CEFTAZIDIMA 1 Г/3 МЛ Инъекционный раствор

Содержание инструкции

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

CEFTAZIDIMA EG STADA 1g/3 ml

powder and solvent for injectable solution for intramuscular use
Generic medicine

Read this leaflet carefully before using this medicine as 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What CEFTAZIDIMA EG STADA is and what it is used for

CEFTAZIDIMA EG STADA 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.
CEFTAZIDIMA EG STADA is used to treat severe bacterial infections of:

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

CEFTAZIDIMA EG STADA can 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 a fever due to a bacterial infection.

2. What you need to know before using CEFTAZIDIMA EG STADA

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Do not use CEFTAZIDIMA EG STADA:

• 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 CEFTAZIDIMA EG STADA.

Tell your doctorbefore starting treatment with CEFTAZIDIMA EG STADA if you think this applies to you. You must not be given CEFTAZIDIMA EG STADA.

Warnings and precautions
Talk to your doctor or nurse before using CEFTAZIDIMA EG STADA.

Take special care with CEFTAZIDIMA EG STADA
Pay attention to some symptoms such as allergic reactions, nervous system disorders and gastrointestinal disorders such as diarrhoea while being treated with CEFTAZIDIMA EG STADA. This will reduce the risk of possible problems. See ( Conditions for which you should be careful) in section

• 4. If you have had an allergic reaction to other antibiotics you may also be allergic to CEFTAZIDIMA EG STADA.

If you need blood or urine tests
CEFTAZIDIMA EG STADA may interfere with the results of tests for the presence of sugar in your urine and a blood test known as the Coombs’ test. If you are undergoing these tests:

Tell the person taking the samplethat you are being treated with CEFTAZIDIMA EG STADA.

Other medicines and CEFTAZIDIMA EG STADA
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
You must not be given CEFTAZIDIMA EG STADA without consulting your doctor if you are taking:

• an antibiotic called chloramphenicol
• a type of antibiotics called aminoglycosidesfor example gentamicin, tobramycin
• diuretic tablets called furosemideTell your doctorif this applies to you.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or nurse for advice before using this medicine.
The doctor will assess the benefit of treatment with CEFTAZIDIMA EG STADA against the risk to the child.

Driving and using machines
CEFTAZIDIMA EG STADA can cause side effects that affect your ability to drive, such as dizziness.
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Do not drive or use machines unless you are sure you are not experiencing any effects.

CEFTAZIDIMA EG STADA contains sodium
This medicine contains 50.5 mg of sodium (the main component of table salt) per vial. This is equivalent to 2.5% of the recommended maximum daily intake of sodium with the diet of an adult.

3. How to use CEFTAZIDIMA EG STADA

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
CEFTAZIDIMA EG STADA is generally administered by a doctor or a nurse.
It can be administered as an injection directly into the muscle.
CEFTAZIDIMA EG STADA is prepared by the doctor, pharmacist or nurse using
water for injectable preparations.

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

Newborn babies (0-2 months)
For each kg of the baby's body weight, 25 to 60 mg of CEFTAZIDIMA
EG STADA will be administered per day divided into two doses.

Children (over 2 months) and children weighing less than 40 kg
For each kg of the newborn or child's body weight, 100 to 150 mg
of CEFTAZIDIMA EG STADA will be administered per day 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 CEFTAZIDIMA EG STADA three times a day. The maximum dose is 9 g per day.

Elderly patients over 65 years of age
The daily dose should generally not 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 than usual. The doctor or nurse will decide
how much CEFTAZIDIMA EG STADA you need based on the severity of kidney disease. The doctor will
monitor you carefully and may have kidney function tests at more regular intervals.

If you use more CEFTAZIDIMA EG STADA than you should
If you accidentally use a higher dose than prescribed, contact your
doctor or the nearest hospital immediately.

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

If you stop treatment with CEFTAZIDIMA EG STADA
Do not stop treatment with CEFTAZIDIMA EG STADA unless your doctor tells you to do so.
If you have any doubts, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Conditions for which attention should be paid
The following serious side effects have occurred in a small number of people, but their
exact frequency is unknown:

• severe allergic reaction. Signs include a raised, itchy rash, swelling, sometimes on the face or in the mouth causing difficulty breathing.
• rash with the formation of blisters resembling small targets (a dark spot in the center surrounded by a clear area with a black ring around the edge).
• widespread rash with blisters and peeling of the skin (these may be signs of Stevens-Johnson syndromeor toxic epidermal necrolysis).
• nervous system disorders: tremors, convulsions and, in some cases, coma. These have occurred in people in whom the dose they were receiving was too high, especially in people with kidney disease.
• rare, serious hypersensitivity reactions with severe rash have been reported, which may be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils (a type of white blood cell), effects on the kidneys, liver and lungs (a reaction called DRESS) have been reported.

