Fentanyl 50 mcg. ml. 2 ml. 10 ampoules
Fentanyl contains fentanyl citrate. It is a narcotic analgesic that relieves pain and prevents its occurrence.
It is applied as an additional narcotic analgesic for local and general anesthetics; or as an anesthetic with oxygen in certain high-risk patients undergoing major surgery.
2. What you need to know before you are given Fentanyl
Do not use Fentanyl
If you are allergic to fentanyl citrate or any of the other ingredients of this medicine (listed in section 6);
If you are allergic to some other morphine derivatives;
In Caesarean section, before being withdrawn fetus from the uterus;
If you suffer from a disease which caused lower sensitivity of the respiratory center or increasing intracranial pressure.
Warnings and Precautions
Talk to your doctor or nurse before using this medicine:
if you have a deficiency of fluids (ie if you are dehydrated);
if you have severe liver or kidney disease;
in hypothyroidism (ie underactive thyroid gland);
if you are elderly or in a weakened condition due to health.
If you are under prolonged opioid therapy or have drug addicted, you may have a need for higher doses of fentanyl.
Other medicines, Fentanyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Data are insufficient application of fentanyl during pregnancy to determine possible damage to the fetus. However, the application of fentanyl in pregnant women requires a comparison between the benefits of the therapy is applied, the potential risk of fetal harm.
Ask your doctor before taking any medicine.
Fentanyl passes into breast milk, therefore breast-feeding is not recommended during the first 24 hours after administration of the drug.
Driving and using machines
Driving and using machines is prohibited within 24 hours after administration of the drug, as you may be less concentrated than usual.
Fentanyl contain sodium
This medicinal product contains 3,5 mg of sodium per milliliter. This must be taken into consideration by patients on a diet with a controlled intake of sodium.
3. How to apply Fentanyl
Fentanyl You should only be administered by healthcare professionals.
Fentanyl is a very strong narcotic analgesic that inhibits the functioning of the respiratory center even at very low doses of the drug. Therefore, Fentanyl should be used only in a hospital where an artificial breathing.
Fentanyl should not be used at home, i.e. outside the hospital.
If you take more dose of Fentanyl-Richter
It is unlikely you will be given more than the amount of Fentanyl-Richter. The application will be monitored during your surgery.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other narcotic derivatives may occur lower respiratory functions apnea (no breathing), muscle rigidity (including affecting the chest muscles), slow heart rate, myoclonus, bradycardia (transient) hypotension (drop in blood pressure) , nausea, vomiting and dizziness.
Other rare side effects may include laryngospasm, allergic reactions and asystole (cardiac arrest).
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.
5. How to store Fentanyl
Keep the ampoules in the original package in the outer carton.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
6. Contents of the pack and other information
The active substance is: 0,10 mg fentanyl (fentanyl) (0,157 mg as fentanyl citrate) in each vial of 2 ml.
The active substance is: 0,25 mg fentanyl (fentanyl) (as 0,3925 mg fentanyl citrate) in each ampoule of 5 ml.
The other ingredients are sodium chloride and water for injection.
Looks like Fentanyl and contents of the pack
Fentanyl solution for injection is colorless or slightly colored solution, clear and practically free from particles.
Volume of solution: 2 ml or 5 ml.
10 2 ml ampoules are placed in a plastic liner and are packaged in a folding carton.