50 microgram / ml injection solution 
fentanyl

What Fentanyl B. Braun is and what it is used for

Fentanyl B. Braun is a medicine used to prevent or relieve severe pain. It belongs to a group of medicines called opioid analgesics.

This medicine is used together with other medicines for pain relief or anesthesia in connection with different types of surgery.

It is also used in patients who receive mechanically assisted breathing in intensive care units.

Fentanyl contained in Fentanyl B Braun may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you get Fentanyl B. Braun

You should not be given Fentanyl B. Braun:

  • if you are allergic to fentanyl or any of the other medicines (called opioids ) or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Your doctor will take special care if you have impaired respiratory function or if you have a severe respiratory illness, e.g. severe asthma or severe bronchitis. In such cases, your breathing will be monitored.

Tell your doctor if you have ever abused or been addicted to opioids, alcohol, prescription drugs, or illegal drugs.

Repeated use of the medicine may make it less effective (you get used to it) or addicted to it.

If treatment is stopped, withdrawal symptoms may occur. Tell your doctor or nurse if you think this is happening to you (see also section 4. Possible side effects ).

Before and while treatment with Fentanyl B. Braun is given, your doctor will make sure that you have access to equipment for emergency care (including antidote) and resuscitation. The doctor will also pay attention to the following:

  • Your blood pressure may increase or decrease after the injection of fentanyl. You may need appropriate care to maintain normal and stable blood pressure.
  • Your heart rhythm can be fast or very slow (even cardiac arrest). If necessary, you can be given medication or appropriate care to restore or maintain normal heart function.
  • Your breathing should also be monitored. If respiratory depression occurs, you will receive adequate care to correct the condition. After the operation, your doctor will check that you are breathing normally and have steady breathing before leaving the recovery room.
  • Fentanyl can cause muscle stiffness (morphine-like effect). Muscle stiffness can also affect the muscles in the chest. Your doctor knows how to avoid muscle stiffness.
  • Your doctor will also be careful if you:- has a severe muscle disease called myasthenia gravis– has a stop or inflammation in the intestine- has brain damage or increased pressure in the skull

Your doctor will be especially careful when calculating the fentanyl dose and may monitor you for an extended period of time if you:

  • has impaired thyroid function
  • have lung disease or impaired respiratory function for other reasons
  • has an increase in the number of normal cells in the prostate (prostate enlargement)
  • have impaired liver or kidney function
  • previously treated with opioid s overtime or abused opioid s
  • suffering from alcoholism.

Children

The safety and efficacy of fentanyl in children under 2 years of age have not been established.

Other drugs and Fentanyl B. Braun

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

This is necessary because your doctor must check if the medicines you are taking are broken down by specific enzymes in your body or affect the function of these enzymes (cytochrome P 450 3A4).

Your doctor especially needs to know if you are taking any of the following:

  • certain medicines for the treatment of high blood pressure ( clonidine )
  • cimetidine (a medicine used to treat heartburn)
  • antiviral agents for the treatment of HIV (eg ritonavir)
  • sleeping pills and drugs that reduce the level of consciousness (sedatives)
  • phenytoin, carbamazepine, or valproate (medicines used to treat epilepsy )
  • drugs for the treatment of mental illness and depression (antidepressants, neuroleptics )
  • muscle relaxants
  • drugs for the treatment of fungal infections such as fluconazole or voriconazole
  • other anesthetics.

Fentanyl B. Braun with alcohol

If this medicine is given to you after you have drunk alcohol, the effect of both the medicine and the alcohol will be much stronger.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not be given this medicine during pregnancy or childbirth. You can be given the medicine after your baby is born and the umbilical cord is cut off.

As this medicine is excreted in human milk, you should refrain from breastfeeding for at least 24 hours after receiving the medicine.

Driving and using machines

Do not drive or use machines for some time after receiving this medicine. Your doctor will tell you when you can continue with activities of this kind. You need someone to accompany you home after discharge and you should avoid alcohol.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

Fentanyl B. Braun contains sodium

Fentanyl B. Braun contains 3.54 mg of sodium per milliliter. Your doctor will take this into account when administering larger doses (eg more than 6.5 ml which corresponds to more than 1 mmol sodium ) if you have been prescribed a low-salt diet.

3. How to use Fentanyl B. Braun

You will be given this medicine as an injection or infusion (ie through a needle or a small tube) into a vein. You can also be given this medicine as an injection into a muscle.

Fentanyl is only given by an experienced anesthetist in a hospital or other place where there is assisted breathing equipment.

Your doctor will give you the dose you need. Dosage one depends on the purpose of use as well as your age, weight, general condition, other diseases, and patient history.

If you take more Fentanyl B. Braun then you should

It is very unlikely that you will get an overdose, as only specially trained doctors will dose the medicine.

