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FORTUM 3 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CEFTAZIDIME PENTAHYDRATE

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10000000140502

GSK-ITA-Verona-ITVER

United Kingdom-GBR

Fortum

N/A

D15077LEA

N/A

N/A

K

1

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TEXT SIZE CONTAINED IN THIS ARTWORK
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The following information is intended for healthcare professionals only:

10000000140502

Fortum® 500 mg powder for solution for injection
Fortum® 1 g, 2 g, 3 g powder for solution for injection
or infusion

ceftazidime
.
Please refer to the Summary of Product Characteristics for further information
. .
Shelf Life
3 years.
After reconstitution:
Chemical and physical in-use stability has been demonstrated for 6 days at 4°C and 9 hours at 25°C in
Water for Injections or compatible fluids listed below.
From a microbiological point of view, the reconstituted solution should 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 to 8°C, unless reconstitution has taken place in
controlled and validated aseptic conditions.
After dilution:
Chemical and physical in-use stability has been demonstrated for 6 days at 4°C and 9 hours
at 25°C in Water for Injections or compatible fluids listed below.
From a microbiological point of view, the reconstituted and diluted solution should 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 to 8°C, unless
reconstitution has taken place in controlled and validated aseptic conditions.
Special precautions for storage
Store below 25°C.
Keep vials in the outer carton to protect from light.
Special precautions for disposal and other handling
All sizes of vials of Fortum 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.
Instructions for constitution
See Table 1 and Table 2 for addition volumes and solution concentrations, which may be useful when
fractional doses are required.
Table 1: Powder for Solution for Injection
Presentation
Amount of diluent to be added (ml) Approximate concentration (mg/ml)
500 mg
Intramuscular
1.5 ml
260
Intravenous bolus 5 ml
90
1 g
Intramuscular
3 ml
260
Intravenous bolus 10 ml
90
2 g
Intravenous bolus 10 ml
170
3 g
Intravenous bolus 15 ml
170
Note:
• The resulting volume of the solution of ceftazidime in reconstitution medium is increased due to the
displacement factor of the drug product resulting in the listed concentrations in mg/ml presented in
the above table.
Table 2: Powder for Solution for Infusion
Presentation
Amount of diluent to be added (ml) Approximate concentration (mg/ml)
1 g
20
Intravenous infusion 50 ml*
2 g
40
Intravenous infusion 50 ml*
3 g
40
Intravenous infusion 75 ml*
* Addition should be in two stages.
Note:
• The resulting volume of the solution of ceftazidime in reconstitution medium is increased due to the
displacement factor of the drug product resulting in the listed concentrations in mg/ml presented in
the above table.
Solutions range in colour 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.

Package Leaflet: Information for the User

Fortum® 500 mg powder
for solution for injection
Fortum® 1 g, 2 g, 3 g
powder for solution for
injection or infusion
ceftazidime
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or nurse.
• If you get any side effects talk to your doctor
or nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1 What Fortum is and what it is used for
2 What you need to know before you are given
Fortum
3 How Fortum is given
4 Possible side effects
5 How to store Fortum
6 Contents of the pack and other information
1. What Fortum is and what it is used for
Fortum is an antibiotic used in adults and children
(including newborn babies). It works by killing
bacteria that cause infections. It belongs to a
group of medicines called cephalosporins.
Fortum is used to treat severe bacterial
infections of:
• the lungs or chest
• the lungs and bronchi in patients suffering
from cystic fibrosis
• the brain (meningitis)
• the ear
• the urinary tract
• the skin and soft tissues
• the abdomen and abdominal wall (peritonitis)
• the bones and joints.
Fortum can also be used:
• to prevent infections during prostate surgery
in men
• to treat patients with low white blood cell
counts (neutropenia) who have a fever due to
a bacterial infection.
2. What you need to know before you are
given Fortum
You must not be given Fortum:
• if you are allergic to ceftazidime or any of
the other ingredients of this medicine (listed in
section 6).
• if you have had a severe allergic reaction
to any other antibiotic (penicillins,
monobactams and carbapenems) as you may
also be allergic to Fortum.
➔ Tell your doctor before you start on Fortum if
you think that this applies to you. You must not
be given Fortum.
Take special care with Fortum
You must look out for certain symptoms such
as allergic reactions, nervous system disorders
and gastrointestinal disorders such as diarrhoea
while you are being given Fortum. This will
reduce the risk of possible problems. See
(‘Conditions you need to look out for’) in section
4. If you have had an allergic reaction to other
antibiotics you may also be allergic to Fortum.
If you need a blood or urine test
Fortum can affect the results of urine tests
for sugar and a blood test known as the
Coombs test. If you are having tests:
➔ Tell the person taking the sample that you
have been given Fortum.
Other medicines and Fortum
Tell your doctor if you are taking, have recently taken
or might take any other medicines. This includes
medicines you can obtain without a prescription.
You shouldn’t be given Fortum without talking to
your doctor if you are also taking:
• an antibiotic called chloramphenicol

