Naropina: detailed information

Package Leaflet: Information for the User

Naropina 2 mg/ml injectable solution / for infusion, 7.5 mg/ml injectable solution, 10 mg/ml injectable solution

ropivacaine hydrochloride
Please read this leaflet carefully before receiving Naropina 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 Naropina is and what it is used for
What you need to know before receiving Naropina
How Naropina is administered
Possible side effects
How to store Naropina
Contents of the pack and other information

1. What Naropina is and what it is used for

The name of the medicine is "Naropina injectable solution" or "Naropina infusion solution".

It contains a medicine called ropivacaine hydrochloride.
It belongs to a group of medicines called local anaesthetics.
It will be administered to you either as an injection or as an infusion, depending on how it is to be used.

Naropina 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 pain from occurring or to provide relief from pain.
It may be used for:

Anaesthetizing parts of the body during surgery, including caesarean section.
Relieving pain during childbirth, after surgery, or after an injury.

Naropina 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, e.g. after surgical procedures.

2. What you should know before taking Naropina

Do not take Naropina:

If you are allergic (hypersensitive) to ropivacaine hydrochloride or to any of the other ingredients of Naropina (see section 6: Further information).
If you are allergic to any other local anaesthetic of the same class (e.g. lidocaine or bupivacaine).
If you have been told you have reduced blood volume (hypovolemia).
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 Naropina.

Warnings and precautions
Talk to your doctor or pharmacist before taking Naropina:

If you have heart, liver or kidney problems, as your doctor may need to adjust the dose of Naropina.
If you have been told that 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 about any pre-existing medical conditions or disorders.

Special caution is required:

In newborn infants, as they are more sensitive to Naropina.
In children up to and including 12 years of age, as certain injections to numb areas of the body have not been evaluated in younger children.
In children up to and including 12 years of age, as the use of Naropina 7.5 mg/ml and 10 mg/ml injections to numb areas of the body has not been evaluated. Doses of Naropina 2 mg/ml and 5 mg/ml may be more suitable.

Other medicines and Naropina
Inform your doctor if you are currently taking, or have recently taken, any other medicines, including those without a prescription, herbal medicines or dietary supplements. Naropina may affect how other medicines work, and some medicines may affect Naropina.
In particular, inform your doctor if you are taking any of the following medicines:

Other local anaesthetics.
Strong painkillers such as morphine or codeine.
Medicines used to treat irregular heartbeat (arrhythmia), such as lidocaine and mexiletine. Your doctor must be informed about these medicines in order to determine the correct dose of Naropina.

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

Medicines for depression (such as fluvoxamine).
Antibiotics used to treat bacterial infections (such as enoxacin). These medicines may slow down the elimination of Naropina from the body. If you are taking any of these medicines, prolonged use of Naropina should be avoided.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, please consult your doctor before taking 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), so your doctor will monitor the fetal heart rate.

Driving and using machines
Naropina may cause drowsiness and affect reaction times. After receiving Naropina, you must not drive or operate tools or machinery until the following day.

Important information about some of the excipients in Naropina:

2 mg/ml:
This medicine contains 33.87 mg of sodium (the main component of table salt) per 10 ml vial/solution. This is equivalent to 1.69% of the maximum daily intake recommended in an adult's diet.
This medicine contains 67.74 mg of sodium per 20 ml vial/solution. This is equivalent to 3.39% of the maximum daily intake recommended in an adult's diet.
This medicine contains 338.7 mg of sodium per 100 ml vial/solution. This is equivalent to 16.93% of the maximum daily intake recommended in an adult's diet.
This medicine contains 677.40 mg of sodium per 200 ml vial/solution. This is equivalent to 33.9% of the maximum daily intake recommended in an adult's diet.
Talk to your doctor or pharmacist if you require one or more 200 ml infusion bags per day over a prolonged period, especially if you have been advised to follow a low-sodium diet.

7.5 mg/ml:
This medicine contains 29.54 mg of sodium per 10 ml vial. This is equivalent to 1.48% of the maximum daily intake recommended in an adult's diet.
This medicine contains 59.08 mg of sodium per 20 ml vial. This is equivalent to 2.95% of the maximum daily intake recommended in an adult's diet.

