Ropivacaine Galenica Senese: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ropivacaine Galenica Senese 2 mg/ml, 7.5 mg/ml, 10 mg/ml injectable solution, mg/ml infusion solution

Ropivacaine hydrochloride
Please read this entire leaflet carefully before Ropivacaine Galenica Senese is administered to you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
This medicine has been prescribed for you personally. Never give it to others. This medicine may be harmful to other people, even if their symptoms are the same as yours.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or nurse.

Contents of this leaflet:

What Ropivacaine Galenica Senese is and what it is used for
Before being given Ropivacaine Galenica Senese
How Ropivacaine Galenica Senese is administered
Possible side effects
How to store Ropivacaine Galenica Senese
Further information

1. What Ropivacaina Galenica Senese is and what it is used for

The name of the medicine is "Ropivacaina Galenica Senese solution for injection" or "Ropivacaina Galenica Senese solution for infusion".

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

Ropivacaina Galenica Senese is used 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 surgical procedures, including caesarean section.
Relieving pain during childbirth, after surgery, or after an injury.

2. Before administration of Ropivacaine Galenica Senese

Ropivacaine Galenica Senese must not be administered to you if:

You are allergic (hypersensitive) to ropivacaine hydrochloride or to any of the other ingredients of Ropivacaine Galenica Senese (see section 6: Further information).
You are allergic to any other local anaesthetic of the same class (e.g. lidocaine or bupivacaine).
You have been diagnosed with reduced blood volume (hypovolaemia).
It is intended for injection 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 Galenica Senese.

Take special care with Ropivacaine Galenica Senese:

Inform your doctor if you have heart, liver or kidney problems, as your doctor may need to adjust the dose of Ropivacaine Galenica Senese.
Inform your doctor if you or a family member has been diagnosed with a rare blood disorder called "porphyria"; in this case, your doctor may choose to administer a different anaesthetic.
Inform your doctor, before treatment, of any previous medical conditions or disorders.

Use of Ropivacaine Galenica Senese with other medicines
Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription and herbal remedies. Ropivacaine Galenica Senese may affect the action of other drugs, and some medicines may affect Ropivacaine Galenica Senese.
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 of the use of these medicines in order to determine the correct dose of Ropivacaine Galenica Senese.

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). The body takes longer to eliminate Ropivacaine Galenica Senese when these medicines are taken. If you are taking any of these medicines, prolonged use of Ropivacaine Galenica Senese should be avoided.

Pregnancy and breastfeeding
Before receiving Ropivacaine Galenica Senese, inform your doctor if you are pregnant, planning to become pregnant or breastfeeding. 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.

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

Important information about some excipients in Ropivacaine Galenica Senese:
Ropivacaine Galenica Senese contains up to 3.7 milligrams (mg) of sodium per millilitre (ml) of solution.
If you are on a controlled sodium diet, this should be taken into account.

3. How Ropivacaine Galenica Senese is administered to you

Ropivacaine Galenica Senese 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 size, age, and physical condition.

Ropivacaine Galenica Senese will be administered as an injection or infusion. The site of administration will depend on the reason for which Ropivacaine Galenica Senese is being given. Your doctor will administer Ropivacaine Galenica Senese 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 given (into the area surrounding the spinal cord). When Ropivacaine Galenica Senese 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, but you may still experience other sensations such as pressure or touch. Your doctor knows the correct method of administering this medicine.

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

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 adverse effects, your doctor will stop administering Ropivacaine Galenica Senese 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 Ropivacaine Galenica Senese, you must inform your doctor immediately.

The most serious adverse effects resulting from an overdose of Ropivacaine Galenica Senese include speech difficulties, muscle spasms, tremors, shaking, epileptic seizures (fits), and loss of consciousness.

4. Possible side effects

Like all medicines, Ropivacaine Galenica Senese may cause side effects, although not everyone gets them.
Important side effects to be aware of:
Sudden, life-threatening allergic reactions (such as anaphylaxis) are rare, affecting between 1 and 10
patients in 10,000. 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. If you think Ropivacaine Galenica Senese 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 between 1 and 10 in 100 people)

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

Uncommon (affects between 1 and 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 Ropivacaine Galenica Senese has been given (see also “If you receive more Ropivacaine Galenica Senese than you should”). These include epileptic seizures (fits), dizziness or mental confusion, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems, speech difficulties, muscle stiffness and tremor.

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

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

Other possible side effects include:

Numbness due to nerve irritation caused by the needle or injection. This usually does not last long.

