2 mg / ml solution for injection / infusion
ropivacaine hydrochloride
What Ropivacaine B. Braun is and what it is used for
The active substance is ropivacaine hydrochloride.
Ropivacaine B. Braun belongs to a group of medicines called local anesthetics.
Ropivacaine B. Braun is used in adults and children of all ages to relieve acute pain. It numbs parts of the body, e.g. after a surgical procedure.
Ropivacaine hydrochloride contained in Ropivacaine B. Braun may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask doctors, pharmacists, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you get Ropivacaine B. Braun
You should not be given Ropivacaine B. Braun
- if you are allergic to ropivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
- if you are allergic to other local anesthetics of the same class (eg lidocaine or bupivacaine).
- for injection into a blood vessel to numb a certain body partner for injection into the cervix to relieve labor pain.
- if you have been told you have low blood volume ( hypovolemia ).
If any of the above apply to you or you are not sure, talk to your doctor before giving Ropivacaine B. Braun.
Warnings and cautions
Talk to your doctor before giving Ropivacaine B. Braun:
- if you have heart, liver, or kidney problems. Your doctor may need to change the dose of Ropivacaine B. Braun.
- if you have found out that you suffer from a rare disease with disturbed production of blood pigments ( porphyria ) or if someone in your family suffers from it. Your doctor may need to give you another anesthetic.
- if your general condition is bad due to age or other factors.
- about any other illnesses or conditions that you have or have had in the past.
Children
The doctor will take special care:
- in newborns because newborns are more sensitive to ropivacaine
- in children, up to 12 years of age as certain ropivacaine injections given to numb parts of the body have not been established in younger children.
Your doctor will adjust the required dose carefully and monitor your child thoroughly.
Other drugs and Ropivacaine B. Braun
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
This is especially true of the following drugs, which may potentiate the effect of Ropivacaine B. Braun:
- other local anesthetics (eg lidocaine )
- strong painkillers (eg morphine)
- drugs for the treatment of irregular heartbeat (eg amiodarone, mexiletine).
Prolonged use of ropivacaine should be avoided if you are given:
- antidepressants (eg fluvoxamine)
- antibiotics for bacterial infections (eg enoxacin).
You may still be given Ropivacaine B. Braun. Your doctor needs to know about these medicines to adjust your dose.
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 is excreted in human milk or affects the breastfed infant.
Driving and using machines
Ropivacaine B. Braun may make you feel drowsy and may affect your ability to react. Do not drive, use tools or machines or work in dangerous conditions until the day after receiving this medicine.
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 B. Braun contains sodium
This medicine contains 3.3 mg sodium (the main ingredient in table salt/table salt) per ml.
This corresponds to 0.17% of the maximum recommended daily sodium intake for adults.
How Ropivacaine B. Braun is given
This medicine is given to you by or under the supervision of an experienced doctor. Ropivacaine B. Braun is given by injection or infusion. The injection site depends on why you are receiving the medicine. Injection one is given by your doctor in one of the following places:
- The part of the body to be anesthetized.
- Close to the part of the body to be anesthetized.
- Elsewhere in the part of the body to be anesthetized. This applies to epidural injections or infusions given in the middle or lower back near the spine.
The medical staff will closely monitor your condition when you receive Ropivacaine B. Braun. The drug prevents nerves from transmitting pain signals to the brain. This means that you cannot feel pain, heat, or cold in the places where the medicine is injected, but you can still feel pressure or touch.
Dosage
Your doctor will decide which dose of Ropivacaine B. Braun you will be given. Dose one depends on the type of pain relief you need and other factors, such as body size, age, and health.
If you are given too much Ropivacaine B. Braun
It is unlikely that you will be given too much or miss a dose as the medicine will be given by a doctor under carefully controlled conditions. Serious side effects are caused by an overdose of Ropivacaine B. Braun requires special care. The caring doctor is trained and prepared for these situations.
If you have been given too much Ropivacaine B. Braun, the first signs are usually: – dizziness or intoxication
numbness of the lips and around the mouth
numbness of the tongue
– hearing problems
– vision problem
The doctor will stop giving the medicine as soon as these symptoms appear to reduce the risk of serious side effects. Therefore, contact your doctor immediately if you get any of these symptoms, or if you think you have been given too much Ropivacaine B. Braun.
More serious side effects caused by an overdose of this medicine are speech disorders, muscle twitching, tremors, tremors, seizures (convulsions), and unconsciousness.
In case of acute toxicity, healthcare professionals take the necessary corrective measures immediately.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines, including Ropivacaine B. Braun, may in rare cases cause fatal allergic reactions (may affect up to 1 in 1,000 people). Talk to your doctor immediately if you get any of the following symptoms after receiving the medicine:
- sudden onset of rash, itching, or hives;
- swelling of the eyelids, face, lips, tongue, throat, or other parts of the body;
- difficulty breathing, sudden wheezing, dizziness.
