1. thuc tap huong dan ghi nhan thuoc
TRANSCRIPT
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7/26/2019 1. Thuc Tap Huong Dan Ghi Nhan Thuoc
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MT S QUY NH LIN QUAN N
VIC GHI NHN THUC
DS. NGUYN TH QUNH NGAKhoa Dc - H Y Dc TP.HCM
1
THC TP PHP CH DC
Bui 6
GHI NHN THUC
C bao nhiu ni dung ca nhn thnh phm
thuc thng thng?
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NI DUNG CA NHN THUC
Nhn thng thng
ND bt buc
ND khng bt buc
3
GHI NHN THUC
K tn cc ni dung bt buc trn nhn thnh phm
thuc thng thng?
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NI DUNG CA NHN THUC THNG THNG
1. Tn thuc
2. Hot cht, hm lng hoc nng
3. Quy cch ng gi
4. Ch nh, cch dng, chng ch nh
5. Dng bo ch, SK, hoc SGPNK, LSX, NSX, HD, KBQ
6. Cc du hiu lu
7. Tn v a ch ca t chc, c nhn chu trch nhim
8. Xut x ca thuc
9. Hng dn s dng thuc5
GHI NHN THUC
C my loi nhn c bit?
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NI DUNG CA NHN THUC
7
Nhn c bit
Nhn nguyn liu
Nhn trn v thuc
Nhn BB c kch thc nh
Nhn pha ch theo n
Nhn phc v mc tiu QG
NI DUNG CA NHN C BIT
NHN NGUYN LIU
- Tn nguyn liu
- Hm lng hoc nng (nu c)
- Tiu chun ca nguyn liu
- Khi lng tnh hoc th tch
- S l sn xut, ngy sn xut
- Hn dng, iu kin bo qun- S ng k (nu c)
- Tn, a ch c s sn xut, xut x ca thuc
Tn, a ch c s nhp khu (i vi nguyn liu nhp khu)
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NI DUNG CA NHN NGUYN LIU
CNG TY HA DC 5a ch: 1 Nguyn Vn A, TX. B, Tnh C
AMPICILLIN (DVN IV)99% C16H19N3O4S
1 kg
L SX :Ngy SX : KBQ :HD : SK :
9
11
GHI NHN THUC
Nu l nguyn liu thuc Gy nghin, hng tm thn v
tin cht dng lm thuc,
th nhn nguyn liu c g c bit?
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NI DUNG CA NHN NGUYN LIU
Gy nghin phi c ch GY NGHIN
Hng tm thn phi c ch HNG TM THN
Tin cht phi c ch TIN CHT DNG LM THUC
Cc ch GY NGHIN, HNG THN, TIN CHT DNG LM
THUC c in m trong khung trn ti gc trn bn phi ca nhn
thuc.
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NI DUNG CA NHN NGUYN LIU
CNG TY HA DCa ch: .......................
MORPHIN CLOHYDRAT (DVN IV)98% C17H19O3, N. HCl
1 kg
L SX :Ngy SX : KBQ :HD : SK :
GYNGHIN
12
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NI DUNG CA NHN NGUYN LIU
CNG TY HA DCa ch: .......................
EPHEDRIN CLOHYDRAT (DVN IV)98% C10H15ON. HCl
1 kg
L SX :Ngy SX : KBQ :HD : SK :
HNG
TM THN
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GHI NHN THUC
Nhn trn v thuc c nhng ni dung no?
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NI DUNG CA NHN C BIT
NHN TRN V THUC
- Tn thuc
- Hot cht, hm lng
Thuc dng phi hp 3 hot cht: ghi hot cht, hm
lng ca tng hot cht
- S l sn xut, hn dng
- Tn CSSX (vit tt bo m nhn din c tn CSSX)
2
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NI DUNG CA NHN C BIT
2
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NI DUNG CA NHN C BIT
2
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NI DUNG CA NHN C BIT
2
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NI DUNG CA NHN C BIT
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GHI NHN THUC
Nhn chai l thuc tim, ng tim, ng ung
c nhng im ging nhau v khc nhau nh th no?
