Ropivacaine Kabi

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Ropivacaine Kabi (Ropivacaine hydrochloride Kabi 10 mg/ml solution for injection), 10 mg/ml

injection solution
Ropivacaine hydrochloride
Ropivacaine Kabi and Ropivacaine hydrochloride Kabi 10 mg/ml solution for injection are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, nurse or other healthcare professional.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist or other healthcare professional. See section 4.

The name of the medicine described in this leaflet is Ropivacaine Kabi, 10 mg/ml, solution for injection. In the leaflet, it is referred to as Ropivacaine Kabi.

Table of contents of the leaflet

• 1. What is Ropivacaine Kabi and what is it used for
• 2. Important information before using Ropivacaine Kabi
• 3. How to use Ropivacaine Kabi
• 4. Possible side effects
• 5. How to store Ropivacaine Kabi
• 6. Contents of the packaging and other information

1. What is Ropivacaine Kabi and what is it used for

• Ropivacaine Kabi contains the active substance ropivacaine hydrochloride.
• It belongs to a group of medicines called local anesthetics. Ropivacaine Kabi is used in adults and adolescents over 12 years of age to numb a part of the body during surgical procedures.

2. Important information before using Ropivacaine Kabi

When not to use Ropivacaine Kabi:

• if the patient is allergic(hypersensitive) to ropivacaine hydrochlorideor any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other local anesthetics of the same group of medicines (such as lidocaine or bupivacaine);
• if the patient has reduced blood volume(hypovolemia);
• by injection into a blood vesselto numb a specific part of the body;
• or by injection into the cervixto relieve pain during childbirth. If the patient is unsure whether any of the above points apply to them, they should consult their doctor before using Ropivacaine Kabi.

Warnings and precautions

Particular care should be taken not to injectRopivacaine Kabi directly
into a blood vesseland not to cause immediate toxic effects.
Injections should not be performed in areas with inflammation.
Before starting treatment with Ropivacaine Kabi, the patient should discuss it with their doctor, nurse or other healthcare professional:

• if the patient is in a state of general weaknessdue to age or other factors,
• if the patient has heart disease(partial or complete heart block),
• if the patient has advanced liver disease,
• if the patient has severe kidney problems. The doctor should be informed if the patient has any of the above conditions, as it may be necessary to adjust the dose of Ropivacaine Kabi.

Before starting treatment with Ropivacaine Kabi, the patient should discuss it with their doctor, nurse or other healthcare professional:

• if the patient suffers from acute porphyria(a disorder of red blood cell pigment production, sometimes leading to neurological symptoms). The doctor should be informed if the patient or a family member suffers from porphyria, as it may be necessary to administer a different anesthetic.

Before starting treatment, the patient should inform their doctor about any illnesses and current complaints.

Children

In children under 12 years of age, other concentrations (2 mg/ml and 5 mg/ml) may be more suitable.

Ropivacaine Kabi and other medicines

The patient should tell their doctor or healthcare professional about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Ropivacaine Kabi may affect the action of some medicines, and some medicines may also affect the action of Ropivacaine Kabi.
In particular, the patient should inform their doctor if they are taking any of the following medicines:

• other local anesthetics,
• strong painkillers, such as morphine or codeine,
• medicines used to treat heart rhythm disorders(arrhythmia), such as lidocaine and mexiletine. The doctor must be informed about the use of these medicines, so that they can assess what dose of Ropivacaine Kabi can be given to the patient.

The patient should also inform their doctor if they are taking any of the following medicines:

• medicines used to treat depression(e.g. fluvoxamine),
• antibioticsused to treat bacterial infections (e.g. enoxacin). due to the prolonged elimination time of Ropivacaine Kabi from the patient's body when using these medicines. The patient should avoid long-term use of Ropivacaine Kabi when using the above-mentioned medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor before using this medicine.
There is no data on the effect of ropivacaine on pregnancy or its penetration into human milk.
Before using any medicine, the patient should consult their doctor or pharmacist if they are pregnant or breastfeeding.

Driving and using machines

Ropivacaine Kabi may cause drowsiness and slowed reactions. After receiving Ropivacaine Kabi, the patient should not drive vehicles or operate any tools and machines until the next day.

Ropivacaine Kabi contains sodium

This medicine contains 2.8 mg of sodium (the main component of common salt) in 1 ml of solution. This corresponds to 0.14% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ropivacaine Kabi

Ropivacaine Kabi is available in the following concentrations: 2 mg/ml, 7.5 mg/ml, 10 mg/ml.
Ropivacaine Kabi will be administered to the patient by a doctor. The dose of the medicine that will be administered to the patient will depend on the type of pain relief required, the patient's body weight, age and physical condition.
Ropivacaine Kabi will be administered by injection. The site of administration of Ropivacaine Kabi will depend on which part of the body needs to be numbed.
Ropivacaine Kabi may be administered in one of the following ways:

• in the part of the body that needs to be numbed,
• near the part of the body that needs to be numbed,
• in a location away from the part of the body that needs to be numbed. This is the case with epidural injection (near the spinal cord).

Administering Ropivacaine Kabi in one of the above ways prevents nerves from transmitting pain information to the brain. The patient will stop feeling pain, heat or cold in the area where it is applied, but may still have other sensations, such as pressure or touch.
The doctor will know how to properly administer this medicine to the patient.

Dosage

The amount of medicine that will be administered to the patient depends on the purpose for which it is used and the patient's health, age and body weight.

Duration of treatment

The administration of ropivacaine usually lasts from 2 to 10 hoursin the case of numbingbefore some surgical procedures and may last up to 72 hoursto relieve painduring or after surgery.

