Ceftazidime Venus 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.

Ceftazidime Venus 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.

Ceftazidime Venus can also be used:

• to prevent infections during prostate surgery in men

• to treat patients with low white blood cell counts (neutropenia) who have an fever due to a

bacterial infection.

You must not be given Ceftazidime Venus:

• 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 Ceftazidime Venus.

→ Tell your doctor before you start on Ceftazidime Venus if you think that this applies to you. You must not be given Ceftazidime Venus.

Take special care with Ceftazidime Venus

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 Ceftazidime Venus. 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 Ceftazidime Venus.

If you need a blood or urine test

Ceftazidime Venus 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 Ceftazidime Venus.

Other medicines and Ceftazidime Venus

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 Ceftazidime Venus 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 Ceftazidime Venus:

• 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 Ceftazidime Venus against the risk to your baby.

Driving and using machines

Ceftazidime Venus 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.

Ceftazidime Venus contains sodium

You need to take this into account if you are on a controlled sodium diet.

Ceftazidime Venus 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.Ceftazidime Venus 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 Ceftazidime Venus 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 Ceftazidime Venus 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 Ceftazidime Venus 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 Ceftazidime Venus 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

Ceftazidime Venus 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 Ceftazidime Venus 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 Ceftazidime Venus

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.

Don’t stop taking Ceftazidime Venus

Don’t stop taking Ceftazidime Venus unless your doctor tells you to. If you have any further questions on the use of this medicine ask your doctor or nurse.

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:

• inflammation or failure of the kidneys

• 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 or pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

To report any side effect(s):

Saudi Arabia:

The National Pharmacovigilance and Drug Safety Centre (NPC)

- Fax: +966-11-205-7662

- Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

- Toll free phone: 8002490000

- E-mail: npc.drug@sfda.gov.sa

- Website: www.sfda.gov.sa/npc

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 30°C.

• Keep vials in the outer carton in order 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 2-8 ℃) or within 9 hours if stored at room

temperature (below 25℃).

• 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.