Other possible side effects:
Very common (may affect more than 1 user in 10)
- low blood pressure ( hypotension ) (this may make you feel dizzy or faint)
- nausea
Common (may affect up to 1 in 10 people)
- tingling and numbness
- dizziness
- vomiting
- slow or fast heartbeat ( bradycardia, tachycardia )
- high blood pressure ( hypertension )
- high body temperature (fever) or tremors (chills)
- back pain
- headache
- difficulty urinating
Uncommon (may affect up to 1 in 100 people)
- concern
- fainting
- breathing difficulties
- low body temperature ( hypothermia )
- Some symptoms may occur if the injection is accidentally given into a blood vessel or if you have been given too much Ropivacaine B. Braun (see also the section, “If you are given too much Ropivacaine B. Braun” above). Symptoms include seizures, dizziness or intoxication, numbness in the lips and around the mouth, numbness in the tongue, hearing problems, vision problems, speech disorders, muscle stiffness, decreased sensation, and tremors.
Rare (may affect up to 1 in 1,000 people)
- heart attack (cardiac arrest)
- irregular heartbeat ( arrhythmia )
Has been reported (occurs in an unknown number of users):
- jerky movements ( dyskinesia )
Possible side effects that have been observed with other local anesthetics and that can also be caused by Ropivacaine B. Braun are:
- Nerve damage. These can in rare cases cause permanent discomfort.
- If too much Ropivacaine B. Braun is given in the spinal fluid, the whole body may be anesthetized.
Children
In infants and children, the side effects are the same as in adults, except for low blood pressure which occurs less frequently in infants and children (occurs in up to 1 in 10 children), and vomiting which occurs more often in children (occurs in more than 1 in 10 children).
How to store Ropivacaine B. Braun
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
Do not freeze.
Doctors or pharmacists are responsible for storing the medicine. They are also responsible for disposing of any unused medicine correctly.
Contents of the packaging and other information
Content declaration
The active substance is ropivacaine hydrochloride.
1 ml Ropivacaine B. Braun contains 2 mg ropivacaine hydrochloride (as ropivacaine hydrochloride monohydrate).
One 10 ml ampoule contains 20 mg of ropivacaine hydrochloride (as ropivacaine hydrochloride monohydrate).
One 20 ml ampoule contains 40 mg of ropivacaine hydrochloride (as ropivacaine hydrochloride monohydrate).
One 100 ml bottle contains 200 mg of ropivacaine hydrochloride (as ropivacaine hydrochloride monohydrate).
One 200 ml bottle contains 400 mg of ropivacaine hydrochloride (as ropivacaine hydrochloride monohydrate).
One 400 ml bottle contains 800 mg of ropivacaine hydrochloride (as ropivacaine hydrochloride monohydrate).
One 500 ml bottle contains 1000 mg of ropivacaine hydrochloride (as ropivacaine hydrochloride monohydrate).
The other ingredients are sodium chloride, hydrochloric acid 0.36% (for pH adjustment ) and sodium hydroxide 0.4% (for pH adjustment ), and water for injections.
What the medicine looks like and the contents of the pack
Ropivacaine B. Braun solution for injection or infusion is a clear, colorless solution provided as:
- 10 ml polyethylene ampoules in packs of 20 ampoules
- 20 ml polyethylene ampoules in packs of 20 ampoules
- 100 ml polyethylene bottles in packs of 1 and 10 bottles
- 200 ml polyethylene bottles in packs of 1 and 10 bottles
- 400 ml polyethylene bottles in packs of 1 and 10 bottles
- 500 ml polyethylene bottles in packs of 1 and 10 bottles
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
B. Braun Melsungen AG
34209 Melsungen
Germany
Manufacturer
B. Braun Melsungen AG, Berlin Manufacturing Plant
Mistelweg 2
12357 Berlin
Germany
or
B. Braun Medical SA
Carretera de Terrassa, 121
08191 Rubí (Barcelona), Spain
Further information on this medicine can be obtained from the representative of the marketing authorization holder:
B. Braun Medical AB
Box 110
182 12 Danderyd
This medicinal product is authorized under the European Economic Area under the names:
| Austria, Germany, Luxembourg: | Ropivacaine HCl B. Braun 2 mg/ml solution for injection or infusion |
| Belgium: | Ropivacaine HCl B. Braun 2 mg/ml solution for injection or infusion |
| Denmark: | Ropivacaine B. Braun |
| Estonia: | Ropivacaine B. Braun 2 mg / ml |
| Finland: | Ropivacaine B. Braun 2 mg / ml injection / infusion test, liuos |
| France: | Ropivacaine B Braun 2 mg / ml, injectable solution or for perfusion |
| Greece: | Ropivacaine HCI B. Braun 2 mg/ml solution for injection or infusion |
| Italy: | Ropivacaine B. Braun 2 mg/ml inoperable or infusion solution |
| Latvia: | Ropivacaine B. Braun 2 mg / ml intravenous injection / infusion |
| Lithuania: | Ropivacaine B. Braun 2 mg / ml injekcinis ar infuzinis tirpalas |
| Netherlands: | Ropivacaine HCl B. Braun 2 mg/ml, solution for injection or infusion |
| Portugal: | Ropivacaína B. Braun Braun 2 mg / ml, injectable solution or for perfusion |
| Spain: | Ropivacaine B.Braun 2 mg / ml injectable solution and for perfusion |
| Sweden: | Ropivacaine B. Braun 2 mg / ml solution for injection or infusion |