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1. 3
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3. 5
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5. 16
6. 17
7. 71
-3-

13 ( 39

Extended Label)
6x9
21

Patient Information Leaflet PIL) A4


-4-

back

1
-5-

back

1.
( 1)
1.1

1
1.2 mg ml

1.3

1.4 ED NED (essential drug non-essential drug

2.
( ( 1
generic name)
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2)

3.

1.2 1.3
3.1
1 2
1 5 5 ( 1
3.2
2.5, 3, 3.5 4 ( )
½, 2/3 ¾
4.

4.1 prn 2)

1
4.2
3)
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5.
5.1

5.2
4) metformin
amlodipine
amlodipine 1 1

6.

6.1 prn
1 2)
-8-

6.2 lactam antibiotic amoxicillin


time dependent
around the clock) 2
2 12
3)
7.
default

5)
7.1 500 ) default 1 6
default 20 10 14

7.2 domperidone 10 ) default


7
7.3 colchicines (0.6 ) acute attack
prophylaxis) default
3
7.4 amoxicillin (500 ) GAS pharyngitis/tonsillitis
10 rheumatic fever/heart disease default
10
5 default
-9-

8. (

8.1
flunarizine cinnarizine
6)

6 cinnarizine
flunarizine

8.2
7)

beta-blocker

ACE inhibitor 8)

7
- 10 -

8.3 metformin

metformin hypoglycemia
7)

8.4 atenolol

8.5

hydrochlorothiazide
antibiotics 5)
8.6
10 11
- 11 -

10

11
Hydrochlorothiazide (HCTZ)

8.7

12)
12
- 12 -

9.

1 2
1

QUM in Thai Elderly


1

8
5
(
, ,
prn

acute attack

10.
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1)
- 14 -

back

extended label)

patient information leaflet PIL

1.

2. 6x9
3. TH SarabunPSK 16 0.95 pt
15
4.
4.1

4.2

4.3

4.4 1
- 15 -

4.5

4.6

4.7

atenolol

1.

2.
- 16 -

back

Patient Information Leaflet - PIL) electronic /

*
Leaflet: PIL)

6
( )
1.
1.1
1.2
1.3 ( )
2.
2.1
2.2
3.
3.1
3.2
3.3
4.
5.
5.1
5.2
6.

*
http://drug.fda.moph.go.th/zone_law/files/d pdf
Click 500
- 17 -

back

1. Paracetamol End of Menu


1.1 Paracetamol tablet (500 mg) (1
1.2 Paracetamol tablet (325 mg) (1
1.3 Paracetamol 120 mg/5 ml syrup/suspension (1
1.4 Paracetamol 250 mg/5 ml syrup/suspension (1
1.5 Paracetamol drop (1
1.6 (2
2. Paracetamol combination
2.1 Paracetamol + Orphenadrine (1
2.1.1 (1
2.2 Paracetamol + Tramadol prn use continuouse use (2
2.2.1 (1
2.3 Paracetamol + Codeine prn use continuous use (2
2.3.1 (1
3. Ibuprofen NSAIDs)
3.1 Ibuprofen tablet prn use continuous use (2
3.2 Ibuprofen syrup (1
3.3 (2

(RDU Label)
- 18 -

4. Cetirizine (non-sedative antihistamines)


4.1 Cetirizine tablet prn use continuous use (2
4.2 Cetirizine syrup prn use continuous use (2
4.3 (1
5. Amoxicillin (Antibiotics)
5.1 Amoxicillin 500 mg GAS pharyngitis (1
5.1.1 (1
5.2 Amoxicillin 500 mg Acute Bacterial Rhinosinusitis (1
5.2.1 (1
5.3 Amoxicillin syrup 125 mg/5 ml 250 mg/5 ml (2
5.3.1 (1
5.4
6. Domperidone
6.1 Domperidone tablet (1
6.2 Domperidone suspension (1
6.3 (2
7. Enalapril (ACE Inhibitors)
7.1 Enalapril 5 20 mg (2
7.2 (1
8. Amlodipine (Calcium Channel Blockers)

