Tazocine - instructions for use, dose, side effects, contraindications

Composition:Composition per bottle 2 g + 0.25 g
Active substances: piperacillin sodium 2084.9 mg (in terms of piperacillin monohydrate 2000.0 mg), sodium tazobactam 268.3 mg (in terms of tazobactam 250.0 mg);
Excipients: sodium citrate dihydrate 110.22 mg (in terms of citric acid 72.0 mg), disodium edetate dihydrate 0.5 mg.
Composition per bottle 4 g + 0.5 g
Active substances: piperacillin sodium 4169.9 mg (in terms of piperacillin monohydrate 4000.0 mg), sodium tazobactam 536.6 mg (in terms of tazobactam 500.0 mg);
Excipients: sodium citrate dihydrate 220.43 mg (in terms of citric acid 144.0 mg), disodium edetate dihydrate 1.0 mg.

Description:Lyophilized powder or porous mass from almost white to white.

Pharmacotherapeutic group:Antibiotic-penicillin semisynthetic + beta-lactamase inhibitor.

ATX: & nbsp

J.01.C.R.05 Piperacillin in combination with enzyme inhibitors

Pharmacodynamics:

Mechanism of action

Tazocin® (sterile piperacillin and tazobactam) is an antibacterial combination drug consisting of a semisynthetic antibiotic sodium piperazillin and an inhibitor βlactamase sodium tazobactam intended for intravenous administration. Thus, tazobactam and piperacillin combine the properties of a broad-spectrum antibacterial drug and an inhibitor βlactamase.

Piperacillin shows bactericidal activity, which is the result of inhibition of septal formation during cell division and cell wall synthesis. Piperacillin and others β-lactam antibiotics block the terminal stage of transpeptidation of peptidoglycan biosynthesiscell wall in sensitive microorganisms through interaction with penicillin-binding proteins (PSB) - bacterial enzymes that carry out this reaction. In experiments in vitro piperacillin is active against various gram-positive and gram-negative aerobic and anaerobic bacteria. Piperacillin has a reduced activity against bacteria having certain enzymes of the family βlactamases, which chemically inactivate piperacillin and others β-lactam antibiotics. Tazobactam, which has its own very low antibacterial activity due to low affinity for PSB, promotes the restoration or enhancement of piperacillin action against many resistant microorganisms. Tazobactam is a potent inhibitor of many βlactamases of class A (penicillinases, cephalosporinases and enzymes with extended activity spectrum). It has a non-persistent activity against carbapenemases of class A and βlactamase D. Tazobactam is practically inactive with respect to most class cephalosporins C and Class B metal-metabalactamases.

Two features of tazobactam and piperanillin underlie increased activity against certain microorganisms possessing βlactamases, which, when evaluated as enzyme preparations, were less inhibited by tazobactam and other inhibitors: tazobactam does not induce chromosome-mediated production βlactamase in a concentration that is achieved by using the recommended dosing regimens, and piperacillin is relatively stable to the action of the series βlactamases.

As well as others β-lactam antibiotics, piperacillin in combination with or without tazobactam, shows a time-dependent bactericidal activity against sensitive microorganisms.

Mechanisms of development of resistance:

There are three main mechanisms for developing resistance to β-lactam antibacterial drugs: changes in target penicillin-binding proteins (PSB), leading to reduced affinity for antibiotics; antibiotic destruction by bacterial βlactamases, as well as a low intracellular concentration of antibiotics due to a decrease in their capture or active transport of antibiotics from the cells.

In Gram-positive bacteria, the main mechanism of resistance to β-lactam antibacterial drugs, including tazobactam and piperacillin, is the change in PSB. This mechanism underlies the resistance to methicillin, which develops in staphylococci, and resistance to penicillin in Streptococcus pneumoniae, as well as Streptococcus spp. groups Viridans. Resistance caused by changes in PSB also develops in Gram-negative strains with complex nutritional needs, such as Haemophilus influenzae and Neisseria gonorrhoeae. The combination of piperacillin / tazobactam is not active against strains in which resistance to β-lactam antibacterial drugs is determined by changes in the PSB. As mentioned above, there are some βlactamases that are not inhibited by tazobactam.

Spectrum of antibacterial activity:

The combination of tazobactam and piperacillin showed activity against most strains of the microorganisms listed below, both in experiments in vitro, and in clinical infections, which are indications for use.

Aerobic and facultative anaerobic Gram-positive microorganisms:

Staphylococcus aureus (only methicillin-sensitive strains)

Aerobic and facultative anaerobic gram-negative microorganisms:

Acinetobacter baumanii

Escherichia coli

Haemophilus influenzae (excluding β-lactamase-negative, ampicillin-resistant strains)

Klebsiella pneumoniae

Pseudomonas aeruginosa (used in combination with aminoglycosides, to which the strain is sensitive)

Gram-negative anaerobes:

Group Bacteroides fragilis (AT. fragilis, AT. ovalus, AT. thelaiotaomicron and AT. vulgatus)

In experiments in vitro the following data were obtained, but their clinical significance is unknown.

Not less than with respect to 90 % of the following microorganisms, the minimum inhibitory concentration (MPK) in vitro less than or equal to the threshold value of sensitivity to tazobactam and piperacillin. However, the safety and efficacy of tazobactam and piperacillin when applied to treat clinical infections caused by these bacteria have not been established in adequate and well-controlled studies.

