TIU LUN BO CH H v tn Nguyn Yn Nhi Lp BH7 MSV 1106025 Cu 1 Nhng im khc bit v tiu chun cht lng ca cc vin

nn c bit so vi vin nn quy c

Loi vin nn Yu cu chung ca thuc vin nn

Tiu chun cht lng r: DVN quy nh dng thit b ERWEKA hoc cc thit b tng t. Mi ln th 6 vin: khng c cn cn trn mt li ca a y, nu cn cn th ch l mt khi mm khng c nhn kh rn s thy c. Nu vin b dnh vo cc a, th lm li th nghim trn 6 vin khc nhng khng cho a vo ng. Mu th t yu cu nu 6 vin r ht. Mi trng th l nc ct 37oC 2oC (nu khng c ch dn trong chuyn lun ring). Vin nn khng bao phi r trong vng 15 pht. Vin bao bo v r trong vng 60 pht. Vin bao tan trong rut phi chu c mi trng HCl 0,1M trong 2 gi v phi r trong h m phosphat pH 6,8 trong vng 60 pht. Vin tan trong nc phi r trong vng 3 pht. Vin si bt r trong vng 5 pht (th trong cc c m cha 200ml nc ct 15 25oC). ng u khi lng Th vi 20 vin. lch cho php theo bng sau: Khi lng trung bnh ca vin lch t l phn trm Ti 80 mg 10 80 250mg 7,5 >250mg 5 Khng c qu hai vin c lch vt qu gii hn cho php v khng c c vin no gp i gii hn . Vin bao tan trong rut khng th ch tiu ny. ng u v hm lng p dng cho vin c hm lng dc cht t hn 2mg hoc t hn 2% khi lng vin. Th vi 10 vin, khng c c vin no nm ngoi gii hn 85 115% hm lng trung bnh. Nu c mt vin nm ngoi gii hn trn nhng nm trong gii hn 75 125% hm lng trung bnh th th li vi 20 vin khc. Thuc t yu cu nu trong 30 vin khng c qu 1 vin nm ngoi 85 115% v khng c vin no nm

Vin nn si

Vin nhai Vin ngm

ngoi 75 125% hm lng trung bnh. Vin tan trong nc khng th ng u hm lng. nh lng Th vi 10 20 vin theo chuyn lun ring, tnh hm lng hot cht trong mi vin theo khi lng trung bnh ca vin. Th nghim ha tan Thit b nh gi l my ha tan, theo UPS gm thit b kiu gi quay, kiu cnh khuy v kiu dng chy. Trc nghim ha tan p dng cho vin nn cha dc cht t tan. Vin th tan khng cn th r. Ngoi cc ch tiu k thut trn, mt s Dc in quy nh nh gi ng nht v ng knh vin. Phn ln cc tiu chun cht lng ca vin nn si c nh gi theo cc tiu chun chung ca vin nn khng bao. Ch c mt s ch tiu c trng nh sau: r: theo DVN II, tp 3: cho mt vin vo cc c m (th tch 250ml) cha 200ml nc ct 15oC 25oC, c xut hin nhiu bt kh bay ra. Vin c coi l r ht nu khng cn cc tiu phn chng cht ln nhau. Lm li th nghim vi 5 vin khc. Mu th t yu cu nu mi vin r trong 5 pht. Xc nh lng CO2 gii phng: tin hnh trong mt dng c ring theo nguyn tc: cho CO2 gii phng t vin tc dng vi dung dch bari hydroxyd 0,05 M. Sau nh lng bari hydroxyd bng dung dch acid oxalic. T tnh ra lng CO2 tham gia phn ng. Tiu chun cht lng nh vin nn thng quy. Khng th r C mi v d chu Ngoi nhng yu cu k thut chung ca thuc vin nn, vin ngm cn p ng yu cu c trng sau: r: vin khng r, gii phng dc cht t t, ko di, vin ngm khi dng ng ming t 30 60 pht, gii phng dc cht bng cch mi mn dn(ha tan dn t ngoi vo trong). Mt s Dc in quy nh thi gian r ca vin ngm l 4 gi. C mi v d chu, hn ch dng t dc khng tan khng gy cm gic sn v phn x nut r vin nn phi phn r trong 3 pht, th theo chuyn lun php th r ca vin nn v vin nang, c mi v d chu Nu khng c quy nh quy nh khc trong chuyn lun ring, thi gian r khng qu 30 pht, vin phi r nhanh trong mi trng t cht lng Khng c cn cn trong a kim loi khi th r, nu cn cn trong a kim loi ch ra khi mm, rng xp, khi dng a thy tinh chc vo th phi khng c nhn rn r vin nn phi phn r trong 3 pht, th theo chuyn lun php

