1mg powder for concentrate for solution for injection / infusion
remifentanil
What Remifentanil Reig Jofre is and what it is used for
Remifentanil Reig Jofre contains remifentanil, which belongs to a group of medicines called opioids, which are used for pain relief. Remifentanil Reig Jofre differs from other drugs in this group in that the effect comes very quickly and its effect is short-lived.
This medicine is used
– for pain relief before and during surgery,
– for pain relief when you are under mechanical breathing assistance in an intensive care unit (for patients aged 18 and over).
Remifentanil contained in Remifentanil Reig Jofre 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 Remifentanil Reig Jofre
You can not get Remifentanil Reig Jofre
– if you are allergic to remifentanil or any of the other ingredients of this medicine (listed in section 6),
– if you are allergic to other painkillers that are similar to fentanyl and that are related to the class of medicines called opioids,
– by injection into the spinal canal,
– as the only drug to initiate anesthesia.
Warnings and cautions
Before taking Remifentanil Reig Jofre, your doctor must tell you
– if you are allergic to any other opioid medications such as morphine or codeine,
– if you suffer from impaired lung function (you may be more sensitive to breathing difficulties),
– if you are over 65 years old, weakened, or have reduced blood volume and/or low blood pressure (you may be more susceptible to heart disorders).
If you are not sure if any of the above applies to you, talk to your doctor or nurse before receiving Remifentanil Reig Jofre.
Other medicines and Remifentanil Reig Jofre
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and (traditional) herbal and herbal medicines. This is because Remifentanil Reig Jofre and other medicines can interact and cause side effects.
You must tell your doctor or pharmacist if you are taking heart or blood pressure medications such as beta-blockers (this includes atenolol, metoprolol, carvedilol, propranolol, and bisoprolol) or calcium channel blockers (this includes amlodipine, diltiazem, and nifedipine).
Concomitant use of Remifentanil Reig Jofre with sedatives such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing ( respiratory depression ), and coma and can be life-threatening. Due to this, concomitant use should only be considered when no other treatment options are possible.
If your doctor still prescribes Remifentanil Reig Jofre at the same time as sedatives, your doctor should limit the dose and the duration of treatment.
Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends and family about paying attention to the signs and symptoms described above. Contact your doctor if you experience such symptoms.
Remifentanil Reig Jofre with food, drink, and alcohol
Once you have received Remifentanil Reig Jofre, do not drink alcohol until you have fully recovered.
Pregnancy, breastfeeding, and fertility
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.
Your doctor will weigh the benefit to you against the risk to your baby if you are given this medicine while you are pregnant.
You should not breastfeed your baby for 24 hours after receiving this medicine. Breast milk pumped out during these 24 hours should be discarded.
Driving and using machines
If you only stay in the hospital for one day, your doctor will tell you how long to wait before leaving the hospital or driving. It can be dangerous to drive a car soon after an operation.
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 Remifentanil Reig Jofre is given
You are never expected to give this medicine to yourself. It is always given to you by a person who has the training to do so.
Remifentanil can be given
-as a single injection into a friend,
-as a continuous infusion in a friend; this is when the medicine is slowly given to you for a long time.
Dosage
How you receive the medicine and the dose you receive depends on it
– the operation or treatment in the intensive care unit that you undergo,
– how bad you are.
Dose one varies from patient to patient. No dose adjustment is required for patients with kidney or liver problems.
After your surgery
Tell your doctor or nurse if you are in pain. If you are in pain after your surgery, they may give you other painkillers.
If you use more Remifentanil Reig Jofre than you should
The effects of Remifentanil Reig Jofre will be closely monitored during your surgery and in the intensive care unit and appropriate measures will be taken quickly if you get too much.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:
Allergic reactions including anaphylactic shock: These are rare (may affect up to 1 in 1,000 people) in people taking Remifentanil Reig Jofre. Signs of this include
– sudden wheezing and chest pain or difficulty breathing,
– swelling of the eyelids, face, lips, mouth or tongue,
raised and itchy rash or “hives” somewhere on the body,
– collapse.
If you notice any of these symptoms, contact your doctor immediately.
Very common (may affect more than 1 in 10 people)
– muscle stiffness,
– low blood pressure,
– feeling sick or nauseous.
Common side effects ( may affect up to 1 in 10 people )
– slow pulse,
– shallow breathing or paused breathing,
itching. _
Uncommon (may affect up to 1 in 100 people )
– lack of acid,
-constipation.
Rare (may affect up to 1 in 1,000 people)
– slow heart rate followed by cardiac arrest in patients receiving Remifentanil Reig Jofre in combination with one or more anesthetic medicines.
Unknown frequency (frequency can not be calculated from available data)
– the physical need for Remifentanil Reig Jofre (drug dependence) or need to increase dose one over time to achieve the same effect ( tolerance development ),
– seizures,
– a type of irregular heartbeat (atrioventricular block).
Side effect scars that you can get after your surgery
Usual
shaking,
– high blood pressure.
Uncommon side effects are
– pain.
Rare side effects
lethargy or fatigue.
Other side effects that occur mainly with rapid discontinuation of Remifentanil Reig Jofre treatment after prolonged administration for more than 3 days
– fast pulse ( tachycardia ),
– high blood pressure ( hypertension ),
restlessness ( agitation ).
How to store Remifentanil Reig Jofre
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 vial after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 25 ° C. After dilution, chemical and physical in-use stability has been demonstrated during use for 4 hours at 25 ° C.
From a microbiological perspective, the drug should be used immediately. If not used immediately, in-use storage times and conditions prior to administration are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ºC, unless reconstitution / dilution has been performed under controlled and validated aseptic conditions.
Do not use Remifentanil Reig Jofre if you notice that the preparation shows visible signs of deterioration after reconstitution.
The reconstituted solution should be used immediately.
Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will discard medicines that are no longer used. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
– The active substance is remifentanil hydrochloride
– The other ingredients are glycine and 37% hydrochloric acid (for PH adjustment)
After reconstitution as directed, each ml contains 1 mg remifentanil
What the medicine looks like and contents of the pack
Remifentanil Reig Jofre is a white or off-white powder for concentrate for solution for injection or infusion.
Each pack contains 5 vials.
Marketing Authorization Holder and Manufacturer
Manufacturer
Laboratory Reig Jofré, SA
C / Gran Capitán, 10
08970 Sant Joan Despí (Barcelona)
Spain
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Remifentanil Reig Jofre 1 mg powder for concentrate for solution for injection or infusion
Norway: Remifentanil Reig Jofre 1 mg powder for concentrate for solution for injection or infusion
Spanien: Remifentanilo Sala 1 mg powder for concentrate for injectable solution or EFG perfusion