Ropivacaine kabi

Patient Information Leaflet

Ropivacaine Kabi, 2 mg/ml, solution for infusion
Ropivacaini hydrochloridum
Please read all of this leaflet carefully before this medicine is used, as it contains
important information for the patient.
­ Keep this leaflet, as you may need to read it again.
­ If you have any further questions, please consult your doctor, nurse or other healthcare professional.
­ If you experience any side effects, including any not listed in this leaflet, tell your doctor, nurse or other healthcare professional. See section 4.
The medicine referred to in this leaflet is Ropivacaine Kabi, 2 mg/ml, solution for infusion.
In this leaflet, it is referred to as Ropivacaine Kabi.

Leaflet Contents

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

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

• Ropivacaine Kabi contains the active substance called ropivacaine hydrochloride.
• It belongs to a group of medicines known as local anaesthetics.

Ropivacaine Kabi, 2 mg/ml, solution for infusion is used in adults and children of all ages for the treatment of acute pain. It numbs specific parts of the body, for example after surgical procedures.

2. Important information before using Ropivacaine Kabi

When not to use Ropivacaine Kabi:

• if the patient is allergic (hypersensitive) to ropivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other local anaesthetics of the same group of medicines (such as lidocaine or bupivacaine);
• if the patient has reduced circulating blood volume (hypovolemia);
• by intravascular administration for regional anaesthesia of a specific body part;
• or by administration into the cervix uteri for pain relief during childbirth.

If the patient is unsure whether any of the above points apply, they should consult a doctor before using Ropivacaine Kabi.

Warnings and precautions

Extreme caution must be taken not to administer Ropivacaine Kabi directly into a blood vessel, to avoid immediate toxic effects. Injections should not be performed in areas affected by inflammation.

Before starting treatment with Ropivacaine Kabi, discuss this with a doctor, nurse,
or other healthcare professional:

• if the patient is in a general state of weakness due to age or other factors,
• if the patient has heart disease (partial or complete heart conduction block),
• if the patient has advanced liver disease,
• if the patient has serious kidney problems.

Inform the doctor 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, discuss the following with a doctor, nurse, or other healthcare professional:

• if the patient suffers from acute porphyria (a disorder of haem production, sometimes leading to neurological symptoms).

Inform the doctor if the patient or a family member suffers from porphyria, as another anaesthetic drug may need to be used.

Before starting treatment, inform the doctor about any medical conditions and current symptoms.

Children

Special caution is required:

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

Ropivacaine Kabi and other medicines

Tell the doctor or healthcare professional about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

Ropivacaine Kabi may affect the action of certain medicines, and some medicines may also affect the action of Ropivacaine Kabi.

In particular, inform the doctor if the patient is taking any of the following medicines:

• other local anaesthetics,
• strong painkillers such as morphine or codeine,
• medicines used to treat heart rhythm disorders (arrhythmias), such as lidocaine and mexiletine.

The doctor must be informed about the use of these medicines in order to assess the appropriate dose of Ropivacaine Kabi.

Also inform the doctor if the patient is 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 prolonged elimination of Ropivacaine Kabi from the patient's body when these medicines are used.

Prolonged use of Ropivacaine Kabi should be avoided when using the above-mentioned medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

There is insufficient data on the effects of ropivacaine on pregnancy or its passage into human milk.

Before using any medicine, consult a doctor or pharmacist if the patient is pregnant or breastfeeding.

Driving and operating machinery

Ropivacaine Kabi may cause drowsiness and slowed reaction times. After receiving Ropivacaine Kabi, the patient should not drive or operate vehicles, tools, or machinery until the following day.

Ropivacaine Kabi contains sodium

This medicine contains 3.4 mg of sodium (the main component of table 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 given 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 given by infusion. The site of administration of Ropivacaine Kabi will depend on which part of the body requires anaesthesia.
Ropivacaine Kabi may be administered at one of the following sites:

