Tazocin 4 g. / 0.5 g. 12 vials
Piperacillin belongs to the group of medicines known as "broad-spectrum penicillin antibiotics". It can kill many types of bacteria. Tazobactam can prevent some resistant bacteria to survive the effects of piperacillin. This means that when piperacillin and tazobactam are administered together, they kill more bacteria.
Tazocin is used in adults and adolescents to treat bacterial infections, such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin or blood. Tazocin may be administered for treating bacterial infections in patients with a low white blood cells (decreased resistance to infection).
Tazocin is indicated for children aged 2-12 years to treat infections of the abdomen such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs) and infections of the gallbladder. Tazocin may be used to treat bacterial infections in patients with a low white blood cells (decreased resistance to infection).
In certain serious infections, your doctor may give you Tazocin in combination with other antibiotics.
2. BEFORE YOU USE Tazocin
Do not use Tazocin:
If you are allergic (hypersensitive) to piperalitsin or tazobactam or any of the other ingredients of Tazocin;
If you are allergic (hypersensitive) to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Tazocin.
Take special care with Tazocin:
If you are allergies. If you have multiple allergies, tell your doctor or other healthcare professional before taking this medicine;
If you have suffered from diarrhea before, or develop diarrhea during or after therapy. In this case, inform your doctor immediately;
If you have low levels of potassium in the blood. Your doctor may want to check your kidney function before treatment and can carry out regular blood tests during treatment;
If you have kidney or liver problems, or are receiving hemodialysis. Your doctor may want to check your kidneys before you take this medicine and can carry out regular blood tests during treatment;
If you are taking certain medicines (called anticoagulants) to prevent excessive blood clotting (see also Using other medicines in this leaflet) or during treatment appeared unexpected bleeding. In this case it is necessary to immediately inform your doctor or other health professional;
If you get seizures during treatment, it is necessary to inform your doctor or other health professional;
If you think you develop a new infection or your current infection worsened. In this case it is necessary to inform your doctor or other health professional.
Children under 2 years
Piperacillin / tazobactam is not recommended for children under 2 years of age due to insufficient data on safety and efficacy.
Using other medicines
Always tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some drugs can interact with piperacillin and tazobactam. These include:
Medicine for gout (probenecid). It may increase the time required to piperacillin and tazobactam to leave your body;
Drugs, blood thinners, or for the treatment of blood clots (eg. Heparin, warfarin or aspirin);
Medicines to relax your muscles during surgery. Tell your doctor if you are placing a general anesthetic;
Methotrexate (a drug used to treat cancer, arthritis or psoriasis). Piperacillin and tazobactam can increase the time it takes for methotrexate to leave your body;
Lowering drugs of potassium in your blood (eg. Tablets, enhancing the flow of urine or certain medicines to treat cancer);
Medicines containing antibiotics gentamicin or tobramycin. Tell your doctor if you have kidney problems.
Effect on laboratory parameters
Tell your doctor or laboratory personnel if you are taking Tazocin and you are a blood test or urine.
Pregnancy and lactation
If you are pregnant, think you may be pregnant or planning to become pregnant, tell your doctor or other health professional before taking this medicine. Your doctor will decide whether Tazocin is right for you.
Piperacillin and tazobactam can reach the fetus or the placenta to the baby through breast milk. If you are breastfeeding, your doctor will decide whether Tazocin is suitable for you.
Driving and using machines
Not expected that the use of Tazocin affect the ability to drive or operate machinery.
Important information about some of the ingredients of Tazocin
Tazocin 4 g / 0,5 g contains 11,16 mmol (256 mg) of sodium.
It should be borne in mind in the case of a diet low in sodium.
3. HOW TO USE Tazocin
Your doctor or other healthcare professional will give you this medicine by intravenous infusion (drip within 30 minutes).
The dosage of the drug depends on the condition you are being treated, your age and whether you have kidney problems.
Adults and adolescents aged 12 years and over
The usual dose is 4,0 g / 0,5 g piperacillin / tazobactam every 6-8 hours intravenous (directly into your blood stream).
Children aged 2 to 12 years
The usual dose for children with abdominal infections is 100 mg / 12,5 mg per kg of body weight of piperacillin / tazobactam administered every 8 hours intravenously (directly into your blood stream). The usual dose for children with low white blood cell count was 80 mg / 10 mg per kg body weight of piperacillin / tazobactam administered every 6 hours intravenously (directly into your blood stream).
