Fortum 250 Mg Powder For Solution For Injection
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Package leaflet: Information for the user
Fortum® 250 mg powder for solution for injection 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 |
Amount per vial |
|
Fortum 250 mg |
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
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 40C) or within 9 hours if stored at room temperature (below 250C).
• 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: 250 mg. The active substance is 250 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 250 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.
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 250 mg
Reference numbers 00004/0304
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.
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