Cleaning of the nasal spray tip is required after each use. The main measures of effectiveness for the two studies were the change in pain intensity as measured on a pain scale and the number of patients who responded to treatment after ten minutes. Fentanyl should therefore be used with caution in patients with previous or pre-existing bradyarrhythmias.
This may reduce the efficacy of Instanyl. Fertility There are no human data on fertility available.
Instanyl is used in patients who are already using opioids a group of painkillers that includes morphine and fentanyl to control long-term cancer pain. Instanyl is intended for nasal use. It is a well-known substance, which has been used to control pain for many years. It is recommended that the patient sit or stand in upright position when administrating Instanyl.
Common cold The overall extent of fentanyl exposure in subjects with common cold without prior treatment with nasal vasoconstrictor is comparable to that in healthy subjects. Treatment with Instanyl should be started by and remain under the supervision of a doctor who has experience in the management of opioid treatment in cancer patients.
In another main study, patients were given increasing doses of Instanyl until the adequate dose for pain relief was reached. In the third study, patients who received Instanyl had faster pain relief than patients who received the comparator medicine.
Thus, it is not possible to definitively separate the effects of Instanyl alone. Dose increase should be done with caution.
Particular caution should be exercised when titrating Instanyl in elderly patients. Frequently, most of these will cease or decrease in intensity with continued use of the medicinal product. If serotonin syndrome is suspected, treatment with Instanyl should be discontinued. Because fentanyl has been in use for many years, the company presented data from scientific literature, as well as from studies that it had carried out. It is advised not to use fentanyl during labour and delivery including caesarean section because fentanyl passes through the placenta and may cause respiratory depression in the foetus.
Instanyl was more effective than placebo at treating breakthrough pain in cancer patients. Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.
The patient should be given Instanyl for a maximum of four episodes of breakthrough pain a day. If the product has not been used for a period of more than seven days, the nasal spray must be primed again by actuating once before the next dose is taken.
Maintenance therapy Once the dose has been established according to the steps described above, the patient should be maintained on this strength of Instanyl. The number of breakthrough pain episodes that responded to treatment was also higher among patients who received Instanyl than those who received placebo.
The potential risk for humans is unknown. Physicians should keep in mind the potential of abuse of fentanyl.
Titration to a higher dose necessitates contact with the health care professional. The adverse reactions considered to be at least possibly related to treatment in the clinical trials of Instanyl are included in the table below. The company that makes Instanyl will also provide educational materials in all Member States to be supplied to patients, doctors and pharmacists, to explain the correct and safe use of the medicine. The treatment for the persistent background pain should be kept as prescribed.
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