NAROPINA 2 мг/мл Инъекционный раствор

Содержание инструкции

1. Naropina 2 mg/ml injectable solution/ for infusion, 7.5 mg/ml injectable solution, 10 mg/ml injectable solution
   1. What is Naropina and what is it used for
   2. What you need to know before you take Naropina
   3. How to take Naropina
   4. Possible side effects
   5. How to store Naropina
   6. Package Contents and Other Information
   7. Product
   8. Preparation
   9. Instructions for use, handling and disposal
2. Naropina 5 mg/ml injectable solution
   1. What is Naropina and what is it used for
   2. What you need to know before you take Naropina
   3. How to take Naropina
   4. Possible side effects
   5. How to store Naropina
   6. Contents of the pack and other information
   7. Product
   8. Preparation
   9. Instructions for use, handling and disposal

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

ropivacaine hydrochloride

Read this leaflet carefully before you receive 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 any side effects occur, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What Naropina is and what it is used for
• 2. What you need to know before you receive Naropina
• 3. How Naropina is administered to you
• 4. Possible side effects
• 5. How to store Naropina
• 6. Contents of the pack and other information

1. What is Naropina and what is it 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 anesthetics.
• It will be given to you either as an injection or as an infusion, depending on how it will be used.

Naropina 7.5 mg/ml and 10 mg/ml is used in adults and children over 12 years of age to make parts of the body numb
(anesthetize). It is used to prevent pain or to provide pain relief.
It can be used for:

• Anesthetizing parts of the body during a surgical procedure, including a Cesarean section.
• Relieving pain during childbirth, after a surgical procedure or after an injury.

Naropina 2 mg/ml is used in adults and children of all ages for the treatment of acute pain. It
makes parts of the body numb (anesthetizes), e.g. after surgical procedures.

2. What you need to know before you take Naropina

Do not take Naropina:

• If you are allergic (hypersensitive) to ropivacaine hydrochloride or any of the other ingredients of Naropina (see section 6: Further information).
• 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).
• 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 any of the above applies to you, consult your doctor before receiving Naropina.

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

• if you have problems with your heart, liver or kidneys, because it may be necessary for the doctor 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 the doctor may administer a different anesthetic.
• Tell your doctor about all previous illnesses or medical conditions.

Particular care must be taken:

• In newborn babies as they are more sensitive to Naropina.
• In children up to and including 12 years of age, as some 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 injections of Naropina 7.5 mg/ml and 10 mg/ml to numb areas of the body has not been evaluated. Dosages of Naropina 2 mg/ml and 5 mg/ml may be more suitable.

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 can affect the mechanism of action of other drugs and some
medicines can have an effect on Naropina.
In particular, tell your doctor if you are taking any of the following medicines:

• Other local anesthetics.
• Strong painkillers, such as morphine or codeine.
• Medicines used to treat irregular heartbeat (arrhythmia), such as lidocaine and mexiletine. The doctor needs to be informed of taking these medicines in order to establish the correct dose of Naropina.

Tell your doctor also if you are taking any of the following medicines:

• Medicines for depression (such as fluvoxamine).
• Antibiotics to treat infections caused by bacteria (such as enoxacin). The body takes longer to eliminate Naropina if you are taking these medicines. If you are taking one of these medicines, prolonged use of Naropina should be avoided.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, 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 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.

Driving and using machines
Naropina can cause drowsiness and affect reaction time. After receiving
Naropina, you should not drive vehicles or use tools or machinery until the next day.

Important information about some excipients of 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 recommended daily intake with the diet of an
adult.
This medicine contains 67.74 mg of sodium (the main component of table salt) per 20 ml vial/solution.
This is equivalent to 3.39% of the maximum recommended daily intake with the diet of an
adult.
This medicine contains 338.7 mg of sodium (the main component of table salt) per 100 ml vial/solution.
This is equivalent to 16.93% of the maximum recommended daily intake with the diet of
an adult.
This medicine contains 677.40 mg of sodium (the main component of table salt) per 200 ml vial/solution.
This is equivalent to 33.9% of the maximum recommended daily intake with the diet of an
adult
Talk to your doctor or pharmacist if you need 1 or more 200 ml bags of infusion solution per
day for 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 (the main component of table salt) per 10 ml vial. This is equivalent to 1.48% of the maximum recommended daily intake with the diet of an adult.

