ITOREX 1000 mg /4 Ml Proszek I Rozpuszczalnik Do Roztworu Do Wstrzykiwań
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Treść ulotki
ITOREX 1 g powder and solvent for injectable solution for intramuscular use
Cefuroxime
Generic medicine
Read this leaflet carefully before you use 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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of this leaflet:
- 1. What Itorex is and what it is used for
- 2. What you need to know before you are given Itorex
- 3. How Itorex is administered
- 4. Possible side effects
- 5. How to store Itorex
- 6. Contents of the pack and other information
1. What Itorex is and what it is used for
Itorex is an antibiotic used in adults and children. It works by killing the bacteria that cause
infections and belongs to a group of medicines called cephalosporins.
Itorex is used to treat infections of:
- lungs or chest
- urinary tract
- skin and soft tissues
- abdomen
Itorex is also used:
- to prevent infections during surgery. The doctor may check the type of bacteria causing the infection and check if the bacteria are sensitive to Itorex during treatment.
2. What you need to know before you are given Itorex
You must not be given ITOREX
- if you are allergic to any antibiotic of the cephalosporin class or to any of the other components of Itorex (listed in section 6)
- if you have had a severe allergic reaction ( hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams and carbapenems). Talk to your doctor beforestarting treatment with Itorex if you think this applies to you, because in this case you must not be given Itorex.
Pay particular attention with Itorex
- Pay attention to some symptoms such as allergic reactions, skin rashes, gastrointestinal disorders such as diarrhea or fungal infections while being treated with Itorex. This will reduce the risk of possible problems. See ( Conditions for which you should be careful) in section 4. If you have had any allergic reaction to other antibiotics such as penicillin, you may also be allergic to Itorex.
- If you need blood or urine tests
- Itorex can interfere with the results of urine or blood tests for the presence of sugar and a blood test known as the Coombs' test. If you are undergoing these tests:
- Inform the person taking the samplethat you are being treated with Itorex.
Other medicines and ITOREX
Tell your doctor if you are taking any other medicine. if you have started to
take any recently or if you start to take new ones. This also includes
over-the-counter medicines.
Some medicines can affect the activity of ITOREX, or make it more likely that you have side
effects. These include:
- aminoglycoside type antibiotics
- diuretic drugssuch as furosemide
- probenecid
- oral anticoagulants
Tell your doctor if this applies to you. You may need further checks to monitor your
kidney function while being treated with ITOREX
Contraceptive pill
Itorex may reduce the effectiveness of the contraceptive pill. If you are taking the pill
contraceptive while being treated with Itorex you should also use a
barrier method of contraception(such as a condom). Ask your doctor for
advice.
Pregnancy, breastfeeding and fertility
Tell your doctor before you are given Itorex:
- if you are pregnant, if you think you may be, or are planning a pregnancy
- if you are breastfeeding Your doctor will assess the benefit of treatment with ITOREX against the risk to your baby.
Driving and operating machinery
Do not drive vehicles or operate machinery if you do not feel well.
ITOREX contains Sodium
If you are following a sodium-controlled diet, tell your doctor before taking
ITOREX, as each vial of medicine contains 56 mg of sodium.
You need to consider the following, if you are following a
diet to control sodium.
1g
This medicine contains 56 mg of sodium (the main component of table salt) in
each vial. This is equivalent to 2.8% of the maximum recommended daily intake of sodium
with the diet of an adult.
3. How Itorex is administered
Itorex is generally administered by a doctor or nurse. It may be
administered as an injection directly into the muscle
Recommended dose
The appropriate dose of Itorex 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; the condition of your
kidneys.
Newborns (from 0 to 3 weeks)
30 to 100 mg of Itorex will be administered per kg of the baby's body weight per
day, divided into two or three doses.
Infants (over 3 weeks) and children
30 to 100 mg of
Itorex will be administered per kg of the infant or child's body weight per day, divided into three or four doses.
