CEFTAZIDIMA 1 G/3 ML Roztwór do wstrzykiwań
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Treść ulotki
CEFTAZIDIMA DOC
1 g/3 ml powder and solvent for injectable solution for intramuscular use
Generic medicine
Read this leaflet carefully before using this medicinebecause 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.
- If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.
Contents of this leaflet:
- 1. What CEFTAZIDIMA DOC is and what it is used for
- 2. What you need to know before you are given CEFTAZIDIMA DOC
- 3. How CEFTAZIDIMA DOC is administered
- 4. Possible side effects
- 5. How to store CEFTAZIDIMA DOC
- 6. Contents of the pack and other information
1. What CEFTAZIDIMA DOC is and what it is used for
CEFTAZIDIMA DOC 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 DOC 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 DOC 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 you are given CEFTAZIDIMA DOC
You must not be given CEFTAZIDIMA DOC:
- if you are allergicto ceftazidimeor any of the other ingredients of this medicine (listedin section 6)
- if you have had a severe allergic reactionto any other antibiotic(penicillins, monobactams and carbapenems) as you may also be allergic to CEFTAZIDIMA DOC.
➔ Tell your doctorbefore starting treatment with CEFTAZIDIMA DOC if you think this applies to you. You must not be given CEFTAZIDIMA DOC.
Warnings and precautions
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 treatment with ceftazidime. Contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Take special care with CEFTAZIDIMA DOC
Pay attention to some symptoms such as allergic reactions, nervous system disorders and gastrointestinal disorders such as diarrhoea while being treated with CEFTAZIDIMA DOC. 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 DOC.
If you need blood or urine tests
CEFTAZIDIMA DOC may interfere with the results of tests for the presence of sugar in the 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 DOC.
Other medicines and CEFTAZIDIMA DOC
Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines you can get without a prescription.
You must not be given CEFTAZIDIMA DOC without consulting your doctor if you are taking:
- an antibiotic called chloramphenicol
- a type of antibiotics called aminoglycosidessuch as gentamicin, tobramycin
- diuretic tablets called furosemide➔ Tell your doctorif this applies to you.
Pregnancy and breastfeeding
Ask your doctor for advice before you are given CEFTAZIDIMA DOC:
- if you are pregnant, suspect you may be pregnant or are planning to become pregnant
- if you are breastfeeding.
The doctor will assess the benefit of treatment with CEFTAZIDIMA DOC against the risk to the baby.
Driving and using machines
CEFTAZIDIMA DOC can cause side effects that affect your ability to drive, such as dizziness.
Do not drive or use machines unless you are sure you are not experiencing any effects.
CEFTAZIDIMA DOC contains sodium.
You need to take the following into consideration if you are on a controlled sodium diet.
This medicine contains 116.4 mg of sodium (the main component of table salt) as anhydrous sodium carbonate per vial. This is equivalent to 5.8% of the maximum recommended daily intake of sodium for an adult.
3. How CEFTAZIDIMA DOC is administered
CEFTAZIDIMA DOC is generally administered by a doctor or nurse.
It can be administered as an injectiondirectly into the muscle.
CEFTAZIDIMA DOC is prepared by the doctor, pharmacist or nurse using water for
injectable preparations.
Recommended dose
The appropriate dose of CEFTAZIDIMA DOC will be decided by the doctor and depends on: the severity and type of infection; whether you are undergoing treatment with other antibiotics; your body weight and age; your
kidney function.
Newborns (0-2 months)
For each kg of the baby's body weight, 25 to 60 mg of CEFTAZIDIMA DOC 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 DOC 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 DOC 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 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 DOC you need based on the severity of your kidney disease. The doctor will monitor you carefully and may have kidney function tests at more regular intervals.
If you are given too much CEFTAZIDIMA DOC
If you accidentally use a higher dose than prescribed, contact your doctor or the nearest
hospital immediately.
If you forget to use CEFTAZIDIMA DOC
If you forget an injection, you should take it as soon as possible. Do not take a double dose (two
injections at the same time) to make up for the missed dose, just take the next dose at the usual time.
If you stop treatment with CEFTAZIDIMA DOC
Do not stop treatment with CEFTAZIDIMA DOC 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 everybody gets them.
Seek immediate medical attention if you experience any of the following symptoms:
- Reddish patches on the trunk, the patches are target-like or circular, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe 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, fatigue, facial swelling, increased eosinophils (a type of white blood cells), effects on the liver, kidney or lung (DRESS syndrome or drug hypersensitivity syndrome)
- Widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
Conditions for which you should pay attention
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, itchy rash, swelling, sometimes on the face or mouth causing difficulty breathing.
- Rash with formation of blisters resembling small targets (a dark spot in thecenter surrounded by a clear area with a black ring around the edge).
- Nervous system disorders:tremors, convulsions and, in some cases, coma. These have occurred in people in whom the dose administered to them was too high, especially in people with kidney disease. ➔ Contact your doctor or nurse urgently if you experience any of these symptoms.
Common side effects
These may affect up to 1in 10patients:
- diarrhoea
- 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 worry 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 to clot
- an increase in liver enzymes.
Uncommon side effects
These may affect up to 1in 100patients:
- inflammation of the intestine that can cause pain or diarrhoea 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 to clot)
- an increase in the level in the blood of urea, azotemia or serum creatinine.
Very rare side effects
These may affect up to 1in 10,000patients:
- 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 in the mouth
- 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 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 DOC
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 expiry. The expiry date refers to the last day of that month.
Before reconstitution, store the vials protected from light and at a temperature not exceeding
25 C°.
The product in solution, after reconstitution with water for injection, should normally be used within 18
hours if stored at room temperature and within 7 days if stored at 4 °C.
Do not dispose of any medicine in the 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 DOC contains
One vial of powder contains:
- The active ingredient is ceftazidime pentahydrate 1.164 g (equivalent to ceftazidime 1 g).
- The other component is anhydrous sodium carbonate.
The solvent vial contains water for injections.
Description of the appearance of CEFTAZIDIMA DOC and contents of the pack
Type III colorless glass vials with elastomer material stoppers and aluminum caps; type I
colorless glass vials.
CEFTAZIDIMA DOC 1 g/3 ml powder and solvent for injectable solution for intramuscular use, 1
vial of powder + 1 vial of 3 ml solvent.
Marketing authorization holder and manufacturer
Marketing authorization holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – Italy.
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. – Via Dante Alighieri 71 - 18038 Sanremo (Imperia) – Italy.
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- Kraj rejestracji
- Postać farmaceutycznaInjectable solution, 1 G/ 3 ML
- Kod ATCJ01DD02
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki KEFTATSIDIMA DOKPostać farmaceutyczna: Injectable solution, 1 G/ 3 MLSubstancja czynna: ceftazidimeProducent: ALMUS S.R.L.Wymaga receptyPostać farmaceutyczna: Powder and solvent for injectable solution, 250 MGSubstancja czynna: ceftazidimeProducent: BIOPHARMA S.R.L.Wymaga receptyPostać farmaceutyczna: Injectable solution, 1 G/ 3 MLSubstancja czynna: ceftazidimeProducent: FG S.R.L.Wymaga recepty
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KEFTATSIDIMA DOK wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w KEFTATSIDIMA DOK jest ceftazidime. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
KEFTATSIDIMA DOK jest produkowany przez DOC GENERICI SRL. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie KEFTATSIDIMA DOK jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić KEFTATSIDIMA DOK w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (ceftazidime) to m.in. KEFTATSIDIMA ALMUS, KEFTATSIDIMA BIOPARMA, KEFTATSIDIMA EG STADA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