This medicine contains 59.08 mg of sodium (the main component of table salt) per 20 ml vial.
This is equivalent to 2.95% of the maximum recommended daily intake with the diet of an adult.

10mg/ml:
This medicine contains 27.96 mg of sodium (the main component of table salt) in each 10
ml vial. This is equivalent to 1.40% of the maximum recommended daily intake with the diet of an adult.
This medicine contains 55.92 mg of sodium (the main component of table salt) in each 20
ml vial. This is equivalent to 2.80% of the maximum recommended daily intake with the diet of an adult

3. How to take Naropina

Naropina will be administered to you by a doctor. The dose administered by the doctor will depend on the type of pain relief needed. It will also depend on your body size, age and physical condition.
Naropina will be administered in the form of an injection or infusion. The part of the body where it will be
administered will depend on the reason why Naropina is being administered. The doctor will administer Naropina

• 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 happens in the case of an epidural or infusion injection (in an area around the spinal cord). When Naropina 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 take more Naropina than you should
Serious side effects resulting from the administration of an excessive dose 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 (vision).

To reduce the risk of serious side effects, the doctor will stop administering Naropina as soon as
these signs should appear. This means that if one of the cases described above occurs, or if
you think you have received too much Naropina, you must inform the doctor immediately.
The most serious side effects resulting from an overdose of Naropina include problems of
speech, muscle spasms, tremors, shaking, seizures (convulsions) and loss of consciousness.

4. Possible side effects

Like all medicines, Naropina can cause side effects, although not everybody 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 per 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; and shortness of breath, wheezing or difficulty breathing; feeling of
loss of consciousness.

If you think that Naropina is causing an allergic reaction, tell your doctor immediately.
Other possible side effects:

Very common (affects more than 1 in 10 people)

• Low blood pressure (hypotension). This can cause dizziness or confusion.
• Feeling sick (nausea).

Common (affects between 1 and 10 people in 100)

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

Uncommon (affects between 1 and 10 people in 1,000)

• Anxiety.
• Reduced skin sensitivity.
• Fainting.
• Difficulty breathing.
• Low body temperature (hypothermia).
• Some symptoms may occur if the injection was given into a blood vessel by mistake or if an excessive dose of Naropina was given (see also “If you receive too much Naropina”). These include seizures (convulsions), dizziness or confusion, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems (vision), speech problems, muscle stiffness and tremor.

Rare (affects between 1 and 10 people in 10,000)

• 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 irritation of the nerves caused by the needle or the 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 between 1 and 10 patients per 10,000), this can cause permanent problems.
• If an excessive dose of Naropina is given 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.

Children
In children, the side effects are the same as in adults, except for low blood pressure
which affects children less frequently (affects between 1 and 10 children per 100) and vomiting which occurs
more often in children (affects more than 1 in 10 children).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the national system
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 which is reported on the pack, after the wording EXP. The expiry date refers to the last day of the month.
• Do not store at a temperature above 30ºC. Do not freeze.
• Normally Naropina will be stored by the doctor or hospital, who are also responsible for the quality of the product if it is not used immediately after opening. The medicinal product must be visually inspected before use. The solution must only be used if clear, substantially free from particles and if the container is intact.
• They are also responsible for the correct disposal of any unused Naropina.

6. Package Contents and Other Information

What Naropina contains
The active ingredient is ropivacaine hydrochloride.
Naropina is supplied in the following dosages: 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 transparent and colourless solution for injection or infusion.
Naropina solution for injection 2 mg/ml, 7.5 mg/ml and 10 mg/ml is available in:

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

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

• bags made of polypropylene of 100 ml (Polybag) in packs of 5
• bags made of polypropylene of 200 ml (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 Milano
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 and in the United Kingdom
(Northern Ireland) with the following denominations:
Austria, Belgium, Germany, Ireland, Luxembourg, Netherlands: Naropin
France: Naropeine
Italy: Naropina
United Kingdom (Northern Ireland): Ropivacaine Hydrochloride
______________________________________________________________________________
The following information is intended exclusively for medical professionals or
healthcare operators.
The information is limited exclusively to what is required for
administration, for the correct preparation and handling of the product and the
information provided is not suitable for deciding on the administration of 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 solution for infusion.