Adults and adolescents
750 mg to 1.5 g of Itorex per day divided into two, three or four doses. Maximum dose: 6 g per day.
Patients with kidney problems
If you have kidney problems, your doctor may change the dose. Talk to your doctor if this applies to you.
4. Possible side effects
Like all medicines, Itorex can cause side effects, although not everybody gets them.
manifest.
Conditions for which you should pay attention
A small number of people treated with Itorex may experience an allergic reaction or a
potentially serious skin reaction. The symptoms of these reactions include:
- severe allergic reaction.Signs include a raised, itchy rash, swelling, sometimes on the face or in the mouth causing difficulty in breathing.
- skin rashwith 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 rashwith blisters and peeling of the skin (These may be signs of Stevens-Johnson syndromeor toxic epidermal necrolysis).
- Other symptoms for which it is necessary that you are aware of while you are intreatment with Itorex:
- fungal infectionsin rare cases, medicines like Itorex can cause an overgrowth of fungi (Candida) in the body, which can lead to fungal infections (such as thrush). This side effect is more likely if you take Itorex for a long time.
- severe diarrhea (pseudomembranous colitis). Medicines like Itorex can cause inflammation of the colon (large intestine) which causes severe diarrhea usually with blood and mucus, stomach pain, fever. Contact your doctor or nurse immediately if you experience any ofthese symptoms.
Common side effects
These may affect up to 1patient in 10:
- pain at the injection site, swelling and redness along the vein. Tell your doctorif any of these conditions worries you Common side effects that can be detected by blood tests:
- increased substances (enzymes) produced by the liver
- changes in the number of white blood cells (neutropeniaor eosinophilia)
- low levels of red blood cells (anemia)
Uncommon side effects
These may affect up to 1patient in 100
- skin rash, itching, irregular rash (urticaria)
- diarrhea, nausea, stomach pain Tell your doctorif you experience any of these conditions. Uncommon side effects that can be detected by blood tests:
- low levels of white blood cells (leukopenia)
- increased bilirubin (a substance produced by the liver)
- positive Coombs test
Other side effects
Other side effects have occurred in a very small number of people, but their
exact frequency is unknown:
- fungal infections
- high temperature (fever)
- allergic reactions
- inflammation of the colon (large intestine) which causes diarrhea usually with blood and mucus, stomach pain
- inflammation in the kidneys and blood vessels
- too fast destruction of red blood cells (hemolytic anemia)
- skin 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) erythemamultiformeTell your doctorif you experience any of these conditions. Side effects that can be detected by blood tests: .
- decreased number of platelets (cells that help blood clotting - thrombocytopenia)
- increased levels of azotemia and creatinine in the blood
Reporting of side effects
If you get any side effect, even if not listed in this
leaflet, please tell your doctor or pharmacist. You can also report side effects
directly through the reporting system at the address:
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 Itorex
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 pack after Exp. The
expiry date refers to the last day of that month.
Store at a temperature below 25°C. Keep the vial in the outer packaging
to protect it from light.
When reconstituted for injection, the medicine can be stored for 5 hours if
maintained at a temperature below 25°C, or for 72 hours if maintained at a temperature
between 2 - 8 °C.
From a microbiological point of view, the medicine must be used immediately. If not
used immediately, the storage times in use and the conditions before use
are the responsibility of the user and should normally not exceed 24 hours between
2-8°C, unless the reconstitution has taken place under controlled and
validated aseptic conditions.
Do not dispose of any medicine in wastewater or household waste. Your doctor or nurse
will dispose of medicines that are no longer used. This will help protect the environment
6. Package Contents and Other Information
What Itorex contains
Each vial contains 1 g of cefuroxime (as cefuroxime sodium).
Each solvent vial contains water for injections
There are no other components.
