Patient leaflet - Fortum 500 mg powder for solution for injection
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 (main component of cooking/table salt)
You need to take this into account if you are on a controlled sodium diet.
Fortum 500 mg
This medicine contains 26 mg (1.13 mmol) of sodium per vial. This is equivalent to 1.3% of the recommended maximum daily dietary intake of sodium for an adult.
Fortum 1 g
This medicine contains 52 mg (2.26 mmol) of sodium per vial. This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.
Fortum 2 g
This medicine contains 104 mg (4.52 mmol) of sodium per vial. This is equivalent to 5.2% of the recommended maximum daily dietary intake of sodium for an adult.
Fortum 3 g
This medicine contains 156 mg (6.78 mmol) of sodium per vial. This is equivalent to 7.8% of the recommended maximum daily dietary intake of sodium for an adult.
3. How Fortum is given
Fortum is usually given by a doctor or nurse.
Fortum 500 mg powder for solution for injection Fortum is given as an injection directly into a vein or into a muscle.
Fortum 1 g powder for solution for injection or infusion Fortum can be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle
Fortum 2 g powder for solution for injection or infusion Fortum can be given as a drip (intravenous infusion) or as an injection directly into a vein.
Fortum 3 g powder for solution for injection or infusion Fortum can be given as a drip (intravenous infusion) or as an injection directly into a vein
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 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 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:
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:
Sandoz Pharmaceuticals d.d., Verovškova ulica 57, 1000 Ljubljana, Slovenia
Manufacturer: ACS Dobfar S.p.A.,
Via Alessandro Fleming 2, 37135 Verona, Italy. This leaflet was last revised in July 2023 Trade marks are owned by or licensed to the Sandoz group of companies. All rights reserved. Signature Panel:
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Technical data:
Novartis data if applicable:
V026 (LT/H/0109) and V030 (SE/1875): Add clarity on reconstitution with respect to the route of administration.
13/07/2023 9pt
FuturaCEEF 130 x 565 mm
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