Vin nn phn tn trong ming Vin nn t m o

Vin nn phn

tn khc Vin nn t di li Vin nn t khoang m Vin nn t trc trng

th ra ca vin nn v vin nang Thuc phi r nhanh trong 1-2 pht, dc cht phi l loi d tan, khi lng vin nh, dc cht phi l loi dng liu thp, khng kch ng nim mc v dng bt rt mn Vin phi r nhanh nhng chm hn so vi vin nn t di li v nhanh hn vin nn ng ung Vin phi r nhanh trong mi trng t cht lng, nu khng c quy nh quy nh khc trong chuyn lun ring, thi gian r khng qu 30 pht

Cu 2: Tm trn th trng mi loi bit dc tng ng vi mi loi vin nn c bit, t dc v cch s dng ca cc vin nn ny ng cha? 1. Vin nn si BIT DC : Dopagan-Effervescent 500mg THNH PHN : Mi vin nn si cha: - Paracetamol................500mg - T dc: Acid citric, Natri hydrocarbonat, Natri carbonat, Sorbitol, Mannitol, Povidon K 30, PEG 6000, Acesulfame K, Natri benzoat ...va 01 vin nn si Phn tch t dc: - T dc sinh kh + Acid: Acid citric + Carbonat: Natri hydrocarbonat, Natri carbonat - T dc dnh: Povidon K 30 - T dc n: Sorbitol, Mannitol - Cht to ngt: Acesulfame K, Sorbitol, Mannitol - Cht bo qun: Natri benzoat - T dc trn: PEG 6000 Cng thc bo ch trn la chn t dc hp l vi cng thc vin nn si vi t dc sinh kh, khi ha tan s to thnh kh CO2 lm cho vin r nhanh CCH DNG V LIU DNG: Dng ung. Ho tan vin thuc trong mt ly nc. Cc ln dng thuc nn cch nhau 4 gi. - Ngi ln : 1 - 2 vin/ln, 3 ln/ngy. Khng dng qu 6 vin/ngy. - Tr em: 60mg/kg/24 gi, chia lm 4 6 ln/ngy. Ch dng cho tr nng trn 13kg. Tng liu hng ngy khng vt qu 80mg/kg/ngy cho tr di 37kg. - Suy thn nng ( thanh thi creatinin di 10ml/pht): Cch khong cc ln dng thuc t nht 8 gi. Phn tch: - Ha tan vin thuc trong mt ly nc: hng dn cha c th, ha tan hon ton, cn ghi c th s ml nc cn thit ha tan, t nc qu khng m bo th tch ha tan, nhiu nc qu gy kh khn khi ung