10 mg/ml:
This medicine contains 27.96 mg of sodium in each 10 ml vial. This is equivalent to 1.40% of the maximum daily intake recommended in an adult's diet.
This medicine contains 55.92 mg of sodium in each 20 ml vial. This is equivalent to 2.80% of the maximum daily intake recommended in an adult's diet.

3. How to take Naropina

Naropina will be administered to you by a doctor. The dose given by the doctor will depend on the type of pain relief required. It will also depend on your body size, age, and physical condition.
Naropina will be administered as an injection or infusion. The site of administration will depend on the reason for which Naropina is being given. Your doctor will administer Naropina 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 an area around the spinal cord). When Naropina is used in any of the above ways, it prevents nerves from transmitting pain signals to the brain. You will not feel pain, heat, or cold sensations, but you may still experience other sensations such as pressure or touch. Your doctor will know the correct method of administering the medicine.

If you are given more Naropina than you should
Serious adverse effects resulting from an overdose of Naropina require special treatment, and your doctor is able to manage these situations.
The first signs of an overdose of Naropina are usually the following:

Feeling dizzy or confused.
Numbness of the lips and around the mouth.
Numbness of the tongue.
Hearing problems.
Vision problems.

To reduce the risk of serious adverse effects, your doctor will stop administering Naropina as soon as any of these signs appear. This means that if any of the above symptoms occur, or if you think you have received too much Naropina, you must inform your doctor immediately.
The most serious adverse effects of an overdose of Naropina include speech difficulties, muscle spasms, tremors, shaking, epileptic seizures (fits), and loss of consciousness.

4. Possible side effects

Like all medicines, Naropina can cause side effects, although not everyone gets them.
Important side effects to watch for:
Life-threatening sudden allergic reactions (such as anaphylaxis, including anaphylactic shock) are rare,
affecting 1 to 10 out of 10,000 users. Possible symptoms include sudden onset of
skin rash, itching or rash with swellings (urticaria); swelling of the face, lips,
tongue or other body parts; breathlessness, wheezing or difficulty breathing; feeling faint or losing consciousness.
If you think Naropina is causing an allergic reaction, contact your doctor immediately.

Other possible side effects:
Very common (affects more than 1 in 10 people)

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

Common (affects 1 to 10 in 100 people)

Paresthesia.
Dizziness.
Headache.
Slow or fast heartbeat (bradycardia, tachycardia).
High blood pressure (hypertension).
Vomiting.
Difficulty urinating.
Elevated temperature (fever) or chills (shivering).
Back pain.

Uncommon (affects 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 is accidentally administered into a blood vessel or if an excessive dose of Naropina is given (see also “If you receive more Naropina than you should”). These include epileptic seizures (fits), dizziness or confusion, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems, speech problems, muscle stiffness and tremor.

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

Heart attack (cardiac arrest).
Irregular heartbeat (arrhythmia).

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

Horner’s syndrome.

Other possible side effects include:

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

Possible side effects observed with other local anesthetics, which may also be caused by
Naropina, are:

Nerve damage. Rarely (affects 1 to 10 in 10,000 people), this may lead to permanent problems.
If an excessive dose of Naropina is administered into the spinal fluid, it may cause numbness (anesthesia) throughout the body.
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, especially in pregnant women, which may sometimes cause 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 stopped.

Children
In children, side effects are the same as in adults, except for low blood pressure, which occurs less frequently in children (affects 1 to 10 in 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 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Naropina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, following the word "EXP". The expiry date refers to the last day of the month.
Do not store above 30°C. Do not freeze.
Naropina will normally be stored by the physician or hospital, who are also responsible for the quality of the product if it is not used immediately after opening. The medicinal product should be inspected visually before use. The solution should only be used if it is clear, essentially free from particles, and if the container is intact.
They are also responsible for the proper disposal of any unused Naropina.

6. Package contents and other information

What Naropina contains
The active substance is ropivacaine hydrochloride.
Naropina is available in the following strengths: 2 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride per ml of solution.
The excipients are sodium chloride, hydrochloric acid and/or sodium hydroxide, and water for injections.

