ACTIQ Lozenges 600 Microgram
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
05-05-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
FENTANYL CITRATE
थमां उपलब्ध:
Cephalon UK Limited
डोज़:
600 Microgram
फार्मास्यूटिकल फॉर्म:
Lozenges
प्राधिकरण की तारीख:
2002-01-23
उत्पाद विशेषताएं
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actiq 600 micrograms compressed lozenge with integral oromucosal applicator.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One lozenge contains 600 micrograms fentanyl (as citrate).
Excipients(s):
Each lozenge contains dextrates (equivalent to approximately 2 grams of glucose), sucrose (approximately 30
milligrams confectioner’s sugar) and propylene glycol (part of the artificial berry flavour and imprinting ink) as
excipients.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Compressed lozenge with integral oromucosal applicator.
Actiq is formulated as a white to off-white compressed powder drug matrix attached using edible glue to a fracture
resistant radio opaque plastic applicator, marked with the dosage strength.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Actiq is indicated for the management of breakthrough pain in patients already receiving maintenance opioid therapy
for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of
otherwise controlled persistent pain.
Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least
25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral
hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In order to minimise the risks of opioid-related side-effects and to identify the “successful” dose, it is imperative that
patients be monitored closely by health professionals during the titration process. Any unused Actiq units that the
patient no longer requires must be disposed of properly. Patients must be reminded
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