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AstraZeneca

Voriconazole Hikma (previously Voriconazole Hospira)
voriconazole

Package leaflet: Information for the user


Voriconazole Hikma 200 mg powder for solution for infusion

voriconazole


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


What Voriconazole Hikma looks like and contents of the pack


Voriconazole Hikma is a white to off-white lyophilised cake.


Voriconazole Hikma is presented in packs of 1 or 5 glass vials as a powder for solution for infusion. Not all pack sizes may be marketed.


Marketing Authorisation Holder

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença 2705-906 Terrugem SNT

Portugal


Manufacturer Hikma Italia S.p.A. Viale Certosa, 10

27100 Pavia Italy


Pfizer Service Company BVBA Hoge Wei 10,

Zaventen, 1930, Belgium


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


AT / BE / DE / NL

Hikma Pharma GmbH Tel: +49 89-45450-302

IT

Hikma Italia S.p.A.

Tél/Tel: + 39 0382 1751801


BG / CY / CZ / DK / EE / ES / EL / FI / HR / HU / IE / IS / LI / LT / LU / LV / MT / NO / PL

/ PT / RO / SE / SI / SK

Hikma Farmacêutica (Portugal), S.A. Tel.: +351 219 608 410

UK

Consilient Health Ltd Tel.: +44(0)203 751 1888

FR

Hikma France

+33(0) 1 87 69 98 43


This leaflet was last revised in


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The following information is intended for healthcare professionals only:


Reconstitution and dilution information

Voriconazole Hikma powder for solution for infusion needs to first be reconstituted with either 19 ml of water for injections or 19 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to obtain an

extractable volume of 20 ml of clear concentrate containing 10 mg/ml voriconazole.


It is recommended that a standard 20 ml (non-automated) syringe be used to ensure that the exact amount

(19.0 ml) of water for injections or of sodium chloride 9 mg/ml (0.9%) solution for injection is dispensed.


After reconstitution with 19 ml of water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection, a clear solution is obtained.


The required volume of the reconstituted concentrate is then added to a recommended compatible infusion solution listed below to obtain a final Voriconazole Hikma solution containing 0.5 to 5 mg/ml of voriconazole.


This medicinal product is for single use only and any unused solution should be discarded and only clear solutions without particles should be used.


Not for administration as a bolus injection.


Prior to use this medicine does not require any special temperature storage conditions. Store in the original package in order to protect from light.


Required volumes of 10 mg/ml Voriconazole Hikma Concentrate


Body Weight

(kg)

Volume of Voriconazole Hikma Concentrate (10 mg/ml) required for:

3 mg/kg dose (number of

vials)

4 mg/kg dose (number of vials)

6 mg/kg dose (number of vials)

8 mg/kg dose (number of vials)

9 mg/kg dose (number of vials)

10

-

4.0 ml (1)

-

8.0 ml (1)

9.0 ml (1)

15

-

6.0 ml (1)

-

12.0 ml (1)

13.5 ml (1)

20

-

8.0 ml (1)

-

16.0 ml (1)

18.0 ml (1)

25

-

10.0 ml (1)

-

20.0 ml (1)

22.5 ml (2)

30

9.0 ml (1)

12.0 ml (1)

18.0 ml (1)

24.0 ml (2)

27.0 ml (2)

35

10.5 ml (1)

14.0 ml (1)

21.0 ml (2)

28.0 ml (2)

31.5 ml (2)

40

12.0 ml (1)

16.0 ml (1)

24.0 ml (2)

32.0 ml (2)

36.0 ml (2)

45

13.5 ml (1)

18.0 ml (1)

27.0 ml (2)

36.0 ml (2)

40.5 ml (3)

50

15.0 ml (1)

20.0 ml (1)

30.0 ml (2)

40.0 ml (2)

45.0 ml (3)

55

16.5 ml (1)

22.0 ml (2)

33.0 ml (2)

44.0 ml (3)

49.5 ml (3)

60

18.0 ml (1)

24.0 ml (2)

36.0 ml (2)

48.0 ml (3)

54.0 ml (3)

65

19.5 ml (1)

26.0 ml (2)

39.0 ml (2)

52.0 ml (3)

58.5 ml (3)


70

21.0 ml (2)

28.0 ml (2)

42.0 ml (3)

-

-

75

22.5 ml (2)

30.0 ml (2)

45.0 ml (3)

-

-

80

24.0 ml (2)

32.0 ml (2)

48.0 ml (3)

-

-

85

25.5 ml (2)

34.0 ml (2)

51.0 ml (3)

-

-

90

27.0 ml (2)

36.0 ml (2)

54.0 ml (3)

-

-

95

28.5 ml (2)

38.0 ml (2)

57.0 ml (3)

-

-

100

30.0 ml (2)

40.0 ml (2)

60.0 ml (3)

-

-


Voriconazole Hikma is a single dose unpreserved sterile lyophile.


Stability after reconstitution:

Chemical and physical in-use stability has been demonstrated for 36 hours at 2°C to 8° C for the reconstituted solution.


Stability after dilution:

Chemical and physical stability of the of the diluted solutions for infusion has been demonstrated for 36 hours at 2°C to 8°C followed by 3 hours at room temperature.


From a microbiological point of view, once reconstituted, the product must be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C (in a refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.


Compatible infusion solutions:

The reconstituted solution can be diluted with:


Sodium chloride 9 mg/ml (0.9%) solution for injection Compound sodium lactate intravenous infusion

5% glucose and lactated ringer’s intravenous infusion

5% glucose and 0.45% sodium chloride intravenous infusion 5% glucose intravenous infusion

5% glucose in 20 mEq potassium chloride intravenous infusion 0.45% sodium chloride intravenous infusion

5% glucose and 0.9% sodium chloride intravenous infusion


The compatibility of Voriconazole Hikma with diluents other than listed above (or listed below under ‘Incompatibilities’) is unknown.


Incompatibilities:


Voriconazole Hikma must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition (e.g. Aminofusin 10% Plus).


Infusions of blood products must not occur simultaneously with Voriconazole Hikma.


Infusion of total parenteral nutrition can occur silmultaneously with Voriconazole Hikma but not in the same line or cannula.


Voriconazole Hikma must not be diluted with 4.2% sodium bicarbonate infusion.