Description of the appearance of Naropina and contents of the pack
Naropina is a clear, colourless solution for injection or infusion.
Naropina 2 mg/ml, 7.5 mg/ml and 10 mg/ml solution for injection is available in:

10 ml polypropylene vials (Polyamp) in packs of 5 or 10.
20 ml polypropylene vials (Polyamp) in packs of 5 or 10.

Naropina 2 mg/ml solution for infusion is available in:

100 ml polypropylene bags (Polybag) in packs of 5.
200 ml polypropylene bags (Polybag) in packs of 5.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milan
Italy

Manufacturer
AstraZeneca AB, Forskargatan 18, 151 36 Södertälje, Sweden
Aspen Notre Dame De Bondeville, 1 Rue de l’Abbaye, 76960 Notre Dame de Bondeville, France

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Germany, Ireland, Luxembourg, Netherlands: Naropin
France: Naropeine
Italy: Naropina
United Kingdom (Northern Ireland): Ropivacaine Hydrochloride
______________________________________________________________________________

The following information is intended exclusively for healthcare professionals

or medical practitioners.
The information provided is limited solely to what is required for
administration, correct preparation, and handling of the product, and is not suitable for determining whether to administer the product.
Please consult the Summary of Product Characteristics for further
information.

1. Product

Naropina 2-7.5-10 mg/ml injectable solution.
Naropina 2 mg/ml infusion solution.

2. Preparation

Precipitation may occur in alkaline solutions, as ropivacaine is poorly soluble at pH
above 6.0.
The medicinal product contains a maximum of 3.7 mg of sodium per ml; this should be taken into consideration in patients on a sodium-restricted diet.
The Naropina 2 mg/ml infusion solution contained in polypropylene bags (Polybag) is chemically and physically compatible with the following medicinal products. Compatibility with other solutions not listed below has not been studied:

Naropine Concentration: 1-2 mg/ml
Drug	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 broader than that used in clinical practice. Epidural infusions of Naropina/sufentanil citrate, Naropina/morphine sulfate, and Naropina/clonidine hydrochloride have not been evaluated in clinical studies.

3. Instructions for use, handling, and disposal

Naropina must be used only by physicians experienced in regional anaesthesia or under their supervision.
Naropina is preservative-free and for single use only. Any residual solution must be discarded.
The primary intact container must not be re-sterilized. The sterile blister pack should be selected when sterility of the vial's outer surface is required.
Stability after first opening
From a microbiological standpoint, the product should be used immediately. If this is not possible, the conditions and duration of storage prior to use are the responsibility of the user; however, storage must not exceed 24 hours at a temperature between 2 and 8°C.
The mixtures are chemically and physically stable for 30 days when stored at a temperature between 20 and 30°C.
Dosage – Adults and adolescents over 12 years of age
The following table provides guidance on recommended dosages for the most common types of block. The dose used should be the lowest required to achieve effective block. The dose to be administered should be chosen based on the physician’s experience and knowledge of the patient’s clinical condition.

	Conc. mg/ml	Volume ml	Dose mg	Onset time 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 blocks and infiltration)	7.5	1–30	7.5–225	1–15	2–6
ACUTE PAIN TREATMENT
Lumbar epidural administration
Bolus Intermittent injections (top-up) (e.g.: labor and delivery analgesia)Continuous infusion e.g.:	2.0 2.0	10–20 10–15 (minimum interval 30 min.)	20–40 20–30	10–15	0.5–1.5
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/a n/a	n/a n/a
Thoracic epidural administration
Continuous infusion (postoperative pain control)	2.0	6–14 ml/h	12–28 mg/h	n/a	n/a
Surgical field block (e.g.: minor nerve blocks and infiltration)	2.0	1–100	2.0–200	1–5	2–6
Peripheral nerve block (e.g.: 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/a	n/a

The doses reported in the table are those considered necessary 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 of action. The "dose" column reports the usual dose ranges required. Reference texts should be consulted regarding factors influencing specific block techniques and individual patient requirements.

