also occur:

Very common (affects more than 1 in 10 people)

Low blood pressure (hypotension). This may cause dizziness or mental confusion;
Feeling unwell (nausea).

Common (affects from 1 to 10 in 100 people)

Tingling in the extremities (paresthesia);
Dizziness;
Headache (cephalalgia);
Slow or fast heartbeat (bradycardia, tachycardia);
High blood pressure (hypertension);
Feeling of discomfort (vomiting);
Difficulty urinating;
Elevated body temperature (fever) or tremors (chills);
Back pain, stiffness (back pain).

Uncommon (affects from 1 to 10 in 1,000 people)

Anxiety;
Reduced skin sensitivity;
Fainting;
Difficulty breathing;
Low body temperature (hypothermia). Some symptoms may occur if the injection has been accidentally administered into a blood vessel or if an excessive dose of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. has been given (see also above “If you receive more ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 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 disturbances, visual disturbances (vision problems), speech difficulties, muscle stiffness and tremors.

Rare (affects from 1 to 10 in 10,000 people)

Heart attack (cardiac arrest);
Irregular heartbeat (arrhythmia);
Allergic reactions, even severe ones (anaphylactic reactions), rapid swelling of the neck and face (angioneurotic edema), urticaria.

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

Horner’s syndrome

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).

Side effects associated with the injection of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. into the lower part of the spine may occur more frequently than with other local anaesthetic procedures, regardless of the local anaesthetic used.
Possible side effects observed with other local anaesthetics, which could also be caused by ROPIVACAINA CLORIDRATO Bioindustria L.I.M., include:

Nerve damage. Rarely (affects from 1 to 10 in 10,000 people), which may lead to permanent problems (e.g. anterior spinal artery syndrome, arachnoiditis, cauda equina syndrome);
If an excessive dose of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is administered into the spinal fluid, the entire body may become numb (anaesthetized, total spinal block);
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 ROPIVACAINA CLORIDRATO Bioindustria L.I.M. than you should”);
Receiving an epidural injection (injection into the space around the spinal nerves) may cause interruption of a nerve pathway from the brain to the head and neck, particularly in pregnant women, which may sometimes result in a condition called Horner’s syndrome. This is characterized by reduced pupil size, drooping of the upper eyelid, and inability of the sweat glands to produce sweat. It will resolve spontaneously once treatment is discontinued.

Children
In children, side effects are the same as in adults, except for low blood pressure, which occurs less frequently in children (affects 1 in 100 children), and feeling unwell, 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, please inform your doctor or nurse. You may also report side effects directly via the national reporting system at the following website:
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 Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C. Do not freeze.
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. is normally stored by the physician or hospital, which are responsible for the product's quality if it is not used immediately after opening. They are also responsible for the proper disposal of any unused ROPIVACAINA CLORIDRATO Bioindustria L.I.M.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What ROPIVACAINA CLORIDRATO Bioindustria L.I.M. contains

The active substance is ropivacaine hydrochloride. Each ml of solution contains 5 mg of ropivacaine hydrochloride.
The excipients are sodium chloride, hydrochloric acid and/or sodium hydroxide, and water for injections.

Description of the appearance of ROPIVACAINA CLORIDRATO Bioindustria L.I.M. and contents of the
package
Pack containing 10 glass vials of 10 ml of clear, colourless injectable solution.
Marketing Authorisation Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A.
(Bioindustria L.I.M. S.p.A.)
Via De Ambrosiis 2, 15067 Novi Ligure (AL) - Italy
This leaflet was last approved on:
The following information is intended exclusively for medical and healthcare professionals.
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 5 mg/ml solution for injection for intrathecal use
Preparation
Due to lack of compatibility studies, ROPIVACAINA CLORIDRATO Bioindustria L.I.M. must not be diluted or mixed with other medicinal products. Precipitation may occur in alkaline solutions, as ropivacaine is poorly soluble at pH above 6.0.
The medicine contains sodium; this should be taken into consideration in patients on a controlled sodium diet.
Special precautions for disposal and handling
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 5 mg/ml is preservative-free and for single use only.
Any unused solution must be discarded.
The medicinal product should be inspected visually before use. The solution should only be used if it is clear, practically free from particles, and if the container is undamaged.
Stability after first opening
From a microbiological standpoint, the product should be used immediately. Otherwise, the conditions and duration of storage prior to use are the responsibility of the user and, in any case, should not exceed 24 hours at a temperature between 2 and 8 °C.
Intrathecal administration for surgical anaesthesia.
Dosage - Adults
The following table provides a dosing guideline for intrathecal block in adults. The dose to be used should be the lowest required to achieve effective block. The administered dose should be selected based on the physician's experience and knowledge of the patient's clinical condition.
Dosing for intrathecal block in adults

