Ropivacaine kabi

Package leaflet: Information for the user

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Ropivacaine Kabi (Ropivacainhydrochlorid Kabi 10 mg/ml Injektionslösung), 10 mg/ml
solution for injection
Ropivacaini hydrochloridum
Ropivacaine Kabi and Ropivacainhydrochlorid Kabi 10 mg/ml Injektionslösung are different trade names
for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, nurse or other healthcare professional.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or other healthcare professional. See section 4.

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

1. What Ropivacaine Kabi is and what it is 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 pack and other information

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

• Ropivacaine Kabi contains an active substance called ropivacaine hydrochloride.
• It belongs to a group of medicines known as local anaesthetics. 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 hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other local anaesthetics in the same group of medicines (such as lidocaine or bupivacaine);
• if the patient has reduced blood volume (hypovolemia);
• by intravascular injection for the purpose of anaesthetizing a specific part of the body;
• or by cervical injection to relieve pain during childbirth.
  If the patient is unsure whether any of the above apply, they should consult their doctor before using Ropivacaine Kabi.

Warnings and precautions
Extreme care must be taken not to inject Ropivacaine Kabi directly into a blood vessel,
which could cause immediate toxic effects.
Injections should not be performed at sites affected by inflammation.
Before starting treatment with Ropivacaine Kabi, discuss the following with your doctor, nurse,
or other healthcare professional:

• if the patient is in a state of general debility 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 dose adjustment of Ropivacaine Kabi may be necessary.

Before starting treatment with Ropivacaine Kabi, discuss the following with your doctor, nurse,
or other healthcare professional:

• if the patient suffers from acute porphyria (disorders in the production of haem, the red pigment in blood, sometimes leading to neurological symptoms).
  Inform the doctor if the patient or a family member suffers from porphyria, as another anaesthetic medicine may need to be used.

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

Children
In children up to and including 12 years of age, different concentrations (2 mg/ml and 5 mg/ml) may be more appropriate.

Ropivacaine Kabi and other medicines
Tell your 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 take.
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 opioid analgesics such as morphine or codeine,
• medicines used to treat heart rhythm disorders (arrhythmias), such as lidocaine and mexiletine.
  The doctor must be informed about these medicines in order to determine 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 these medicines are being taken.

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 her doctor before using this medicine.
There is no data available on the effects of ropivacaine on pregnancy or its passage into human breast milk.
Before using any medicine, consult a doctor or pharmacist if the patient is pregnant or breastfeeding.

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

Ropivacaine Kabi contains sodium
This medicine contains 2.8 mg of sodium (the main component of table salt) per 1 ml of solution. This corresponds to 0.14% of the maximum recommended daily sodium intake in the adult diet.

3. How to use Ropivacaine Kabi

Ropivacaine Kabi is available in the following strengths: 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 given to the patient will depend on the type of required pain relief, body weight, age, and the patient's physical condition.
Ropivacaine Kabi will be given by injection. The site of administration of Ropivacaine Kabi will depend on which part of the body requires anesthesia.
Ropivacaine Kabi may be administered at one of the following sites:

• the part of the body to be anesthetized,
• near the part of the body to be anesthetized,
• at a site distant from the part of the body to be anesthetized. This occurs in the case of epidural injection (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 area of application, but may still experience other sensations, such as pressure or touch.
The doctor will know the correct way to administer this medicine to the patient.
Dosage
The amount of medicine given to the patient depends on the purpose for which the medicine is used and on the patient's health status, age, and body weight.
Duration of treatment
Administration of ropivacaine usually lasts from 2 to 10 hours in the case of anesthesia for certain surgical procedures and may last up to 72 hours for pain relief during or after surgery.
Use 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 feeling of "emptiness 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 having 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 tremors, tremors, chills, seizures (seizure attacks), 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 bumpy 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 a doctor or other healthcare professional.

Other possible adverse reactions:
Very common (may affect more than 1 in 10 patients):

• low blood pressure (hypotension), which may cause dizziness or feeling faint,
• nausea.

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

• tingling or prickling sensations (paresthesia),
• dizziness,
• headache,
• slow or fast heartbeat (bradycardia, tachycardia),
• high blood pressure (hypertension),
• vomiting,
• difficulty passing urine (urinary retention),
• high body temperature (fever) or chills (shivering),
• 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 injection or when 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 feeling faint, numbness of lips and around the mouth,
numbness of the tongue, hearing disturbances, visual disturbances, speech difficulties,
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 available data):
• Horner’s syndrome.

Other possible adverse reactions:

• numbness caused by nerve irritation from needle insertion or injection, usually short-lived,
• involuntary muscle movements (dyskinesia).

Possible adverse reactions observed with other local anaesthetic medicines, 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 large a dose of 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 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 not listed in this leaflet, inform a doctor, pharmacist or other healthcare professional. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ropivacaine Kabi

No special storage instructions are required.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Do not use this medicine if any contamination of the injection 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. This will help protect the environment.

6. Contents of the pack and other information

What Ropivacaine Kabi contains

• The active substance is ropivacaine hydrochloride: 10 mg/ml. Each 10 ml polypropylene ampoule contains 100 mg of ropivacaine (as ropivacaine hydrochloride).
• Other components 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 solution for injection.
Ropivacaine Kabi is available in transparent PP ampoules in blisters with a capacity of 10 ml.
Pack sizes:
1, 5, or 10 ampoules per blister, all in a cardboard carton.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation 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
Relabelled and repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German Marketing Authorisation number, country of export: 78019.00.00
Parallel Import Authorisation number: 184/25
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Information intended exclusively for medical professionals:

Preparation for administration
Ropivacaine Kabi must 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 must be discarded.
The medicinal product should be visually inspected before use. The solution should only be used if it is clear, free from particulate matter, and the packaging is undamaged.
The packaging must not be re-sterilized in an autoclave.
Pharmaceutical incompatibilities
There are no compatibility studies; therefore, this medicinal product must not be mixed with other medicinal products.
Precipitation may occur in alkaline solutions, as ropivacaine exhibits low solubility at pH > 6.0.
Disposal of unused medicinal product or waste
Any unused residues of the medicinal product or waste materials must be disposed of in accordance with local regulations.