• the part of the body to be anaesthetized,
• near the part of the body to be anaesthetized,
• at a site distant from the part of the body to be anaesthetized. This occurs in the case of epidural infusion (around the spinal cord). Administration of Ropivacaine Kabi in one of the above ways prevents nerves from transmitting pain signals to the brain. The patient will no longer feel pain, heat, or cold in the treated area, but may still experience 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 given to the patient depends on the intended use of the medicine and on the patient's health status, age, and body weight. Duration of treatment Administration of ropivacaine usually lasts from 0.5 to 6 hours, but may last up to 72 hours for pain relief during or after surgical procedures. Administration of a higher than recommended dose of Ropivacaine Kabi Severe adverse reactions resulting from administration of an excessive dose of Ropivacaine Kabi require specialized treatment, and the treating physician is trained to manage such situations. Initial symptoms of overdose with Ropivacaine Kabi may include:
• hearing and vision problems (visual disturbances),
• numbness of the lips, tongue, and around the mouth,
• dizziness or a "blank" feeling in the head,
• tingling,
• speech disturbances characterized by poor articulation (dysarthria),
• muscle stiffness, muscle tremors, seizures (convulsions),
• low blood pressure,
• slow or irregular heartbeat. These symptoms may precede cardiac arrest, respiratory arrest, or severe seizures. To minimize the risk of severe adverse reactions, the doctor will immediately discontinue administration of Ropivacaine Kabi if any of the above symptoms occur. This means that if the patient experiences any of the above symptoms or suspects that they have received a higher than recommended dose of Ropivacaine Kabi, the patient should immediately inform the doctor or another healthcare professional.
  Severe adverse reactions associated with administration of an excessive dose of Ropivacaine Kabi include speech disturbances, muscle twitching, tremors, chills, seizures (epileptic fits), and loss of consciousness.
  If the patient experiences any of the above symptoms, they should immediately inform the doctor or another healthcare professional.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Important adverse reactions to be aware of:
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 rash,
• itchy or lumpy rash (urticaria),
• swelling of the face, lips, tongue, or other parts of the body,
• shortness of breath, wheezing, or difficulty breathing; feeling of fainting. If the patient suspects that Ropivacaine Kabi is causing an allergic reaction, they should immediately inform the doctor or other healthcare professionals. Other possible adverse reactions: Very common (may affect more than 1 in 10 patients):
• low blood pressure (hypotension), which may cause dizziness or a "blank" feeling in the head,
• nausea. Common (may affect up to 1 in 10 patients):
• tingling or prickling sensation (paraesthesia),
• dizziness,
• headache,
• slow or fast heartbeat (bradycardia, tachycardia),
• high blood pressure (hypertension),
• vomiting,
• difficulty passing urine (urinary retention),
• high temperature (fever) or shivering (chills),
• muscle stiffness,
• back pain. Uncommon (may affect up to 1 in 100 patients):
• anxiety,
• loss of skin sensation or sensitivity,
• fainting,
• breathing difficulties,
• drop in body temperature (hypothermia),
• some symptoms may occur due to accidental intravascular infusion or if the patient receives a higher than recommended dose of Ropivacaine Kabi (see also section 3 "Use of a higher than recommended dose of Ropivacaine Kabi" above). These include: seizures, dizziness or a "blank" feeling in the head, numbness of the lips and around the mouth,
• numbness of the tongue, hearing disturbances, visual disturbances, speech difficulties,
• muscle stiffness and tremor. 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 available data):
• Horner’s syndrome. Other possible adverse reactions:
• numbness, caused by nerve irritation due to needle insertion or injection, usually short-lived,
• involuntary muscle movements (dyskinesia). Possible adverse reactions observed with other local anaesthetics, which may also be caused by Ropivacaine Kabi, include:
• nerve damage. This is rare (occurring in 1 to 10 out of 10,000 patients) and may lead to permanent problems.
• If too much Ropivacaine Kabi is administered into the cerebrospinal fluid, the entire body may become numb (anaesthetized).
• An epidural injection (injection into the space around the spinal nerves) may interrupt the nerve pathway from the brain to the head and neck, particularly in pregnant women, which may sometimes lead to a condition called Horner’s syndrome. This is characterized by reduced pupil size, drooping of the upper eyelid, and inability of sweat glands to produce sweat. It resolves spontaneously after discontinuation of treatment. Children In children, adverse reactions are the same as in adults, except for low blood pressure, which occurs less frequently in children (in 1 out of 10 out of 100 children), and vomiting, which occurs more frequently in children (in more than 1 out of 10 children). Reporting of adverse reactions If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ropivacaine Kabi

Keep this medicine out of the 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 stated month.
Store below 30°C.
Do not use this medicine if any contamination of the infusion solution is observed.
If the medicine is not used immediately after opening, the physician or hospital is responsible
for the storage and quality of Ropivacaine Kabi, as well as for the proper disposal of unused medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. These measures help protect the environment.

6. Contents of the pack and other information

What Ropivacaine Kabi contains

• The active substance 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.
• Other ingredients are: sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

What Ropivacaine Kabi looks like and contents of the pack
Ropivacaine Kabi is a clear, colourless infusion solution. Ropivacaine Kabi 2 mg/ml infusion solution is available in transparent polyolefin bags with a PP port, in 100 ml and 200 ml sizes.
Pack sizes:
1 bag in an outer foil pouch made of transparent polypropylene film, in a cardboard box.
5 bags in outer foil pouches made of transparent polypropylene film, in a cardboard box.
10 bags in outer foil pouches made of transparent polypropylene film, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw, Poland

Manufacturer
HP Halden Pharma AS
Svinesundsveien 80
1788 Halden, Norway

For further information about this medicinal product, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw, Poland
Tel: +48 22 345 67 89

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Information intended exclusively for medical professionals:

Preparation for use
Ropivacaine Kabi should be administered only by or under the supervision of physicians experienced
in performing regional anesthesia (see section 3).
Shelf-life after opening
Use immediately.
Ropivacaine Kabi is intended for single use only.
Any unused solution should be discarded.
The medicinal product should be visually inspected before use. The solution should be used only if it is
clear, free from particulate matter, and the packaging is undamaged.
The packaging must not be re-sterilized in an autoclave. The bag should be removed from the
foil packaging at the time it is needed for use.
Pharmaceutical incompatibilities
Compatibility studies have not been conducted with solutions other than those listed below.
Precipitation may occur in alkaline solutions, as ropivacaine has low solubility at pH > 6.0.
Compatibility
Ropivacaine for infusion solution in plastic infusion bags is chemically and physically compatible with the following medicinal products:

* The concentration ranges presented 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 studied in clinical trials.
The above mixtures maintain chemical and physical stability for 30 days at temperatures
ranging from 20°C to 30°C. From a microbiological standpoint, the mixture should be used immediately. If
not used immediately, the user is responsible for the storage duration and conditions prior to use, which
should generally not exceed 24 hours at a temperature of 2 to 8°C.
Disposal of unused medicinal product
Any unused residues of the medicinal product or waste materials should be disposed of in accordance with
local regulations.