2 mg / ml solution for infusion .
What Ropivacaine Fresenius Kabi is and what it is used for
- Ropivacaine Fresenius Kabi contains the active substance ropivacaine hydrochloride.
- It belongs to a group of medicines called local anesthetics.
Ropivacaine Fresenius Kabi 2 mg/ml solution for infusion is used in adults and children of all ages for acute pain relief. It numbs parts of the body, e.g. after surgery.
Ropivacaine hydrochloride contained in Ropivacaine Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you get Ropivacaine Fresenius Kabi
You should not be given Ropivacaine Fresenius Kabi
- If you are allergic (hypersensitive) to ropivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6),
- If you are allergic to other local anesthetics within the same class (eg lidocaine or bupivacaine)
- if you have been told you have low blood volume ( hypovolemia ).
- in a blood vessel to numb a certain body part, or in the cervix to relieve labor pain.
Talk to your doctor before receiving Ropivacaine Fresenius Kabi if you are not sure if any of the above apply to you.
Warnings and cautions
Take special care to avoid injecting Ropivacaine Fresenius Kabi directly into a blood vessel to avoid direct toxic effects. The drug should not be administered in inflamed areas.
Tell your doctor, nurse, or other healthcare professional before giving you Ropivacaine Fresenius Kabi:
- if your general condition is bad due to age or other factors,
- if you have heart problems (partial or total AV block ),
- if you have severe liver problems,
- if you have severe kidney problems.
Tell your doctor if you have any of these problems as the dose of Ropivacaine Fresenius Kabi may need to be adjusted.
Tell your doctor, nurse, or other healthcare professional before giving you Ropivacaine Fresenius Kabi:
- if you suffer from acute porphyria (problems with the build-up of red blood pigments that in some cases cause neurological symptoms).
Tell your doctor if you or someone in your family suffers from porphyria as another anesthetic may need to be used.
Tell your doctor before treatment if you suffer from any diseases or medical conditions.
Special care must be taken:
- In newborns because they are more susceptible to Ropivacaine Fresenius Kabi 2 mg/ml solution for infusion.
- In children under 12 years of age, when injecting Ropivacaine Fresenius Kabi 2 mg/ml solution for infusion, a solution for numbing parts of the body has not been established in younger children.
Other medicines and Ropivacaine Fresenius Kabi
Tell your doctor or healthcare professional if you have recently taken, or might take any other medicines. This is because Ropivacaine Fresenius Kabi can affect the way some medicines work and some medicines can affect Ropivacaine Fresenius Kabi.
In particular, tell your doctor if you are taking any of the following medicines:
- Other local anesthetics
- Strong painkillers, e.g. morphine or codeine
- Drugs used to treat irregular heartbeats ( arrhythmia ), such as lidocaine and mexiletine.
Your doctor needs to know these medicines to be able to determine the right dose of Ropivacaine Fresenius Kabi for you.
Also, tell your doctor if you are taking any of the following medicines:
- Antidepressants (eg fluvoxamine)
- Antibiotics to treat infections caused by bacteria (such as enoxacin).
This is because your body will take longer to get rid of Ropivacaine Fresenius Kabi if you take these medicines. If you are taking any of these medicines, long-term use of Ropivacaine Fresenius Kabi should be avoided
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. It is not known whether ropivacaine has effects during pregnancy or is excreted in human milk.
Driving and using machines
Ropivacaine Fresenius Kabi may make you feel drowsy and may affect your ability to react. Do not drive or use any tools or machines until the day after you receive Ropivacaine Fresenius Kabi.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Ropivacaine Fresenius Kabi contains sodium chloride
This medicine contains 3.4 mg of sodium (the main ingredient in table salt/table salt) per ml. This corresponds to 0.17% of the recommended daily intake of sodium for adults.
How to use Ropivacaine Fresenius Kabi
Ropivacaine Fresenius Kabi will be given to you by a doctor. The dose that your doctor gives you depends on the type of pain relief you need. It also depends on your body size, age, and physical condition.
Ropivacaine Fresenius Kabi is given to you as an infusion. Which part of the body it should be used for depends on why you are getting Ropivacaine Fresenius Kabi. Your doctor will give you Ropivacaine Fresenius Kabi in one of the following places:
- The part of the body that needs to be anesthetized.
- Close to the part of the body that needs to be anesthetized.
- In an area away from the part of the body that needs to be anesthetized. This is the case if you are given an epidural infusion (in the area around the spine).
When Ropivacaine Fresenius Kabi is used in one of these places, the nerves are stopped from being able to send pain messages to the brain. It stops feelings of pain, heat, or cold in the area where it is used but you may still have other feelings such as pressure or touch.
Your doctor will know which place is the right one to give you this medicine.