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

Nerve damage. Rarely (affects between 1 and 10 in 10,000), this may lead to permanent problems.
If an excessive dose of Ropivacaine Galenica Senese is administered into the spinal fluid, the whole body may become numb (anesthetized).

Children
In children, side effects are the same as in adults, except for low blood pressure, which is less frequent in children (affects between 1 and 10 in 100 children), and vomiting, which occurs more frequently in children (affects more than 1 in 10 children).
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ropivacaine Galenica Senese

Keep out of the reach and sight of children.
Do not use Ropivacaine Galenica Senese 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.
Normally, Ropivacaine Galenica Senese will 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 must be inspected visually before use. The solution should only be used if clear, essentially free from particles, and if the container is intact.
They are also responsible for the proper disposal of any unused Ropivacaine Galenica Senese.

6. Other information

What Ropivacaine Galenica Senese contains
The active substance is ropivacaine hydrochloride.
Ropivacaine Galenica Senese is supplied 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 water for injections.

Description of the appearance of Ropivacaine Galenica Senese and the contents of the pack
Ropivacaine Galenica Senese is a clear, colourless solution for injection or infusion.
Ropivacaine Galenica Senese 2 mg/ml, 7.5 mg/ml and 10 mg/ml solution for injection is available as:
2 mg/ml solution for injection:
Pack of 5 glass vials (Type I) of 10 ml in sterile blister
Pack of 5 glass vials (Type I) of 10 ml in blister
Pack of 1 pre-filled glass syringe (Type I) of 10 ml in sterile blister

7.5 mg/ml solution for injection:
Pack of 5 glass vials (Type I) of 10 ml in sterile blister
Pack of 5 glass vials (Type I) of 10 ml in blister
Pack of 1 pre-filled glass syringe (Type I) of 10 ml in sterile blister

10 mg/ml solution for injection:
Pack of 5 glass vials (Type I) of 10 ml in sterile blister
Pack of 5 glass vials (Type I) of 10 ml in blister
Pack of 1 pre-filled glass syringe (Type I) of 10 ml in sterile blister

Ropivacaine Galenica Senese infusion solution 2 mg/ml is available as:
2 mg/ml infusion solution:
Pack of 5 polyolefin bags of 100 ml
Pack of 5 polyolefin bags of 200 ml
Pack of 5 polyolefin bags of 500 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l. - Via Cassia Nord 351, 53014 Monteroni d’Arbia (Siena) - Italy

The manufacturer responsible for batch release is:
Industria Farmaceutica Galenica Senese S.r.l. - Via Cassia Nord 351, 53014 Monteroni d’Arbia (Siena) - Italy

The following information is intended exclusively for medical or healthcare professionals.
The information provided is limited strictly to what is required for administration, correct preparation and handling of the product. The information contained herein is not suitable for determining whether the product should be administered.
Please consult the Summary of Product Characteristics for further information.

1. Product

Ropivacaine Galenica Senese 2-7.5-10 mg/ml injectable solution.
Ropivacaine Galenica Senese 2 mg/ml infusion solution.

2. Preparation

Precipitation may occur in alkaline solutions since ropivacaine is poorly soluble at pH
above 6.0.
The medicinal product contains up to 3.7 mg of sodium per ml, which should be taken into consideration in patients on a controlled sodium diet.
The Ropivacaine Galenica Senese 2 mg/ml infusion solution contained in PVC-free polyolefin bags must not be mixed with any other medicinal product.

3. Instructions for use, handling and disposal

Ropivacaine Galenica Senese must be used only by physicians experienced in regional anaesthesia or under their supervision.
Ropivacaine Galenica Senese is preservative-free and for single use only. Any unused solution must be discarded.
The intact primary 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.
Dosage - Adults and children over 12 years of age
The following table provides guidance on recommended dosages for the most common types of block. The dose used should be the lowest required to achieve effective block. The administered 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 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
Peripheral 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.: - labor and delivery analgesia - postoperative pain control	2.0 2.0 2.0 2.0	10–20 10–15 (minimum interval 30 min.) 6–10 ml/h 6–14 ml/h	20–40 20–30 12–20 mg/h 12–28 mg/h	10–15 n/a n/a	0.5–1.5 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
Peripheral block (e.g.: minor nerve blocks and infiltration)	2.0	1–100	2.0–200	1–5	2–6
Peripheral nerve blocks (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

In general, surgical anesthesia (e.g., via epidural administration) requires the use of higher concentrations and doses.
Ropivacaine Galenica Senese 10 mg/ml is recommended for epidural anesthesia in surgical procedures requiring complete motor block. Lower concentrations and doses are advised for analgesia (e.g., via epidural administration for the treatment of acute pain).

