Ropivacaine Kabi

Leaflet accompanying the packaging: information for the user

Ropivacaine Kabi, 5 mg/ml, solution for injection
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, you may need to read it again.
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In case of any doubts, consult a doctor, nurse or other healthcare professional.
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If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, nurse or other healthcare professional. See section 4.
The name of the medicine is: Ropivacaine Kabi, 5 mg/ml, solution for injection
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, 5 mg/ml, solution for injection is used

• in adults and adolescents over 12 years of age for anesthesia(anesthesia) of parts of the body during surgical procedures. It is injected into the lower part of the spine. It helps to quickly stop pain in the patient from the waist down for a limited time (usually 1 to 2 hours). Known as "subarachnoid anesthesia" (subarachnoid).
• in children from 1 to 12 years of age for anesthesia(anesthesia) of certain parts of the body. It is used to stop or alleviate pain.

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 injecting into a blood vesselto anesthetize a part of the body;
• 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 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 these conditions, as it may be necessary to adjust the dose of Ropivacaine Kabi. Injection into the lower part of the spinemay cause low blood pressureor slow heart rate. In such a case, the doctor will take appropriate action. 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 tell their doctor about all previous illnesses and current complaints.

Children

Particular care should be taken in children:

• because the safety of injecting Ropivacaine Kabi into the lower part of the spine has not been established,
• under 1 year of age, because the safety of using Ropivacaine Kabi to anesthetize 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 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 whether Ropivacaine Kabi can be administered to the patient in a suitable dose. 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 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 0.138 mmol (or 3.17 mg) of sodium (the main component of table salt) per ml.
This corresponds to 0.16% 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 to be administered to the patient will depend on the type of pain relief required, the patient's weight, age and physical condition.
Ropivacaine Kabi will be administered as an injection. The site of administration of Ropivacaine Kabi will depend on which part of the body needs to be anesthetized.
Ropivacaine Kabi may be administered in one of the following ways:

• injection into the lower part of the spine,
• injection near the part of the body to be anesthetized. The use of 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 injection site, but may still have other sensations, such as pressure or touch. The doctor will know how to administer the medicine to the patient correctly.

Dosage

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

Duration of treatment

The administration of ropivacaine usually lasts from 2 to 6 hoursin the case of anesthesiabefore certain surgical procedures. It is administered by injection into the lower part of the spine (subarachnoid injection).

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 to deal with 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 seizures. 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 effects associated 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 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 heart rate (bradycardia, tachycardia),
• high blood pressure (hypertension),
• vomiting,
• difficulty urinating (urinary retention),
• high temperature (fever) or chills (shivering),
• 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 1000 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 irritation of the nerve caused by needle puncture or injection, usually not lasting long,
• involuntary muscle movements (dyskinesia). Side effects associated with the use of Ropivacaine Kabi administered into the lower part of the spine may occur more frequently compared to other local anesthesia procedures, regardless of the anesthetic used.

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),
• an 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 upper eyelid and inability of the sweat glands to produce sweat. It will resolve on its own after the 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). Ropivacaine Kabi should not be used in the form of an injection into the lower part of the spine in infants and children under 12 years of age.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ropivacaine Kabi

This medicine does not require special storage conditions.
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 blister, ampoule or carton.
The expiry date refers to the last day of the month.
Do not use this medicine if you notice any contamination in the solution for injection.
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 5 mg/ml. Each 10 ml polypropylene ampoule contains 50 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 pack contains

Ropivacaine Kabi is a clear, colorless solution for injection.
Ropivacaine Kabi, 5 mg/ml, solution for injection is available in transparent polypropylene ampoules of 10 ml.
Pack sizes:
1, 5, 10 ampoules in a blister pack, all in a carton.
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, please 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 under the following names:

Date of last revision of the leaflet:08.11.2024
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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
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 subjected to re-sterilization in an autoclave. If a sterile external surface is required, an intact blister pack should be used.
Incompatibilities
No compatibility studies have been performed, so this medicine should not be mixed with other medicines.
In alkaline solutions, precipitation may occur, as ropivacaine has poor solubility at pH > 6.0.
Disposal of unused medicine
Any unused medicine or waste material should be disposed of in accordance with local regulations.