1 mg, 2 mg, 5 mg powder for concentrate for injection/infusion solution
remifentanil
What Ultiva is and what it is used for
Ultiva contains remifentanil which belongs to a group of medicines called opioids, which are used for pain relief. Ultiva differs from other drugs in this group in that the effect comes very quickly and that its action is short-lived.
Ultiva is used:
- for pain relief before and during an operation
- for pain relief while on mechanical ventilation in an intensive care unit (for patients aged 18 and over).
Remifentanil may also be approved to treat other conditions not mentioned in this product information. 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 receive Ultiva
You cannot receive Ultiva:
- if you are allergic to remifentanil or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to fentanyl analogs (painkillers similar to fentanyl and related to the class of medicines called opioids )
- by injection into the spinal canal
- as the only drug to initiate anesthesia.
- If you are not sure if any of these apply to you, talk to your doctor, nurse, or pharmacist before you are given Ultiva.
Warnings and precautions
Before you receive this medicine, your doctor must know:
- if you are allergic to any other opioid medications such as morphine or codeine
- if you suffer from reduced lung function (you may be more sensitive to breathing difficulties)
- if you are over 65, debilitated, or have reduced blood volume and/or low blood pressure (you may be more susceptible to heart problems).
- If you are not sure if any of these apply to you, talk to your doctor or nurse before you are given Ultiva.
Before using remifentanil, tell your doctor if:
- You or someone else in your family has ever abused or been addicted to alcohol, prescription drugs, or illegal drugs.
- You are smoking.
- You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.
This medicine contains remifentanil, which is an opioid medicine. Repeated use of opioid pain relievers can cause the drug to become less effective (you get used to it). It can also lead to dependence and abuse, with the risk of life-threatening overdose. If you think you are becoming dependent on Ultiva, you must talk to your doctor.
Withdrawal reactions, including rapid heartbeat, high blood pressure, and restlessness, have occasionally been reported when treatment with this medicine is stopped suddenly, especially when treatment has been continued for more than three days (see also section 4. Possible side effects ). If you experience these symptoms, your doctor may reintroduce the drug and gradually reduce the dose.
Other medicines and Ultiva
Tell your doctor or pharmacist if you are taking, have recently taken, or may be taking other medicines, including herbal and non-prescription medicines. You must tell your doctor or pharmacist if you are taking any of the following medicines:
- heart or blood pressure medicines, such as beta-blockers or calcium channel blockers.
- medicines for the treatment of depression, such as selective serotonin reuptake inhibitors ( SSRIs ), serotonin-norepinephrine reuptake inhibitors ( SNRIs ), and monoamine oxidase inhibitors ( MAOIs ). It is not recommended to use these medicines at the same time as Ultiva because they can increase the risk of serotonin syndrome, a potentially life-threatening condition.
Concomitant use of Ultiva with sedatives or medicines for sleep problems, such as benzodiazepines or similar medicines, increases the risk of sleepiness, breathing difficulties ( respiratory depression ), and coma and can be life-threatening. Because of this, concomitant use should only be considered when no other treatment options are possible. Simultaneous use of opioids and drugs used to treat epilepsy, nerve pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, and respiratory depression and can be life-threatening.
If your doctor nevertheless prescribes Ultiva at the same time as sedative drugs, the doctor must limit the dose and the duration of treatment.
Tell your doctor if you are taking any sedative medication and carefully follow the doctor’s dosage recommendations. It may be helpful to inform friends and family to be aware of the signs and symptoms described above. Contact your doctor if you experience such symptoms.
Ultiva with alcohol
After receiving Ultiva, you should not drink alcohol until you have fully recovered.
Pregnancy and breastfeeding
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 using this medicine.
Your doctor will weigh the benefit to you against the risk to your baby if you receive this medicine while you are pregnant.
If you receive this medicine during labor or near delivery, it may affect your baby’s breathing. You and your child will be monitored for signs of severe sleepiness and difficulty breathing.
You should not breastfeed your child for 24 hours after receiving this medicine. Breast milk pumped out during these 24 hours must be discarded.