(RDU Label)
- 19 -

8.1 Amlodipine 5 10 mg (2
8.2 (1
9. Metformin
9.1 Metformin 500 mg 850 mg (2
9.2 (1
10. Sulfonylurea
10.1 Glibenclamide 2.5 5 mg (2
10.2 Glipizide 5 mg (1
10.3 (1
11. Simvastatin (Statins)
11.1 Simvastatin 10, 20 40 mg (3
11.2 (1
12. Colchicine
12.1 For acute gout attack (1
12.2 For gout prophylaxis/maintenance dose (1
12.3 (1
13. Allopurinol
13.1 Allopurinol 100 300 mg (2
13.2 (1

Top of Menu

(RDU Label)
- 20 -

Paracetamol 500 mg tablet back

. 5/12/2557
CETAMOL (PARACETAMOL) 500 10
1
6

500
8

. 5/12/2557
PARACETAMOL 500 10
1
6
( comment#7)
500
8
Comment
1. default 2 4-6 4
2 4

(RDU Label)
- 21 -

2. default 2 1
2
3. 6
4-6 4
4. default 6 1 2
4 8 Tylenol USA
2011 500 2 6
Tylenol USA 6
Tylenol Extra Strength 500 /

5. default 20 10
1 2 20
6.

8 12

7. PTC
1
1
1 6

(RDU Label)
- 22 -

Paracetamol 325 mg tablet back

/ 5/12/2557
CEMOL (PARACETAMOL) 325 15
1 2
4

325
5
Comment
1. default 1 2

2. default 4 2
4 2 4 = 3,900 /
3. 5 ( 10 TYLENOL® Dosage for
Adults Tylenol USA website LexiComp Drug Database
http://www.tylenol.com/safety-dosing/usage/dosage-for-adults

(RDU Label)
- 23 -

4. 325

5. 325 regular strength)


500 extra strength)

6. 325 2
500 1 -
325 2

7. 325 2 43.3

500 2 66.7
8. The Acetaminophen Hepatotoxicity Working Group. Center for Drug Evaluation and
Resarch. Food and Drug Administration. Department of Health and Human Services.
February 26, 2008 500 325
650 3,250

http://www.fda.gov/downloads/UCM pdf

(RDU Label)
- 24 -

Paracetamol 120 mg/5 ml syrup back

/ 5/12/2557
CETTA (PARACETAMOL) SYRUP 120 /5 1
1 (5 5
4

120 5
5

Paracetamol 250 mg/5 ml syrup back

/ 5/12/2557
SARA (PARACETAMOL) SYRUP 250 /5 1
1 (5 5
4

250 5
5
Comment
1. 10-15 / / 1,000 75
/ /24
2. 1 5 5

(RDU Label)
- 25 -

Paracetamol Drop 100 mg/ml 0.6 mg/0.6 ml) back

./ 05/12/2557
KIT DROP ( ) 100 /1 1
1 1
4

100 1
5
Comment
1.
4
Paracetamol drop ( ) 500 mg/5 ml Paracetamol syrup
( ) 120 mg/5ml
2.
ml.
3. 2012

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gui
dances/UCM pdf

(RDU Label)
- 26 -

back

1.

2. 15
1,000 /
4,000 24
3.

4.
10

1.

2. 15
1,000 /
75 24
4,000 /24
3.

4.
5

(RDU Label)
- 27 -

Paracetamol + Orphenadrine back

. 5/12/2557
paracetamol + orphenadrine (450+ 35 ) 10
1
6 3

Comment
1.
2.

3. default 1
US FDA 325

4. US FDA
325

325
325

http://www.fda.gov/Drugs/DrugSafety/ucm394916.htm
5.

6.
a.

(RDU Label)
- 28 -

b. general purpose)

c. Beers Criteria
7. orphenadrine Occasionally useful for
musculoskeletal pain

+ back

+
1. -
-

2.

-
Beers Criteria
3.

sedation)
4. anti-cholinergic effect

(RDU Label)
- 29 -

Paracetamol + Tramadol prn use back

. 5/12/2557
ULTRACET 325+37.5 15
1
6

default IT
Paracetamol + Tramadol continuous use back

. 5/12/2557
ULTRACET 325+37.5 15
1
3

Comment
1.

(RDU Label)
- 30 -

2.

