CEFTAZIDIME 2G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance: CEFTAZIDIME PENTAHYDRATE

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Ceftazidime 1g
Ceftazidim 2g
Denmark
Ceftazidim Fresenius 500 mg, pulver til
infusionsvæske, opløsning
Ceftazidim Fresenius 1g, pulver til
injektionsvæske, opløsning
Ceftazidim Fresenius 2g, pulver til injektionsog infusionsvæske, opløsning
Estonia
Ceftazidime Fresenius 500 mg
Ceftazidime Fresenius 1000 mg
Ceftazidime Fresenius 2000 mg
Greece
Ceftazidime Fresenius, σκόνη για ενέσιµο
διάλυµα, 1000mg
Ceftazidime, κόνις γιa dιάλυµa pρος ένesη/
έγχυsη, 2000mg

Norway
Ceftazidim Fresenius 500 mg pulver til
injeksjonsvæske, oppløsning
Ceftazidim Fresenius 1g, pulver til
injeksjonsvæske, oppløsning
Ceftazidim Fresenius 2g, pulver til injeksjons-/
infusjonsvæske, oppløsning
Poland
Ceftazidime
Slovenia
Ceftazidim Fresenius 1000 mg prašek za
raztopino za injiciranje
Ceftazidim Fresenius 2000mg prašek za
raztopino za injiciranje ali infundiranje
Slovakia
Ceftazidime 500 mg
Ceftazidime 1g
Ceftazidim 2g

2 doses per day
volume per partial dose



Body weight [kg]

25 mg



3

0.45 ml

1.00 ml



4

0.55 ml

1.30 ml



5

0.70 ml

1.65 ml

6

0.85 ml

2.00 ml

When ceftazidime is dissolved, carbon dioxide is
released and a positive pressure develops. For ease
of use, the recommended techniques of reconstitution
described below should be followed.

Strength 2000 mg for iv bolus (1700mg in 10 ml)

See table for addition volumes and solution
concentrations, which may be useful when fractional
doses are required.

a total volume of at least 50 ml and administer by
intravenous infusion over 15 to 30 min.
NOTE: To preserve product sterility, it is important that
a gas relief needle is not inserted through the vial
closure before the product has dissolved.
For single use only.
Reconstituted solution: Chemical and physical in use
stability has been demonstrated up to 6h at 25 ºC
and 12h at 5 ºC after reconstitution of the product
with water for injection, 1% lidocaine solution, 0.9%
sodium chloride solution, ringer lactate and 10%
glucose solution. From a microbiological point of view,
the product should be used immediately.
Discard any unused solution in accordance with
local requirements.

Instructions for reconstitution:

2 doses per day
volume per partial dose




Compatible intravenous fluids:
At ceftazidime concentrations between 40 mg/ml and
260 mg/ml the Ceftazidime powders for injection may
be mixed in commonly used solutions for infusion:
- sodium chloride 9 mg/ml (0.9%) solution
(physiological saline solution),
- Ringer Lactate Solution
- Glucose 10 mg/ml (10%) solution
When reconstituted for intramuscular use, the
Ceftazidime powder for injection can also be diluted
with lidocaine 10 mg/ml (1%) solutions.

60 mg



The dilution is to be made under aseptic conditions.
The solution is to be inspected visually for particulate
matter and discoloration prior to administration.
The solution should only be used if the solution is clear
and free from particles.

100 mg

30 mg

100 mg



10

1.65 ml

5.55 ml

1.10 ml

3.70 ml



20

3.30 ml

11.10 ml

2.20 ml

7.40 ml



30

5.00 ml

16.65 ml

3.30 ml

11.10 ml



40

6.65 ml

22.20 ml

4.40 ml

14.80 ml

For 500 mg IM/IV and 1g IM/IV:
Preparation of solutions for bolus injection
1. Insert the syringe needle through the vial closure
and inject the recommended volume of diluent. The
vacuum may assist entry of the diluent. Remove the
syringe needle.
2. Shake to dissolve: carbon dioxide is released and a
clear solution will be obtained in about 1 to 2 minutes.
3. Invert the vial. With the syringe plunger fully
depressed, insert the needle through the vial closure
and withdraw the total volume of solution into the
syringe (the pressure in the vial may aid withdrawal).
Ensure that the needle remains within the
solution and does not enter the head space. The
withdrawn solution may contain small bubbles of
carbon dioxide; they may be disregarded.
These solutions may be given directly into the vein or
introduced into the tubing of a giving set if the patient
is receiving parenteral fluids. Ceftazidime is compatible
with above mentioned intravenous fluids.



50

8.30 ml

27.75 ml

5.55 ml

18.50 ml

For 2g infusion vials

lntramuscular use:
Ceftazidime should be reconstituted with water for
injections or Lidocaine Hydrochloride 10 mg/ml (1%)
solution for injection as indicated in the table below.
Information for Lidocaine should be consulted before
reconstitution of ceftazidime with lidocaine.



