Preferred products will be: Donepezil 5mg tab, Donepezil 10mg tab, Donepezil ODT, Rivastigmine cap/patch, Memantine tab Anti-Parkinson’s Agents Preferred products will be: Amantadine, Benztropine, Carbidopa/Levodopa IR, Carbidopa/Levodopa ER, Pramipexole IR, Ropinirole IR, Selegeline, Trihexyphenidyl tab/elixir Ophthalmic Allergy Agents The sticky side of the patch should not be touched. Neupro is applied once a day. Differences in bioavailability of rotigotine ranged from 2% (upper arm The apparent volume of distribution in humans is approximately 84 l/kg.Rotigotine is metabolised to a great extent. The patch should be pressed down firmly with the palm of the hand for about 30 seconds, so that it sticks well.Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.Magnetic resonance imaging or cardioversion (see section 4.4).If a Parkinson's disease patient is insufficiently controlled while on treatment with rotigotine switching to another dopamine agonist might provide additional benefit (see section 5.1)The backing layer of Neupro contains aluminium. <> Sudden onset of sleep during daily activities, in some cases without awareness of any warning signs, has been reported. This should be considered when prescribing rotigotine.Neupro contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people.Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as neuroleptics (e.g. The improved room temperature patch formulation showed better skin adhesion than the cold storage formulation with >90% of patches showing sufficient adhesion (i.e. The relevance of these findings to humans is not known.In a carcinogenicity study, male rats developed Leydig cell tumours and hyperplasia.
Then, the patch is fold back and the second part of the release liner is removed. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> �������H�m��ع,�*��2�AgI���T��� Ϣ�w���Fy�H��\�*`.���@�7˴���,e��"OY�P~�{�уGͱ#����@��?��?^'/�;���Ǜ��5�S q�YE|�lmz�RT�+)",���,�/],�K� ����B��X��z5'dv�o7��6�) (g�]?�G�{�qĕ,EZ(��Ƚ�y��O��*�"�Ă�Ի�J�_�u����$;1F��t�a9��!+��� ���rtfD�� �/��4#i1� The potential risk for humans is unknown. Each patch of 20 cmEach patch releases 6 mg of rotigotine per 24 hours. guanfacine ER (PA), methylphenidate, modafanil One half of the release liner should be removed and the sticky side should be applied and pressed firmly to the skin. The majority of application site reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of treatment with Neupro in only 4.3% of all subjects receiving Neupro.The following table covers adverse drug reactions from the pooled studies mentioned above in patients with Parkinson's disease and from post-marketing experience. For most patients an effective dose is reached within 3 to 7 weeks at doses of 8 mg/24 h up to a maximum dose of 16 mg/24 h.For doses higher than 8 mg/24 h multiple patches may be used to achieve the final dose e.g. Rotigotine did not influence male fertility in rats, but clearly reduced female fertility in rats and mice, because of the effects on prolactin levels which are particularly significant in rodents.Rotigotine did not induce gene mutations in the Ames test, but did show effects in the colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, pigment yellow 95, pigment black 7).Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, Peel off sachet in a plastic box: One side is composed of an ethylene copolymer (innermost layer), an aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene (innermost layer), aluminium, ethylene copolymer and paper.The box contains 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, individually sealed in sachets.After use the patch still contains active substance.
phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of Neupro, and co-administration should be avoided. This site uses cookies. 3 0 obj Efficacy was determined by the subject's response to therapy in terms of responder and absolute points improvement in the scores of ADL and Motor Examination combined (UPDRS part II+III).At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i.e. The patient should be monitored closely, including heart rate, heart rhythm and blood pressure.
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