* With regard to major nerve block, a dose recommendation may only be given 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, up to two additional doses may be given, for a total of 50 mg.
n/a = not applicable.
The dose for major nerve block 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 Warnings and Precautions).

In general, surgical anesthesia (e.g., via epidural administration) requires higher concentrations and dosages. Naropina 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 management of acute pain).

Administration method – Adults and adolescents over 12 years of age

To avoid intravascular injection, careful aspiration is recommended before and during injection. When a large dose is to be administered, 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. The drug should be injected slowly or in fractional doses at a rate of 25–50 mg per minute, with close monitoring of vital signs and maintenance of verbal contact. If signs of toxicity occur, administration must be immediately discontinued.

When performing prolonged blocks, either via continuous epidural infusion or repeated bolus administration, the potential risk of achieving toxic plasma concentrations or inducing local neurotoxicity should be considered.

Cumulative doses of up to 675 mg of ropivacaine administered within 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 up to 800 mg/day have been administered with a relatively low incidence of adverse reactions.

For postoperative pain management, the following technique is recommended: unless already established before surgery, an epidural block is performed using Naropina 7.5 mg/ml administered via an epidural catheter. Analgesia is then maintained with an infusion of Naropina 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. This technique has been associated with a significant reduction in the need for opioid use.

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

The use of Naropina at concentrations higher than 7.5 mg/ml in cesarean section has not been documented.

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)
Caudal single 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) Continuous infusion up to 72 hours From 6 to 12 months Bolus dosea) Continuous infusion up to 72 hours From 1 to 12 years Bolus doseb) Continuous 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 variations 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 per patient. Reference texts should be consulted regarding factors affecting specific block techniques and individual patient requirements.

a) Within the dose range indicated, 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.

Table 3 Peripheral nerve blocks: Infants and children from 1 to 12 years of age

| Conc. | Volume | Dose | |-----------|------------|----------| | mg/ml | ml/kg | mg/kg |

ACUTE PAIN TREATMENT
(peri- and post-operative)

Single injection for peripheral nerve blocks
2.0 | 0.5–0.75 | 1.0–1.5
e.g. ilioinguinal nerve block, brachial plexus block, fascia iliaca compartment block

Multiple blocks
2.0 | 0.5–1.5 | 1.0–3.0

Continuous infusion for peripheral nerve blocks in children aged 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

Administration method – Paediatric patients aged 0 to 12 years

To avoid intravascular administration, careful aspiration is recommended before and during injection. The patient's vital signs must be closely monitored during injection. If signs of toxicity occur, administration must be immediately discontinued.

A gradual administration of the calculated dose of local anaesthetic 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 nervous system toxic events in children. Lower concentrations (2 mg/mL and 5 mg/mL) are more appropriate for administration in these populations.

Doses for peripheral nerve blocks in infants and children provide guidance for use in children without serious illness. More conservative doses and careful monitoring are recommended for children with serious 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 premature children has not been documented.

Patient Information Leaflet: Information for the user

Naropina 5 mg/ml solution for injection

ropivacaine hydrochloride
Read this leaflet carefully before taking Naropina 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 Naropina is and what it is used for
What you need to know before Naropina is given to you
How Naropina is administered
Possible side effects
How to store Naropina
Contents of the pack and other information

1. What Naropina is and what it is used for

The name of the medicine is "Naropina injectable solution".

It contains a medicine called ropivacaine hydrochloride.
It belongs to a group of medicines called local anaesthetics.

Naropina 5 mg/ml is used:

In adults to numb (anaesthetize) the part of the body where surgery is to be performed. Naropina is injected into the lower part of the spine. Pain is rapidly blocked from the waist down for a limited period (usually 1 to 2 hours). This is known as a "spinal block (or spinal)".
In children from 1 to 12 years of age to numb (anaesthetize) areas of the body. It is used to block the onset of pain or to relieve pain.

2. What you should know before taking Naropina

Do not take Naropina:

if you are allergic (hypersensitive) to ropivacaine hydrochloride or to any of the other ingredients of Naropina (see section 6: Further information).
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).
injected 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 Naropina.

