Patient Information Leaflet

Fortum® Monovial®

ceftazidime pentahydrate powder for injection

This leaflet contains information about Fortum. Please read it carefully. Keep it safe as you may want to read it again. If you want to know more about your illness or your medicine, ask your pharmacist or doctor.

What Fortum Monovial contains

Each Monovial contains:

• The active ingredient - ceftazidime 2 grams (as pentahydrate) powder for injection.
• Other ingredient - sodium carbonate. Each vial contains 104 mg sodium.
• Fortum Monovial is supplied as a single dose vial of ceftazidime 2 grams.

What Fortum does

Fortum contains ceftazidime which is an antibiotic belonging to the cephalosporin class.

Antibiotics are used to kill the bacteria or “germs” that cause infections.

Fortum is used to treat infections caused by one germ, a mixture of germs and also severe infections in general. The types of infection that can be treated by Fortum include the following: infections of the chest, ear, nose, throat, urinary system, gut, abdomen, gall bladder, bones, joints, brain (meningitis), flesh and skin. It can also be used to treat infections that may occur after dialysis or to prevent infections that may occur after some surgical operations.

Your doctor has decided to give you Fortum because he has found you have an infection or to protect you from infection before an operation. Sometimes Fortum may be used at the same time as other antibiotics to help treat or prevent infection.

Before having Fortum

This medicine suits most people but there are some people who should not take it. Ask yourself these questions to check whether Fortum is right for you.

• Have you previously experienced an allergic reaction to Fortum, ceftazidime, or any other antibiotics e.g. penicillin?
• Do you think you may be pregnant?
• Are you breast-feeding?
• Do you have kidney disease?
• Are you taking a diuretic (water tablet) such as frusemide?
• Are you taking any other antibiotic e.g. chloramphenicol or aminogylcoside antibiotics?
• Are you on a low sodium diet?

If you answer “yes” to any of these questions, inform your doctor before having Fortum. If you are unsure ask your doctor or pharmacist for advice.

How Fortum is given

Fortum Monovial is given as a “drip” (intravenous infusion).

Fortum is supplied as a powder, so before it can be given it must be diluted and made into a solution. This is normally done by your doctor or nurse.

Fortum Monovial 2 g preparation can only be used for certain doses. In the dosage regimens below, for doses less than 2 g, for 3 g doses and all intramuscular doses (injections given into the muscle), the standard Fortum for Injection vial packs should be used.

The usual adult dose is 1 g three times a day or 2 g twice a day. Doses may be less or more and more frequent depending on the severity and type of infection, your weight, age and kidney function.

 

The duration of treatment depends on the type of infection.

For prevention of an infection after surgery, 1 g is given before the operation and a second dose after the operation.

For infants and children, the dose is based on body weight.

Children aged over 2 months: 30 mg to 100 mg per kilo daily divided into 2 or 3 separate doses.

Severely ill children may receive up to 150 mg per kilo daily (to a maximum of 6 g daily), divided into 3 separate doses.

New-born and children aged under 2 months: 25 mg to 60 mg per kilo daily divided into 2 or 3 separate doses. Due to the small doses required, Fortum Monovial is not intended for those under 2 months of age.

For elderly patients the total daily dose should normally not be more than 3 g, especially in those over 80 years of age.

For patients with moderate to severe kidney problems the dose of Fortum will be reduced.

For patients with renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration the dose is 1 g daily in divided doses.

For patients who have haemodialysis courses, the appropriate dose should be repeated after each haemodialysis period. This is because some of the Fortum may be removed from the body during this type of dialysis and so needs to be topped up.

Fortum can be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD). It can be given intravenously or can be incorporated into the dialysis fluid (usually 125-250 mg for 2 L of dialysis fluid).

For the treatment of lung infections in patients with cystic fibrosis with normal kidney function, high doses of 100 mg to 150 mg per kilogram of body weight per day (up to 9 grams a day in adults or 6 grams a day in children), given in 3 divided doses should be used. In some cases, the parent of a cystic fibrosis child or an adult patient with cystic fibrosis may be specially instructed on how to give Fortum at home.

Your medication will usually be given to you by a health professional - if you think you may have missed a dose or have received too much medicine please tell your doctor or nurse.

If, in a rare situation, you have been instructed by your doctor to give yourself Fortum and you think you have given too much, don’t delay, ask your doctor what to do or contact your nearest hospital emergency department. If you have missed a dose, give another as soon as you remember and then carry on as before. As with all antibiotics it is important that you are given Fortum regularly and the full course is completed.

Side effects

Along with its needed effects, a medicine may cause unwanted effects. Most people given this medicine find it causes no problems. As with other antibiotics, some people find they have an allergy to it.

Tell your doctor immediately if any of the following rare severe allergy symptoms occur:

• Sudden wheeziness and tightness of chest
• Swelling of eyelids, face or lips
• Skin lumps or hives
• Skin rash (red spots), itchiness, fever
• Collapse

Check with your doctor as soon as possible if any of the following side effects occur:

Where to keep your injections

As with all medicines, keep Fortum vials safely away from children.

Store any unopened vials at room temperature below 25°C (77°F). Made up injections are best used straight away. If this is not possible, store them in a fridge at 2-8°C (36°F to 46°F) for no longer than 24 hours.

Protect from light by keeping the vials in their cartons.

Further information

This leaflet does not tell you everything about your medication. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

You may be able to find out more about prescribed medicines from books in public libraries.