3.
a.
b. paracetamol + tramadol 6
1 3
c. pain score

d.

e.

f. NSAIDs 2
g. adjuvant therapy
neuropathic pain, bone pain, visceral pain musculoskeletal
pain

+ back

+
1. -
-

2.

3.

4.

(RDU Label)
- 31 -

Paracetamol + Codeine prn use back

. 5/12/2557
PARAMED-CO 500+15 15
1
6

default IT
Paracetamol + Codeine continuous use back

. 5/12/2557
PARAMED-CO 500+15 15
1
3

Comment
1.

(RDU Label)
- 32 -

2.

3. Comment +

+ back

1. -
-

2.

3.

4. PIL)

(RDU Label)
- 33 -

Ibuprofen 400 mg prn back

. 5/12/2557
HEIDI (IBUPROFEN) 400 10
1
6 3
*
400

default IT
Ibuprofen 400 mg continuous use back

. 5/12/2557
CEFEN (IBUPROFEN) 400 40
1
3
*
400

Comment
1. prn 1

(RDU Label)
- 34 -

a. 3 maximum dose analgesic antipyretic


1.2 g day (drug information handbook 2014)
b. GI bleeding
10

c.
prn
GI side
effect omeprazole
2. continuous
rheumatoid arthritis GI bleeding
3.
4. IT prn
use continuous use
5. *

(RDU Label)
- 35 -

Ibuprofen syrup/suspension back

/ 5/12/2557
NEUROFEN (IBUPROFEN) SYRUP 100 /5 1
1 5 5
6 4

100 /5

Comment
1. 6 -12 <39 C 5 mg/kg/dose
39 C 10 mg/kg/dose 6-8 40 mg/kg/day
2. 4-10 mg/kg/dose 6-8
3. ibuprofen
syringe

(RDU Label)
- 36 -

back
NSAIDs

1.

2.

1.
low dose aspirin

30
8
2.
3.

1.

2.

3.

4. 3

5.

(RDU Label)
- 37 -

Cetirizine tablet prn back

. 5/12/2557
CETIRIZINE 10 10
1
1

10

default IT
Cetirizine tablet continuous use back

. 5/12/2557
ZYRMED (CETIRIZINE) 10 30
1
1

10

Comment
1. second generation antihistamine

(RDU Label)
- 38 -

2. non-sedating antihistamine
Textbook of Pediatrics
3.
1st generation (sedating) antihistamine

4. 1st generation (sedating) antihistamine


anti-cholinergic sedative effect

(RDU Label)
- 39 -

Cetirizine syrup prn back

/ 5/12/2557
CETRIZIN (CETIRIZINE) 5 /1 1
1 5 5
1

5 1

default IT
Cetirizine syrup continuous use back

/ 5/12/2557
ZENSIL (CETIRIZINE) 5 /1 1
1 5 5
1

Comment
1. Comment cetirizine tablet

(RDU Label)
- 40 -
back
non-sedating antihistamine

/
1.

non-
sedating antihistamine
2.

3.
sedating antihistamine
PTC

PTC

(RDU Label)
- 41 -

Amoxicillin 500 mg GAS pharyngitis back

. 5/12/2557
GPO MOX (AMOXICILLIN) 500 20
1
2 12

500

GAS pharyngitis bacterial sinusitis default


IT
Comment
1. PTC
2. 1 2
2 2
a. Clinical practice guideline for the diagnosis and management of group A
streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of
America.
http://cid.oxfordjournals.org/content/early/2012/09/06/cid.cis629.full
b. American Academy of Pediatrics. Red Book: 2012. Report of the Committee
on Infectious Diseases.
c. Harrison's Principles of Internal Medicine. 18th ed. 2012.
3. 20 10 rheumatic fever
Group A Streptococcus (GAS) amoxicillin 2x2 20
guideline 10
4. 12 pharmacokinetic lactam antibiotics
around the clock

(RDU Label)
- 42 -

5.

6.

