Cefuroxime 1.5 g.

What is Cefuroxime Actavis is and what it is used
Cefuroxime Actavis is an antibiotic that is used in adults and children. It works by killing bacteria that cause infections. Belongs to a group of drugs called cephalosporins.

Cefuroxime Actavis is used to treat infections of:
lungs or chest;
urinary tract;
skin and soft tissues;
belly.
Cefuroxime Actavis is also used for:
prevention of infections in surgical operations.
2. What you need to know before you are given Cefuroxime Actavis You should not apply Cefuroxime Actavis
if you are allergic (hypersensitive) to cephalosporin antibiotics or any of the other ingredients of this medicine (listed in section 6);
if you have ever had a severe allergic reaction (hypersensitivity) reaction to other beta-lactam antibiotics (penicillins, carbapenems and monobactams).
If you think this applies to you, tell your doctor before you start treatment with Cefuroxime Actavis, because in such cases should not be given to you Cefuroxime Actavis.

Take special care with Cefuroxime Actavis
While you apply Cefuroxime Actavis should be monitored for symptoms such as allergic reactions and gastrointestinal disorders such as diarrhea. This will reduce the risk of possible problems. See ('Conditions you need to look out for') in Section 4. If you have had an allergic reaction to other antibiotics, such as penicillin, you may be allergic to Cefuroxime Actavis.
If you need to make your blood or urine
Cefuroxime Actavis may influence the results of examination of urine or blood in determining the level of sugar on blood test known as the Coombs test. If you are having these tests:
Tell the person sample that you apply Cefuroxime Actavis.

Other medicines and Cefuroxime Actavis
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some medicines may influence the use of Cefuroxime Actavis or increase the chance of you getting side effects. These include:
aminoglycosides - type antibiotics;
water tablets (diuretics) such as furosemide;
probenecid;
oral anticoagulants.
Tell your doctor if this applies to you. You may need you perform additional tests to monitor your kidney function while taking Cefuroxime Actavis.

Birth control pills
Cefuroxime Actavis may reduce the effectiveness of birth control pills. If you take birth control while you are being treated with Cefuroxime Actavis should also use a barrier method of contraception (such as condoms). Ask your doctor for advice.

Pregnancy, lactation and fertility
Tell your doctor before you are given Cefuroxime Actavis
if you are pregnant, think you may be pregnant or planning to become pregnant;
if you are breastfeeding.
Your doctor will assess the benefit of treatment with Cefuroxime Actavis to you against the risk to your baby.

Driving and using machines
Do not drive or operate machinery if you feel unwell.

Important information about some of the ingredients of Cefuroxime Actavis
Cefuroxime Actavis contains sodium. This should be considered in patients on a diet with a controlled intake of sodium (salt).

Cefuroxime Actavis
amount of active
substance
Amount of sodium
Vial
750 mg 42 mg
1,5 g 83 mg
   
3. How to use Cefuroxime Actavis
Cefuroxime Actavis is usually administered by a doctor or nurse. It can be given in a drip (intravenous infusion) or by direct injection into a vein or muscle.

Usual dose:
Cefuroxime Actavis exact dose needed for you will be determined by your doctor depending on: the severity and type of infection, whether you are taking other antibiotics, weight and age and how well your kidneys.

Infants (0-3 weeks):
Per 1 kg weight of the baby will be administered 30 to 100 mg cefuroxime Actavis daily, divided into two or three doses.

Infants (aged 3 weeks) and children:
Per 1 kg weight of the baby or infant will be administered 30 to 100 mg cefuroxime Actavis daily, divided into three or four doses.

Adults and adolescents:
750 mg to 1,5 g Cefuroxime Actavis daily, divided into two, three or four doses.
Maximum dose: 6 g daily.

Patients with kidney problems
If you have kidney problems, your doctor may change your dose.
Talk to your doctor if this applies to you.

4. Possible side effects
Like all medicines, Cefuroxime Actavis can cause side effects, although not everybody gets them.

Conditions to watch
A small number of people taking Cefuroxime Actavis get an allergic reaction or potentially serious skin reaction. Symptoms of these reactions include:
severe allergic reaction. Her signs include raised and itchy rash, swelling, sometimes of the face or mouth which may cause difficulty in breathing;
skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area with a dark ring around it);
widespread rash with blisters and peeling skin (it may be signs of Stevens-Johnson and toxic epidermal necrolysis);
fungal infections. In rare instances, medications such as Cefuroxime Actavis can cause overgrowth of yeast (Candida) in the body which may result in fungal infections (such as thrush). This adverse reaction is more likely if Cefuroxime Actavis you apply for an extended period of time.
Immediately contact your doctor or nurse if you experience any of these symptoms.

Common side effects
May affect up to 1 in 10 patients:
pain at injection site, swelling and redness along the vein.
Tell your doctor if any of these symptoms bother you.
Common side effects that may occur in a blood test:
elevated substances (enzymes) that are formed in the liver;
changes in the number of white blood cells (neutropenia or eosinophilia);
low levels of red blood cells (anemia).
Uncommon side effects
May affect up to 1 in 100 patients:
skin rash, itching and lumpy rash (urticaria);
diarrhea, nausea, stomach pain.
Tell your doctor if you experience any of these symptoms.

Uncommon side effects that may occur in a blood test:
low white blood cell count (leucopenia);
increased bilirubin (a substance that is formed in the liver);
positive Coombs test.
Other adverse reactions:
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 causing diarrhea usually with blood and mucus, stomach pain;
inflammation of the kidneys and blood vessels;
very rapid destruction of red blood cells (hemolytic anemia);
erythema multiforme - a skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area with a dark ring around it).
Tell your doctor if you experience any of these symptoms.

Side effects that may occur in a blood test:
reduction in the number of platelets (cells that help the blood to clot - thrombocytopenia);
elevated urea nitrogen and serum creatinine in the blood.
If you get side effects:
Tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.

5. How to store Cefuroxime Actavis
At temperatures below 25 ° C.
Keep out of the reach and sight of children.
After addition of water for injections, the solution is stored at 2 ° to 8 ° C in a refrigerator for 24 hours. Upon storage, the color of the reconstituted solution and suspension may be made more intense.
Store in original container, protected from light.
Do not use Cefuroxime Actavis powder for solution for injection after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not use this medicine if you notice discoloration of the solution than the one described, turbidity or precipitate formation.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Cefuroxime Actavis
Cefuroxime Actavis 750 mg powder for solution for injection
The active substance in a vial cefuroxime sodium 789 mg, eq. 750 mg cefuroxime.
The product does not contain any excipients.