Contact your doctor or nurse urgently if you experience any of these symptoms.
Common side effects (may affect up to 1 in 10 people)

• diarrhea
• swelling and redness along the vein
• raised red rash that may be itchy
• pain, burning, swelling or inflammation at the injection site.

Tell your doctorif any of these conditions worries you.
Common side effects that can be detected by blood tests are:

• an increase in a type of white blood cells (eosinophilia)
• an increase in the number of cells that help blood clotting 4/6
• an increase in liver enzymes.

Uncommon side effects (may affect up to 1 in 100 people):

• inflammation of the intestine that can 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 doctorif you experience any of these conditions.

Uncommon side effects that can be detected by blood tests are:

• a reduction in the number of white blood cells
• a reduction in the number of platelets (cells that help blood clotting)
• an increase in the level in the blood of urea, azotemia or serum creatinine.

Very rare side effects (may affect up to 1 in 10,000 people)

• inflammation or kidney failure

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

• pins and needles sensation
• unpleasant taste
• yellowing of the whites of the eyes or skin

Other side effects that can be detected by blood tests are:

• too fast destruction of red blood cells
• an increase in some types of white blood cells
• severe decrease in the number of white blood cells.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at 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 CEFTAZIDIMA EG STADA

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 on the
outer packaging after Exp. The expiry date refers to the last day of that month.
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Before reconstitution, store the vials protected from light and at a temperature below 25
°C.
The product in solution, after reconstitution with water for injections, should normally be used within 8
hours if stored at room temperature (25°C) and within 48 hours if stored in a refrigerator (2° -
4°C).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CEFTAZIDIMA EG STADA contains
One vial of powder contains:
Active ingredient: ceftazidime 1 g (as pentahydrate) with sodium carbonate.
Excipients: Anhydrous sodium carbonate
Solvent vial contains:
Excipients: water for injections

Description of the appearance of CEFTAZIDIMA EG STADA and contents of the pack
Colourless type III glass vial with an elastomer stopper and an aluminium cap; vial
of colorless type I glass.

CEFTAZIDIMA EG STADA 1g/3 mlpowder and solvent for injectable solution for use
intramuscularly
1 vial of powder + 1 solvent vial of 3 ml

Marketing Authorisation Holder
FG S.r.l. –Via San Rocco, 6 – 85033 Episcopia (Potenza)

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l.
Via Dante Alighieri, 71 - 18038 Sanremo (IM)
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________________________________________________________________________________
The following information is intended for healthcare professionals only

Please refer to the Summary of Product Characteristics for further
information
Shelf life
2 years

Special precautions for storage
Before reconstitution, store the vials protected from light and at a temperature below
25°C.
The product in solution, after reconstitution with water for injections, should normally be used within 8
hours if stored at room temperature (25°C) and within 48 hours if stored in a refrigerator (2° -
4°C).

Incompatibilities
Ceftazidime should not be mixed in the same infusion set or syringe with
aminoglycosides. Precipitation has been reported when adding vancomycin to
ceftazidime solutions.

Special precautions for disposal and handling
All types of CEFTAZIDIMA EG STADA vials are supplied with reduced pressure. Since the
product dissolves, carbon dioxide is released and positive pressure develops.
Small bubbles of carbon dioxide in the reconstituted solution can be ignored.
Instructions for reconstitution
See the table for the addition of volumes and concentrations of the solution that may be
useful if fractional doses are required.

The colour of solutions may vary from pale yellow to amber depending on the
concentration, type of diluent and storage conditions used. Within the
recommended guidelines, the activity of the product is not affected by such colour variations.
Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with:
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• sodium chloride 9 mg/ml (0.9%) for injections
• sodium lactate M/6 for injections
• compound sodium lactate for injections (Hartmann's solution)
• glucose 5% for injections
• sodium chloride 0.225% and glucose 5% for injections
• sodium chloride 0.45% and glucose 5% for injections
• sodium chloride 0.9% and glucose 5% for injections
• sodium chloride 0.18% and glucose 4% for injections
• glucose 10% for injections
• Dextran 40 10% for injections in sodium chloride 0.9% for injections
• Dextran 40 10% for injections in glucose 5% for injections
• Dextran 70 6% for injections in sodium chloride 0.9% for injections
• Dextran 70 6% for injections in glucose 5% for injections

Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with
lactate solution for intra-peritoneal dialysis.
Ceftazidime can be reconstituted for intramuscular use with lidocaine hydrochloride 0.5% or 1%
for injections.
Unused medicine or waste material derived from such medicine should be disposed of in
accordance with local regulations.
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