Deltazime

PACKAGE LEAFLET

DELTAZIME 250 mg/ 1 ml

powder and solvent for injectable solution for intramuscular use
DELTAZIME 500 mg/ 1.5 ml
powder and solvent for injectable solution for intramuscular use
DELTAZIME 1 g / 3 ml
powder and solvent for injectable solution for intramuscular use
DELTAZIME 1 g / 10 ml
powder and solvent for injectable solution for intravenous use
DELTAZIME 2 g powder for solution for infusion
Ceftazidime
Read this leaflet carefully before using this medicine.
Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor.

Contents of this leaflet:

1. What Deltazime is and what it is used for
2. Before you are given Deltazime
3. How Deltazime is administered
4. Possible side effects
5. How to store Deltazime
6. Further information

1. WHAT DELTAZIME IS AND WHAT IT IS USED FOR

Deltazime is an antibiotic used in adults and children (including newborns).
It works by killing the bacteria that cause infections and belongs to a group of medicines called
cephalosporins.
Deltazime is used to treat serious bacterial infections of the:

• lungs or chest

• lungs and bronchi in patients with cystic fibrosis

• brain (meningitis)

• ear

• urinary tract

• skin and soft tissues

• abdomen and abdominal wall (peritonitis)

• bones and joints

• Deltazime may also be used:

• to prevent infections during prostate surgery in men

• to treat patients with a low number of white blood cells (neutropenia) who have fever due to a bacterial infection.

2. BEFORE Deltazime IS GIVEN TO YOU

Do not receive Deltazime if:

• you are allergic (hypersensitive) to ceftazidime or to any of the excipients of this medicine (listed in section 6).
• you have previously experienced a severe allergic reaction to any other antibiotic (penicillins, monobactams, or carbapenems), as you may also be allergic to Deltazime.

Tell your doctor before starting treatment with Deltazime if you think this applies to you. Deltazime must not be given to you.

Take special care with Deltazime
Be cautious about certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disturbances such as diarrhoea while being treated with Deltazime. This will reduce the risk of potential problems. See “Conditions requiring caution” in section 4. If you have had an allergic reaction to other antibiotics, you may also be allergic to Deltazime.

If you need blood or urine tests
Deltazime may interfere with test results for glucose in urine and with the blood test known as the Coombs test. If you are undergoing these tests:
Inform the person collecting the sample that you are being treated with Deltazime.

Using Deltazime with other medicines
Tell your doctor if you are taking any other medicines, if you have recently started taking any, or if you begin taking new ones. This includes medicines obtained without a prescription.
You must not be given Deltazime without first consulting your doctor if you are taking:

• an antibiotic called chloramphenicol
• a type of antibiotics called aminoglycosides, for example gentamicin, tobramycin
• diuretic tablets called furosemide

Tell your doctor if this applies to you.

Pregnancy and breastfeeding
Inform your doctor before Deltazime is administered to you:

• if you are pregnant, think you might be pregnant, or are planning a pregnancy
• if you are breastfeeding

Your doctor will assess the benefits of treatment with Deltazime against any potential risks to the baby.

Driving and using machines
Deltazime may cause side effects that could affect your ability to drive, such as dizziness. Do not drive or operate machinery unless you are certain you will not be affected.

Important information about Deltazime excipients
Deltazime contains sodium
You need to take into account the following if you are on a controlled sodium diet.

3. HOW DELTAZIME IS ADMINISTERED

Deltazime is generally administered by a doctor or nurse. It can be given as an intravenous infusion or as an injection directly into a vein or muscle.
Deltazime is prepared by the doctor, pharmacist, or nurse using water for injection or appropriate infusion fluids.

Usual dose
The appropriate dose of Deltazime will be decided by your doctor and depends on: the severity and type of infection; whether you are being treated with other antibiotics; your body weight and age; and the condition of your kidneys.

Newborns (0–2 months)
For each kg of the child's body weight, 25 to 60 mg of Deltazime will be administered daily, divided into two doses.

Children (over 2 months) and children weighing less than 40 kg
For each kg of the infant’s or child’s body weight, 100 to 150 mg of Deltazime will be administered daily, divided into three doses. The maximum dose is 6 g per day.

Adults and adolescents weighing 40 kg or more
1 to 2 g of Deltazime three times daily. The maximum dose is 9 g per day.

Patients over 65 years of age
The daily dose generally should not exceed 3 g per day, especially if over 80 years of age.

Patients with kidney problems
You may be given a different dose than the usual one. The doctor or nurse will decide how much Deltazime you need based on the severity of your kidney disease. Your doctor will monitor you closely and may perform kidney function tests at more regular intervals.

If you are given more Deltazime than you should
If you accidentally receive a higher dose than prescribed, contact your doctor or the nearest hospital immediately.

If you forget to use Deltazime
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose (two injections at the same time) to make up for a forgotten dose.

