देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
fentanyl, Quantity: 6.3 mg
Sandoz Pty Ltd
Fentanyl
Drug delivery system, transdermal
Excipient Ingredients: polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; 2,2'-azobisisobutyronitrile; 2-hydroxyethyl acrylate
Transdermal
5, 10, 7, 8, 3, 2, 4, 1
(S8) Controlled Drug
For the management of pain associated with cancer, palliative cancer and other conditions in patients where: - other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and - the pain is opioid-responsive, and - severe enough to require daily, continuous long term opioid treatment. Not for use in opioid-naive patients.
Visual Identification: Dull, homogenous, rectangular transdermal drug delivery system on release liner, imprint on backing foil 'fentanyl 37.5 microgram/h'; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-12-22
_Product Information Page 1 _ _Fentanyl Sandoz 12 / 25 / 37 / 50 / 75 / 100µg/h transdermal drug delivery system _ _04/2017 _ _Sandoz Pty Ltd _ _ _ _Version 08 _ _ _ PRODUCT INFORMATION FENTANYL SANDOZ ® 12 / 25 / 37 / 50 / 75 / 100ΜG/H TRANSDERMAL DRUG DELIVERY SYSTEM NAME OF THE MEDICINE _ _ _Generic name: _ Fentanyl _Chemical name: _ N-phenyl-N-[1-(2-phenylethyl)- 4-piperidinyl]propanamide _Chemical structure: _ CAS: 437-38-7 Empirical formula: C 22 H 28 N 2 O MW: 336.5g/mol DESCRIPTION _ _ Fentanyl is a derivative of 4-anilinopiperidine. Fentanyl is a white to off white solid which is slightly soluble in aqueous neutral and alkaline solutions but is readily soluble in acidic aqueous solutions and organic solvents. It has a pKa of 8.4 and a partition coefficient (n-octanol:aqueous buffer pH 11) log P of 3.94. Two polymorphic forms (I and II) have been identified for fentanyl, although polymorphic form II spontaneously converts to polymorphic form I. Fentanyl Sandoz is a fentanyl matrix transdermal drug delivery system (patch). It is a drug in adhesive formulation designed to release fentanyl continuously for 72 hours after application to intact skin. It is available in six different strengths delivering fentanyl 12, 25, 37, 50, 75 or 100 micrograms/hour to the systemic circulation. The amount of fentanyl released from each patch per hour is proportional to the surface area. The composition per unit area of all patches is identical. Fentanyl Sandoz is a transparent rounded oblong unit comprising a protective liner and two functional layers. From the outer surface to the surface adhering to skin, these layers include the following: a backing of polyethylene terephthalate (PET) film; a drug in adhesive reservoir, which contains fentanyl and acrylic-vinylacetate copolymer; an oversized protective liner of siliconised PET. Before use, the protective liner covering the adhesive layer is removed and discarded. _ _ _Product Information Page 2 _ _Fentanyl Sandoz 12 / 25 / 37 / 50 / 75 / 100µg/h transdermal drug del पूरा दस्तावेज़ पढ़ें