Ropivacaine Kabi 2 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ropivacaine Kabi 2 mg/ml solution for injection EFG

Ropivacaine hydrochloride

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, nurse, or any other healthcare professional.
• If you experience any adverse reactions, consult your doctor, nurse, or any other healthcare professional, even if they are adverse reactions not listed in this leaflet. See section 4.

The name of this medicine is “Ropivacaine Kabi 2 mg/ml solution for injection EFG”, but throughout the rest of this leaflet it will be 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 being given Ropivacaine Kabi
3. How Ropivacaine Kabi is used
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 ropivacaine hydrochloride
• It belongs to a group of medicines called local anesthetics

Ropivacaine Kabi 2 mg/ml solution for injection is indicated in adults and children of all ages for the treatment of acute pain. It numbs (anesthetizes) parts of the body, e.g., after surgery.

2. What you need to know before Ropivacaine Kabi is administered to you

Ropivacaine Kabi will not be administered to you if:

• you are allergic (hypersensitive) to ropivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
• you are allergic to any other local anaesthetic of the same class (such as lidocaine or bupivacaine)
• you have been diagnosed with reduced plasma volume (hypovolemia)
• it is to be injected directly into the bloodstream to numb a specific area of your body
• or into the cervix to relieve pain during childbirth

If you are unsure whether any of the above apply to you, consult your doctor before Ropivacaine Kabi is administered.

Warnings and precautions

Special care must be taken to avoid any injection of Ropivacaine Kabi directly into the bloodstream, to prevent any immediate toxic effects. It must not be injected into inflamed areas.

Inform your doctor, nurse, or any other healthcare professional before Ropivacaine Kabi is administered:

• if your general health condition is poor due to age or other factors
• if you have heart problems (complete or partial blockage of heart conduction)
• if you have severe liver disease
• if you have severe kidney problems

Inform your doctor if you have any of these conditions, as a dose adjustment of Ropivacaine Kabi may be necessary.

Inform your doctor, nurse, or any other healthcare professional before Ropivacaine Kabi is administered:

• if you have acute porphyria (a disorder affecting the production of blood pigment, which may sometimes cause neurological symptoms)

Inform your doctor if you or a family member has porphyria, as another anaesthetic may need to be used.

Tell your doctor about any medical condition or illness you have before starting treatment.

Children

Special caution is required:

• In newborns, as they are more susceptible to Ropivacaine Kabi 2 mg/ml injectable solution
• In children under 12 years of age, as certain injections of Ropivacaine Kabi 2 mg/ml injectable solution for numbing body parts have not yet been established

Use of Ropivacaine Kabi with other medicines

Tell your doctor or healthcare professional if you are taking, have recently taken, or might need to take any other medicines. This is because Ropivacaine Kabi may affect how some medicines work, and other medicines may affect Ropivacaine Kabi.

In particular, inform your doctor if you are taking any of the following medicines:

• Other local anaesthetics
• Strong painkillers, such as morphine or codeine
• Medicines used to treat irregular heartbeats (arrhythmia), such as lidocaine or mexiletine

Your doctor needs to know this in order to calculate the correct dose of Ropivacaine Kabi to administer.

Additionally, inform your doctor if you are taking any of the following medicines:

• Medicines for depression (such as fluvoxamine)
• Antibiotics used to treat bacterial infections (such as enoxacin)

This is because your body may take longer to eliminate Ropivacaine Kabi if you are taking these medicines. If you are taking any of these medicines, prolonged use of Ropivacaine Kabi should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before this medicine is administered.

It is unknown whether ropivacaine affects pregnancy or passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Ropivacaine Kabi may cause drowsiness and affect your reaction speed. Do not drive or operate tools or machinery after receiving Ropivacaine Kabi until the following day.

Ropivacaine Kabi contains sodium chloride.

This medicine contains 3.4 mg of sodium (the main component of table/cooking salt) per millilitre. This corresponds to 0.17% of the maximum daily recommended sodium intake for an adult.

3. How to use Ropivacaína Kabi

Ropivacaína Kabi will be administered to you by a physician. The dose your doctor gives you will depend on the type of pain relief you require, as well as your size, age, and physical condition.

Ropivacaína Kabi is given as an injection. The part of the body where it is administered will depend on why you are receiving Ropivacaína Kabi. Your doctor will administer Ropivacaína Kabi at one of the following sites:

• The part of the body that needs to be numbed
• Near the part of the body that needs to be numbed
• In an area away from the part of the body that needs to be numbed—this applies when an epidural infusion (into the space near the spinal cord) is given

When Ropivacaína Kabi is used in any of these ways, it prevents nerves from sending pain signals to the brain. It blocks your ability to feel pain, heat, or cold in the treated area, although you may still perceive other sensations such as pressure or touch.

Your doctor is trained in the proper method of administering this medicine.

Dosage

The dose used will depend on the purpose of treatment and your health status, age, and weight.

Duration of treatment

Administration of ropivacaine typically lasts between 2 and 10 hours when used for anesthesia prior to certain surgical procedures, and up to 72 hours when used for pain relief during and after surgery.

If you are given more Ropivacaína Kabi than you should

Serious adverse effects due to an overdose of Ropivacaína Kabi require special treatment, and your treating physician is prepared to manage such situations.