- Cc ln dng thuc cch nhau 4 gi - 6 gi 2. Vin nhai BIT DC : CVS Antacid Chewable Tablets Assorted Fruit Hng sx: CVS Pharmacy THNH PHN Dc cht: Calcium Carbonate (750 mg). T dc: Adipic Acid, Blue 1, Corn Starch, Crospovidone, Dextrose, Flavors, Magnesium Stearate, Maltodextrin, Red 27, Red 30, Sucrose, Talc, Yellow 6, Yellow 10. Phn tch: - T dc n: Corn Starch - T dc siu r: Crospovidone - iu v: Adipic Acid, Dextrose, Maltodextrin, Sucrose - iu hng: Falvors - To mu: Red 27, Red 30, Yellow 6, Yellow 10 , Blue 1 - T dc trn: Magnesium Stearate, Talc C th khng s dng t dc siu r trong cng thc vin nhai v vin c r bng lc nhai c hc, c t dc iu v, iu hng che du mi v kh chu Hng dn s dng: Nhai trit 2-4 vin khi cc triu chng xy ra, lp li hng gi nu cc triu chng tr li hoc theo ch dn ca bc s. B sung canxi: nhai trit thuc hai ln mi ngy. Khng dng qu 10 vin trong vng 24 gi, hoc s dng liu lng ti a ca sn phm ny trong hn 2 tun, ngoi tr di s hng dn v gim st ca bc s. Bo qun nhit phng. Cch s dng ca dng vin nhai ny c hng dn chi tit. 3. Vin ngm BIT DC: Strepsils Original Nh sn xut : Strepsils THNH PHN Mi vin ngm cha: Hot cht: 2,4-Dichlorobenzyl Alcohol (dybenal) 1,2 mg, Amylmetacresol 0.6 mg. T dc: tinh du anit, tinh du bc h, menthol(di dng levomenthol), acid tartaric, ng tinh ch, glucose lng, ponceur 4R edicol, carmoisine edicol. Phn tch: - iu hng: tinh du anit, tinh du bc h, menthol(di dng levomenthol) - iu v: acid tartaric, ng tinh ch, glucose lng - T dc n: ng tinh ch, glucose lng - To mu: ponceur 4R edicol, carmoisine edicol. Trong cng thc ca vin ngm ny khng cn cha t dc r, c t dc iu v, iu hng che du mi v kh chu. Liu lng v cch dng: Ngm 1 vin tan chm trong ming cch khong 2-3 gi. Khng dng qu liu ch nh. Nu cc triu chng ko di, hi kin bc s. Hng dn s dng ng vi dng bo ch vin ngm.

4. Vin nn phn tn trong ming BIT DC Claritin RediTabs Indoor & Outdoor Allergies 12 Hour 5 mg THNH PHN Dc cht: Loratadine (5 mg). T dc: Citric Acid khan, Gelatin, Mannitol, Mint Flavor. Phn tch: T dc r Citric Acid khan iu v Citric Acid khan T dc dnh Gelatin T dc n Mannitol iu hng Mint Flavor. Khng thy c t dc r l cc polymer thn nc trong cng thc trong khi y l dng bo ch cn r nhanh trong ming, c ch r l do nc bt thm vo vo lm cc t dc r trng n. y ch thy citric acid khan c ha tan nhanh lm vin r nhanh HNG DN S DNG 1. Bc cnh bn ngoi. 2. Nh nhng y vin thuc ra. 3. t vin thuc trn li v ngm ming li. Vin thuc s tan r. t 1 vin trn li; vin thuc s tan r khi c hoc khng c nc. Ngi ln v tr em t 6 tui tr ln: 1 vin trong 12 gi, khng qu 2 vin trong 24 gi. Tr em di 6 nm tui: Hy hi bc s. Ngi dng c bnh gan hoc bnh thn: Hy hi bc s. Hng dn cch s dng vi dng vin nn phn tn trong ming ny rt y v chi tit 5. Vin nn t m o BIT DC Clomaz - Forte THNH PHN Hot cht : Mi vin nn t m o cha 500 mg Clotrimazol. T dc : Lactose, Avicel pH 101, natri lauryl sulfat, Croscarmellose natri, natri citrat dehydrat, acid citric khan, bt Talc, Magnesi stearat v nc ct. Phn tch: T dc trn Magnesium stearate, bt talc, Cht din hot natri lauryl sulfat, T dc n Lactose, Avicel pH 101 T dc siu r Croscarmellose natri

iu chnh pH natri citrat dehydrat, acid citric khan, Dung mi nc ct Cc t dc s dng hp l cho vin nn t m o, cn r nhanh trong mi trng t dch, iu chnh pH gim kch ng , kh nng thm tt nh cht din hot Cch s dng : 1. iu tr nhim nm ln u:mt t iu tr 3 ngy cho vim m o do nm Candida l . Vo 3 m lin tip, mi m t 1 vin su vo m o. 2. iu tr ti nhim hoc nhim nm hn hp:mt t iu tr 6 ngy l . iu tr ny cng p dng cho nhim nm hn hp vi cc loi nm ni trn. Vo 6 m lin tip, mi m t 1 vin nn su vo m o. Nu cn, mi ngy t 2 vin, mt vin bui sng, mt vin bui ti trong 6-12 ngy lin tc. t thuc tt nht, nn nm nga vi u gi hi co li. d phng ti nhim, bn tnh nn bi kem clotrimazol ti ch. Ghi ch: Nn iu tr v hon tt iu tr trc khi c kinh. Hng dn s dng r rng vi dng vin nn ny.