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NI DUNG CA NHN C BIT
NHN TRN BAO B TRC TIP C KCH THC NH
Nhn chai l thuc tim, ng tim, ng ung
Ging : - Tn c s sn xut
- Tn thuc, hot cht, hm lng
- Th tch, khi lng
- SK, s LSX, HD
Khc :ng tim ng ung
Ghi ng dng Ghi dng ch
tb, tdd, tm Khng c tim
3
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NI DUNG CA NHN C BIT
NHN TRN BAO B TRC TIP C KCH THC NH
ng tim ng ung
Ghi ng dng Ghi dng ch
tb, tdd, tm Khng c tim
3
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GHI NHN THUC
Nhn thuc pha ch theo n v
Nhn thuc phc v chng trnh mc tiu y t quc gia
C im g c bit?
NI DUNG CA NHN C BIT
NHN THUC PHA CH THEO N
- Tn thuc, dng bo ch
- Hot cht, nng hoc hm lng
- Ngy pha ch, hn dng
- ng dng
- Tn bnh nhn
- Tn ngi pha ch
- Tn, a ch c s pha ch thuc.
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NI DUNG CA NHN C BIT
NHN THUC PHC V CHNG TRNH MC TIU Y T QG
C y ni dung bt buc theo qui nh + dng ch :
THUC CHNG TRNH KHNG C BN
5
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GHI NHN THUC
Cch vit SK, GPNK, S l SX, NSX, HD, KBQ
nh th no?
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NI DUNG CA NHN THNH PHM
Gm 6 mc
1/ S ng k ( SK : xx xxxx xx )
2/ S giy php nhp khu : ( GPNK : xxxx/QLD xx )
3/ S l sn xut (L SX : xxxx), do c s Q
4/ Ngy sn xut ( NSX : xx xx xx, hoc xx xx xxxx)
5/ Hn dng (HD)
Nu nhn ghi NSX v HD bng ting nc ngai th phi ghi
thm trn nhn ph l : NSX, HD xem Mfg Date Exp Date
6/ iu kin bo qun (KBQ)
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NI DUNG CA NHN THNH PHM
CC DU HIU CN LU
- Thuc k n phi ghi k hiu Rx gc bn tri ca tn thuc v dng
ch THUC BN THEO N
- Thuc tim phi ghi r ng dng ca thuc (tb, tdd, tm)
- Thuc nh mt, thuc tra mt ghi dng ch THUC TRA MT
- Thuc nh mi ghi dng ch THUC NH MI
- Thuc dng ngoi da ghi dng ch THUC DNG NGOI- Thuc ng ng ung ghi dng ch KHNG C TIM
- Trn nhn thuc phi ghi dng ch XA TM TAY TR EM, C
K HNG DN S DNG TRC KHI DNG
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NI DUNG CA NHN THNH PHM
CNG TY C PHN DC TW MEDIPHARCO-TENAMYD8 Nguyn Trng T, Tp.Hu, Vit Nam
MULTIVITAMIN10 V x 10 vin, vin nn di bao phim
Cng thc : L SX :Cng dng : Ngy SX :Cch dng : HD :
KBQ : SK :
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NI DUNG CA NHN THNH PHM
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NI DUNG CA NHN THNH PHM
CNG TY C PHN DC PHM OPC1017 Hng Bng, Phng 12, Qun 6, TP.HCM
Rx QADevirHp 3 v x 10 vin nn
Cng thc: L SX :Cng dng: Ngy SX :Cch dng: HD :
KBQ: SK :
THUC BN THEO N31
NI DUNG CA NHN THNH PHM
CNG TY C PHN DC PHM 3-210 Cng trng Quc t, Qun 1, TP.HCM
THUC TRA MT
NaCl 0,9%L 10ml
Cng thc: L SX:Cng dng: Ngy SX:Cch dng: HD:
KBQ: SK:
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NI DUNG CA NHN THNH PHM
X NGHIP DC PHM TRUNG NG 25120 Hai B Trng, Qun 1, TP.HCM
THUC NH MI
RHINEX 0.05%Chai 15ml
Cng thc : L SX :
Cng dng : Ngy SX :Cch dng : HD :KBQ : SK :
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XIN CHN THNH CM N
S THEO DI CA CC BN
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