Ropivacaine Kabi 10 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ropivacaine Kabi 10 mg/ml solution for injection EFG

Ropivacaine hydrochloride

Read this 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 side effects, talk to your doctor, nurse or any other healthcare professional, even if it is a side effect not listed in this leaflet. See section 4.

The name of this medicine is “Ropivacaine Kabi 10 mg/ml solution for injection EFG”, but throughout the rest of this leaflet it will be 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 you are 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 ropivacaine hydrochloride.

• It belongs to a group of medicines called local anaesthetics.

Ropivacaine Kabi 10 mg/ml solution for injection is indicated in adults and adolescents over 12 years of age to numb (anaesthetize) specific parts of the body during 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 components of this medicine (listed in section 6)
• if you are allergic to any other local anaesthetic of the same class (such as lidocaine or bupivacaine)
• if you have been diagnosed with reduced plasma volume (hypovolemia)
• directly into the bloodstream to numb a specific area of your body
• nor into the cervix to relieve pain during childbirth

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

Warnings and precautions

Special care must be taken to avoid any injection of Ropivacaine Kabi directly into the bloodstream in order 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 to you:

• 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 to you:

• 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 care must be taken:

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

Use of Ropivacaine Kabi with other medicines

Tell your doctor or healthcare professional about any other medicines you are taking, have recently taken, or might need to take. 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 (arrhythmias), 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 eliminates Ropivacaine Kabi more slowly when 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 might be pregnant, or are planning to become pregnant, consult your doctor before receiving this medicine.

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 2.8 mg of sodium (main component of table/cooking salt) per millilitre. This corresponds to 0.14% 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 doctor. The dose your doctor gives you will depend on the type of pain relief you need, as well as your size, age, and physical condition.

Ropivacaína Kabi will be 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 is the case when an epidural infusion (into the area near the spine) is given

When Ropivacaína Kabi is used in one of these ways, it prevents nerves from sending pain signals to the brain. It prevents you from feeling pain, heat, or cold in the treated area, but you may still experience other sensations such as pressure or touch.

Your doctor knows the correct way to administer this medicine.

Dosage

The dose used will depend on why the medicine is being given and on your health, age, and weight.

Duration of treatment

Administration of ropivacaine usually lasts between 2 and 10 hours in the case of anesthesia prior to certain surgical procedures, and up to 72 hours in the case of pain relief during and after surgery.

If you are given more Ropivacaína Kabi than you should

Serious adverse effects due to receiving more Ropivacaína Kabi than required require special treatment, and the doctor treating you is prepared to manage such situations.

The first signs that you have been given too much Ropivacaína Kabi are usually the following:

• Ear and vision (visual) problems
• Numbness of lips, tongue, and around the mouth
• Dizziness or mild lightheadedness
• Tingling
• 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. This means that if any of these symptoms occur, or if you think you may have received too much Ropivacaína Kabi, inform your doctor or healthcare professional immediately.

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

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

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 every 10,000 patients. Possible symptoms include:

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

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 every 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 cause interruption of 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 every 100 children), and general malaise, which occurs more frequently in children (affects more than 1 in 10).

Reporting of adverse effects:

If you experience any type of adverse effect, consult 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 Medicinal Products: 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 observe any precipitate in the injectable solution.

Normally, your doctor or hospital will store Ropivacaine Kabi and are responsible for maintaining the product quality once it has been 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 packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the container and additional information

Composition of Ropivacaine Kabi

• The active substance is ropivacaine hydrochloride 10 mg/ml. Each 10 ml polypropylene ampoule contains 100 mg of ropivacaine (hydrochloride).

Each 20 ml polypropylene ampoule contains 200 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 packaging

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

Ropivacaine Kabi 10 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 pack

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18

08005 Barcelona

Manufacturer

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

This medicinal product is authorized in the European Economic Area (EEA) Member States 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, clinicians experienced in regional anaesthesia (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-sterilized in an autoclave.

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

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