Dose one depends on what the medicine is used for and also on your health, age, and weight.
Administration of ropivacaine normally lasts between 0.5 and 6 hours but can last for up to 72 hours for pain relief during or after surgery.
If you take more Ropivacaine Fresenius Kabi than you should;
Serious side effects are from ingesting too much Ropivacaine Fresenius Kabi needs special treatment and your doctor is trained to deal with these situations. The first signs if you have been given too much Ropivacaine Fresenius Kabi are usually the following
- hearing and vision problems,
- numbness of the lip, tongue, and around the mouth,
- dizziness and intoxication,
- speech disorders 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 side effects, your doctor will stop giving you Ropivacaine Fresenius Kabi as soon as these signs appear. This means that if any of these happen to you, or if you think you have been given too much Ropivacaine Fresenius Kabi, tell your doctor and healthcare professional immediately.
Serious side effects from giving too much Ropivacaine Fresenius Kabi include difficulty speaking, muscle twitching, tremors, tremors, seizures, and unconsciousness.
Talk to a doctor or healthcare professional if you notice any of the above symptoms.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects are to be aware of:
Sudden life-threatening allergic reactions (eg anaphylaxis ) are rare and may affect up to 1 in 1,000 people. Possible symptoms include
- sudden onset of rash,
- an itchy or lumpy rash (hives),
- swelling of the face, lips, tongue, or other parts of the body,
- shortness of breath, wheezing, or difficulty breathing.
If you think that Ropivacaine Fresenius Kabi gives you an allergic reaction, tell your doctor or healthcare professional immediately.
Other possible side effects:
Very common (may affect more than 1 user in 10)
- Low blood pressure ( hypotension ). This can make you feel dizzy and faint.
Common (may affect up to 1 in 10 people)
- Tingling and numbness ( paresthesia ),
- Slow or fast heartbeat ( bradycardia, tachycardia )
- High blood pressure ( hypertension )
- Difficulty urinating ( urinary retention )
- Fever or chills
- Back pain
Uncommon (may affect up to 1 in 100 people)
- Decreased sensitivity or sensation in the skin
- Breathing difficulties
- Low body temperature ( hypothermia )
- Some symptoms may occur if one injection was accidentally given into a blood vessel or if you have been given too much Ropivacaine Fresenius Kabi (see section 3 above, “If you have been given too much Ropivacaine Fresenius Kabi”). Symptoms include seizures (cramps), dizziness or intoxication, numbness in the lips and around the mouth, numbness in the tongue, hearing problems, vision problems, speech disorders, muscle stiffness, tremors
Rare (may affect up to 1 in 1,000 people)
- Heart attack (cardiac arrest)
- Uneven heart rhythm ( arrhythmia )
Other possible side effects include:
- Numbness due to nerve irritation caused by the needle or injection. This is usually not for a long time.
- Involuntary muscle movements ( dyskinesia ).
Possible side effects that have been observed with other local anesthetics and that can also be caused by Ropivacaine Fresenius Kabi include:
- Nerve damage. These can in rare cases (may occur in up to 1 in 1000 users) cause permanent discomfort.
- If too much Ropivacaine Fresenius Kabi is given in the spinal fluid, the whole body may be anesthetized.
In children, the side effects are the same as in adults, except for low blood pressure which occurs less frequently in children (may occur in up to 1 in 10 children), and vomiting which occurs more often in children (may occur in more than 1 in 10 children).
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
751 03 Uppsala
How to store Ropivacaine Fresenius Kabi
Keep out of sight and reach of children.
Ropivacaine Fresenius Kabi should be used before the expiry date which is stated on the sachet and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Do not use Ropivacaine Fresenius Kabi if a precipitate appears in the infusion solution.
Your doctor or hospital will normally store Ropivacaine Fresenius Kabi and will be responsible for the quality of the opened product that is not used immediately. They are also responsible for ensuring that unused Ropivacaine Fresenius Kabi is disposed of properly.
The medicine should not be disposed of via wastewater or household waste. The doctor, nurse, or pharmacist will take care of medicines that are no longer needed. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substance is ropivacaine 2 mg/ml. One 100 ml bag contains 200 mg of ropivacaine (in the form of hydrochloride). A 200 ml bag contains 400 mg of ropivacaine (in the form of hydrochloride).
- The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.
What the medicine looks like and the contents of the pack
Ropivacaine Fresenius Kabi solution for infusion is a clear, colorless solution for infusion.
Ropivacaine Fresenius Kabi 2 mg/ml solution for infusion is supplied in 100 ml and 200 ml transparent plastic bags.
1 bag with an outer bag
5 bags with outer bag
10 bags with outer bag
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Fresenius Kabi AB
751 74 Uppsala
Fresenius Kabi Norge AS
PO Box 430