2. Preparation

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

* The concentration range reported in the table is wider than what is 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 only be used by physicians experienced in regional anesthesia or under their supervision.
Naropina is preservative-free and for single use only. Any residual solution must be discarded.
The intact primary container must not be resterilized. The sterile blister pack should be chosen
in cases where sterility of the vial’s outer surface is also required.

Validity after first opening
From a microbiological point of view, the product must be used immediately. If this does not occur,
the conditions and storage times before use are the responsibility of the user, these, in any
case, must not exceed 24 hours at a temperature between 2 and 8°C.
Mixtures are chemically and physically stable for 30 days, if stored at a temperature between
20 and 30°C.

Dosage - Adults and adolescents 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 used must
be the lowest required to achieve an effective block. The dose to be administered must be chosen
based on the physician’s experience and knowledge of the patient’s clinical condition.

The doses reported in the table are those considered necessary to produce 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. The dose ranges are reported in the "dose" column.
Reference texts should be consulted both regarding aspects that affect specific block techniques, and regarding the individual needs of the patient.
*With reference to major nerve block, a dose is recommended only for brachial plexus block.
For other types of major nerve block, lower doses may be required. However, at present,
there is no experience of specific recommended doses for other types of block.

• 1) Doses should be administered incrementally 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 up to a total of 50 mg 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. 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., for epidural administration) requires the use of higher concentrations and
dosages. The use of Naropina 10 mg/ml is recommended for epidural anesthetics in surgical procedures
where complete motor block is required. Lower concentrations and dosages are recommended
for analgesia (e.g., for epidural administration for the treatment of acute pain).

Method of administration - Adults and adolescents 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 (adrenaline) 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, closely monitoring the patient’s vital signs
and maintaining verbal contact. If symptoms of toxicity occur, the
administration must be stopped immediately.
When performing prolonged blocks, either by continuous epidural infusion or by repeated bolus administration, the possible risk of reaching toxic plasma concentrations
or inducing local neuronal damage must be considered.
Cumulative doses of up to 675 mg of ropivacaine administered over 24 hours for surgical anesthesia and
post-operative analgesia have been well tolerated in adults, as have continuous epidural
infusions up to 28 mg/h for 72 hours in the post-operative period.
In a limited number of patients, higher doses up to 800 mg/day have been administered with a relatively low number of adverse reactions.
For the treatment of post-operative pain, the following technique is recommended: unless already induced before surgery, an epidural block is performed with Naropina 7.5 mg/ml administered through
an epidural catheter. Analgesia is then maintained with an infusion of Naropina 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 to use opioids has been observed.
When performing prolonged blocks of peripheral nerves, either through continuous infusion or through
repeated injections, the risks of reaching a toxic plasma concentration or of
causing local neuronal damage must be assessed.
In cesarean delivery, the use of Naropina at concentrations higher than 7.5 mg/ml has not been documented.

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

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 of the dosage may often be necessary, which must be based on ideal 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 both regarding aspects that affect specific block 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.

Table 3 Peripheral nerve blocks: Infants and children from 1 to 12 years
Conc.
mg/ml

Volume
ml/kg

Dose
mg/kg

TREATMENTOFPAIN
ACUTE
(peri- and post-operative)

Single injection for peripheral nerve block

• 2.0 0.5-0.75 1.0-1.5

e.g. ilioinguinal nerve block, brachial plexus block, iliac fascia compartment block 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 paediatrics. Individual variations may be
necessary. In paediatric patients with high body weight, a gradual
reduction of the dosage may often be necessary, which must be based on ideal weight. Reference texts must
be consulted both regarding aspects that affect specific block techniques, and regarding
the individual needs of the patient.

Method of administration - Paediatric patients from 0 to 12 years of age
To avoid intravascular administration, careful aspiration is recommended before and during
the injection. The patient’s vital signs must be closely monitored during
the injection. If signs of toxicity occur, administration must be stopped immediately.
Gradual administration of the calculated dose of local anesthetic is recommended, whatever
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 illnesses. 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.

