FORTUM FOR INJECTION 1G

Active substance: CEFTAZIDIME PENTAHYDRATE

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10000000092078

Information for the Healthcare Professional

Fortum®

for Injection 3 g, 2 g, 1 g and 500 mg
ceftazidime

.
. .

Dosage and Administration Information Only
Please refer to the Summary of Product Characteristics for further information
• Posology and method of administration
Method of administration
Fortum should be administered by intravenous injection or infusion, or by deep intramuscular injection. Recommended
intramuscular injection sites are the upper quadrant of the gluteus maximus or lateral part of the thigh. Fortum solutions may be
given directly into the vein or introduced into the tubing of a giving set if the patient is receiving parenteral fluids.
The standard recommended route of administration is by intravenous intermittent injection or intravenous continuous
infusion. Intramuscular administration should only be considered when the intravenous route is not possible or less
appropriate for the patient.
The dose depends on the severity, susceptibility, site and type of infection and on the age and renal function of the patient.
Posology
Adults and children > 40 kg
Intermittent Administration
Infection
Dose to be administered
Broncho-pulmonary infections in cystic fibrosis
100 to 150 mg/kg/day every 8 h, maximum 9 g per day1
Febrile neutropenia
2 g every 8 h
Nosocomial pneumonia
Bacterial meningitis
Bacteraemia*
Bone and joint infections
1-2 g every 8 h
Complicated skin and soft tissue infections
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients on CAPD
Complicated urinary tract infections
1-2 g every 8 h or 12 h
Peri-operative prophylaxis for transuretheral resection of 1 g at induction of anaesthesia,
prostate (TURP)
and a second dose at catheter removal
Chronic suppurative otitis media
1 g to 2 g every 8h
Malignant otitis externa
Continuous Infusion
Infection
Dose to be administered
Febrile neutropenia
Loading dose of 2 g followed by a continuous infusion of
4 to 6 g every 24 h1
Nosocomial pneumonia
Broncho-pulmonary infections in cystic fibrosis
Bacterial meningitis
Bacteraemia*
Bone and joint infections
Complicated skin and soft tissue infections
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients on CAPD
1 In adults with normal renal function 9 g/day has been used without adverse effects.
* When associated with, or suspected to be associated with, any of the infections listed in section 4.1.
Infection

100-150 mg/kg/day in three divided
doses, maximum 6 g/day

Febrile neutropenia
Nosocomial pneumonia
Broncho-pulmonary infections in cystic fibrosis
Bacterial meningitis
Bacteraemia*
Bone and joint infections
Complicated skin and soft tissue infections
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients
on CAPD
Infection

Loading dose of 60-100 mg/kg
followed by a continuous infusion
100-200 mg/kg/day, maximum 6 g/day

150 mg/kg/day in three divided doses,
maximum 6 g/day

100-150 mg/kg/day in three divided
doses, maximum 6 g/day

Continuous Infusion

Neonates and infants ≤ 2 months
Intermittent Administration

1g
2g
3 g

Intramuscular
Intravenous bolus
Intramuscular
Intravenous bolus
Intravenous infusion
Intravenous bolus
Intravenous infusion
Intravenous bolus
Intravenous infusion

Amount of diluent to be added (ml)
1.5 ml
5 ml
3 ml
10 ml
50 ml*
10 ml
50 ml*
15 ml
75 ml*

Approximate concentration (mg/ml)
260
90
260
90
20
170
40
170
40

*Note: Addition should be in two stages.
All sizes of vials as supplied are under reduced pressure. As the product dissolves, carbon dioxide is released and a positive pressure
develops. For ease of use, it is recommended that the following techniques of reconstitution are adopted:
Preparation of solution 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.

Usual dose

Complicated urinary tract infections
Chronic suppurative otitis media
Malignant otitis externa
Neutropenic children
Broncho-pulmonary infections in cystic fibrosis
Bacterial meningitis
Bacteraemia*
Bone and joint infections
Complicated skin and soft tissue infections
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients
on CAPD

Vial size
500mg

Usual dose

Most infections

25-60 mg/kg/day in two divided
doses1
1 In neonates and infants ≤ 2 months, the serum half life of ceftazidime can be three to four times that in adults.
* Where associated with, or suspected to be associated with, any of the infections listed in section 4.1.
Elderly
In view of the age related reduced clearance of ceftazidime in elderly patients, the daily dosage should not normally exceed 3 g in
those over 80 years of age.
Paediatric population
The safety and efficacy of Fortum administered as continuous infusion to neonates and infants ≤ 2 months has not been
established.
Hepatic imparment
Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment. There are no study data
in patients with severe hepatic impairment. Close clinical monitoring for safety and efficacy is advised.
Renal impairment
Ceftazidime is excreted unchanged by the kidneys. Therefore, in patients with impaired renal function, the dosage should be
reduced. An initial loading dose of 1 g should be given. Maintenance doses should be based on creatinine clearance.

Package Leaflet: Information for the User

Fortum®

for Injection 3 g, 2 g, 1 g and 500 mg
ceftazidime

Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor.
In this leaflet:
1 What Fortum is and what it is used for
2 Before you are given Fortum
3 How Fortum is given
4 Possible side effects
5 How to store Fortum
6 Further 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. Before you are given Fortum
You must not be given Fortum:
• If you are allergic (hypersensitive) 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.
Taking other medicines
Tell your doctor if you are taking any other medicines,
if you’ve started taking any recently or you start taking
new ones. 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 chlorampenicol
• a type of antibiotic called aminoglycosides
e.g. gentamicin, tobramycin
• water tablets called furosemide
➔ Tell your doctor if this applies to you.
Pregnancy and breast-feeding
Tell your doctor 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.
Important information about some of the
ingredients of Fortum
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 used
Fortum is usually given by a doctor or a 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 usual 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.

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 2 g vials) and 75 ml (for 3 g vials) of compatible diluent, added in TWO stages as below:1. Introduce the syringe needle through the vial closure and inject 10 ml of diluent for 2 g vial and 15 ml for 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 15-30 minutes.
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.
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 most commonly used intravenous fluids.
Any unused product or waste material should be disposed of in accordance with local requirements.
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 Intraperitoneal Dialysis Fluid (Lactate).
Ceftazidime may be constituted for intramuscular use with 0.5% or 1% Lidocaine Hydrochloride Injection.
When admixed at 4 mg/ml with (both components retain satisfactory potency):
• Hydrocortisone (hydrocortisone sodium phosphate) 1 mg/ml in 0.9% Sodium Chloride Injection BP or 5% Dextrose Injection BP
• Cefuroxime (cefuroxime sodium) 3 mg/ml in 0.9% Sodium Chloride Injection BP
• Cloxacillin (cloxacillin sodium) 4 mg/ml in 0.9% Sodium Chloride Injection BP
• Heparin 10 u/ml or 50 u/ml in 0.9% Sodium Chloride Injection BP
• Potassium Chloride 10 mEq/L or 40 mEq/L in 0.9% Sodium Chloride Injection BP
The contents of a 500 mg vial of Fortum for Injection, reconstituted with 1.5 ml Water for Injections, may be added to metronidazole
injection (500 mg in 100 ml) and both retain their activity.
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.
Leaflet last updated September 2012.
The information in this leaflet applies only to Fortum for Injection
Fortum is a registered trademark of the GlaxoSmithKline group of companies
© 2012 GlaxoSmithKline group of companies

If you are given more Fortum than you should
If you accidentally use more Fortum 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. However, if it is almost time for your next
injection, skip the missed injection. Don’t take a double
dose (two injections at the same time) to make up for a
missed dose.
If you stop using Fortum
Don’t stop taking Fortum unless your doctor tells you to.
If you have any questions ask your doctor or nurse.

• 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.
If you get side effects
➔ Tell your doctor or pharmacist if any of the effects
become severe or troublesome, or if you notice
any side effects not listed in this leaflet.

4. Possible side effects

Keep out of the reach and sight of children.
Fortum is for use in hospital only and the expiry date and
storage instructions stated on the vial label and carton
are for the doctor, nurse or pharmacist’s information. The
doctor, pharmacist or nurse will make up your medicine.

Like all medicines, Fortum 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.
➔ 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 itchy
• 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.
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

5. How to store Fortum

6. Further 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 3 g, 2 g, 1 g and 500 mg is supplied as sterile
powder in glass vials. Each individual vial is packed in
a carton. These are supplied to the hospital in packs
of 1 or 5 for all except the 3 g strength which is only
available as a single pack. 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:
GlaxoSmithKline UK, 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 00004/0294 (3 g and 2 g),

00004/0293 (1 g) or
00004/0292 (500 mg)
This is a service provided by the Royal National Institute
of Blind People.
Leaflet date: September 2012
Fortum is a registered trademark of the GlaxoSmithKline
group of companies
© 2012 GlaxoSmithKline group of companies
.
. .

10000000092078

Children < 40 kg
Infants and toddlers> 2 months and
children < 40 kg
Intermittent Administration

For recommended maintenance doses of ceftazidime in renal
impairment (including haemodialysis and peritoneal dialysis), follow
the dosage recommendations in the SPC.
• Overdose
Overdosage can lead to neurological sequelae including
encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in
.
patients with renal impairment. Serum levels of ceftazidime can be reduced by haemodialysis.
. .
• Incompatibilities
Ceftazidime is less stable in Sodium Bicarbonate injection than other intravenous fluids. It is not recommended as a diluent.
Ceftazidime and aminoglycosides should not be mixed in the same giving set or syringe.
Precipitation has been reported when vancomycin has been added to ceftazidime in solution. It is recommended that giving sets
and intravenous lines are flushed between administration of these two agents.
• Instructions for use/handling
Instructions for reconstitution: See table for addition volumes and solution concentrations, which may be useful when fractional
doses are required.
Preparation of solution

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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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