Starcef

PACKAGE LEAFLET: INFORMATION FOR THE USER

Starcef 500 mg/1.5 ml powder and solvent for injectable solution, 1 g/3 ml powder and solvent for injectable solution

Ceftazidime
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Starcef is and what it is used for
2. What you need to know before using Starcef
3. How to use Starcef
4. Possible side effects
5. How to store Starcef
6. Contents of the pack and other information

1. What Starcef is and what it is used for

Starcef 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.
Starcef is used to treat serious bacterial infections of the:

• lungs or chest
• lungs and airways in patients with cystic fibrosis
• brain ( meningitis )
• ear
• urinary tract
• skin and soft tissues
• abdomen and abdominal wall ( peritonitis )
• bones and joints.

Starcef may also be used:

• to prevent infections during surgical operations on the prostate in men
• to treat patients with a low number of white blood cells ( neutropenia ) who have fever due to a bacterial infection.

2. What you need to know before using Starcef

Starcef must not be administered to you if:

• You are allergic 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 Starcef.

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

Warnings and precautions
Be cautious of certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disorders such as diarrhoea while being treated with Starcef. 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 Starcef.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ceftazidime treatment. Seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.

If you need blood or urine tests
Starcef 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 Starcef.

Other medicines and Starcef
Inform your doctor if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription.

Do not take Starcef without first consulting your doctor if you are currently taking:

• An antibiotic called chloramphenicol
• A class of antibiotics called aminoglycosides, for example gentamicin, tobramycin
• Diuretic tablets called furosemide
  Tell your doctor if this applies to you.

Pregnancy, breastfeeding, and fertility
Ask your doctor for advice before being given Starcef:

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant
• If you are breastfeeding with breast milk

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

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

Starcef contains sodium

Starcef 500 mg/1.5 ml
This medicine contains 29.46 mg of sodium (the main component of table salt) per vial of powder. This corresponds to 1.47% of the maximum daily dietary intake recommended for an adult.

Starcef 1 g/3 ml
This medicine contains 58.92 mg of sodium (the main component of table salt) per vial of powder. This corresponds to 2.95% of the maximum daily dietary intake recommended for an adult.

3. How to use Starcef

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

Recommended dose
The dose of Starcef 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)
From 25 to 60 mg of Starcef per kg of body weight per day, divided into two doses.

Children (over 2 months) and children weighing less than 40 kg
From 100 to 150 mg of Starcef per kg of body weight per day, divided into three doses. The maximum dose is 6 g per day.

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

Patients over 65 years of age
The daily dose should generally 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 usual. The doctor or nurse will decide how much Starcef you need based on the severity of your kidney disease. Your doctor will monitor you closely and may carry out kidney function tests at more regular intervals.

If you use more Starcef than you should
If you accidentally use more than the prescribed dose, contact your doctor or the nearest hospital immediately.

If you forget to use Starcef
If you miss an injection, you should have it as soon as possible. Do not take a double dose (two injections at the same time) to make up for the missed dose; simply take the next dose at the usual time.

Do not stop treatment with Starcef
Do not stop treatment with Starcef unless your doctor tells you to. If you have any further questions about 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 everyone gets them.
Conditions requiring immediate attention
The following serious side effects have occurred in a small number of people, but their exact frequency is unknown.
Contact your doctor immediately if you notice any of the following symptoms:

• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty breathing.
• Nervous system disorders: tremors, seizures and, in some cases, coma. These have occurred in patients who were given too high a dose, especially in people with kidney disease.
• Skin rash with blister-like lesions resembling small targets, characterized by a dark spot in the center surrounded by a lighter area with a black ring around the edge (erythema multiforme).
• Reddish patches on the trunk; the patches are target-like or circular macules, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized pustular eruption).

Common side effects
These may affect up to 1 in 10 patients:

• Diarrhea
• Swelling and redness along the vein
• Raised, red, possibly itchy rash
• Pain, burning, swelling, or inflammation at the injection site. Tell your doctor if any of these conditions concern you.

Common side effects 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 side effects
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. Tell your doctor if you experience any of these conditions.

Uncommon side effects 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, blood urea nitrogen, or serum creatinine.

Very rare side effects
These may affect up to 1 in 10,000 patients:

• Kidney inflammation or kidney failure

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

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

Other side effects 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.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Stacef

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 outer packaging after "exp." The expiry date refers to the last day of that month.
Store below 25°C.

Reconstituted solution
The doctor, pharmacist, or nurse will prepare the medicine in water for injections or in compatible fluids. Once prepared, the medicine should be used within 6 days if stored in a refrigerator (at 4⁰C) or within 9 hours if stored at room temperature (below 25⁰C).