The first signs of having received too much Ropivacaína Kabi are usually the following:

• Hearing and vision problems
• Numbness of the lips, tongue, and around the mouth
• Dizziness or mild lightheadedness
• Tingling sensations
• Speech disturbances characterized by poor articulation (dysarthria)
• Muscle stiffness, muscle twitching, seizures
• Low blood pressure
• Slow or irregular heartbeat

These symptoms may precede cardiac arrest, respiratory arrest, or severe seizures.

To reduce the risk of serious adverse effects, your doctor will stop administering Ropivacaína Kabi as soon as these signs appear. Therefore, if you experience any of these symptoms, or think you may have received too much Ropivacaína Kabi, inform your doctor or healthcare personnel immediately.

More serious adverse effects from receiving too much Ropivacaína Kabi include speech difficulties, muscle stiffness, tremors, agitation, seizures, and loss of consciousness.

Inform your doctor or healthcare professional if you notice any of the symptoms listed above.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Important adverse effects to be aware of:

Sudden allergic reactions that may be life-threatening (such as anaphylaxis, including anaphylactic shock) are rare, affecting between 1 and 10 out of 10,000 patients. Possible symptoms include:

• sudden appearance of rashes,
• itching or irritation (urticaria),
• swelling of the face, lips, tongue, or other body parts,
• shortness of breath, difficulty breathing,
• feeling faint or losing consciousness.

If you think Ropivacaïne Kabi is causing you an allergic reaction, inform your doctor or healthcare professional immediately.

Other possible adverse effects:

Very common (may affect more than 1 in 10 people)

• Low blood pressure (hypotension). This may make you feel dizzy or lightheaded
• Nausea

Common (may affect up to 1 in 10 people)

• Tingling (paresthesia)
• Dizziness
• Headache
• Slow or fast heart rate (bradycardia, tachycardia)
• High blood pressure (hypertension)
• Vomiting
• Difficulty urinating (urinary retention)
• High body temperature (fever), trembling (chills)
• Muscle stiffness (rigor)
• Back pain

Uncommon (may affect up to 1 in 100 people)

• Anxiety

• Decreased skin sensitivity

• Fainting

• Difficulty breathing

• Low body temperature (hypothermia)

• Some symptoms may occur if the injection is accidentally administered into a blood vessel, or if too much Ropivacaïne Kabi has been given (see also section 3 “If you are given more Ropivacaïne Kabi than you should” above). These include seizures (fits), dizziness or lightheadedness, numbness of the lips and around the mouth, tongue numbness, hearing problems, vision problems, speech problems, muscle stiffness, and tremors.

Rare (may affect up to 1 in 1,000 people)

• Heart attack (cardiac arrest)
• Irregular heartbeat (cardiac arrhythmias)

Frequency not known (cannot be estimated from available data):

Horner’s syndrome

Other possible side effects include:

• Numbness due to nerve irritation caused by the needle or injection. This usually does not last long
• Involuntary muscle movements (dyskinesia)

Possible adverse effects observed with other local anesthetics that may also occur with Ropivacaïne Kabi include:

• Nerve damage. Rarely (affects between 1 and 10 out of 10,000 patients), this may cause permanent problems
• If Ropivacaïne Kabi is administered into the spinal fluid, the entire body may become numb (anesthetized)
• Receiving an epidural injection (injection into the space around the spinal nerves) may disrupt a nerve pathway from the brain to the head and neck, especially 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 lack of sweating from sweat glands. It will resolve on its own once treatment is stopped.

Children

In children, adverse effects are the same as in adults, except for low blood pressure, which occurs less frequently in children (affects between 1 and 10 out of 100 children), and general malaise, which occurs more often in children (affects more than 1 in 10).

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ropivacaine Kabi

This medicine does not require any special storage conditions.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, ampoule, or carton. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any precipitate in the injectable solution.

Normally, your doctor or hospital will store Ropivacaine Kabi and will be responsible for maintaining the product quality once opened, if it is not used immediately. They are also responsible for the proper disposal of any unused Ropivacaine Kabi.

Medicines must not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines or their packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ropivacaína Kabi

• The active substance is ropivacaine hydrochloride 2 mg/ml. Each 10 ml polypropylene ampoule contains 20 mg of ropivacaine (hydrochloride).

Each 20 ml polypropylene ampoule contains 40 mg of ropivacaine (hydrochloride).

• The excipients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

Appearance of the product and contents of the pack

Ropivacaína Kabi solution for injection is a clear, colourless solution for injection.

Ropivacaína Kabi 2 mg/ml solution for injection is available in clear polypropylene ampoules of 10 ml and 20 ml.

Pack sizes:

1, 5 and 10 ampoule(s)

1, 5 and 10 ampoule(s) in blister packs

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18

08005 Barcelona

Spain

Manufacturer

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

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

Date of the most recent review of this leaflet: November 2024

“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/”

This information is intended for healthcare professionals only:

Handling

Ropivacaine Kabi should only be used by, or under the supervision of, clinical personnel experienced in regional anesthesia (see section 3).

Validity period after opening

Use immediately.

Ropivacaine Kabi products are for single use only. Any unused solution should be discarded.

The medicine should be inspected visually before use. The solution should only be used if it is clear, practically free from particles, and if the container is undamaged.

Intact packaging must not be re-autoclaved.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Precipitation may occur in alkaline solutions, as ropivacaine has low solubility at pH > 6.0.

Disposal

Disposal of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.