If you stop treatment with Deltazime
Do not stop treatment with Deltazime unless your doctor tells you to do so. If you have any doubts, consult your doctor or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Deltazime can cause adverse reactions, although not everyone experiences them.
Conditions requiring attention
The following serious adverse reactions have occurred in a small number of people, but their exact frequency is unknown:

• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty in breathing.
• Skin rash with blisters resembling small targets (a dark spot in the center surrounded by a pale area with a black ring around the edge).
• Widespread rash with blisters and skin peeling (these may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Nervous system disorders: tremors, seizures, and in some cases, coma. These have occurred in patients receiving too high a dose, especially in those with kidney disease.

Contact your doctor or nurse urgently if you experience any of these symptoms.
Common adverse reactions
These may affect up to 1 in 10 patients:

• Diarrhea
• Swelling and redness along the vein
• Raised red rash which may be itchy
• Pain, burning, swelling, or inflammation at the injection site.

Inform your doctor if any of these conditions concern you.
Common adverse reactions that may be detected by blood tests include:

• Increase in a type of white blood cells (eosinophilia)
• Increase in the number of cells that help blood clot
• Increase in liver enzymes.

Uncommon adverse reactions
These may affect up to 1 in 100 patients:

• Inflammation of the intestine which may cause pain or diarrhea that may contain blood
• Candidiasis – fungal infections in the mouth or vagina
• Headache
• Dizziness
• Stomach pain
• Nausea or vomiting
• Fever and chills.

Inform your doctor if you experience any of these conditions.
Uncommon adverse reactions that may be detected by blood tests include:

• Decrease in the number of white blood cells
• Decrease in the number of platelets (cells that help blood clotting)
• Increase in blood levels of urea, azotemia, or serum creatinine.

Other adverse reactions
Other adverse reactions have occurred in a small number of people, but their exact frequency is unknown:

• Inflammation or kidney failure
• Sensation of pins and needles
• Unpleasant taste in the mouth
• Yellowing of the whites of the eyes or skin.

There have been rare reports of severe hypersensitivity reactions with severe skin rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increased eosinophils (a type of white blood cell), and effects on the kidneys, liver, and lungs (a reaction called DRESS).
Other adverse reactions that may be detected by blood tests include:

• Too rapid destruction of red blood cells
• Increase in certain types of white blood cells
• Severe decrease in the number of white blood cells.

If you experience adverse reactions
Inform your doctor or pharmacist if any of the adverse reactions become severe or concerning, or if you notice any adverse reaction not listed in this leaflet.

5. HOW TO STORE DELTAZIME

Expiry date: see the expiry date stated on the packaging.
The expiry date refers to the product in its original, unopened packaging, correctly stored.
Warning: do not use the medicinal product after the expiry date stated on the packaging.
Before reconstitution, store vials at a temperature not exceeding 25°C and protect from light.
The reconstituted solution, after reconstitution with water for injections or with compatible infusion liquids (e.g. glucose-saline solution or sodium lactate solution), must be used within 6 hours if stored at room temperature, or within 1 day if stored at 4°C.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep Deltazime out of the reach and sight of children.

6. OTHER INFORMATION

What Deltazime contains
DELTAZIME 250 mg/1 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
Active substance: Ceftazidime pentahydrate 291 mg (equivalent to 250 mg of ceftazidime)
Excipients: Powder vial: Anhydrous sodium carbonate; solvent vial: water for injections

DELTAZIME 500 mg/1.5 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
Active substance: Ceftazidime pentahydrate 582 mg (equivalent to 500 mg of ceftazidime)
Excipients: Powder vial: Anhydrous sodium carbonate; solvent vial: water for injections

DELTAZIME 1 g/3 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
Active substance: Ceftazidime pentahydrate 1.164 g (equivalent to 1 g of ceftazidime)
Excipients: Powder vial: Anhydrous sodium carbonate; solvent vial: water for injections

DELTAZIME 1 g/10 ml powder and solvent for injectable solution for intravenous use
One vial of powder contains:
Active substance: Ceftazidime pentahydrate 1.164 g (equivalent to 1 g of ceftazidime)
Excipients: Powder vial: Anhydrous sodium carbonate; solvent vial: water for injections

DELTAZIME 2 g powder for infusion solution
One vial contains:
Active substance: Ceftazidime pentahydrate 2.328 g (equivalent to 2 g of ceftazidime)
Excipients: Anhydrous sodium carbonate

Description of the appearance of Deltazime and contents of the pack
Powder and solvent for injectable solution for intramuscular use
Carton pack containing 1 vial of 250 mg powder + 1 solvent vial of 1 ml
Carton pack containing 1 vial of 500 mg powder + 1 solvent vial of 1.5 ml
Carton pack containing 1 vial of 1 g powder + 1 solvent vial of 3 ml

Powder and solvent for injectable solution for intravenous use
Carton pack containing 1 vial of 1 g powder + 1 solvent vial of 10 ml

Powder for infusion solution
Carton pack containing 1 vial of 2 g powder

Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Strada Solaro, 75/77 - 18038 Sanremo (IM)