• a type of antibiotic called aminoglycosides
e.g. gentamicin, tobramycin
• water tablets called furosemide
➔ Tell your doctor if this applies to you.
Pregnancy, breast-feeding and fertility
Ask your doctor for advice before you are given
Fortum:
• If you are pregnant, think you might be
pregnant or are planning to become pregnant
• If you are breast-feeding
Your doctor will consider the benefit of treating
you with Fortum against the risk to your baby.
Driving and using machines
Fortum can cause side effects that affect your
ability to drive, such as dizziness. Don’t drive
or use machines unless you are sure you’re not
affected.
Fortum contains sodium
You need to take this into account if you are on a
controlled sodium diet.
Fortum Strength
Fortum 500 mg
Fortum 1 g
Fortum 2 g
Fortum 3 g

Amount per vial
26 mg
52 mg
104 mg
156 mg

3. How Fortum is given
Fortum is usually given by a doctor or nurse.
It can be given as a drip (intravenous infusion)
or as an injection directly into a vein or into a
muscle.
Fortum is made up by the doctor, pharmacist or
nurse using water for injections or a suitable
infusion fluid.
The recommended dose
The correct dose of Fortum for you will be decided
by your doctor and depends on: the severity and
type of infection; whether you are on any other
antibiotics; your weight and age; how well your
kidneys are working.
Newborn babies (0-2 months)
For every 1 kg the baby weighs, they’ll be
given 25 to 60 mg Fortum per day divided in
two doses.
Babies (over 2 months) and children who
weigh less than 40 kg
For every 1 kg the baby or child weighs, they’ll
be given 100 to 150 mg of Fortum per day divided
in three doses. Maximum 6 g per day.
Adults and adolescents who weigh 40 kg or more
1 to 2 g of Fortum three times daily. Maximum of
9 g per day.
Patients over 65
The daily dose should not normally exceed
3 g per day, especially if you are over 80 years of age.
Patients with kidney problems
You may be given a different dose to the usual
dose. The doctor or nurse will decide how much
Fortum you will need, depending on the severity
of the kidney disease. Your doctor will check you
closely and you may have more regular kidney
function tests.
If you are given more Fortum than you
should
If you accidentally use more than your prescribed
dose, contact your doctor or nearest hospital
straight away.
If you forget to use Fortum
If you miss an injection, you should have it
as soon as possible. Don’t take a double dose
(two injections at the same time) to make up for
a missed dose.
Don’t stop taking Fortum
Don’t stop taking Fortum unless your doctor tells
you to. If you have any further questions on the use
of this medicine ask your doctor or nurse.

.
. .

Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with:
• sodium chloride 9 mg/ml (0.9%) solution for injection
.
• M/6 sodium lactate injection
. .
• compound sodium lactate injection (Hartmann’s solution)
• 5% dextrose injection
• 0.225% sodium chloride and 5% dextrose injection
• 0.45% sodium chloride and 5% dextrose injection
• 0.9% sodium chloride and 5% dextrose injection
• 0.18% sodium chloride and 4% dextrose injection
• 10% dextrose Injection
• Dextran 40 injection 10% in 0.9% sodium chloride injection
• Dextran 40 injection 10% in 5% dextrose Injection
• Dextran 70 injection 6% in 0.9% sodium chloride injection
• Dextran 70 injection 6% in 5% dextrose injection.
Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with Intra-peritoneal
Dialysis Fluid (Lactate).
Ceftazidime at concentrations detailed in Table 1 may be constituted for intramuscular use
with 0.5% or 1% Lidocaine Hydrochloride Injection.
The contents of a 500 mg vial of ceftazidime for injection, constituted with 1.5 ml water for
injections, may be added to metronidazole injection (500 mg in 100 ml) and both retain
their activity.
500 mg powder for solution for injection, 1 g, 2 g, 3 g powder for solution for injection or infusion.:
THIS SECTION TO BE PRESENTED WITH PICTOGRAMS AS ON PREVIOUS ARTWORK
Preparation of solution for bolus injection:
1. Insert the syringe needle through
2. Shake to dissolve: carbon
the vial closure and inject the
dioxide is released and
recommended volume of diluent. The
a clear solution will be
vacuum may assist entry of the diluent.
obtained in about 1 to
Remove the syringe needle.
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 the intravenous fluids listed above.
1 g, 2 g, 3 g powder for solution for injection or infusion.:
Preparation of solutions for iv infusion from ceftazidime injection in standard vial presentation
(mini-bag or burette-type set):
Prepare using a total of 50 ml (for 1 g and 2 g vials) and 75 ml (for 3 g vials) of compatible diluents
(listed above), added in TWO stages as below.
1. Introduce the syringe needle through the vial closure and inject 10 ml of diluent for the 1 g and 2 g vials,
and 15 ml for the 3 g vial.
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 a total volume of at least 50 ml (75 ml for the 3 g vial), and administer by intravenous
infusion over 15 to 30 min.
Note: To preserve product sterility, it is important that the gas relief needle is not inserted through the
vial closure before the product has dissolved.
Any residual antibiotic solution should be discarded.
For single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
This leaflet was last revised in May 2016.
The information in this leaflet applies only to Fortum for Injection.
Fortum is a registered trade mark of the GSK group of companies.
© 2016 GSK group of companies. All rights reserved.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Conditions you need to look out for
The following serious side effects have occurred
in a small number of people but their exact
frequency is unknown:
• severe allergic reaction. Signs include
raised and itchy rash, swelling, sometimes
of the face or mouth causing difficulty in
breathing.
• Skin rash, which may blister, and looks like
small targets (central dark spot surrounded by a
paler area, with a dark ring around the edge).
• A widespread rash with blisters and
peeling skin. (These may be signs of
Stevens-Johnson syndrome or toxic epidermal
necrolysis).
• Nervous system disorders: tremors, fits
and, in some cases coma. These have occurred
in people when the dose they are given is
too high, particularly in people with kidney
disease.
• There have been rare reports of severe
hypersensitivity reactions with severe rash,
which may be accompanied by fever, fatigue,
swelling of the face or lymph glands, increase of
eosinophils (type of white blood cells), effects on
liver, kidney or lung (a reaction called DRESS).
➔ Contact a doctor or nurse immediately if
you get any of these symptoms.
Common side effects
These may affect up to 1 in 10 people:
• diarrhoea
• swelling and redness along a vein
• red raised skin rash which may be itchiness
• pain, burning, swelling or inflammation at the
injection site.
➔ Tell your doctor if any of these are troubling
you.
Common side effects that may show up in blood
tests:
• an increase in a type of white blood cell
(eosinophilia)
• an increase in the number of cells that help the