Administration method – Adults and children over 12 years of age
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, whereas 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 per minute, with close monitoring of the patient's vital signs and maintenance of verbal contact. If symptoms of toxicity occur, administration must be immediately discontinued.

When performing prolonged blocks, either by continuous epidural infusion or by repeated bolus administration, the potential risk of achieving toxic plasma concentrations or inducing local neurotoxicity should be considered. Cumulative doses up to 675 mg of ropivacaine administered within 24 hours for surgical anesthesia and postoperative analgesia have been well tolerated in adults, as well as continuous epidural infusions 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 the management of postoperative pain, the following technique is recommended: unless already established before surgery, an epidural block is performed using Ropivacaine Galenica Senese 7.5 mg/ml administered via epidural catheter. Analgesia is then maintained with an infusion of Ropivacaine Galenica Senese 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 the analgesic effect should be performed in order to remove the catheter as soon as pain intensity allows. With this technique, a significant reduction in the need for opioid use has been observed.

When performing prolonged peripheral nerve blocks, either by continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations or causing local neuronal damage should be evaluated.

For cesarean section, the use of ropivacaine at concentrations exceeding 7.5 mg/ml has not been documented.

Dosage – Pediatric patients aged 0 to 12 years
For pediatric patients aged 0 to 12 years, only the 2 mg/ml concentration is indicated.

	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

Administration method - Pediatric patients from 0 to 12 years of age
To avoid intravascular administration, careful aspiration is recommended before and during injection. The patient's vital signs must be closely monitored throughout the injection. If signs of toxicity occur, administration must be immediately discontinued.
A gradual administration of the calculated dose of local anesthetic is recommended, regardless of the route of administration.
The use of ropivacaine in premature children has not been documented.

4. Marketing Authorization Holder

Industria Farmaceutica Galenica Senese S.r.l. - Via Cassia Nord 351, 53014 Monteroni d'Arbia (Siena) - Italy
Date of approval of this leaflet:

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ropivacaine Galenica Senese 5 mg/ml injectable solution

(Ropivacaine hydrochloride)
Please read this entire leaflet carefully before Ropivacaine Galenica Senese is administered to you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or nurse.
This medicine has been prescribed for you personally. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or nurse.

Contents of this leaflet:

What Ropivacaine Galenica Senese is and what it is used for
Before administration of Ropivacaine Galenica Senese
How Ropivacaine Galenica Senese is administered
Possible side effects
How to store Ropivacaine Galenica Senese
Further information

1. What Ropivacaina Galenica Senese is and what it is used for

The name of the medicine is "Ropivacaina Galenica Senese solution for injection".

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

Ropivacaina Galenica Senese 5 mg/ml is used to numb (anaesthetize) the part of the body where a surgical procedure is to be performed. Ropivacaina Galenica Senese is injected into the lower part of the spine. Pain is rapidly eliminated from the waist downwards, for a limited period (usually 1 to 2 hours). This is known as a "spinal block (or spinal anaesthesia)".

2. Before administration of Ropivacaine Galenica Senese

Do not administer Ropivacaine Galenica Senese if:

you are allergic (hypersensitive) to ropivacaine hydrochloride or to any of the other ingredients of Ropivacaine Galenica Senese (see section 6: Further information).
you are allergic to any other local anaesthetic of the same class (e.g. lidocaine or bupivacaine).
you have been told that you have reduced blood volume (hypovolaemia).
it is to be 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 Ropivacaine Galenica Senese.

Take special care with Ropivacaine Galenica Senese:

Inform your doctor if you have heart, liver or kidney problems, as your doctor may need to adjust the dose of Ropivacaine Galenica Senese.
Inform your doctor if you or a family member has been diagnosed with a rare blood disorder called "porphyria"; in this case, your doctor may choose to administer a different anaesthetic.
Inform your doctor, prior to treatment, of any pre-existing medical conditions or disorders.

Taking Ropivacaine Galenica Senese with other medicines
Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription and herbal medicines. Ropivacaine Galenica Senese may affect how other medicines work, and some medicines may affect Ropivacaine Galenica Senese.
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 of these medicines in order to determine the correct dose of Ropivacaine Galenica Senese.

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). The body takes longer to eliminate Ropivacaine Galenica Senese when these medicines are taken. If you are taking any of these medicines, prolonged use of Ropivacaine Galenica Senese should be avoided.

Pregnancy and breastfeeding
Before receiving Ropivacaine Galenica Senese, inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. 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.

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

Important information about some of the excipients in Ropivacaine Galenica Senese:
Ropivacaine Galenica Senese contains up to 3.5 milligrams (mg) of sodium per millilitre (ml) of solution. If you are on a controlled sodium diet, this should be taken into account.

