1 mg / 2 mg / 5 mg powder for concentrate for solution for injection or infusion
remifentanil
What Remifentanil B. Braun is and what it is used for
Remifentanil B. Braun belongs to a group of medicines called opioids. It differs from other drugs in this group in that it has a rapid and short-term effect.
- Remifentanil B. Braun can be used to prevent you from feeling pain before and during surgery.
- Remifentanil B. Braun can be used to relieve pain when you receive mechanical breathing assistance in an intensive care unit (for patients aged 18 and over).
Remifentanil contained in Remifentanil B. Braun may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 use Remifentanil B. Braun
You should not receive Remifentanil B. Braun
- if you are allergic to remifentanil, any of the other ingredients of this medicine (listed in section 6.), or fentanyl derivatives (such as alfentanil, fentanyl, or sufentanil). An allergic reaction may manifest as rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue. You may recognize this from previous experience
- as an injection into the spinal canal
- as the only drug to initiate anesthesia
Warnings and cautions
Talk to your doctor before receiving Remifentanil B. Braun:
- if you have ever had any side effects during surgery
- if you have ever had an allergic reaction or have received information that you are allergic to:
- any medicine used during surgery
- opioid drugs (eg morphine, fentanyl, pethidine, codeine ), see also the section above “ You should not receive Remifentanil B. Braun ”
- if you suffer from impaired lung and/or liver function (you may be more susceptible to breathing difficulties).
Older
If the drug is used for surgery under general anesthesia, the initial dose of one of Remifentanil B. Braun should be reduced in elderly patients.
Elderly or weak patients (due to decreased blood volume and/or low blood pressure ) are more susceptible to cardiac or circulatory disorders.
Children
Remifentanil B. Braun is not recommended for newborns and infants (children under one year of age).
Experience in treating children with Remifentanil B. Braun in intensive care is limited.
Other medicines and Remifentanil B. Braun
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially important for the following medicines as they may affect or be affected by Remifentanil B. Braun:
- Medicines for blood pressure or heart problems (so-called beta-blockers or calcium channel blockers). These medicines can increase the effect of Remifentanil B. Braun on your heart (lowering blood pressure and heart rate ).
- Other sedatives such as benzodiazepines . Your doctor will change the dose of one of these medicines when you receive Remifentanil B. Braun.
It is still possible that Remifentanil B. Braun may be given to you and your doctor may decide what is right for you.
Remifentanil B. Braun with alcohol
Once you have received Remifentanil B. Braun, do not drink alcohol until you have fully recovered.
Pregnancy and breastfeeding
Remifentanil B. Braun should not be given to pregnant women unless medically justified.
Remifentanil B. Braun is not recommended during childbirth or cesarean section.
It is recommended that you stop breastfeeding for 24 hours after receiving Remifentanil B. Braun.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the possible risks and benefits of Remifentanil B. Braun if you are pregnant or breastfeeding.
Driving and using machines
This medicine is only given to patients who are hospitalized. If you are discharged early after receiving Remifentanil B. Braun, do not drive, use machines, or work in hazardous conditions. You should not go home alone.
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.
How to use Remifentanil B. Braun
This medicine should only be given under carefully controlled conditions and emergency equipment must be available. This medicine is given by or under the supervision of an experienced doctor who is well aware of how this type of medicine should be used and works.
You are never expected to give yourself this medicine. It is always given to you by a person who has qualified training to do this.
This medicine can only be given by injection or infusion directly into a vein. The time for injection/infusion must not be less than 30 seconds. This medicine must not be injected into the spinal canal (intrathecally or epidurally).
Dosage The dose
and length of the infusion is determined by your doctor and may vary depending on, for example, your body weight, age, physical condition, other medicines you are receiving, and what surgery you are going to undergo.
Dosage for adults:
For most patients, infusion rates of between 0.1 and 2 micrograms per kilogram body weight per minute are sufficient. The dose may be reduced or increased by your doctor depending on your condition and/or how you react.
Dosage in the elderly
If the drug is used for surgery under general anesthesia, the initial dose of Remifentanil B. Braun should be reduced in an appropriate manner for the elderly.
Dosage for children (1 to 12 years):
For most children, an infusion rate of between 0.05 and 1.3 micrograms per kilogram body weight per minute is sufficient to keep them anesthetized during surgery. Dose one can be adjusted by the doctor and can be as high as 3 micrograms per kilogram of body weight per minute.
Experience in treating children in intensive care with Remifentanil B. Braun is limited.
This medicine is not recommended for newborns and infants (children under one year of age).
Dosage for special patient groups
For severely overweight or seriously ill patients, the initial dose will be reduced or increased depending on how the patient responds.
For patients with hepatic or renal impairment and patients undergoing neurosurgery, a reduced dose is not necessary.
If you take more Remifentanil B. Braun than you should If you forgot to give Remifentanil B. Braun
Because Remifentanil B. Braun is usually given by a doctor or nurse under carefully controlled conditions, it is unlikely that you will receive too much or that you will miss a dose.
If you have been given too much of this medicine, or if you suspect that you have been given too much, appropriate action will be taken quickly by your healthcare team.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may be serious and require immediate medical attention.
Common (may affect up to 1 in 10 people)
- respiratory arrest ( apnea )
Rare (may affect up to 1 in 1,000 people)
- severe allergic reactions including shock, circulatory failure, and myocardial infarction in patients receiving remifentanil with one or more anesthetics
- slow heart rate followed by heart block in patients receiving remifentanil with one or more anesthetics.
No known frequency (can not be calculated from the available data)
- seizures
- heart block.
Other side effects:
Very common (may affect more than 1 user in 10)
- muscle stiffness
- nausea
- vomiting
- low blood pressure ( hypotension ).
Common (may affect up to 1 in 10 people)
- slow pulse ( bradycardia )
- shallow breathing ( respiratory depression )
- itching
- chills after surgery
- high blood pressure ( hypertension ) after surgery.
Uncommon (may affect up to 1 in 100 people)
- constipation
- pain after surgery
- hypoxia ( hypoxia )
Rare (may affect up to 1 in 1,000 people)
- drowsiness (during recovery after surgery)
No known frequency (can not be calculated from the available data)
- tolerance development
Discontinuation of treatment
In case of sudden discontinuation of remifentanil, rapid heart rate, high blood pressure, and agitation have been reported, especially after treatment lasting more than three days.
Like other medicines of this type ( opioids ), long-term use of Remifentanil B. Braun can lead to addiction. Ask your doctor for advice.
How to store Remifentanil B. Bran
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 after EXP. and on the label after Exp. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in a cold place. Do not freeze.
Do not use this medicine if the solution is not clear and particle-free or if the container is damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is remifentanil. One vial contains either 1 mg, 2 mg, or 5 mg remifentanil (as hydrochloride). After reconstitution as directed, each ml contains 1 mg of remifentanil.
- The other ingredients are glycine and hydrochloric acid.
What the medicine looks like and the contents of the pack
Remifentanil B. Braun is a white to off-white or yellowish powder for concentrate for solution for injection/infusion. It comes in colorless glass bottles.
Pack sizes :
Remifentanil B. Braun 1 mg powder for concentrate for solution for injection/infusion: 5 vials per pack
Remifentanil B. Braun 2 mg powder for concentrate for solution for injection/infusion: 5 vials per pack
Braifentanil B. powder for concentrate for solution for injection/infusion: 5 vials per pack
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
| B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany | Postal address: 34209 Melsungen |
Manufacturer
Hameln rds sro
Horná 36
900 01 Modra
Slovakia