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FORTUM FOR INJECTION 250MG

Active substance(s): CEFTAZIDIME PENTAHYDRATE

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Reason for update: Type IB addition of DRESS – Response to MHRA Request
MHRA Approval Date: TBC
Text Date: 09/07/2015
Text Issue and Draft No.: issue4draft1
SPC Issue and Draft No.: issue10draft1
CO Number: TBC

[GlaxoSmithKline Logo]
Package leaflet: Information for the user

Fortum® for Injection 250 mg
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.

1

Reason for update: Type IB addition of DRESS – Response to MHRA Request
MHRA Approval Date: TBC
Text Date: 09/07/2015
Text Issue and Draft No.: issue4draft1
SPC Issue and Draft No.: issue10draft1
CO Number: TBC

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.

Reason for update: Type IB addition of DRESS – Response to MHRA Request
MHRA Approval Date: TBC
Text Date: 09/07/2015
Text Issue and Draft No.: issue4draft1
SPC Issue and Draft No.: issue10draft1
CO Number: TBC

Fortum contains sodium
You need to take this into account if you are on a controlled sodium diet.
Fortum Strength
Fortum 250 mg

Amount per vial
13 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

Reason for update: Type IB addition of DRESS – Response to MHRA Request
MHRA Approval Date: TBC
Text Date: 09/07/2015
Text Issue and Draft No.: issue4draft1
SPC Issue and Draft No.: issue10draft1
CO Number: TBC

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, just take your
next dose at the usual time.
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.
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 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:

Reason for update: Type IB addition of DRESS – Response to MHRA Request
MHRA Approval Date: TBC
Text Date: 09/07/2015
Text Issue and Draft No.: issue4draft1
SPC Issue and Draft No.: issue10draft1
CO Number: TBC





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:




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.

Reason for update: Type IB addition of DRESS – Response to MHRA Request
MHRA Approval Date: TBC
Text Date: 09/07/2015
Text Issue and Draft No.: issue4draft1
SPC Issue and Draft No.: issue10draft1
CO Number: TBC

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.
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.
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 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:
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 250 mg

Reason for update: Type IB addition of DRESS – Response to MHRA Request
MHRA Approval Date: TBC
Text Date: 09/07/2015
Text Issue and Draft No.: issue4draft1
SPC Issue and Draft No.: issue10draft1
CO Number: TBC

Reference numbers 00004/0304
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in July 2015.
Fortum is a registered trade mark of the GSK group of companies
© 2015 GSK group of companies
[GlaxoSmithKline Logo]

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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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