6. Vin nn phn tn BIT DC Hafixim 100 THNH PHN Cefixim 100 mg T dc va 1 vin (Kollidon CL-M, avicel, bt hng du, aspartam, mu vng tartrazin, aerosil, magnesi stearat). Phn tch: T dc siu r Kollidon CL-M T dc n: Avicel T dc trn aerosil, magnesi stearat iu hng bt hng du, To mu mu vng tartrazin iu v aspartam LIU DNG V CCH DNG: Hafixim 100 vin nn phn tn c dng ch yu cho tr em, vi liu ung trung bnh l 50 -100 mg x 2 ln/ ngy. Trong trng hp bnh nng c th tng liu gp i. Trnh dng cho tr em di 06 thng. Hoc theo ch dn ca Thy thuc. Cha ch r cch s dng, dng vi bao nhiu nc. 7. Vin nn t di li BIT DC ALFACHIM THNH PHN Cho mt n v ng gi nh nht: 1 vin: - Chymotrypsin 4,2 mg (Tng ng vi 4200 n v chymotrypsin USP v tng ng vi 21 katal)

- T dc va 1 vin (T dc gm: Tinh bt m, ng trng, talc, magnesi stearat). Phn tch: T dc n Tinh bt m, ng trng T dc trn talc, magnesi stearat T dc r Tinh bt m Vin ngm di li r theo c ch trng n ca tinh bt khi c thm nc bt, ngoi ra, ng trng d tan cng lm cho vin r nhanh Cch dng & liu dng: C th dng ng ung hoc ngm di li. - ng ung: Nut 2 vin / ln, 3 n 4 ln mi ngy. - Ngm di li: 4 n 6 vin mi ngy, chia lm nhiu ln (phi vin nn tan dn di li, khng c nhai b vin hay nut nguyn vin thuc). Hng dn s dng r rng. 8. Vin nn t khoang m BIT DC FENTORA THNH PHN Dc cht Fentanyl citrate T dc Mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate. Phn tch: T dc n Mannitol, sodium starch glycolate T dc r theo c ch sinh kh bicarbonate, sodium carbonate, citric acid T dc trn magnesium stearate. HNG DN S DNG Mt khi thuc c ly ra khi v, bnh nhn nn ngay lp tc t ton b vin FENTORA vo trong khoang ming (trn pha sau rng hm , gia m trn v li) hoc t ton b vin FENTORA di li. Bnh nhn khng nn chia nh vin. Vin FENTORA khng nn c nghin nt, ht, nhai hoc nut chng, v iu ny s dn n nng thp hn so vi khi dng theo ch dn. Vin FENTORA nn gia m v li hoc di li cho n khi n tan r hon ton, thng mt khong 14-25 pht. Sau 30 pht, nu vin FENTORA vn cn, bnh nhn c th c nut vi mt ly nc. Chng ti ngh bnh nhn t lun phin hai bn ming khi dng liu tip theo ca FENTORA trong khoang ming.

Hng dn s dng r rng, chi tit. 9. Vin nn t trc trng BIT DC PENTASA THNH PHN Dc cht mesalamine T dc acetylated monoglyceride, castor oil, colloidal silicon dioxide, ethylcellulose, hydroxypropyl methylcellulose, starch, stearic acid, bt ng, talc, white wax. Dch bao FD&C Blue #1, gelatin, titanium dioxide, v cc thnh phn khc Phn tch: T dc n bt ng, starch, T dc dnh ethylcellulose, hydroxypropyl methylcellulose, T dc trn colloidal silicon dioxide, talc, T dc thn du acetylated monoglyceride, castor oil, stearic acid, white wax. T dc to dch bao gelatin T dc to mu dch bao FD&C Blue #1 T dc cn quang dch bao titanium dioxide Liu lng v cch dng Thuc n: Vim lot i trng: Ngi ln: t trc trng 1 g (1 vin thuc n), 1-2 ln/ngy. Ch dn s dng: 1. Nn i tiu trc khi t vin thuc n. 2. M ti cha v nhm ch c du x. 3. Bc ngn tay t thuc bng mt trong nhng bao bo v ngn tay c sn trong hp thuc. Vin thuc n c t vo trc trng cho n khi cm thy c s khng li nu c ri bin mt. 4. d s dng, c th lm t vin thuc n bng nc hoc kem m. 5. Nu vin thuc n b y ra ngoi trong vng 10 pht u, c th t 1 vin khc. 6. Vt b v nhm v bao bo v ngn tay dng. Vin phng thch chm: Chung: Tr em: Khng khuyn dng cho tr em di 2 tui. Ti liu lm sng v vic iu tr cho tr em cn hn ch. Ch dng mesalazine cho tr em trong trng hp nh gi li ch d tnh vt hn nguy c c th c. Ngi cao tui: Khng cn gim liu. Bnh nhn suy thn: Xem phn Ch phng v thn trng lc dng. Vim lot i trng, bnh ang hot ng Ngi ln: Liu dng cho tng bnh nhn, ti a 4,5 g mesalazine/ngy, chia lm nhiu ln. Tr em trn 2 tui: Liu dng cho tng bnh nhi, liu thng thng l 20-30 mg mesalazine/kg th trng/ngy, chia lm nhiu ln. Vim lot i trng, iu tr duy tr