10
7.
7.1 Page Sore Throat
https://www.facebook.com/Corejeb/photos_stream?tab=photos_albums
7.2 Album Antibiotic Smart Use Page Rational Drug Use
https://www.facebook.com/media/set/?set=a.896405347066408.1073741852.8964047
83733131&type=3
7.3 Album Page Rational Drug Use
https://www.facebook.com/media/set/?set=a.
&type=

back

2.
10

3. 10
8 pharyngitis/tonsillitis
10 Group A
Streptococcus
4.
rheumatic fever/heart disease
Antibiotic Smart
5. Use 3

(RDU Label)
- 43 -

Amoxicillin 500 mg bacterial sinusitis back

. 5/12/2557
GPO MOX (AMOXICILLIN) 500 30
1
3 8

500

GAS pharyngitis bacterial sinusitis default


IT
Comment
1. acute bacterial rhinosinusitis (bacterial sinusitis)

a. rhinosinusitis) 10
b. 39 C)
3-4
c. 5-6
double-sickening)

(RDU Label)
- 44 -

IDSA Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children


and Adults Chow et al, 2012)
2. amoxicillin ( drug of choice co-amoxiclav high dose)
usual dose high (double) dose

a. systemic toxicity)
C
orbital cellulitis)
intracranial extensions of infection)
b. S.pneumoniae

c. S.pneumoniae
NARST 2014 S.pneumoniae penicillin
68.2 * oxacillin test disk
diffusion method) MIC quantitation method

intermediate resistance (MIC, 0.12 to 1.0 mcg/ml) resistant (MIC, >1.0


mcg/ml)
3. 2c amoxicillin (1.5 / acute
bacterial rhinosinusitis 3
S.pneumoniae, H.influenzae M.catarrhalis
4. amoxicillin 2 2 1 / 20 5

a. J00 Acute nasopharyngitis (common cold)


b. J01 Acute sinusitis bacterial sinusitis usual dose (1.5-
2 / high (double) dose (3-4 / ) co-amoxiclav drug
of choice criteria
1
c. J02/J03 Acute pharyngitis/tonsillitis low dose 1
2 10 2 10
d. J04 Acute laryngitis and tracheitis
e. J05 Acute obstructive laryngitis (croup) and epiglottis

(RDU Label)
- 45 -

f. J06 Acute upper respiratory infections of multiple and unspecified


sites
5. usual dose acute bacterial rhinosinusitis
a. 45 / /

b. - - -
875 12

6. high (double) dose acute bacterial rhinosinusitis


a. - / /

b. - - - IDSA
guideline 2012)
7. amoxicillin
around the clock 3
8
back

2. acute rhinosinusitis

5-6
10
3.

4.

Antibiotic Smart
5. Use 3

(RDU Label)
- 46 -

Amoxicillin suspension/syrup back

/ 5/12/2557
GPO MOX AMOXICILLIN) 125 /5 2
1 5
3 8

125 5

back

/ 5/12/2557
GPO MOX AMOXICILLIN) 250 /5 2
1 5
3 8

250 5

(RDU Label)
- 47 -

back

2.
8 10

1-2
3. 1-2

4. Antibiotic Smart
Use 3

(RDU Label)
- 48 -

500 back

http://drug.fda.moph.go.th/zone_law/files/d pdf

(RDU Label)
- 49 -

Domperidone tablet prn back

5/12/2557
MOTILIUM DOMPERIDONE) 10 10
1
4 3

10

Domperidone suspension prn back

/ 5/12/2557
DOMINOX DOMPERIDONE) 1 / 1
2.5 2.5
4 3

1 1

Comment
1. domperidone 23 2014
EMEA)

(RDU Label)
- 50 -

QT prolong Torsade)

http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Do
mperidone_ European_Commission_final_decision/WC pdf
2. domperidone the relief of the
symptoms of nausea and vomiting
dyspepsia GERD

3. 10
1 30 / 35
0.25 / 1 / 0.75 / 1
/
4. 7
5. domperidone
EMEA

https://www.medicines.org.uk/emc/medicine/
https://www.medicines.org.uk/emc/medicine/
6.
7. domperidone
EMEA domperidone
a.
b.

http://www.midlandsmedicines.nhs.uk/filestore/domperidone% GI% restrictions


% May% pdf
8. post domperidone
Rational Drug Use Facebook
https://www.facebook.com/media/set/?set=a.896405187066424.1073741846.8964047
83733131&type=3
9. domperidone 30 mg/day
7

(RDU Label)
- 51 -

back

Patient
Information Leaflet)

-
Concomitant use of the following
substances is contraindicated
2. 1 > QTc-prolonging medicinal products
-arrhythmics class IA (e.g., disopyramide,
3. 3 hydroquinidine, quinidine)
4. 7 -arrhythmics class III (e.g., amiodarone,
dofetilide, dronedarone, ibutilide, sotalol)
5. >60
pimozide, sertindole)

escitalopram)
erythromycin,
levofloxacin, moxifloxacin, spiramycin)
e)

halofantrine, lumefantrine)
-intestinal medicines (e.g.,
cisapride, dolasetron, prucalopride)
1
mizolastine)
.,
toremifene, vandetanib, vincamine)

diphemanil, methadone)
> Potent CYP3A4 inhibitors (regardless of their
QT prolonging effects), i.e.:

azole antifungals
- hromycin, clarithromycin
and telithromycin)
https://www.medicines.org.uk/emc/me
2. 0.25 / /
dicine/29304#INTERACTIONS
3. 0.75 / /
4. 7
5.

(RDU Label)
- 52 -

Enalapril 5 20 mg back

. 5/12/2557
ENARIL (ENALAPRIL) 5 90
1
1

Comment
1. PTC
2.

3.
hypertension
http://dict.longdo.com/search/hypertension
4.

heart failure

5. 5

6.
ED
NED
7.

(RDU Label)
- 53 -
back
ACE Inhibitors

1.

2. Patient
Information Leaflet)

(RDU Label)
- 54 -

Amlodipine 5 10 mg back

. 5/12/2557
AMLOPINE (AMLODIPINE) 5 90
1
1

Comment
1. PTC
2.

3.
hypertension
http://dict.longdo.com/search/hypertension
4.

angina pectoris

5. 5

6.
ED
NED
7.

(RDU Label)
- 55 -
back

long acting CCBs

1.

2. Patient
Information Leaflet)

simvastatin

amlodipine
3.

1%

gingival hyper-
plasia)

(RDU Label)
- 56 -

Metformin 500 850 mg back

. 5/12/2557
MIFORMIN (METFORMIN) 500 60
1
2
(
500

Comment
1. Metformin
adherence

OPD

2. adherence

enalapril

3.

hypoglycemia)
4. lactic acidosis

5. patient information leaflet


6. Rational Drug Use Facebook
Like
a. 1 2
76 Likes

(RDU Label)
- 57 -

b. 1 2
23 Likes
c. 1 2
7 Likes
a. b.

back

1. 2

2.
Patient
Information Leaflet)
3.

4. 4
5)

5.

(RDU Label)
- 58 -

Glibenclamide 2.5 5 mg back

. 5/12/2557
DIABENOL (GLIBENCLAMIDE) 5 60
1
2
(
5

Comment
1. lexicomp with
meal)
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s030lbl.pdf
2. WHO (2012), National Kidney Foundation (2012), Canadian
Diabetes Association 2013 Singapore Health Science Authority (2013)
>60 3 eGFR <60
2
ml/min/1.73m )
http://www.who.int/selection_medicines/committees/expert/19/applications/Sulfon
ylurea_18_5_A_R.pdf
https://www.kidney.org/sites/default/files/docs/diabetes-ckd-update-2012.pdf
http://guidelines.diabetes.ca/browse/Chapter
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Safety_Informat
ion_and_Product_Recalls/Product_Safety_Alerts/2013/recommendations_to.html
3.
4. high alert drug

2 (2557)
5. glipizide

(RDU Label)
- 59 -

Glipizide 5 mg back

. 5/12/2557
DIPAZIDE (GLIPIZIDE) 5 60
1
2
(
5

Comment
1. lexicomp
2. glibenclamide (glyburide) >60
eGFR <60 ml/min/1.73m2)
3.
4. high alert drug

5. sulfonylurea
glibenclamide (glyburide)

(RDU Label)
- 60 -

back
/
1.

Patient
Information Leaflet)
2.

3.

4.

(RDU Label)
- 61 -

Simvastatin 10, 20 40 mg back

. 5/12/2557
ZIMMEX (SIMVASTATIN) 20 90
1
1
(
20

Comment
1.

2.

3.
cholesterol, LDL triglyceride HDL
4. common name
5.
rhabdomyolysis

6. statin
Page http://www.facebook.com/pages/ /
?sk=photos_stream&tab=photos_albums
link
https://www.facebook.com/media/set/?set=a.
&type=

(RDU Label)
- 62 -

back

/
1.

2.

macrolide,
3. amlodipine, amiodarone, verapamil,
diltiazem gemfibrozil

4.

(RDU Label)
- 63 -

Colchicine (Acute Attack) back

. 5/12/2557
COLCINE (COLCHICINE) 0.6 3
2
1 1

0.6

Comment
1. 2 1 1
2012 American College of Rheumatology Guidelines for Management
of Gout. Part 2: Therapy and Antiinflammatory Prophylaxis of Acute Gouty Arthritis
https://www.rheumatology.org/practice/clinical/guidelines/Gout_Part_ _ACR- -
pdf
2. . .
2555 colchcine 0.6 2-4
Terkeltaub RA (2010) http://www.ncbi.nlm.nih.gov/pubmed/20131255
multicenter, randomized, double-blind,
placebo-controlled, parallel-group study low-dose colchicine
(1.8 mg total over 1 hour) high-dose colchicine (4.8 mg total over 6 hours)
1.2 0.6 1

3. pharmacokinetic properties colchicines 1


2 1 colchicines
2-4

(RDU Label)
- 64 -

http://onlinelibrary.wiley.com/doi/ art. pdf


4. acute
attack maintenance prophylaxis

5. 3
colchicines

6. colchicine 2 tab stat 1 tab 1


6 4.8 24 1 1-2 10
low-
dose 1.8 24 1x4
1.8 24 2
1 1
7. Colchicine drug interaction CYP3A4 Inhibitors moderate
strong inhibitor colchicine colchicine
Risk D) strong inhibitor
Risk X)
8. colchicine
Confusion and altered level of consciousness; Bone marrow hypoplasia, profound
leucopaenia, and thrombocytopaenia; Cardiac dysrhythmias and cardiovascular

(RDU Label)
- 65 -

collapse; Respiratory distress and respiratory failure; Oliguria and acute renal
failure; Metabolic acidaemia Death

(RDU Label)
- 66 -

Colchicine (Prophylaxis, Maintenance dose) back

. 5/12/2557
COLCINE (COLCHICINE) 0.6 14
1
1

0.6

Comment
1. Colchicine can be
taken with or without food.
http://www.nlm.nih.gov/medlineplus/druginfo/meds/a html
2.
maintenance prophylaxis acute attack

3.
maintenance
multi-organ failure

(RDU Label)
- 67 -

back

1.

2.

PIL)

3.

(RDU Label)
- 68 -

Allopurinol 100, 300 mg back

. 5/12/2557
PURIDE (ALLOPURINOL) 100 30
1
1

100

Comment
1. allopurinol

2. (100 )

800
3. SJS/TENS allopurinol
HLA-B*5801 SJS/TEN 348
HLA-B* 5801 15
1 7

1,000 7 02-951-1485
4. allopurinol severe
cutaneous adverse reactions (SCAR) 7.0 mg/dL)

(RDU Label)
- 69 -

back

1.
2. HLA-B*58:01
2

3. allopurinol

4.

HLA-B*58:01

allopurinol

:
HLA-
B*58:01 allopurinol

HLA-B*58:01
HLA-B*58:01 8.4-15%

HLA-B*58:01 393 -
1,085

(RDU Label)
- 70 -

6. back
indicator) L - Label
(Indicator I)
1 2 3 4 5
LABEL 13 100% 45 60 75
-I-01
45% 59% 74% 90% 90%
39 * 39 <18 18-23 24-29 30-35 >35
16 ** 16 <8 8-10 11-12 13-14 >14
(21 * 21 <10 10-12 13-15 16-18 >18
15 <7 7-9 10-11 12-13 >13
(15 ***
13
x 100 13
* 13
39
** 1
***
metformin

1 12 paracetamol
combination 3 15

(Indicator I)
1 2 3 4 5
LABEL 13 100% 45 60 75
-I-02
45% 59% 74% 90% 90%

(RDU Label)
- 71 -

13

x 100 13

13

ACE Inhibitors
enalapril 5 20 2
lisinopril ramipril

(RDU Label)

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