Your doctor will calculate the dose depending on the weight of your child, but the daily dose will not exceed 4 g / 0,5 g Tazocin.
Tazocin will be given until all of your symptoms (5 to 14 days).
Patients with renal impairment
May be necessary for your doctor to reduce the dose of Tazocin or frequency of administration. Your doctor may want to test your blood to make sure that the dosage is appropriate for you, especially if you have to take this medicine for a long time.
If you use more than the amount of Tazocin
As you Tazocin given by a doctor or other health professional is unlikely your dose to be mistaken. However, if you experience side effects such as convulsions, or think you are being given too high a dose, contact your doctor immediately.
If omitted use of Tazocin
If you think you have not been implemented Tazocin dose, tell your doctor or other health professional.
If you have any further questions concerning the application of this medicine, ask your doctor or other health professional.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Tazocin can cause side effects, although not everybody gets them.
Tell your doctor if you experience any of these potentially serious side effects to Tazocin:
Serious side effects of Tazocin are:
severe skin rashes (Stevens-Johnson, toxic epidermal necrolysis), appearing initially as red spots or circular patches often with blisters in the base. Additional features include ulcers in the mouth, throat, nose, limbs, genitals and conjunctivitis (red and swollen eyes). The rash may develop to widespread blistering or peeling of the skin and can potentially be life-threatening;
swelling of the face, lips, tongue and other parts of the body;
shortness of breath, wheezing or difficulty breathing;
severe rash, itching or hives on the skin;
yellowing of eyes or skin;
damage to blood cells (the signs include sudden shortness of breath, red or brown colored urine, nosebleeds and bruising);
severe or persistent diarrhea, accompanied by fever or weakness;
unexpected bleeding, especially if you are taking anticoagulants such as warfarin.
If any of these side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or other health professional.
Possible side effects listed according to the following frequencies:
Common: affects 1 to 10 people in every 100;
Uncommon: affects 1 to 10 people in every 1000;
Rare: affects 1 to 10 people per 10 000;
Very rare: affects less than 1 person in every 10,000.
Common side effects:
diarrhea, vomiting, nausea;
Uncommon side effects:
thrush (a fungal infection);
reduced (abnormal) in white blood cells (leukopenia, neutropenia) and platelets (thrombocytopenia);
low blood pressure, inflammation of the veins (appearing as tenderness or redness in the affected area);
jaundice (yellowing of the skin or whites of the eyes), inflammation of the lining of the mouth, constipation, indigestion, upset stomach;
elevated levels of certain enzymes in the blood (increased alanine aminotransferase increased, aspartate aminotransferase);
increased content of products of muscle metabolism in the blood (increased creatinine content);
fever, reaction at the injection site;
infection caused by yeast (candidal superinfection).
Rare side effects:
reduction (abnormal) in the number of red blood cells or blood pigment (hemoglobin), reduction (abnormal) in the number of red blood cells, resulting in premature failure (hemolytic anemia), pinpoint hemorrhages (purpura), nosebleeds (epistaxis) and prolonged bleeding time, an increase (beyond the normal range) of a specific type of white blood cells (eosinophilia);
severe allergic reaction (anaphylactic / anaphylactoid reactions, including shock);
form of infection in the intestines (pseudomembranous colitis), abdominal pain;
liver inflammation (hepatitis), increased levels of breakdown products of blood pigment (bilirubin), increased levels of certain enzymes in the blood (increased alkaline phosphatase, increased gamma-glutamyltransferase);
skin reactions with redness and formation of skin lesions (exanthema, erythema multiforme), skin reactions associated with blistering (bullous dermatitis);
joint and muscle pain;
impaired renal function and kidney problems;
chills / rigidity.
Very rare side effects:
strong decrease of granular white blood cells (agranulocytosis), a strong decrease in the red blood cells, white blood cells and platelets (pancytopenia);
prolonged coagulation (prolonged partial thromboplastin time, prothrombin time prolonged), abnormal laboratory values (positive direct test Coombs), an increased number of platelets (thrombocythaemia);
reduced levels of potassium in your blood (hypokalemia), low blood sugar (glucose), lowering blood protein albumin decreased levels of total protein;
separation of the surface layer of the skin all over the body (toxic epidermal necrolysis), serious allergic reaction affecting the entire body, manifested in skin rashes and mucous membranes and skin blisters (Stevens-Johnson);
increased levels of BUN.