Ngi ln: Liu dng cho tng bnh nhn, liu khuyn co l ti a 2 g mesalazine/ngy, chia lm nhiu ln. Tr em trn 2 tui: Liu dng cho tng bnh nhi, liu thng thng l 20-30 mg mesalazine/kg th trng/ngy, chia lm nhiu ln. Bnh Crohn, bnh ang hot ng v iu tr duy tr Ngi ln: Liu dng cho tng bnh nhn, ti a 4,5 g mesalazine/ngy, chia lm nhiu ln. Tr em trn 2 tui: Liu dng cho tng bnh nhi, liu thng thng l 20-30 mg mesalazine/kg th trng/ngy, chia lm nhiu ln. Nn iu tr cch khc nu bnh nhn b bnh Crohn cp khng p ng vi 4 g mesalazine/ngy trong vng 6 tun v bnh nhn b bnh Crohn trong trng hp c cn bng pht bnh mc d iu tr duy tr bng 4 g mesalazine/ngy. Khng c nhai vin nn phng thch chm. d s dng, c th b vin nn hoc pha thnh hn dch trong nc hoc nc tri cy ngay trc khi dng. iu quan trng l dng cc liu u n t c hiu qu mong mun. Hn dch tht trc trng i vi bnh giai on cp tnh v phng nga ti pht: Ngi ln: Thng thng dng 1 l vo bui ti lc i ng. Bnh nhn nn i v sinh trc khi dng thuc tht trc trng - xem Ch dn s dng. Lc k l thuc trc khi dng. Hn dch tht trc trng c bo v bng mt ti nhm v nn s dng ngay sau khi m. Bnh nhn cao tui: Khng cn thit phi gim liu, tuy nhin nn c bit thn trng kim tra chc nng thn. i vi bnh nhn suy chc nng thn v/hoc suy chc nng gan, xem Chng ch nh v Ch phng v thn trng lc dng. Tr em: Khng nn dng Pentasa 1 g cho tr em v kinh nghim v liu dng tr em cn hn ch. CH DN S DNG Pentasa 1 g c bo v bng mt ti nhm m ch c tho b ngay trc khi s dng. 1. Nn i tiu trc khi dng thuc tht trc trng. 2. Tho b ti nhm. 3. Lc k l nha trc khi dng. 4. Vn np l mt vng. 5. t mt bn tay ca bn vo trong bao nha i km v nm gi l thuc. 6. Chun b t th dng hn dch tht trc trng, chng hn nm nghing bn tri. 7. Cn thn a u l vo trong trc trng v bp thuc ra t t. C th dng bng cch bp nhiu ln. 8. Ko u l ra trong khi vn cn bp l thuc. 9. Gi nguyn t th trn t 5 n 10 pht hay cho n khi s kch thch, nu c, bin mt. 10. Cun bao ln l thuc trc khi vt b. LU ! Tm tri ging v lt nn c bo v trong trng hp thuc ra ngoi,

v Pentasa 1 g c th lm bc mu vi. Nu iu xy ra th phi mang cc th ny i ngm ngay lp tc. Hng dn s dng r rng v chi tit.