Driving ability and use of machinery
If you are only staying 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 soon after surgery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Ultiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is almost “sodium-free”.
How Ultiva is given
You are never expected to give this medicine yourself. It is always given to you by a person who has the training to do so.
Ultiva can be given:
- as a single injection into a vein
- as a continuous infusion into a vein. This is when the medicine is slowly given to you over a longer period.
How you receive the medicine and the dose you receive depends on:
- the surgery or intensive care unit treatment you are undergoing
- how hurt you are.
The dose varies from patient to patient. No dose adjustment is needed for patients with kidney or liver problems.
After your surgery
- Tell the doctor or nurse if you are in pain. If you are in pain after your surgery, they may give you other pain relievers.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions including anaphylactic shock: These are rare (may affect up to 1 in 1,000 people) in people taking Ultiva. Signs of this include:
- raised and itchy rash (hives)
- swelling of the face or mouth ( angioedema ) causing difficulty in breathing
- collapse.
- If you notice any of these symptoms, contact your doctor immediately.
Very common side effects are
These may occur in more than 1 in 10 people :
- muscle stiffness (muscle rigidity )
- low blood pressure ( hypotension )
- nausea and vomiting.
Common side effects are
These may occur in up to 1 in 10 people :
- slow heart rate ( bradycardia )
- shallow breathing ( respiratory depression )
- temporary cessation of breathing ( apnea )
- itching
- cough.
Less common side effects are
These may occur in up to 1 in 100 people :
- lack of oxygen ( hypoxia )
- constipation.
Rare side effects ar
These may occur in up to 1 in 1,000 people :
- slow heart rate ( bradycardia ) followed by cardiac arrest in patients receiving Ultiva in combination with one or more anesthetic drugs.
Other side effects ar
Other side effects have occurred in a very small number of people but their exact frequency is unknown:
- the physical need for Ultiva ( drug dependence ) or the need to increase the dose over time to achieve the same effect ( tolerance development )
- convulsions
- a type of irregular heart rhythm ( atrioventricular block ).
- irregular heart rhythm ( arrhythmia )
- Withdrawal syndrome (may cause the following side effects: increased heart rate, high blood pressure, restlessness or agitation, nausea, vomiting, diarrhea, anxiety, chills, shaking, and sweating)
Side effects you may experience after your surgery
Common side effects are
- tremors
- high blood pressure ( hypertension ).
Less common side effects are
- pain.
Rare side effects ar
- lethargy or tiredness.
Other side effects that mainly occur with rapid discontinuation of Ultiva treatment after prolonged administration for more than 3 days
- fast heart rate ( tachycardia )
- high blood pressure ( hypertension )
- restlessness ( agitation ).
How to store Ultiva
Keep this medicine out of sight and reach of children.
Use before the expiry date which is stated on the vial and carton after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25 ºC.
A ready-made solutions should be used immediately.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Store in the original packaging together with this leaflet.
Contents of the packaging and other information
Contents declaration
- The active substance is remifentanil hydrochloride.
- Other ingredients are glycine, hydrochloric acid (for pH adjustment), and sodium hydroxide (can be used for pH adjustment if necessary).
- After preparation according to prescription, each ml contains 1 mg of remifentanil.
Appearance and package sizes of the medicine
Ultiva is available in the following strengths:
- 1 mg Ultiva is a white to yellow-white lyophilized substance for intravenous use, in 3 ml vials.
- 2 mg Ultiva is a white to yellow-white lyophilized substance for intravenous use, in 5 ml vials.
- 5 mg Ultiva is a white to yellow-white lyophilized substance for intravenous use, in 10 ml vials.
The powder should be mixed with an appropriate diluent before intravenous use (see Information for Healthcare Professionals for further information). After mixing into a solution, Ultiva is clear and colorless. Each strength of Ultiva is supplied in packs of 5 vials.
Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland.
Phone: +46 856 642 572
Manufacturer
GlaxoSmithKline Manufacturing SpA
Strada Provinciale Asolana 90, 43056
San Polo di Torrile (Parma)
Italy
or
Aspen Pharma Ireland Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland