1
Artesunate 60mg Saline solution 5 ml 5 6 WEIGH THE PATIENT DETERMINE THE NUMBER OF VIALS NEEDED Weight less than 25 kg 26-50 kg 51-75 kg 76-100 kg 60 mg vial 1 2 3 4 ADMINISTER 1 2 3 4 DILUTE Reconstituted artesunate + saline solution (or dextrose 5%) Volume for dilution Artesunate nate 60mg 1 ml Sodium Bicarbonate Saline solution 5 ml GUIDELINES FOR ADMINISTRATION OF INJECTABLE ARTESUNATE FOR SEVERE MALARIA PRODUCT DESCRIPTION 1 CALCULATE THE DOSE Calculate and withdraw the required dose in ml according to route of administration: Artesunate powder 60mg Bicarbonate ampoule Saline solution * Dose: For children < 20 kg: 3.0 mg/kg For children > 20 kg and adults: 2.4 mg/kg Can be given by intravenous route (IV) or intramuscular route (IM). IV is the preferred route of administration. Please refer to the patient information leaflet for more information. Inject full contents of bicarbonate ampoule (1 ml) into artesunate vial. Artesunate powder bicarbonate ampoule B A Artesunate ate 60mg 1ml Sodium Bicarbonate Artesunate 60mg 1ml Sodium Bicarbonate Artesunate 60mg The reconstituted solution will clear in about 2 mins. Discard if not clear. Shake until dissolved. Solution will be cloudy. Artesunate ate 60mg D C IV IM Bicarbonate solution volume 1 ml 1 ml Saline solution volume 5 ml 2 ml Total volume 6 ml 3 ml Artesunate 60 mg solution concentration 10 mg/ml 20 mg/ml Withdraw all the air from the vial. Artesunate 60mg Artesunate ate 60mg Saline solution 5 ml Artesunate reconstituted saline solution B A Inject required volume of saline into the reconstituted solution. Artesunate solution is now ready for use. Artesunate ate 60mg D C IM: Inject slowly. Spread the doses of more than 2 ml over different sites for babies and 5 ml for adults. IV: slow bolus 3-4 ml per minute. IMPORTANT Water for injection is not an appropriate dilutant © MMV 20141029 1. World Health Organization (WHO) List of Prequalified Medicinal Products (http://apps.who.int/prequal/query/ProductRegistry.aspx?list=ma): artesunate injectable, reference N° MA051, prequalified on 05-Nov-2010. 2. World Health Organization, Management of Severe Malaria - A practical handbook - Third edition - April 2013 - (http://www.who.int/malaria/publications/atoz/9789241548526/en/index.html) RECONSTITUTE Activate the drug: artesunate powder + bicarbonate ampoule (immediately before use) DOSING SCHEDULE 7 IMPORTANT Prepare a fresh solution for each administration. Discard any unused solution after use. 1. Give 3 parenteral doses over 24 hours as indicated in the opposite table 2. Give parenteral doses for a minimum of 24 hours once started irrespective of the patients ability to tolerate oral treatment earlier. Day 1 Dose 1: on admission (0 Hours) Dose 2: 12 hours later Day 2 Dose 3: 24 hours after first dose - When the patient can take oral medication, prescribe a full 3-day course of recommended first line oral Artemisinin Combination Therapy (ACT). The first dose of ACT should be taken between 8 and 12 hours after the last injection of artesunate. - Until the patient is able to take oral medication, continue parenteral treatment (one dose a day) for a maximum of 7 days. - A course of injectable artesunate should always be followed by a 3-day course of ACT. Evaluate the patient’s progress regularly. This document is intended to demonstrate to health workers how to prepare and administer injectable artesunate, a treatment for severe malaria. It is not intended to provide personal medical advice. The responsibility for the interpretation and use of this material lies with the reader. In no event shall MMV be liable for damages arising from its use. © 2014 Medicines for Malaria Venture (MMV). All rights reserved. A copy of this document can only be made upon MMV’s written authorization. WHO RECOMMENDED TREATMENT 2 * Water for injection is not an appropriate dilutant Remark: the upper limit for each weight band is 0.9 kg e.g. 14 - 16 kg covers 14 - 16.9 kg. Weight kg Dose mg ml 20 - 25 60 3 26 - 29 70 4 30 - 33 80 4 34 - 37 90 5 38 - 41 100 5 42 - 45 110 6 46 - 50 120 6 51 - 54 130 7 55 - 58 140 7 59 - 62 150 8 63 - 66 160 8 67 - 70 170 9 71 - 75 180 9 76 - 79 190 10 80 - 83 200 10 84 - 87 210 11 88 - 91 220 11 92 - 95 230 12 96 - 100 240 12 Weight kg Dose mg ml 20 - 25 60 6 26 - 29 70 7 30 - 33 80 8 34 - 37 90 9 38 - 41 100 10 42 - 45 110 11 46 - 50 120 12 51 - 54 130 13 55 - 58 140 14 59 - 62 150 15 63 - 66 160 16 67 - 70 170 17 71 - 75 180 18 76 - 79 190 19 80 - 83 200 20 84 - 87 210 21 88 - 91 220 22 92 - 95 230 23 96 - 100 240 24 Example: Example: 6.24 ml rounded up to 7 ml 3.12 ml rounded up to 4 ml Dose needed (ml) for 26 kg child: Dose needed (ml) for 26 kg child: 10 2.4 x 26 = 6.24 ml 20 2.4 x 26 = 3.12 ml 2.4 mg x body weight (kg) IV artesunate solution concentration 10 mg/ml 2.4 mg x body weight (kg) IM artesunate solution concentration 20 mg/ml Round up to the next whole number Round up to the next whole number Example: Example: 2.4 ml rounded up to 3 ml 1.2 ml rounded up to 2 ml Dose needed (ml) for 8 kg child: Dose needed (ml) for 8 kg child: 10 3.0 x 8 = 2.4 ml 20 3.0 x 8 = 1.2 ml 3.0 mg x body weight (kg) IV artesunate solution concentration 10 mg/ml 3.0 mg x body weight (kg) IM artesunate solution concentration 20 mg/ml Round up to the next whole number Round up to the next whole number Weight kg Dose mg ml 6 - 7 20 1 8 - 10 30 2 11 - 13 40 2 14 - 16 50 3 17 - 20 60 3 Weight kg Dose mg ml 6 - 7 20 2 8 - 10 30 3 11 - 13 40 4 14 - 16 50 5 17 - 20 60 6 More than 20 kg Less than 20 kg Concentration: 10 mg/ml For intravenous route (IV) Concentration: 20 mg/ml For intramuscular route (IM) Concentration: 10 mg/ml Concentration: 20 mg/ml

guidelines for administration of injectable artesunate

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Page 1: guidelines for administration of injectable artesunate

ArtesunateateArtesunateate

Artesunateate

Artesunateate

Artesunateate60mg

Artesunateate30mg

Artesunateate60mg

Artesunateate120mg

Artesunateate120mg

Artesunateate30mg

ArtesunateateArtesunateate60mg 60mg

1ml

1ml

60mg

60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Salin

e solu

tion

5 ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Artesunate60mg

Artesunate60mg

Artesunate60mg

5 6

WEIGH THE PATIENT

DETERMINE THE NUMBER OF VIALS NEEDEDWeight less than 25 kg 26-50 kg 51-75 kg 76-100 kg

60 mg vial 1 2 3 4

ADMINISTER

1

2

3

4 DILUTE Reconstituted artesunate + saline solution (or dextrose 5%) Volume for dilution

Artesunatenate

60mg1 m

l

Sodium

Bicarbonate

Saline solutio

n

5 ml

Artesunatenate

60mg

1 ml

Sodium

Bicarbonate

Saline solutio

n5 m

l

GUIDELINES FOR ADMINISTRATION OF INJECTABLE ARTESUNATE FOR SEVERE MALARIA

PRODUCT DESCRIPTION 1 CALCULATE THE DOSE Calculate and withdraw the required dose in ml according to route of administration:

Artesunatepowder 60mg

Bicarbonateampoule

Saline solution *

Dose: For children < 20 kg: 3.0 mg/kg For children > 20 kg and adults: 2.4 mg/kg

Can be given by intravenous route (IV) or intramuscular route (IM). IV is the preferred route of administration.Please refer to the patient information leaflet for more information.

Inject full contents of bicarbonate ampoule (1 ml) into artesunate vial.

Artesunatepowder

bicarbonateampoule

BA

ArtesunateateArtesunateate

Artesunateate

Artesunateate

Artesunateate60mg

Artesunateate30mg

Artesunateate60mg

Artesunateate120mg

Artesunateate120mg

Artesunateate30mg

ArtesunateateArtesunateate60mg 60mg

1ml

1ml

60mg

60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Salin

e solu

tion

5 ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Artesunate60mg

Artesunate60mg

Artesunate60mg

ArtesunateateArtesunateate

Artesunateate

Artesunateate

Artesunateate60mg

Artesunateate30mg

Artesunateate60mg

Artesunateate120mg

Artesunateate120mg

Artesunateate30mg

ArtesunateateArtesunateate60mg 60mg

1ml

1ml

60mg

60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Salin

e solu

tion

5 ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Artesunate60mg

Artesunate60mg

Artesunate60mg

ArtesunateateArtesunateate

Artesunateate

Artesunateate

Artesunateate60mg

Artesunateate30mg

Artesunateate60mg

Artesunateate120mg

Artesunateate120mg

Artesunateate30mg

ArtesunateateArtesunateate60mg 60mg

1ml

1ml

60mg

60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Salin

e solu

tion

5 ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Artesunate60mg

Artesunate60mg

Artesunate60mg

The reconstituted solution will clear in about 2 mins. Discard if not clear.

Shake until dissolved. Solution will be cloudy.

ArtesunateateArtesunateate

Artesunateate

Artesunateate

Artesunateate60mg

Artesunateate30mg

Artesunateate60mg

Artesunateate120mg

Artesunateate120mg

Artesunateate30mg

ArtesunateateArtesunateate60mg 60mg

1ml

1ml

60mg

60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Salin

e solu

tion

5 ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Artesunate60mg

Artesunate60mg

Artesunate60mg

DC

IV IM

Bicarbonate solution volume 1 ml 1 ml

Saline solution volume 5 ml 2 ml

Total volume 6 ml 3 ml

Artesunate 60 mg solution concentration 10 mg/ml 20 mg/ml

Withdraw all the air from the vial.

ArtesunateateArtesunateate

Artesunateate

Artesunateate

Artesunateate60mg

Artesunateate30mg

Artesunateate60mg

Artesunateate120mg

Artesunateate120mg

Artesunateate30mg

ArtesunateateArtesunateate60mg 60mg

1ml

1ml

60mg

60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Salin

e sol

utio

n5

ml

Salin

e so

lutio

n5

ml

Salin

e so

lutio

n5

ml

Salin

e so

lutio

n5

ml

Artesunate60mg

Artesunate60mg

Artesunate60mg

ArtesunateateArtesunateate

Artesunateate

Artesunateate

Artesunateate60mg

Artesunateate30mg

Artesunateate60mg

Artesunateate120mg

Artesunateate120mg

Artesunateate30mg

ArtesunateateArtesunateate60mg 60mg

1ml

1ml

60mg

60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Salin

e solu

tion

5 ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Artesunate60mg

Artesunate60mg

Artesunate60mg

Artesunatereconstituted

saline solution

BA Inject required volume of saline into the reconstituted solution.

Artesunate solution is now ready for use.

ArtesunateateArtesunateate

Artesunateate

Artesunateate

Artesunateate60mg

Artesunateate30mg

Artesunateate60mg

Artesunateate120mg

Artesunateate120mg

Artesunateate30mg

ArtesunateateArtesunateate60mg 60mg

1ml

1ml

60mg

60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

1ml

Sodi

umBi

carb

onat

e

Artesunate60mg

1ml

Sodi

umBi

carb

onat

e

Salin

e solu

tion

5 ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Salin

e sol

utio

n5

ml

Artesunate60mg

Artesunate60mg

Artesunate60mg

DC

IM: Inject slowly. Spread the doses of more than 2 ml over different sites for babies and 5 ml for adults.

IV: slow bolus 3-4 ml per minute.

IMPORTANT

Water for injection is not an appropriate dilutant

© M

MV

2014

1029

1. World Health Organization (WHO) List of Prequalified Medicinal Products (http://apps.who.int/prequal/query/ProductRegistry.aspx?list=ma): artesunate injectable, reference N° MA051, prequalified on 05-Nov-2010.

2. World Health Organization, Management of Severe Malaria - A practical handbook - Third edition - April 2013 - (http://www.who.int/malaria/publications/atoz/9789241548526/en/index.html)

RECONSTITUTE Activate the drug: artesunate powder + bicarbonate ampoule (immediately before use)

DOSING SCHEDULE7

IMPORTANT

•Prepare a fresh solution for each administration.•Discard any unused solution after use.

1. Give 3 parenteral doses over 24 hours as indicated in the opposite table

2. Give parenteral doses for a minimum of 24 hours once started irrespective of the patients ability to tolerate oral treatment earlier.

•Day 1 Dose 1: on admission (0 Hours) Dose 2: 12 hours later

•Day 2 Dose 3: 24 hours after first dose

- When the patient can take oral medication, prescribe a full 3-day course of recommended first line oral Artemisinin Combination Therapy (ACT). The first dose of ACT should be taken between 8 and 12 hours after the last injection of artesunate.

- Until the patient is able to take oral medication, continue parenteral treatment (one dose a day) for a maximum of 7 days.

- A course of injectable artesunate should always be followed by a 3-day course of ACT.

•Evaluate the patient’s progress regularly.

This document is intended to demonstrate to health workers how to prepare and administer injectable artesunate, a treatment for severe malaria. It is not intended to provide personal medical advice. The responsibility for the interpretation and use of this material lies with the reader. In no event shall MMV be liable for damages arising from its use.© 2014 Medicines for Malaria Venture (MMV). All rights reserved. A copy of this document can only be made upon MMV’s written authorization.

WHORECOMMENDED TREATMENT 2

* Water for injection is not an appropriate dilutant

Remark: the upper limit for each weight band is 0.9 kg e.g. 14 - 16 kg covers 14 - 16.9 kg.

Weight kg

Dosemg ml

20 - 25 60 326 - 29 70 430 - 33 80 434 - 37 90 538 - 41 100 542 - 45 110 646 - 50 120 651 - 54 130 755 - 58 140 759 - 62 150 863 - 66 160 867 - 70 170 971 - 75 180 976 - 79 190 1080 - 83 200 1084 - 87 210 1188 - 91 220 1192 - 95 230 12

96 - 100 240 12

Weight kg

Dosemg ml

20 - 25 60 626 - 29 70 730 - 33 80 834 - 37 90 938 - 41 100 1042 - 45 110 1146 - 50 120 1251 - 54 130 1355 - 58 140 1459 - 62 150 1563 - 66 160 1667 - 70 170 1771 - 75 180 1876 - 79 190 1980 - 83 200 2084 - 87 210 2188 - 91 220 2292 - 95 230 23

96 - 100 240 24

Example: Example:

6.24 ml rounded up to 7 ml 3.12 ml rounded up to 4 ml

Dose needed (ml) for 26 kg child: Dose needed (ml) for 26 kg child:

102.4 x 26 = 6.24 ml

202.4 x 26 = 3.12 ml

2.4 mg x body weight (kg)

IV artesunate solutionconcentration 10 mg/ml

2.4 mg x body weight (kg)

IM artesunate solutionconcentration 20 mg/mlRound up to the next whole numberRound up to the next whole number

Example: Example:

2.4 ml rounded up to 3 ml 1.2 ml rounded up to 2 ml

Dose needed (ml) for 8 kg child: Dose needed (ml) for 8 kg child:

103.0 x 8 = 2.4 ml

203.0 x 8 = 1.2 ml

3.0 mg x body weight (kg)

IV artesunate solutionconcentration 10 mg/ml

3.0 mg x body weight (kg)

IM artesunate solutionconcentration 20 mg/ml

Round up to the next whole number Round up to the next whole number

Weight kg

Dosemg ml

6 - 7 20 18 - 10 30 2

11 - 13 40 214 - 16 50 317 - 20 60 3

Weight kg

Dosemg ml

6 - 7 20 28 - 10 30 311 - 13 40 414 - 16 50 517 - 20 60 6

Mo

re t

han

20 k

gLe

ss t

han

20 k

g

Concentration: 10 mg/ml

For intravenous route (IV)

Concentration: 20 mg/ml

For intramuscular route (IM)

Concentration: 10 mg/ml Concentration: 20 mg/ml