60

10.00 ml 33.30 ml

6.65 ml

22.20 ml

Preparation of solutions for iv infusion from ceftazidime
injection in standard vial presentation (minibag or
burette-type set):

Intravenous use – infusion (see section 3):
For intravenous infusion, the content of the 2 g infusion
vial should be reconstituted with 10 ml of water for
injections (for bolus) and 50 ml of water for injections
(intravenous infusion) or one of the compatible
intravenous fluids. Alternatively, the content of the
500 mg or 1 g vial should be reconstituted and an



500 mg powder for
solution for injection
Intramuscular
Intravenous bolus

1.5 ml
5 ml

260
90

Latvia
Ceftazidime Fresenius 500 mg
Ceftazidime Fresenius 1000 mg
Ceftazidime Fresenius 2000 mg

This medicinal product is for single use only. Discard
any unused contents. Reconstitute immediately
before use

1 g powder for
solution for injection
Intramuscular
Intravenous bolus

3 ml
10 ml

260
90

Intravenous use – injection:
For direct intermittent intravenous administration,
ceftazidime should be reconstituted with water for
injections (see table below). The solution has to be
injected slowly directly into the vein over a period
of up to 5 minutes or given through the tubing of
a giving set.

2 g powder for
solution for injection
or infusion
Intravenous bolus
Intravenous infusion

Amount of
diluent to
be added
(ml)

10 ml
50 ml*

* Addition should be in 2 stages

170
40

60 mg



3

0.25 ml

0.55 ml



Approximate
concentration
(mg/ml)

25 mg

4

0.30 ml

0.70 ml

5

0.40 ml

0.85 ml



This leaflet was last approved in 07/2011.
-------------------------------------------------------------The following information is intended for medical or
healthcare professionals only:

Vial size

Body weight [kg]



Hungary
Ceftazidim 1 g por oldatos injekcióhoz
Ceftazidim 2 g por oldatos injekcióhoz vagy
infúzióhoz

Netherlands
Ceftazidim 500mg, poeder voor oplossing
voor injectie.
Ceftazidim 1000mg, poeder voor oplossing
voor injectie.
Ceftazidim Fresenius 2000mg, poeder voor
oplossing voor injectie/infusie

500 mg for injection (450mg in 5 ml) and
1000 mg for injection (900mg in 10 ml)

Instructions for constitution

UK
Ceftazidime 500 mg
Ceftazidime 1 g
Ceftazidime 2 g

Latvia
Ceftazidime Fresenius 500 mg
Ceftazidime Fresenius 1000 mg
Ceftazidime Fresenius 2000 mg

Posology: 25 to 60 mg/kg b.w./day given as two
divided doses

All sizes of vials of Ceftazidime are supplied under
reduced pressure. As the product dissolves, carbon
dioxide is released and a positive pressure develops.
Small bubbles of carbon dioxide in the constituted
solution may be ignored.

Finland
Ceftazidim Fresenius 1 g injektiokuiva-aine,
liuosta varten
Ceftazidim Fresenius 2 g injektio-/
infuusiokuiva-aine, liuosta varten

Luxemburg
Ceftazidim 0,5 g Pulver zur Hersellung einer
Injektionslösung
Ceftazidim 1 g Pulver zur Hersellung einer
Injektionslösung
Ceftazidim 2 g Pulver zur Herstellung einer
Injektionslösung oder Infusionslösung

Preparation of solutions of Ceftazidime for use
in children

appropriate quantity of the resulting solution should
be added to an IV container with one of the compatible
intravenous fluids. Administer by intravenous infusion
over 15 - 30 minutes. Intermittent intravenous infusion
with a Y-type giving set can be accomplished with
compatible solutions. However, during infusion of
a solution containing ceftazidime, it is desirable to
discontinue the other solution.

6

0.50 ml

1.00 ml

Posology: 30 to 100 mg/kg b.w./day given as 2 or
3 divided doses
500 mg for injection (450mg in 5 ml) and 1000 mg

for injection (900mg in 10 ml)
2 doses per day
volume per partial dose




B
ody weight [kg] 30 mg

3 doses per day
volume per partial

Strength 2000 mg for iv bolus (1700mg in 10 ml)



2 doses per day
volume per partial dose

B
ody weight [kg] 30 mg


3 doses per day
volume per partial

100 mg

30 mg

100 mg

0.90 ml

2.95 ml

0.55 ml

1.95 ml

20
1.80
ml

5.90 ml

1.15 ml

3.90 ml

10



30

2.70 ml

8.85 ml

1.75 ml

5.90 ml



40

3.60 ml

11.75 ml

2.35 ml

7.85 ml



50

4.45 ml

14.70 ml

2.95 ml

9.80 ml



60

5.30 ml

17.65 ml

3.50 ml

11.75 ml

1. Introduce the syringe needle through the vial closure
and inject 10 ml of diluent.
2. Withdraw the needle and shake the vial to give a
clear solution.
3. Do not insert a gas relief needle until the product
has dissolved. Insert a gas relief needle through the
vial closure to relieve the internal pressure.
4. Transfer the reconstituted solution to final delivery
vehicle (e.g. mini-bag or burette-type set) making up

Solutions range from light yellow to amber depending
on concentration, diluent and storage conditions used.
Within the stated recommendations, product potency
is not adversely affected by such colour variations.

797107/01
V001

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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