Keep the vials in the original packaging to protect them from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package Contents and Other Information

What Starcef Contains

• Starcef is available in the following strengths: 500 mg/1.5 ml and 1 g/3 ml. The active substance is ceftazidime (present as ceftazidime pentahydrate).
  Starcef 500 mg/1.5 ml powder and solvent for injectable solution contains 500 mg of ceftazidime.
  Starcef 1 g/3 ml powder and solvent for injectable solution contains 1 g of ceftazidime.
• The only other component is sodium carbonate (anhydrous sterile).
• See section 2 for further important information about sodium, one of the components of Starcef.

Description of the Appearance of Starcef and Contents of the Package
Starcef 500 mg/1.5 ml powder and solvent for injectable solution:

• 1 vial of sterile powder, white to cream-colored, 500 mg, contained in a 17 ml glass vial with a bromobutyl rubber stopper and an aluminum seal + 1 glass ampoule containing 1.5 ml of solvent

Starcef 1 g/3 ml powder and solvent for injectable solution:

• 1 vial of sterile powder, white to cream-colored, 1 g, contained in a 17 ml glass vial with a bromobutyl rubber stopper and an aluminum seal + 1 glass ampoule containing 3 ml of solvent

The doctor, pharmacist, or nurse will prepare the injection or infusion in water for
injections or in a suitable infusion fluid. Once prepared, Starcef changes color from
light yellow to amber. This is perfectly normal.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: F.I.R.M.A. S.p.A. – Via di Scandicci, 37 - Florence
Manufacturer:
MITIM S.r.l. - Via Cacciamali, 34-38 - Brescia

The following information is intended exclusively for healthcare professionals:
Please refer to the Summary of Product Characteristics for further information

Shelf Life
3 years

After reconstitution:
Chemical and physical in-use stability has been demonstrated for 6 days at 4°C and 9 hours at 25°C in water for injections or in the compatible fluids listed below.
From a microbiological standpoint, the reconstituted solution should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless reconstitution has taken place under controlled and validated aseptic conditions.

After dilution:
Chemical and physical in-use stability has been demonstrated for 6 days at 4°C and 9 hours at 25°C in water for injections or in the compatible fluids listed below.
From a microbiological standpoint, the reconstituted and diluted solution should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless reconstitution has taken place under controlled and validated aseptic conditions.

Special Precautions for Storage
Store below 25°C.
Keep vials in the original packaging to protect from light.

Special Precautions for Disposal
All types of Starcef vials are supplied under reduced pressure. As the product dissolves, carbon dioxide is released and positive pressure develops. Small bubbles of carbon dioxide in the reconstituted solution may be disregarded.

Instructions for Reconstitution
See the Table for guidance on volume additions and resulting solution concentrations, which may be useful when fractional doses are required.

Note:

• The resulting volume of the ceftazidime solution in the reconstitution medium increases due to the displacement factor of the medicinal product, resulting in the concentrations listed in mg/ml shown in the table above.

The color of the solutions may vary from pale yellow to amber depending on the concentration, type of diluent, and storage conditions used. Within the recommended guidelines, the product's activity is not impaired by such color variations.

Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with:

• Sodium chloride 9 mg/ml (0.9%) for injections
• Sodium lactate M/6 for injections
• Compound sodium lactate for injections (Hartmann's solution)
• Dextrose 5% for injections
• Sodium chloride 0.225% and dextrose 5% for injections
• Sodium chloride 0.45% and dextrose 5% for injections
• Sodium chloride 0.9% and dextrose 5% for injections
• Sodium chloride 0.18% and dextrose 4% for injections
• Dextrose 10% for injections
• Dextran 40 10% for injections in sodium chloride 0.9% for injections
• Dextran 40 10% for injections in dextrose 5% for injections
• Dextran 70 6% for injections in sodium chloride 0.9% for injections
• Dextran 70 6% for injections in dextrose 5% for injections

Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with peritoneal dialysis lactate solution.

Ceftazidime at the concentrations listed in the Table may be reconstituted for intramuscular use with 0.5% or 1% lidocaine hydrochloride for injections.

The contents of a 500 mg vial of injectable ceftazidime, reconstituted with 1.5 ml of water for injections, may be added to metronidazole solutions (500 mg in 100 ml), and both will retain their activity.

500 mg and 1 g powder for injectable solution
Preparations for injection solutions for bolus injection

1. Insert the syringe needle through the vial closure and inject the recommended amount of diluent. The absence of air may facilitate entry of the diluent. Remove the syringe needle.
2. Shake to dissolve: carbon dioxide will be released and a clear solution will be obtained within 1–2 minutes.
3. Turn the vial. With the syringe plunger fully depressed, insert the needle through the vial opening and withdraw the total volume of solution into the syringe (the pressure in the vial may assist withdrawal). Ensure that the needle remains within the solution and does not enter the headspace. The withdrawn solution may contain small bubbles of carbon dioxide; these may be disregarded.

These solutions may be administered directly intravenously or introduced through an infusion set if the patient is receiving parenteral fluids. Ceftazidime is compatible with the infusion fluids listed above.

Any remaining antibiotic solution must be discarded.

For single use only.

Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.