Naropina 5 mg/ml injectable solution

ropivacaine hydrochloride

Read this leaflet carefully before you receive 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 get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What Naropina is and what it is used for
• 2. What you need to know before you receive Naropina
• 3. How Naropina is administered to you
• 4. Possible side effects
• 5. How to store Naropina
• 6. Contents of the pack and other information

1. What is Naropina and what is it 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 anesthetics.

Naropina 5 mg/ml is used:

• In adults to numb (anesthetize) the area of the body where surgery needs to be performed. Naropina is injected into the lower part of the spine. Pain is quickly eliminated 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 to numb (anesthetize) areas of the body. It is used to block the onset of pain or to relieve pain.

2. What you need to know before you take 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 anesthetic of the same class (e.g. lidocaine or bupivacaine).
• If you have been told that you have a reduced blood volume (hypovolemia).
• 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 any of the above applies to you, consult your doctor before receiving Naropina.

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

• if you have problems with your heart, liver or kidneys, because 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 disease called “porphyria”, in this case your doctor may give you a different anesthetic.

Tell your doctor about all previous illnesses or medical conditions.
Particular care must be taken:

• 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 areas of the body 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 over-the-counter medicines and herbal medicines. Naropina can affect the mechanism of action of other drugs and some medicines can have an effect on Naropina.
In particular, tell your doctor if you are taking any of the following medicines:

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

Tell your doctor also if you are taking any of the following medicines:

• Medicines for depression (such as fluvoxamine).
• Antibiotics to treat infections caused by bacteria (such as enoxacin). The body takes longer to eliminate Naropina if you are taking these medicines. If you are taking one of these medicines, prolonged use of Naropina should be avoided.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are 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 given 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.

Driving and using machines
Naropina can cause drowsiness and affect reaction time. After receiving Naropina, you must not drive vehicles or use tools or machinery until the next day.

Important information about some of the excipients in Naropina
This medicine contains 31.51 mg of sodium (the main component of table salt) per 10 ml vial.
This is equivalent to 1.58% of the maximum recommended daily intake of sodium with the diet of an adult

3. How to take Naropina

Naropina will be administered to you by a doctor. The dose administered by the doctor will depend on the type of pain relief needed. It will also depend on your body size, age and physical condition.
Naropina will be administered in the form of

• injection into the lower part of the spine
• injection into the area near the part of the body that needs to be anesthetized.

When Naropina is injected into the body, 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 take more Naropina than you should
Serious side effects resulting from the administration of an excessive dose of Naropina require
special treatment and the attending physician is able to manage these situations. The first signs of an
overdose of Naropina are usually the following:

• Feeling of dizziness or mental confusion.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing problems.
• Vision problems (vision).

To reduce the risk of serious side effects, the doctor will stop administering Naropina as soon as
these signs should appear. This means that, if one of the cases above occurs, or if
you think you have received too much Naropina, you must inform the doctor immediately.
The most serious side effects resulting from an overdose of Naropina include problems of
speech, muscle spasms, tremors, shaking, seizures (convulsions) and loss of consciousness.

4. Possible side effects

Like all medicines, Naropina can cause side effects, although not everybody gets them.

Important side effects to watch out for:
Sudden, life-threatening allergic reactions (such as anaphylaxis, including anaphylactic shock) are rare, affecting between 1 and 10 users per 10,000.
Possible symptoms include sudden onset of skin rash, itchy or raised rash (urticaria); swelling of the face, lips, tongue or other parts of the body; and shortness of breath, wheezing or difficulty breathing; feeling of
loss of consciousness. If you think that Naropina is causing an allergic reaction, tell your doctor immediately.
Other possible side effects:

Very common (affects more than 1 in 10 people)

• Low blood pressure (hypotension). This can cause dizziness or confusion.
• Feeling sick (nausea).

Common (affects 1 to 10 people in 100)

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

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

• Anxiety.
• Reduced skin sensitivity.
• Fainting.
• Difficulty breathing.
• Low body temperature (hypothermia).
• Some symptoms may occur if the injection was given into a blood vessel by mistake or if an excessive dose of Naropina was administered (see also above “If you receive too much Naropina”). These include seizures, dizziness or confusion, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems (vision), speech problems, muscle stiffness and tremor.

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

• 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 irritation of the nerves 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 spine may
occur more frequently than with other local anesthesia procedures, regardless of the local anesthetic
used.

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

• Nerve damage. Rarely (affects 1 to 10 patients in 10,000), this can cause permanent problems.
• If an excessive dose of Naropina 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 lead to 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.