If you still get an overdose, this could lead to slow breathing or even respiratory arrest, or disturbing heart function or circulation. It can also cause seizures, unconsciousness, muscle stiffness (even in the pectoral muscles), and water in the lungs.

The treatment consists of adequate oxygen supply if necessary artificial ventilation, and the supply of special drugs that counteract the effect of fentanyl. If your blood volume is low, you may get fluid. You will be closely monitored during treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects can be serious. Contact a doctor immediately if you get any of the following side effects, so that the doctor can end the treatment:

Very common (may affect more than 1 user in 10):

  • increased pressure in the skull.

Common (may affect up to 1 in 10 people):

  • hypersensitivity s
  • depression of the central nervous system (impaired senses such as feeling sleepy or uncoordinated, blurred vision, slurred speech, or decreased awareness of the environment)
  • irregular heartbeats
  • short-term respiratory arrest
  • low blood pressure.

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

  • cramps
  • very slow heart rate
  • cramps in the larynx
  • difficulty breathing or even respiratory arrest.

Very rare (may affect up to 1 in 10,000 people):

  • spasm of the trachea
  • water in the lungs
  • breathing difficulties due to closure of the larynx.

Has been reported (occurs in an unknown number of users):

  • serotonergic syndrome (may be life-threatening)Signs of the serotonergic syndrome may include irritability, altered consciousness, confusion, hallucinations, coma, diarrhea, high body temperature, high blood pressure, excessive sweating, tremors, dilated pupils, increased reflexes, muscle twitching, tremors, muscle stiffness, coordination disorder, coordination disorder. nausea and increased heart rate.

Other side effects:

Very common (may affect more than 1 user in 10):

  • increased content of a hormone that reduces urinary excretion
  • drowsiness, drowsiness, dizziness
  • reduction of pupil one
  • dilation of blood vessels
  • cough at the beginning of treatment
  • vomiting, nausea
  • muscle stiffness (including the muscles of the chest) after high doses of fentanyl.

Common (may affect up to 1 in 10 people):

  • fast heartbeat
  • high blood pressure
  • slow heart rate
  • confusion
  • visual disturbances
  • restlessness
  • drop in blood pressure when standing or sitting up
  • slow or weak breathing after surgery
  • constipation
  • difficulty urinating
  • confusion after surgery.

Uncommon (may affect up to 1 in 100 people):

  • exhilaration.

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

  • too high a level of carbon dioxide in the blood.

Has been reported (occurs in an unknown number of users):

  • muscle twitching
  • habituation
  • intestinal obstruction
  • delirium (symptoms may include a combination of anxiety, restlessness, disorientation, confusion, fear, seeing and hearing things that do not exist, sleep disturbance, nightmares)
  • symptoms of withdrawal syndrome (may manifest as the following side effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating).

Additional side effects are in children

In children, movement disorders, increased sensitivity and withdrawal symptoms have been observed after long-term treatment.

5. How to store Fentanyl 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 label and carton after EXP. The expiration date is the last day of the specified month.

Keep the vial are in the outer carton. Sensitive to light.

6. Contents of the packaging and other information

Content declaration

  • The active substance is fentanyl (as fentanyl citrate).

1 ml solution for injection contains 50 micrograms of fentanyl

2 ml ampoule contains 100 micrograms of fentanyl

5 ml ampoule contains 250 micrograms fentanyl

10 ml ampoule contains 500 micrograms of fentanyl

  • Other ingredients are:
    • sodium chloride (see point 2)
    • water for injections

What the medicine looks like and the contents of the pack

Fentanyl B. Braun solution for injection is a clear, colorless aqueous solution.


Packaging: Fentanyl B. Braun is available in clear, colorless glass ampoules. 
Pack sizes: 10×2 ml, 10×5 ml and 10×10 ml.

Marketing Authorization Holder and Manufacturer

B. Braun Melsungen AG 
Carl-Braun Strasse 1 
34212 Melsungen 
Germany

Postal address: 
34209 Melsungen 
Germany

Local representative:

B. Braun Medical AB 
Box 110 
182 12 Danderyd

This medicinal product is authorized under the European Economic Area under the names:

Denmark Fentanyl “B. Braun” 50 micrograms / ml solution for injection
Luxembourg Fentanyl B. Braun 0.1 mg / 2 ml, injectable solution
Luxembourg Fentanyl B. Braun 0.25 mg / 5 ml, injectable solution
Luxembourg Fentanyl B. Braun 0.5 mg / 10 ml, injectable solution
Portugal Fentanilo B. Braun 0.1 mg injectable solution
Portugal Fentanilo B. Braun 0.25 mg injectable solution
Portugal Fentanilo B. Braun 0.5 mg injectable solution
Germany Fentanyl B. Braun 0.1 mg solution for injection
Germany Fentanyl B. Braun 0.25 mg solution for injection
Germany Fentanyl B. Braun 0.5 mg solution for injection

Muhammad Nadeem

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