Description of the appearance of Itorex and contents of the pack
Colourless glass vial, with a bromobutyl rubber stopper and aluminium seal
with a tear-off plastic protection containing 1 g of cefuroxime (as cefuroxime
sodium) powder + vial of water for injections as a solvent.
Marketing Authorisation Holder
Tecnopharma S.r.l., Via Sestri n° 29A/3 – Genoa
Manufacturer
Esseti Farmaceutici S.r.l., Via Campobello 15 – Pomezia (RM)
The following information is intended exclusively for doctors or healthcare professionals:
Instructions for reconstitution
Addition of volumes and concentrations of the solution that may be useful if
fractional doses are required.
**The resulting volume of the cefuroxime solution in the reconstitution medium is increased due to
the distribution factor of the active ingredient, which leads to the concentrations listed in
mg/ml.
Compatibility
1.5 g of cefuroxime sodium reconstituted with 15 ml of water for injections can be
added to an injectable solution of metronidazole (500 mg/100 ml).
1.5 g of cefuroxime sodium is compatible with azlocillin 1 g (in 15 ml) or 5 g (in 50 ml).
Cefuroxime sodium (5 mg/ml) can be used in an injectable solution of xylitol 5% w/v or 10%
w/v.
Cefuroxime sodium is compatible with aqueous solutions containing up to 1% of lidocaine
hydrochloride.
Cefuroxime sodium is compatible with the following infusion fluids:
Sodium chloride 0.9% w/v for injectable preparations BP Dextrose 5% for injectable preparations BP
Sodium chloride 0.18% w/v plus Dextrose 4% for injectable preparations BP Dextrose 5% and Sodium
chloride 0.9% w/v for injectable preparations BP Dextrose 5% and Sodium chloride 0.45% for
injectable preparations Dextrose 5% and Sodium chloride 0.225% for injectable preparations Dextrose
10% for injectable preparations
Ringer's lactate solution for injectable preparations USP Sodium lactate M/6 for injectable
preparations
Compound sodium lactate for injectable preparations BP (Hartmann's solution).
The stability of cefuroxime sodium in 0.9% w/v sodium chloride solution for
injectable preparations BP and in 5% dextrose solution for injectable preparations is not
affected by the presence of sodium phosphate hydrocortisone.
Cefuroxime sodium has also been found to be compatible when mixed in intravenous
infusion with: Heparin (10 and 50 units/ml) in 0.9% w/v sodium chloride injectable solution;
Potassium chloride (10 and 40 mEqL) in 0.9% w/v sodium chloride injectable solution.
| Addition of volumes and concentrations that may be useful if fractional doses are required | ||||
| Type of vial | Route of administration | Physical state | Amount of water to add (ml) | m Approximate cefuroxime concentration (mg/ml)** |
| a 1 g powder for injectable solution | ||||
| 1 g | intramuscular | suspension | F 4 ml | 216 |
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- Kraj rejestracji
- Postać farmaceutycznaPowder and solvent for injectable solution, 1000 MG + 4 ML
- Kod ATCJ01DC02
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki ITOREXPostać farmaceutyczna: Film-coated tablet, 250 MGSubstancja czynna: cefuroximeProducent: EG S.P.A.Wymaga receptyPostać farmaceutyczna: Powder for injectable solution, 750 MGSubstancja czynna: cefuroximeProducent: K24 PHARMACEUTICALS S.R.L.Wymaga receptyPostać farmaceutyczna: Film-coated tablet, 250 MGSubstancja czynna: cefuroximeProducent: MYLAN S.P.A.Wymaga recepty
Odpowiedniki ITOREX w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
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ITOREX nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w ITOREX jest cefuroxime. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
ITOREX jest produkowany przez TECNOPHARMA S.R.L.. 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 ITOREX 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 ITOREX 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 (cefuroxime) to m.in. KEFUROXIMA EG, KEFUROXIMA K24 PARMAKEUTIKALS, KEFUROXIMA MYLAN. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