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 in 10 children out of 100) and feeling unwell which
occurs more frequently in children (affects more than 1 in 10 children).

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national system of
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 which is stated on the packaging, after the wording EXP. The expiry date refers to the last day of the month.
• Do not store at a temperature above 30ºC. Do not freeze.
• Normally Naropina will be stored by the doctor or hospital, who are also responsible for the quality of the product if it is not used immediately after opening. The medicinal product must be visually inspected before use. The solution must only be used if clear, substantially free from particles and if the container is intact.
• They are also responsible for the correct disposal of any unused Naropina.

6. Contents of the pack 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 and colourless injectable solution.
Naropina injection 5 mg/ml is available in:

• vials made of polypropylene containing 10 ml (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 professionals or healthcare operators.
The information is limited exclusively to what is required for administration, for the correct
preparation and handling of the product and the information provided is not suitable for deciding on
the administration of the product.
Please consult the Summary of Product Characteristics for further information.

1. Product

Naropina 5 mg/ml injectable solution

2. Preparation

In the absence of compatibility studies, this medicine cannot be diluted or mixed with other medicinal products.
Precipitation may occur in alkaline solutions as ropivacaine is poorly soluble at a pH higher than 6.0.
The medicine contains a maximum of 3.5 mg of sodium per ml, this should be taken into consideration in patients on a controlled sodium diet.

3. Instructions for use, handling and disposal

Naropina 5 mg/ml is preservative-free and for single use only. Any residual solution must be discarded.
The medicine must be visually inspected before use. The solution must only be used if it is
clear, practically free from particles and if the container is undamaged.
An intact container must not be resterilized. The blister pack should be chosen in cases where
sterility of the vial's outer surface is also required.
Intrathecal administration for surgical anesthesia.

Dosage
The following table is a guide to dosage for intrathecal block in adults.
The dose to be used should be the lowest required to achieve an effective block.
The dose to be administered must be chosen based on the physician's experience and knowledge of the
patient's clinical condition.

The doses reported in the table are those considered necessary to produce an adequate block and must be
considered as a guide for use in adults. However, individual variations may occur
regarding the onset of action and duration. The "Dose" column shows the average dose ranges
required. Reference texts should be consulted, both regarding aspects that affect
specific blocking techniques, and regarding the individual needs of the patient.

Method of administration
To avoid accidental intravascular injection, careful aspiration is recommended before and during
the injection.
Aspiration must be performed before and during the administration of the main dose, which must be
injected slowly, at a rate of 25-50 mg/minute, keeping the patient's vital parameters under close observation
and maintaining verbal contact.
If symptoms of toxicity occur, the injection must be stopped immediately.
Intrathecal injection must be performed after the subarachnoid space has been identified and cerebrospinal fluid (CSF) flows clear from the spinal needle or is detected through aspiration.

Paediatric population
Intrathecal administration has not been studied in infants and young children, or in children.
The safety and efficacy of ropivacaine 5 mg/ml for peripheral nerve block have not been established for
infants under 1 year of age.
Naropina 5 mg/ml is not approved for use in children under 1 year of age. Particular attention should be paid
to neonates due to the immaturity of metabolic pathways.
The wide variations in plasma ropivacaine concentrations observed in clinical studies conducted in neonates
suggest that there may be an increased risk of systemic toxicity in this age group.

Single injection for single peripheral nerve block
Paediatric population
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 necessary, which should be based on ideal weight.
Reference texts should be consulted both regarding aspects that affect specific blocking techniques, and regarding the individual needs of the patient.
Doses for peripheral block in infants and children provide guidelines for use in children without
serious illnesses. More conservative doses and careful monitoring are recommended for children with serious
illnesses.
Naropina 5 mg/ml is not approved for use in children under 1 year of age; the use of ropivacaine in
premature infants has not been documented.

Method of administration
To avoid intravascular injection, careful aspiration is recommended before and during the injection. The
patient's vital parameters must be kept under close observation during the injection.
If symptoms of toxicity occur, administration must be stopped immediately.
A gradual administration of the calculated dose of local anesthetic is recommended.
With echo-guided techniques, lower doses are often necessary (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 the onset of systemic toxic events.
For blocks, it is recommended to use lower concentrations of ropivacaine when high volumes are needed
greater than 3 mg/kg dose (0.6 ml/kg) (e.g. iliac fascia compartment block).