Warnings and precautions
Talk to your doctor or pharmacist before taking Naropina:

if you have heart, liver or kidney problems, as your doctor may need to adjust the dose of Naropina.
if you have been told that you or a family member has a rare blood disorder called "porphyria"; in this case, your doctor may administer a different anaesthetic.

Inform your doctor about all pre-existing medical conditions or disorders.
Special caution is needed:

in children, as injections of Naropina into the lower part of the spine have not been evaluated in children.
in children under 1 year of age, as injections of Naropina to numb body areas have not been evaluated in younger children.

Other medicines and Naropina
Tell your doctor if you are taking or have recently taken any other medicines, including those without a prescription and herbal medicines. Naropina may affect how other medicines work, and some medicines may affect Naropina.
In particular, inform your doctor if you are taking any of the following medicines:

Other local anaesthetics.
Strong painkillers, such as morphine or codeine.
Medicines used to treat irregular heartbeat (arrhythmia), such as lidocaine and mexiletine. Your doctor must be informed about taking these medicines in order to determine the correct dose of Naropina.

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

Medicines for depression (such as fluvoxamine).
Antibiotics used to treat bacterial infections (such as enoxacin). Your body takes longer to eliminate Naropina if you are taking these medicines. If you are taking any of these medicines, prolonged use of Naropina 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 taking 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), so your doctor will monitor the fetal heart rate.

Driving and using machines
Naropina may cause drowsiness and affect reaction speed. After receiving Naropina, you must not drive or operate tools or machinery until the following day.

Important information on some of the excipients in Naropina
This medicine contains 31.51 mg of sodium (a key component of common table salt) per 10 ml vial. This is equivalent to 1.58% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to take Naropina

Naropina will be administered to you by a doctor. The dose given by the doctor will depend on the type of pain relief required, as well as on your body build, age, and physical condition.

Naropina will be administered in the following forms:

Injection into the lower part of the spinal column
Injection into the area near the part of the body to be anesthetized

When Naropina 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.
Your doctor knows the correct way to administer this medicine.

If you are given more Naropina than you should

Serious adverse effects resulting from an overdose of Naropina require special treatment, and your doctor is able to manage these situations. The first signs of a Naropina overdose are usually the following:

Feeling dizzy or mentally confused
Numbness of the lips and around the mouth
Numbness of the tongue
Hearing problems
Vision problems (visual disturbances)

To reduce the risk of serious adverse effects, your doctor will stop administering Naropina as soon as any of these signs appear. This means that if any of the above-mentioned symptoms occur, or if you think you have received too much Naropina, you must inform your doctor immediately.

The most serious adverse effects of a Naropina overdose include speech difficulties, muscle spasms, tremors, shaking, epileptic seizures (fits), and loss of consciousness.

4. Possible side effects

Like all medicines, Naropina can cause side effects, although not everyone experiences them.
Important side effects to monitor:
Life-threatening allergic reactions (such as anaphylaxis, including anaphylactic shock) are rare,
affecting 1 to 10 out of 10,000 users. Possible symptoms include sudden onset of
skin rash, itching or hives; swelling of the face, lips,
tongue or other parts of the body; shortness of breath, wheezing or difficulty breathing; feeling faint. If you think Naropina is causing an allergic reaction, inform your doctor
immediately.
Other possible side effects:
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 1 to 10 in 100 people)

Paresthesia.
Dizziness.
Headache.
Slow or fast heartbeat (bradycardia, tachycardia).
High blood pressure (hypertension).
Feeling of discomfort (vomiting).
Difficulty urinating.
Elevated temperature (fever) or chills (shivering).
Back pain.

Uncommon (affects 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 is accidentally administered into a blood vessel or if an excessive dose of Naropina is given (see also above “If you receive more Naropina than you should”). These include seizures (fits), dizziness or mental confusion, numbness of the lips and around the mouth, tongue numbness, hearing problems, vision problems, speech difficulties, muscle stiffness and tremor.

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

Heart attack (cardiac arrest).
Irregular heartbeat (arrhythmia).

Not known (frequency cannot be estimated from available data)

Horner’s syndrome.

