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Fortum for Injection (Ceftazidime)

What Fortum is and what it is used for

Fortum for Injection 3 g, 2 g, 1 g or 500 mg (called ‘Fortum’ in this leaflet) is an antibiotic for injection or infusion into a vein or muscle. It contains the medicine, ceftazidime (as ceftazidime pentahydrate).

Fortum is used to treat infections in different parts of the body caused by bacteria.

Before you have Fortum

Do not have Fortum if you:

  • are allergic (hypersensitive) to ceftazidime, ceftazidime pentahydrate or cephalosporin antibiotics
  • have ever had an allergic (hypersensitive) reaction to any antibiotic. This can include a skin rash or swelling of the face or neck
  • have kidney problems

Do not have Fortum if any of the above apply. If you are not sure, talk to your doctor, pharmacist or nurse before having Fortum

Blood tests

If you are having any blood tests, let the doctor or nurse know that you are on Fortum. This is because Fortum can affect the results of these tests. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that can be bought without a prescription and herbal medicines This is because Fortum can affect the way some other medicines work. Also some other medicines can affect the way Fortum works. Fortum should not be taken without first discussing this with your doctor if you are also taking:

  • water tablets (diuretics) such as furosemide

If you still need to have Fortum, you will have regular tests to check your kidneys

  • aminoglycoside-type antibiotics such as neomycin or gentamycin
  • an antibiotic called chloramphenicol

Fortum may stop the contraceptive pill working. You will need to use extra contraceptive precautions, such as using a condom. If you need any advice, talk to your doctor or pharmacist.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine if you think you might be or if you are pregnant or if you are breast-feeding.

Important information about one of the ingredients of Fortum:

  • Fortum 500 mg contains 26 mg of sodium per vial.
  • Fortum 1 g contains 52 mg of sodium per vial.
  • Fortum 2 g contains 104 mg of sodium per vial.
  • Fortum 3 g contains 156 mg of sodium per vial.

This should be considered if you are on a controlled sodium diet.

How Fortum is given

You will never give yourself this medicine. A qualified person, like a doctor or a nurse, will give you this medicine.

The correct dose of Fortum will be decided by your doctor and depends on the severity of and type of infection, whether you are on any other antibiotics and your weight and age.

Fortum will usually be given by a doctor or nurse either directly into a vein (intravenously) or into a muscle (intramuscularly). In some cases, it may be given as a “drip” (intravenous infusion).

Fortum is made up by the doctor, pharmacist or nurse using Water for Injections or a suitable infusion fluid

Adult doses range from 1 g to 6 g per day every 8 or 12 hours by IM or IV. These will be reduced for elderly patients or those with kidney problems.

The usual doses are as follows.

Adults

Most infections: 1 g every 8 hours or 2 g every 12 hours.

Urinary tract (water) infections: 500 mg or 1 g every 12 hours.

Less serious infections: 500 mg every 12 hours or 1 g every 12 hours.

Very severe infections or if you have immune problems: 2 g every 8 or 12 hours or 3 g every 12 hours.

For cystic fibrosis (an inherited lung condition), if you do not have kidney problems: 100 mg to 150 mg per kilogram per day as 3 divided doses. Up to 9 g per day might be prescribed.

To stop infections during prostate surgery: 1 g when you have your anaesthetic. You may be given a second dose when your water tube (catheter) is removed.

Elderly patients

The daily dose should not normally exceed 3 g, especially if you are over 80 years of age.

Children

Babies and children aged over 2 months

Cystic fibrosis, immune problems or meningitis:

Doses up to 150 mg per kilogram per day in 3 divided doses may be prescribed. The maximum dose for babies and children over 2 months is 6 g per day.

Newborn babies less than 2 months old

Usual dose: 25 mg to 60 mg per kilogram per day of the baby’s body weight as 2 divided doses.

Adults, elderly patients or children and babies with kidney problems may be given a different dose to the usual dose. The doctor or nurse will advise how much Fortum you will need, depending on the severity of the kidney disease.

Your doctor will keep a close check on you and you may have more regular kidney function tests.

If you are on Fortum for a long time

Thrush (a yeast infection of moist areas of the body) may develop if Fortum is used for a long time. If this occurs and you have been taking Fortum for longer than recommended, tell your doctor.

If you have too much Fortum

It is unlikely you will be given too much, but if you think you have been given too much Fortum, tell your doctor, pharmacist or nurse immediately. Signs might include fits or coma.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Fortum can cause side effects, although not everybody gets them.

Very rarely, a sudden and severe allergic reaction to Fortum can occur. If you get any of the following symptoms tell your doctor, pharmacist or nurse immediately:

  • Swelling of the face, lips, tongue or other parts of the body.
  • Breathing difficulties.

Other side effects include:

The following is common (affects less than 1 in 10 people)

  • changes to your white blood cells which might make you more susceptible to infections
  • increased numbers of platelets in the blood which might make you more prone to blood clots

The following is uncommon (affects less than 1 in 100 people)

  • high temperature (fever), chills, a sore throat or other signs of an infection or if they bruise more easily. These may be signs of a problem with your blood cells.
  • inflammation of the large bowel (colon) with diarrhoea sometimes containing blood, pain and fever.

The following are very rare (affects less than 1 in 10,000 people)

  • a skin reaction known as ‘erythema multiforme’ where you may develop: itchy reddish-purple patches on the skin especially on the palms of the hands or the soles of the feet, ‘hive-like’ raised swollen areas on the skin, tender areas of the surfaces of the mouth, eyes and private parts. You may have a fever and be very tired
  • rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems
  • other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itch, scaling. These may be associated with fever, headaches and body aches
  • a serious condition affecting your blood, symptoms of which are fever and mouth or throat ulcers
  • yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might result in jaundice
  • an excessive breakdown of red blood cells causing a form of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes
  • liver problems or liver failure.

If any of the above happen to you speak to your doctor or nurse straight away as your medicine should be stopped.

Sometimes you may get less severe skin reactions such as:

  • A mildly itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on forearms, legs, palms, hands, or feet
  • A rash consisting of raised spots on a flat or discoloured area of skin.

The frequency for these is common (less than 1 in 10 people).

If you have this talk to your doctor or nurse as Fortum will need to be stopped.

The other possible side effects are:

Common (affects less than 1 in 10 people)

  • diarrhoea
  • pain, burning, swelling or inflammation at the site of the injection
  • changes in the results of blood tests for liver function
  • false positive red blood cell status tests (Coombs or rhesus test)

Uncommon (affects less than 1 in 100 people)

  • the blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself
  • fever
  • itching
  • headache
  • dizziness
  • feeling sick (nausea)
  • vomiting
  • stomach pain

Very rare (affects less than 1 in 10,000 people)

  • pins and needles
  • bad taste

If any of the side effects get serious, or if you have any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Fortum

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.

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 penta hydrate).

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.

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