Using a higher dose of Ropivacaine Kabi than recommended

Severe side effects resulting from the administration of too high a dose of Ropivacaine Kabi require specialized treatment, and the attending physician is trained in the procedures for such situations. The first symptoms of an overdose of Ropivacaine Kabi may include:

• hearing and vision problems (vision disturbances),
• numbness of the lips, tongue and around the mouth,
• dizziness or a feeling of "emptiness in the head",
• tingling,
• speech disorders characterized by poor articulation (dysarthria),
• muscle stiffness and tremors, convulsions (seizures),
• low blood pressure,
• slow or irregular heartbeat. These symptoms may precede cardiac arrest, respiratory arrest or severe seizures.

In order to minimize the risk of severe side effects, the doctor will stop administering Ropivacaine Kabi immediately if the above symptoms occur. This means that if the patient experiences any of the above symptoms or thinks they have received a higher dose of Ropivacaine Kabi than recommended, they should immediately inform their doctor or other healthcare professional.
Severe side effects related to the administration of too high a dose of Ropivacaine Kabi include speech disorders, muscle tremors, shivering, chills, seizures (seizure attacks) and loss of consciousness.
If the patient experiences any of the above symptoms, they should immediately inform their doctor or other healthcare professional.

4. Possible side effects

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

Important side effects to look out for:

Sudden life-threatening allergic reactions(such as anaphylaxis, including anaphylactic shock) are rare and occur in 1 to 10 out of 10,000 patients. Possible symptoms include:

• sudden onset of rash,
• itchy or lumpy rash (hives),
• swelling of the face, lips, tongue or other parts of the body,
• shortness of breath, wheezing or difficulty breathing; feeling of loss of consciousness.

If the patient thinks that Ropivacaine Kabi is causing an allergic reaction, they should immediately inform their doctor or other healthcare professionals.

Other possible side effects:

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

• low blood pressure (hypotension), which may cause dizziness or a feeling of emptiness in the head,
• nausea (nausea).

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

• tingling sensation (paresthesia),
• dizziness,
• headache,
• slow or rapid heartbeat (bradycardia, tachycardia),
• high blood pressure (hypertension),
• vomiting,
• difficulty urinating (urinary retention),
• high temperature (fever) or shivering (chills),
• muscle stiffness,
• back pain.

Uncommon(may affect up to 1 in 100 patients):

• restlessness,
• loss of skin sensation or sensitivity,
• fainting,
• breathing difficulties,
• drop in body temperature (hypothermia),
• some symptoms may occur as a result of unintentional intravascular injection or when the patient receives a higher dose of Ropivacaine Kabi than recommended (see also section 3 "Using a higher dose of Ropivacaine Kabi than recommended" above). These include:

seizures, dizziness or a feeling of emptiness in the head, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems, speech problems, muscle stiffness and tremors.
Rare(may affect up to 1 in 1,000 patients):

• heart attack (cardiac arrest),
• irregular heartbeat (arrhythmia). Frequency not known(frequency cannot be estimated from the available data):
• Horner's syndrome.

Other possible side effects:

• numbness caused by nerve irritation due to needle puncture or injection, usually not lasting long,
• involuntary muscle movements (dyskinesia).

Possible side effects observed with other local anesthetics, which may also be caused by Ropivacaine Kabi, include:

• nerve damage. This occurs rarely (in 1 to 10 out of 10,000 patients), may cause permanent problems,
• if too much Ropivacaine Kabi is injected into the spinal fluid, the entire body may become numb (anesthetized). Epidural injection (injection into the space around the spinal nerves) may interrupt the nerve pathway from the brain to the head and neck, especially in pregnant women, which can sometimes lead to a condition called Horner's syndrome. It is characterized by a decrease in pupil size, drooping eyelid and inability of sweat glands to produce sweat. It will resolve on its own after treatment is discontinued.

Children

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

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist or other healthcare professional. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the use of this medicine.

5. How to store Ropivacaine Kabi

There are no special precautions for storage.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Do not use this medicine if you notice any contamination in the injection solution.
If the medicine is not used immediately after opening, the doctor or hospital is responsible for storing and ensuring the quality of Ropivacaine Kabi, as well as for the proper disposal of unused medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ropivacaine Kabi contains

• The active substance of Ropivacaine Kabi is ropivacaine hydrochloride: 10 mg/ml. Each 10 ml polypropylene ampoule contains 100 mg of ropivacaine (as ropivacaine hydrochloride).
• The other ingredients are: sodium chloride, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), water for injections.

What Ropivacaine Kabi looks like and what the pack contains

Ropivacaine Kabi is a clear, colorless solution for injection.
Ropivacaine Kabi is available in transparent PP ampoules in a blister pack of 10 ml capacity.
Pack sizes:
1, 5, 10 ampoules in a blister pack, all in a cardboard box.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1
61352 Bad Homburg v.d.H., Germany

Manufacturer:

Fresenius Kabi Norge AS
Svinesundsveien 80
1788 Halden
Norway

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German authorization number: 78019.00.00

Parallel import authorization number: 184/25

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of leaflet approval: 23.05.2025

[Information about the trademark]
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Information intended only for healthcare professionals:
Preparation for use
Ropivacaine Kabi should only be administered by or under the supervision of doctors experienced in performing regional anesthesia (see section 3).
Shelf life after opening
It should be used immediately.
Ropivacaine Kabi is intended for single use only.
Any unused solution should be discarded.
The medicine should be inspected visually before use. The solution should only be used if it is clear, free from particles and its packaging is undamaged.
Packaging should not be re-sterilized in an autoclave.
Incompatibilities
There are no compatibility studies, so this medicine should not be mixed with other medicines.
In alkaline solutions, precipitation may occur, as ropivacaine has limited solubility at pH > 6.0.
Disposal of leftovers
Any unused medicine or waste should be disposed of in accordance with local regulations.