Other possible side effects include:

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

Side effects associated with injecting Naropina into the lower part of the spinal column may
occur more frequently than with other local anaesthetic procedures, regardless of the specific local anaesthetic used.
Possible side effects observed with other local anaesthetics, which may also be caused by
Naropina, include:

Nerve damage. Rarely (affects 1 to 10 in 10,000 people), this may lead to permanent problems.
If an excessive dose of Naropina is administered into the spinal fluid, the entire body may become numb (anaesthetized).
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, especially 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 sweat glands to produce sweat. It resolves spontaneously when 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 1 in 100 children) and feeling unwell 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 nurse.
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 Naropina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, following the word EXP. The expiry date refers to the last day of the month.
Do not store above 30°C. Do not freeze.
Naropina will normally be stored by the physician or hospital, who are also responsible for the product's quality if it is not used immediately after opening. The medicinal product should be inspected visually before use. The solution should only be used if it is clear, essentially free from particles, and if the container is intact.
They are also responsible for the proper disposal of any unused Naropina.

6. Package contents and other information

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

Description of the appearance of Naropina and contents of the pack
Naropina is a clear, colourless injectable solution.
Naropina 5 mg/ml injectable solution is available in:

10 ml polypropylene vials (Polyamp) in packs of 5 or 10.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milan
Italy

Manufacturer
AstraZeneca AB, Forskargatan 18, 151 36 Södertälje, Sweden
Aspen Notre Dame De Bondeville, 1 Rue de l’Abbaye, 76960 Notre Dame de Bondeville, France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria, Belgium, Germany, Luxembourg, Netherlands: Naropin
France: Naropeine
Italy: Naropina

__________________________________________________________________________
The following information is intended exclusively for medical or healthcare professionals.
This information is limited solely to what is required for administration, correct preparation and handling of the product, and is not suitable for determining whether to administer the product.
Please consult the Summary of Product Characteristics for further information.

1. Product

Naropina 5 mg/ml solution for injection

2. Preparation

In the absence of compatibility studies, this medicinal product 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 medicinal product contains up to 3.5 mg of sodium per ml, which should be taken into consideration in patients on a sodium-controlled diet.

3. Instructions for use, handling and disposal

Naropina 5 mg/ml is preservative-free and for single use only. Any unused portion of the solution must be discarded.
The medicinal product must be inspected visually before use. The solution should be used only if it is
clear, practically free from particles, and if the container is undamaged.
The intact container must not be resterilized. The blister pack packaging should be selected when sterility of the vial's outer surface is required.
Intrathecal administration for surgical anaesthesia.
Dosing
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 must 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
Intrathecal administration
Surgery	5.0	3-5	15-25	1-5	2-6

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

Method of administration
To avoid accidental intravascular injection, careful aspiration is recommended before and during injection.
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, under close monitoring of vital signs and maintaining verbal contact.
If signs of toxicity occur, the injection must be immediately discontinued.
Intrathecal injection must be performed only after the subarachnoid space has been identified and clear cerebrospinal fluid (CSF) flows freely from the spinal needle or is obtained by aspiration.

Paediatric population
Intrathecal administration has not been studied in infants, neonates, or children.
The safety and efficacy of ropivacaine 5 mg/ml for peripheral nerve block have not been established in infants under 1 year of age.
Naropina 5 mg/ml is not approved for use in children under 1 year of age. Particular caution is required in neonates due to immature metabolic pathways.
The wide variability in plasma concentrations of ropivacaine observed in clinical studies in neonates suggests an increased risk of systemic toxicity in this age group.

Single injection for single peripheral nerve block
Paediatric population

	Conc. mg/ml	Volume ml/kg	Dose mg/kg
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 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.
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.
Naropine 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.
Method of administration
To avoid intravascular injection, careful aspiration before and during injection is recommended. The patient's vital signs must be closely monitored during injection.
If signs of systemic toxicity occur, administration must be immediately discontinued.
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, it is recommended to use lower concentrations of ropivacaine when high volumes exceeding 3 mg/kg dose (0.6 ml/kg) are required (e.g. fascia iliaca compartment block).