Ropivacaine Kabi

Leaflet accompanying the packaging: information for the user

Ropivacaine Kabi, 2 mg/ml, solution for infusion
Ropivacaine hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

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Keep this leaflet, so you can read it again if you need to.
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If you have any doubts, consult a doctor, nurse, or other healthcare professional.
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If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, nurse, or other healthcare professional. See section 4.
The name of the medicine is Ropivacaine Kabi, 2 mg/ml, solution for infusion.
In this 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, 2 mg/ml, solution for infusion is used in adults and children of all ages
to treat acute pain. It numbs parts of the body, e.g., after 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 decreased blood volume(hypovolemia);
• by injecting into a blood vesselfor the purpose of numbing a specific part of the body;
• or by injecting into the cervixto relieve pain during childbirth. If the patient is unsure whether any of the above points apply to them, they should consult a doctor before using Ropivacaine Kabi.

Warnings and precautions

Particular caution should be exercised not to administerRopivacaine 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(disorders 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

Particular caution should be exercised:

• in newborns, as they are more sensitive to Ropivacaine Kabi, 2 mg/ml, solution for infusion.
• in children under 12 years of age, as the safety of using Ropivacaine Kabi, 2 mg/ml, solution for infusion for numbing certain parts of the body in younger children has not been established.

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 report to 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 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),
• antibiotics used 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 passage 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 slow down 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 3.4 mg of sodium (the main component of common salt) per 1 ml of solution. This corresponds to 0.17% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ropivacaine Kabi

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 infusion. The site of administration of Ropivacaine Kabi will depend on which part of the body needs to be numbed.
Ropivacaine Kabi can be administered in one of the following ways:

• the part of the body that is to be numbed,
• near the part of the body that is to be numbed,
• in a location away from the part of the body that is to be numbed. This is the case with epidural infusion (near the spinal cord). Administering Ropivacaine Kabi in one of the above ways prevents the 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 administer the medicine correctly to the patient.

Dosage

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

Duration of treatment

The administration of ropivacaine usually lasts from 0.5 to 6 hours, but may last up to 72 hoursto relieve pain during 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 treating doctor 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, muscle tremors, convulsions (seizures),
• low blood pressure,
• slow or irregular heartbeat. These symptoms may precede cardiac arrest, respiratory arrest, or severe convulsions. To minimize the risk of severe side effects, the doctor will stop administering Ropivacaine Kabi as soon as 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 effectsassociated with the administration of too high a dose of Ropivacaine Kabi include:
  • speech disorders,
  • muscle tremors, tremors, shivers, convulsions (seizures), 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 appearance of a 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):
  • feeling of tingling and numbness (paresthesia),
  • dizziness,
  • headache,
  • slow or fast 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 if 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 and vision problems, speech disorders,
  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 that 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 cause interruption of 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 of the eyelid, and inability of the sweat glands to produce sweat. It resolves on its own after the treatment is stopped.

  Children

  Side effects in children 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 or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
  Side effects can also be reported to the marketing authorization holder.
  Reporting side effects will help to gather more information on the safety of the medicine.

  5. How to store Ropivacaine Kabi

  The medicine should be stored out of sight and reach of children.
  Do not use this medicine after the expiry date (EXP) stated on the packaging.
  The expiry date refers to the last day of the month.
  Store at a temperature below 30°C.
  Do not use this medicine if you notice any contamination in the infusion 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 the medicine is ropivacaine hydrochloride 2 mg/ml. Each 100 ml polyolefin bag contains 200 mg of ropivacaine hydrochloride.
  • Each 200 ml polyolefin bag contains 400 mg of 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 packaging contains

  Ropivacaine Kabi is a clear, colorless solution for infusion.
  Ropivacaine Kabi, 2 mg/ml, solution for infusion is available in transparent, polyolefin bags with a PP port, with a capacity of 100 ml and 200 ml.
  Pack sizes:
  1 bag in a foil outer bag made of transparent polypropylene film, in a cardboard box.
  5 bags in foil outer bags made of transparent polypropylene film, in a cardboard box.
  10 bags in foil outer bags made of transparent polypropylene film, in a cardboard box.
  Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer

  Marketing authorization holder

  Fresenius Kabi Polska Sp. z o.o.
  Al. Jerozolimskie 134
  02-305 Warsaw

  Manufacturer

  HP Halden Pharma AS
  Svinesundsveien 80
  1788 Halden
  Norway
  To obtain more detailed information about this medicine, the patient should contact the marketing authorization holder:
  Fresenius Kabi Polska Sp. z o.o.
  Al. Jerozolimskie 134
  02-305 Warsaw
  tel.: +48 22 345 67 89

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

  Member State	Medicine name
  Netherlands	Ropivacaïne Fresenius Kabi 2 mg/ml oplossing voor infusie
  Austria	Ropivacainhydrochlorid Kabi 2 mg/ml Infusionslösung
  Estonia	Ropivacaine Kabi
  Hungary	Ropivacaine Fresenius Kabi 2 mg/ml oldatos infúzió
  Lithuania	Ropivacaine hydrochloride Kabi 2 mg/ml infuzinis tirpalas
  Latvia	Ropivacaine Kabi 2 mg/ml šķīdums infūzijām
  Malta	Ropivacaine Kabi 2 mg/ml
  Poland	Ropivacaine Kabi
  Slovakia	Ropivacaine Kabi 2 mg/ml infúzny roztok
  Belgium	Ropivacaïne Fresenius Kabi 2 mg/ml oplossing voor infusie
  Cyprus	Ropivacaine/Kabi 2mg διάλυμα για έγχυση
  Germany	Ropivacainhydrochlorid Kabi 2 mg/ml Infusionslösung
  Denmark	Ropivacaine Fresenius Kabi, infusionsvaeske, opløsning, 2 mg/ml
  Greece	Ropivacaine/Kabi 2mg διάλυμα για έγχυση
  Spain	Ropivacaina Kabi 2 mg/ml solución para perfusión
  Finland	Ropivacain Fresenius Kabi 2 mg/ml infuusioneste, liuos
  France	Ropivacaïne Kabi 2 mg/ml solution pour perfusion en poche
  Italy	Ropivacaina Kabi
  Luxembourg	Ropivacaïne Fresenius Kabi 2 mg/ml Infusionslösung
  Norway	Ropivacain Fresenius Kabi 2 mg/ml, infusjonsvæske, oppløsning
  Portugal	Ropivacaína Kabi
  Sweden	Ropivacain Fresenius Kabi 2 mg/ml, infusionsvätska, lösning
  Slovenia	Ropivakainijev klorid Kabi 2 mg/ml raztopina za infundiranje
  United Kingdom (Northern Ireland)	Ropivacaine 2 mg/ml solution for infusion

  Date of last revision of the leaflet:08.11.2024
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  Information intended for healthcare professionals only:
  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
  Use immediately.
  Ropivacaine Kabi is intended for single use only.
  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 impurities, and its packaging is undamaged.
  Packaging should not be resterilized in an autoclave. The bag should be removed from the foil packaging when it is needed for use.
  Incompatibilities
  No compatibility studies have been performed with solutions other than those listed below.
  In alkaline solutions, precipitation may occur, as ropivacaine has poor solubility at pH > 6.0.
  Compatibility
  Ropivacaine in solution for infusion in plastic infusion bags is chemically and physically compatible with the following medicines:
  * The concentration ranges shown in the table are broader than those usually used in clinical practice.
  Epidural infusion of ropivacaine/sufentanil citrate, ropivacaine/morphine sulfate, and ropivacaine/ clonidine hydrochloride has not been clinically tested.
  The above mixtures maintain chemical and physical stability for 30 days at a temperature of 20°C to 30°C. From a microbiological point of view, the mixture should be used immediately. If it is not used immediately, the user is responsible for the storage time and conditions before use, and it should not usually exceed 24 hours at a temperature of 2°C to 8°C.
  Disposal of unused medicinal product
  Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

  Ropivacaine Kabi concentration: 1-2 mg/ml
  Added substance	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 micrograms/ml