Treatment with piperacillin was associated with an increased incidence of fever and rash in patients with cystic fibrosis.
5. HOW TO STORE Tazocin
Keep out of the reach and sight of children.
Tazocin not use after the expiry date stated on the carton and vial after "EXP". The expiry date refers to the last day of that month.
Unopened vials: Do not store above 25 ° C.
Disposable. Discard any unused material.
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. FURTHER INFORMATION
The active substances are piperacillin and tazobactam.
Each vial contains 4 g piperacillin (as sodium salt) and 0,5 g Tazobactam (as sodium salt).
The other ingredients are citric acid and edetate disodium (EDTA).
Tazocin looks like and contents of the pack
Tazocin 4 g / 0,5 g is a white to off-white powder in a vial. Packs containing 1, 5, 10, 12, 25 or 50 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
PFIZER EUROPE MA EEIG, United Kingdom.
Wyeth Lederle S.r.l., Italy.
The following information is intended for healthcare professionals only:
Instructions for use
Tazocin is administered by intravenous infusion (drip for 30 minutes).
Reconstitute each vial with the appropriate amount of solvent shown in the table below, using one of the compatible solvents. Shake until complete dissolution of the product. Shaking constantly, in most cases the preparation going on between 5 and 10 minutes (for detailed instructions, see the attached table).
Amount in the vial
* Volume of solvent to add into the vial
2 g / 0,25 g (2 g piperacillin and tazobactam 0,25 g) 10 ml
4 g / 0,5 g (4 g piperacillin and tazobactam 0,5 g) 20 ml
* Compatible solvents for reconstitution:
0.9% (9 mg / ml) sodium chloride solution for injection
Sterile water for injection (1);
(1) The maximum recommended volume of sterile water for injection per dose is 50 ml.
The reconstituted solution should be withdrawn from the vial with a syringe. After reconstitution as directed, the vial contents withdrawn by syringe contains the declared amount of piperacillin and tazobactam.
The reconstituted solution may be further diluted to the desired volume (eg. 50 ml to 150 ml) with one of the compatible solvents:
0.9% (9 mg / ml) sodium chloride solution for injection;
6% dextran in 0.9% sodium chloride;
Ringer's lactate for injection;
Ringer's acetate / malate.
When Tazocin co-administered with other antibiotics (eg. Aminoglycosides), they must be applied separately. Co-administration of beta-lactam antibiotics and aminoglycosides in vitro may result in inactivation of the aminoglycoside. It was found that amikacin and gentamicin are consistent with the in vitro Tazocin in certain solvents in certain concentrations (see. Coadministration of Tazocin with aminoglycosides below).
Tazocin should not be mixed with other drugs in a syringe or infusion bottle since data on their compatibility.
Due to the chemical instability Tazocin should not be used with solutions containing only sodium bicarbonate.
Tazocin is compatible with lactated Ringer's solution, and may be administered simultaneously via a Y-shaped venous line.
Tazocin should not be added to blood products, and albumin hydrolysates.
Concomitant administration of Tazocin with aminoglycosides
Because of in-vitro inactivation of the aminoglycoside by beta-lactam antibiotics have been suggested to separate administration of aminoglycosides and Tazocin. Tazocin and the aminoglycoside should be prepared and diluted separately when concomitant therapy with aminoglycosides.
Where recommended simultaneous application, Tazocin is compatible for simultaneous administration via a Y-shaped intravenous line only with the following aminoglycosides under the described conditions below:
Amino-glycoside Doza Tazocin volume of solvent (in ml) for Tazocin concentration aminogliko-
nucleosides dose range * (mg / ml)
Amikacin 2g / 0.25g
4g / 0.5g 50, 100,
150 1.75 - 7.5 0.9% sodium chloride or 5% glucose
Gentamicin 2g / 0.25g
4g / 0.5g 50, 100,
150 0.7 - 3.32 0.9% sodium chloride or 5% glucose
* The dose of aminoglycoside should be based on patient weight, status of infection (serious or life-threatening) and renal function (creatinine clearance).
Compatibility of Tazocin with other aminoglycosides has not been established. Only those described in the table above concentrations and solvents for amikacin and gentamicin and the corresponding doses of Tazocin are set to be compatible for co-administration by means of a Y-shaped venous line (venflon). Co-administration by a Y-shaped intravenous line in a manner different from that described above can result in inactivation of the aminoglycoside by Tazocin.