	Conc. mg/ml	Volume ml	Dose mg	Onset of activity minutes	Duration hours
SURGICAL ANESTHESIA Intrathecal administration
Surgery	5.0	3-5	15-25	1-5	2-6

The doses reported in the table are considered appropriate to produce an adequate block and should be regarded as guidelines for use in adults. However, individual variations may occur with respect to onset time and duration. The "Dose" column indicates the usual dose ranges required. Reference texts should be consulted regarding factors affecting specific block techniques as well as individual patient requirements.

Paediatric population
Intrathecal administration has not been studied in infants or children.

Method of administration
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. must be used only by physicians experienced in regional anaesthesia or under their supervision.
To avoid accidental intravascular injection, careful aspiration is recommended before and during injection. Accidental intravascular injection may be recognized by a temporary increase in heart rate.
Aspiration must be performed before and during administration of the main dose, which should be injected slowly at a rate of 25–50 mg/minute, with close monitoring of vital signs and maintenance of verbal contact. If signs of toxicity occur, the injection must be immediately discontinued.
Intrathecal injection should be performed only after the subarachnoid space has been identified and cerebrospinal fluid (CSF) flows clearly from the spinal needle or is detected by aspiration.

Single injection for single peripheral nerve block
Posology – Paediatric population from 1 year up to and including 12 years of age

	Conc. mg/ml	Volume ml/kg	Dose mg/kg
Treatment of acute pain (peri- and post-operative)
Single injection for single peripheral nerve block (e.g. ilioinguinal nerve block, brachial plexus block) in children aged 1 to 12 years	5.0	0.5-0.6	2.5-3.0

The dose indicated in the table should be considered as a guide for use in paediatrics.
Individual variations may be necessary.
In paediatric patients with high body weight, a gradual reduction in dosage is often required, based on ideal body weight.
Reference texts should be consulted regarding both 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 diseases. More conservative doses and careful monitoring are recommended for children with serious diseases.
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 5 mg/ml is not approved for use in children under 1 year of age; the use of ropivacaine in premature children has not been documented.
The safety and efficacy of ropivacaine 5 mg/ml for peripheral nerve block have not been established in infants under 1 year of age.
ROPIVACAINA CLORIDRATO Bioindustria L.I.M. 5 mg/ml is not approved for use in children under 1 year of age. Particular attention must be paid to neonates due to the immaturity of metabolic pathways.
The wide variations in plasma concentrations of ropivacaine observed in clinical studies conducted in neonates suggest that there may be an increased risk of systemic toxicity in this age group.

Method of administration
Paediatric population
To avoid intravascular injection, careful aspiration is recommended before and during injection. The patient's vital parameters must be closely monitored during injection.
If symptoms of toxicity occur, administration must be immediately discontinued.
A gradual administration of the calculated dose of local anaesthetic is recommended.
With ultrasound-guided techniques, lower doses are often required (see section 5.2).
High total plasma concentrations have been observed when ropivacaine 5 mg/ml was used at doses of 3.5 mg/kg (0.7 mg/ml) without occurrence of systemic toxic events.
For blocks, lower concentrations of ropivacaine are recommended when high volumes exceeding 3 mg/kg dose (0.6 ml/kg) are required (e.g. fascia iliaca compartment block).

For further information, consult the Summary of Product Characteristics.