blood to clot
• an increase in liver enzymes.
Uncommon side effects
These may affect up to 1 in 100 people:
• inflammation of the gut which can cause pain,
or diarrhoea which may contain blood
• thrush (fungal infections in the mouth or vagina)
• headache
• dizziness
• stomach ache
• feeling sick or being sick
• fever and chills.
➔ Tell your doctor if you get any of these.
Uncommon side effects that may show up in
blood tests:
• a decrease in the number of white blood cells
• a decrease in the number of blood platelets
(cells that help the blood to clot)
• an increase in the level of urea, urea nitrogen
or serum creatinine in the blood.
Very rare side effects
These may affect up to 1 in 10,000 people:
• inflammation or failure of the kidneys
Other side effects
Other side effects have occurred in a small number
of people but their exact frequency is unknown:
• inflammation or failure of the kidneys
• pins and needles
• unpleasant taste in the mouth
• yellowing of the whites of the eyes or skin.
Other side effects that may show up in blood tests:
• red blood cells destroyed too quickly
• an increase in a certain type of white blood cells
• severe decrease in the number of white blood
cells.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Fortum
Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date
which is stated on the vial and carton after EXP.
The expiry date refers to the last day of that
month.
• Store below 25°C.
• Keep vials in the outer carton to protect from
light.
• Reconstituted and diluted solution: The
doctor, pharmacist or nurse will make up your
medicine in Water for Injections or compatible
fluids. Once made up, this medicine should
be used within 6 days if stored in refrigerator
(at 4°C) or within 9 hours if stored at room
temperature (below 25°C).
• Do not throw away any medicines via
wastewater or household waste. Your doctor
or nurse will throw away any medicine that is
no longer required. This will help protect the
environment.
6. Contents of the pack and other
information
What Fortum contains
• Fortum is available in the following strengths:
3 g, 2 g, 1 g and 500 mg. The active substance
is 3 g, 2 g, 1 g or 500 mg of ceftazidime
(present as ceftazidime pentahydrate).
• The only other ingredient is sodium carbonate
(anhydrous sterile).
• See section 2 for further important information
about sodium, one of the ingredients of Fortum.
What Fortum looks like and contents of the
pack
Fortum 500 mg powder for solution for injection
is a sterile white to cream powder filled in glass
17 ml vial with a bromobutyl rubber plug and a
flip-off type aluminium overseal.
Available in packs of 1, 5 or 10 vials.
Fortum 1 g powder for solution for injection or
infusion is a sterile white to cream powder filled
in glass 17 ml, 26 ml, 60 ml or 77 ml vial with
a bromobutyl rubber plug and a flip-off type
aluminium overseal.
Available in packs of 1, 5, 10, 50 or 100 vials.
Fortum 2 g powder for solution for injection or
infusion is a sterile white to cream powder filled in
glass 60 ml or 77 ml vial with a bromobutyl rubber
plug and a flip-off type aluminium overseal.
Available in packs of 1, 5, 10, 25 or 50 vials.
Fortum 3 g powder for solution for injection or
infusion is a sterile white to cream powder filled
in glass 127 ml vial with a bromobutyl rubber
plug and a flip-off type aluminium overseal.
Available as a single pack of 1 vial.
Not all pack sizes may be marketed.
Your doctor, pharmacist or nurse will make the
injection or infusion up with Water for Injections
or a suitable infusion fluid. When made up,
Fortum varies in colour from light yellow to
amber. This is perfectly normal.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Glaxo Operations UK Ltd., Stockley Park West,
Uxbridge, Middlesex. UB11 1BT
Manufacturer: GlaxoSmithKline
Manufacturing S.p.A., Verona, Italy.
Other formats
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product names Fortum for Injection

3 g, 2 g, 1 g or 500 mg
Reference numbers 00004/0292
This is a service provided by the Royal National
Institute of Blind People.
This leaflet was last revised in May 2016.
Fortum is a registered trade mark of the .
. .
GSK group of companies.
© 2016 GSK group of companies. All rights
reserved.
10000000140502

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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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