Ropivacaine kabi

Package leaflet: Information for the user

Ropivacaine Kabi, 5 mg/ml, solution for injection
Ropivacaini hydrochloridum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.
­ Keep this leaflet, so that you can read it again if necessary.
­ If you have any further questions, please ask 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 name of the medicine referred to in this leaflet is: Ropivacaine Kabi, 5 mg/ml, solution for injection
In this leaflet, it is referred to as Ropivacaine Kabi.
Contents of the leaflet

1. What Ropivacaine Kabi is and what it is used for
2. What you need to know before being given Ropivacaine Kabi
3. How Ropivacaine Kabi is given
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, 5 mg/ml, solution for injection is used

• in adults and adolescents over 12 years of age for anaesthesia (numbing) of a part of the body during surgical procedures. It is injected into the lower part of the patient's spine. It helps to rapidly stop pain from the waist downwards for a limited period (usually 1 to 2 hours). This is known as spinal anaesthesia (subarachnoid block).
• in children from 1 to 12 years of age for anaesthesia (numbing) of specific parts of the body. It is used to prevent or relieve pain.

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 of the same drug class (such as lidocaine or bupivacaine);
• if the patient has reduced circulating blood volume (hypovolemia);
• by administration into a blood vessel for regional anaesthesia;
• by administration into the cervix 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 care must be taken not to inject Ropivacaine Kabi directly into a blood vessel, as this may cause immediate toxic effects.
Injections should not be performed at sites affected by inflammation.
Before starting treatment with Ropivacaine Kabi, discuss the following with a doctor, nurse, or other healthcare professional:

• if the patient is in a state of general 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 dose adjustment of Ropivacaine Kabi may be necessary.
  Injection into the lower part of the spine may cause low blood pressure or slowing of heart function. In such cases, the doctor will take appropriate measures.
  Before starting treatment with Ropivacaine Kabi, discuss the following with a doctor, nurse, or other healthcare professional:

• if the patient suffers from acute porphyria (disorders in the production of haem, the red pigment in blood, which may sometimes lead 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, tell the doctor about all previous illnesses and current health conditions.

Children
Particular caution is required in children:

• because the safety of administering Ropivacaine Kabi injections into the lower spine has not been established;
• in children under 1 year of age, because the safety of using Ropivacaine Kabi 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, has recently taken, or plans to take.
Ropivacaine Kabi may affect the action of certain medicines, and some medicines may 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.
  Avoid prolonged use of Ropivacaine Kabi when taking 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 during 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 tools or machinery until the following 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 dietary intake of sodium 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, body weight, age, and the patient's physical condition.
Ropivacaine Kabi will be given as an 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:

• injection into the lower part of the spine,
• injection near the part of the body to be anesthetized.

Administration of Ropivacaine Kabi in either of the above ways prevents nerves from transmitting pain signals to the brain. The patient will no longer feel pain, heat, or cold at the injection site, 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 purpose for which the medicine is used, as well as the patient's health status, age, and body weight.

Duration of treatment
Ropivacaine administration usually lasts from 2 to 6 hours in the case of anesthesia for certain surgical procedures. It is administered via injection into the lower part of the spine (intrathecal administration).

Use of a higher than recommended dose of Ropivacaine Kabi
Severe adverse effects 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 "hollow feeling" in the head,
• tingling,
• speech disturbances characterized by poor articulation (dysarthria),
• muscle stiffness, tremor, 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 effects, the doctor will immediately discontinue administration of Ropivacaine Kabi if any of the above symptoms occur. This means that if any of the above symptoms occur in the patient, or if the patient believes they have received a higher than recommended dose of Ropivacaine Kabi, the patient should immediately inform the doctor or another healthcare professional.

Severe adverse effects associated with administration of an excessive dose of Ropivacaine Kabi include speech disturbances, muscle tremors, tremor, chills, seizures (seizure attacks), and loss of consciousness. If any of the above symptoms occur in the patient, the doctor or another healthcare professional must be informed immediately.

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 faint. If the patient thinks that Ropivacaine Kabi is causing an allergic reaction, they should inform a doctor or other healthcare professional immediately. Other possible adverse reactions: 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. Common (may affect up to 1 in 10 patients):
• tingling and pricking 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 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 following 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 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 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 not lasting long,
• involuntary muscle movements (dyskinesia). Adverse reactions associated with the use of Ropivacaine Kabi administered into the lower spine may occur more frequently compared to other local anaesthetic procedures, regardless of the anaesthetic agent used. 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 spinal fluid, the entire body may become numb (anaesthetized),
• 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, 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). Ropivacaine Kabi should not be used as an injection into the lower spine in infants and children under 12 years of age. Reporting of adverse reactions If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should inform their doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
  Al. Jerozolimskie 181C
  02-222 Warsaw
  tel.: + 48 22 49 21 301
  faks: + 48 22 49 21 309
  website: https://smz.ezdrowie.gov.pl
  Adverse reactions can also be reported to the marketing authorization holder.
  By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Ropivacaine Kabi

This medicine does not require special storage conditions.
The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the blister, ampoule,
or cardboard box.
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 should 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 5 mg/ml. Each 10 ml polypropylene ampoule contains 50 mg of 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 5 mg/ml solution for injection is available in transparent polypropylene ampoules with a capacity of 10 ml. Pack sizes: 1, 5, or 10 ampoules in a PC/PE blister, all contained in a cardboard carton.

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 on 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 countries 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).
Period of validity after opening
Use immediately after opening.
Ropivacaine Kabi is for single use only.
Any unused solution must 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 container is undamaged.
The packaging must not be re-sterilized in an autoclave. If a sterile external surface is required, an intact blister pack should be used.
Pharmaceutical incompatibilities
There are no compatibility studies; therefore, this medicinal product should 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
Any unused portions of the medicinal product or waste materials must be disposed of in accordance with local regulations.