Land: Armenien
Sprache: Englisch
Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
levodopa, carbidopa
Apotex Inc.
N04BA02 վերարտադրված դեղ
levodopa, carbidopa
100mg+ 25mg
tablets
(100) in plastic container
Prescription
Registered
2017-10-23
IMPORTAN.I': PLEASE READ PART III: CONSUMER INFORMATION t'APo-LEvocARB Levodopa and Carbitlopa Tablets This leaflct is a summary nnd will not tell you everything about P' APO-LEVOCARB. Contact your doctor or pharmacist ifyou have any questions about the drug. Remember - This medicine is prescribed fol the particular condition that you have. Do not give this medicine to other people, nor use it for any other condition. APO-LEVOCARB is available only on prescription from your physician. What the medication is used for: Your physician has prescribed APO-LEVOCARB to treat the symptoms of Parkinson's disease. Parkinson's disease is a chronic disorder characterized by slow and unsteady movemenl, muscular stiffness, and trcmor. [l untreated, Parkinson's disease can cause difäculty in perlorming normal daily activities. What it does: APO-LEVOCARB is a combination ollevodopa, the metabolic precursor ofdopamine, and carbidopa, an aromatic amino acid decalboxylase inhibitor. It treats the symptoms of Parkinson's disease. It is believed that the syrnptoms of Parkinson's disease are caused by a lack of dopamine, a natulally occuring chemical produccd by ceftain brain cells. Dopamine has the role of relaying messages in cefiain regions ofthe brain that control muscle movement. Dilficulty in movement results when too little dopamine is producecl. Levoclopa acts to replenish dopamine in the blain, rvhile carbidopa ensurcs that enough levoclopa gets to the blain where it is neecied. In rnany patients, this reduces the symptolxs of Parkinson's disease. When it should not be used: Do not take APO-LEVOCARB: . are allergic to any ofits ingledients . have any suspicious skin lesions (moles) which have not been examined by your doctor or if you have cvel hacl skin cancer I ale being tleated with certain MAO inhibitor drugs, such as lor depression, within the last 2 rveeks . have narrow-angle glaucoma . have untreated heart, liver, kidney, lung, blood or holmonal disease r have been told that you should not take sympathomirnetic drugs Lesen Sie das vollständige Dokument
Appendix 1,9 1) Name of the Product: Apo-LEVocARB Tablets 1Omgi 100mg, 2bmg/100mg and 25mgl250mg (Carbidopa and Levodopa Tablets USp) 2'l Qualitative and Quantitative Formula .10.8 mg rbidopa US equals 10 mg of Carbidopa anhydrous 5 mg of Carbidopa an ydrous i|:t . J Ji. oIh Page I of 17 Apotex pofska $p. z o.o. Ul ûsirr.,brarnska g5, Û4-1ig Warszawa tei. 02231 12000, fax 022s1 i t0ò'ó- Nlp: t080016022 Component and Quality Standard (and Grade, if applicable) Function of Component Yo wlw of tablet Quantity per unit (mg/tablet) 10mg/100m9 Carbidopa USP (Micronized) Active 5.14 10.9' Levodopa USP Active 47.62 100.0 Microcrystalline Cellulose NF (PH101) Filler/Binder 24.9 52.2 Sorbitol NF Crystalline Fines Maintain alkaline pH 18.14 38,1 Croscarmellose Sodium NF Disintegrant 1.90 4.0 Magnesium Stearate NF Lubricant 1.90 4.0 lndigotine Al Lake 12-14o/o (Blu e#2) Dye 0.23 0.5 Brilliant Blue FCF At Lake 12% Dye 0.19 0.4 Total Tablet Weight 100.0 21A.0 Quant¡ty per unit (mg/tablet) Component and Quality Standard (and Grade, if applicable) Function of Component %wlw oÍ tablet 25mg/'t00mg Carbidopa USP (Micronized) Active 11.49 27.0* Levodopa USP Active 42.55 100.0 Microcrystalline Cellulose NF (PHl01) Filler/Binder 23.62 55.5 Sorbitol NF Crystalline Fines Maintain alkaline pH 17.02 40.0 Croscarmellose Sodium NF Disintegrant 1.70 4.0 Magnesium Stearate NF Lubricant 2,13 5.0 D&C Yellow # 10 Atuminum Lake 14- 18% Dye 1,49 Itr ' !: ,?',5,1 ;{- TotalTablet Weight 100.0 'ì 'í .2710 ¡ rt Ç "27 0 mg Carbidopa SP equals ol-,ç4 Component and Quality Standard (and Grade, if applicable) Function of Component o/o wlw of tablet Quantlty per unit (mg/tablet) 25mg/250m9 Carbidopa USP (Micronized) Active 5.24 27,4* Levodopa USP Active 48.07 250.0 Microcrystalline Cellulose NF (PH101) Filler/Binder 25.0 130.0 Sorbitol NF Crystalline Fines Maintain alkaline pH 18.09 94.1 Croscarmellose Sodium NF Disintegrant 1.92 10.0 Magnesium Stearate NF Lubricant 1.53 8.0 lndigotine Al Lake 12-14% (Blue#2) Dye 0.11 0.6 Brilliant Blue FCF AlLa Lesen Sie das vollständige Dokument