3. How Ropivacaine Galenica Senese is administered to you

Ropivacaine Galenica Senese will be administered as an injection into the lower part of your spine. When Ropivacaine Galenica Senese is injected into your 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 receive more Ropivacaine Galenica Senese than you should

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

Dizziness or mental confusion
Numbness of the lips and around the mouth
Numbness of the tongue
Hearing problems
Vision problems

The more serious adverse effects of an overdose of Ropivacaine Galenica Senese include speech difficulties, muscle spasms, tremors, shaking, epileptic seizures (fits), and loss of consciousness.

4. Possible side effects

Like all medicines, Ropivacaine Galenica Senese can cause side effects, although not everyone experiences them.
Important side effects to be aware of:
Severe, sudden and potentially life-threatening allergic reactions (such as anaphylaxis) are rare, affecting between 1 and 10
patients in 10,000. Possible symptoms include sudden onset of rash, itching or
eruption with swelling (urticaria); swelling of the face, lips, tongue or other parts of the body;
shortness of breath, wheezing or difficulty breathing. If you think Ropivacaine Galenica Senese is
causing an allergic reaction, inform your doctor immediately.

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

Headache.
Decreased heart rate (bradycardia).
Low blood pressure (hypotension).
Feeling unwell (nausea).
Vomiting.
Difficulty urinating.

Common (affects from 1 to 10 patients in 100)

Paresthesia.
Dizziness.
Reduced skin sensitivity.
Fainting.
Breathing difficulties.
Back pain.
Low body temperature (hypothermia).
Rigidity (rigor).

Other possible side effects include:

Numbness due to nerve irritation caused by the needle or injection. This usually does not last long.

Possible side effects observed with other local anaesthetics, which could also be caused by
Ropivacaine Galenica Senese, are:

Nerve damage. Rarely (affects from 1 to 10 patients in 10,000), this may cause permanent problems.
If an excessive dose of Ropivacaine Galenica Senese is administered into the spinal fluid, it may cause numbness (anaesthesia) throughout the entire body. If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at the website http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ropivacaine Galenica Senese

Keep Ropivacaine Galenica Senese out of the reach and sight of children.
Do not use Ropivacaine Galenica Senese after the expiry date stated on the packaging after the word EXP. The expiry date refers to the last day of the month.
Do not store above 30°C. Do not freeze.
Ropivacaine Galenica Senese is normally 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, substantially free from particles, and if the container is intact.
They are also responsible for the proper disposal of any unused Ropivacaine Galenica Senese.

6. Other information

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

Description of the appearance of Ropivacaine Galenica Senese and packaging contents
Ropivacaine Galenica Senese is a clear, colourless injectable solution.
Ropivacaine Galenica Senese 5 mg/ml injectable solution is available in the following pack sizes:

Pack of 5 type I glass vials of 10 ml in blister
Pack of 5 type I glass vials of 10 ml in sterile blister
Pack of 1 pre-filled glass syringe of type I, 10 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l. - Via Cassia Nord 351, 53014 Monteroni d’Arbia (Siena) - Italy
The manufacturer responsible for batch release is:
Industria Farmaceutica Galenica Senese S.r.l. - Via Cassia Nord 351, 53014 Monteroni d’Arbia (Siena) - Italy
______________________________________________________
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 the product should be administered.
Please consult the Summary of Product Characteristics for further information.

2. Product

Ropivacaine Galenica Senese 5 mg/ml injectable solution.

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; this should be taken into consideration in patients on a controlled sodium diet.

3. Instructions for use, handling and disposal

Ropivacaine Galenica Senese 5 mg/ml is preservative-free and intended for single use only. Any remaining 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.
The intact container must not be resterilized. The blister pack packaging should be selected when sterility of the outer surface of the vial is required.

Dosage
The following table provides dosage guidance for intrathecal block in adults. The dose to be used should be the lowest required to achieve effective block. The administered 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 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 those considered suitable to produce an 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 dose ranges usually required. Reference textbooks should be consulted regarding factors influencing specific block techniques as well as individual patient requirements.

Method of administration
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 the patient's vital signs and maintenance of verbal contact. If symptoms 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 flows from the spinal needle or is obtained by aspiration.

Children under 12 years of age
Intrathecal administration has not been studied in infants, neonates, or children.

4. Marketing Authorization Holder

Industria Farmaceutica Galenica Senese S.r.l. - Via Cassia Nord 351, 53014 Monteroni d'Arbia (Siena) - Italy
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