Aerobic and facultative anaerobic Gram-positive microorganisms:

Enterococcus faecalis (only ampicillin or penicillin-sensitive strains) Staphylococcus epidermidis (only methicillin-sensitive strains)

Slreptococcus agalaetiae ⁺

Streptococcus pneumonia ⁺ (only penicillin-sensitive strains)

Slreptococcus pyogenes ⁺

Slreptococcus spp. Group Viridans ⁺

Aerobic and facultative anaerobic gram-negative microorganisms:

Citrobacter koseri Moraxella catarrhalis Morganella morganii Neisseria gonorrhoeae

Proteus mirabilis

Proteus vulgaris

Serratia marcescens

Providencia stuartii

Providencia rettgeri

Salmonella enterica

Gram-positive anaerobes:

Clostridium perfringens

Gram-negative anaerobes:

Bacteroides distasonis

Prevotella melaninogenica

⁺He produce βlactamase and, in this connection, are sensitive only to piperacillin.

Pharmacokinetics:

Distribution

The mean concentrations of piperacillin and tazobactam in plasma in equilibrium are presented in Tables 1 - 2. The maximum concentrations of piperacillin and tazobactam in plasma are reached immediately after completion of intravenous administration. The concentration of piperacillin administered in combination with tazobactam is similar to that of administering piperacillin in an equivalent dose as monotherapy.

Table 1

The values of equilibrium plasma concentrations in adults after five-minute intravenous administration of tazobactam and piperacillin

Values of plasma piperazillin concentration (μg / ml)

The dose of piperacillin / tazobactam	5** mines	30 mines	1 h	2 hours	3 h	4 h
2 g / 0.25 g	237	76	38	13	6	3
4 g / 0.5 g	364	165	92	37	16	7

Values of tazobactam concentration in plasma (μg / ml)

The dose of piperacillin / tazobactam	5** mines	30 mines	1 h	2 hours	3 h	4 h
2 g / 0.25 g	23,4	8,0	4,5	1,7	0,9	0,7
4 g / 0.5 g	34,3	17,9	10,8	4,8	2,0	0,9

**Ending 5 minute introduction

Table 2

The values of equilibrium concentrations in plasma in adults after a thirty minute intravenous administration of tazobactam and piperacillin

Values of plasma piperazillin concentration (μg / ml)

The dose of piperacillin / tazobactam

30**

mines

1 h

1,5 h

2 h

3 hours

4 hours

2 g / 0.25 g

134

4 g / 0.5 g

298

141

Values of tazobactam concentration in plasma (μg / ml)

The dose of piperacillin / tazobactam

30**

mines

1 h

1,5 h

2 h

3 h

4 h

2 g / 0.25 g

14,8

7,2

4,2

2,6

1,1

0,7

4 g / 0.5 g

33,8

17,3

11,7

6,8

2,8

1,3

**Ending 30 minute introduction

When the dose of the combination is increased piperacillin 2 g / tazobactam 0,25 g to 4 g / 0.5 g, respectively, there is a disproportionate increase in the values (approximately 28 %) concentrations of piperacillin and tazobactam.

The binding with proteins of both piperacillin and tazobactam is approximately 30 %, while the presence of tazobactam does not affect the binding of piperacillin, and the presence of piperacillin on the binding of tazobactam.

Tazobactam and piperacillin widely distributed in tissues and body fluids, including in the intestinal mucosa, the mucosa of the gallbladder, lungs, bile, the female reproductive system (uterus, ovaries and fallopian tubes) and bones. Average concentrations in tissues range from 50 before 100 % concentration in plasma.

Biotransformation

As a result of metabolism piperacillin is converted into a low-activity desethyl derivative; tazobactam - in the inactive metabolite.

Excretion

Piperacillin and tazobactam are excreted by the kidneys through glomerular filtration and tubular secretion. Piperacillin is rapidly excreted unchanged, 68 %

The administered dose is found in the urine. Tazobactam and its metabolites are rapidly excreted by renal excretion, 80 % of the administered dose is detected unchanged, and the remaining amount in the form of metabolites. Piperacillin, tazobactam and dezetylpiperacillin also excreted with bile.

After the administration of a single dose and repeated doses of Tazocin® to healthy subjects, the half-life of piperacillin and tazobactam from plasma varied from 0,7 before 1,2 hours and did not depend on the dose of the drug or the duration of the infusion. With a decrease in creatinine clearance, the half-life of piperacillin and tazobactam is prolonged. Tazobactam does not affect the pharmacokinetics of piperacillin. Piperacillin reduces the rate of excretion of tazobactam.

Impaired renal function

As the ground clearance decreaseseatinin periods of half-life of piperacillin and tazobactam are increasing.With a decrease in creatinine clearance below 20 ml / min, the half-lives of piperacillin and tazobactam increase, respectively, in 2 and 4 fold, compared with those in patients with normal renal function.

During hemodialysis is derived from 30 before 50 % piperacillin and 5 % of the dose of tazobactam in the form of a metabolite. When peritoneal dialysis is performed, respectively, about 6 and 21 % piperacillin and tazobactam, and 18 % of the tazobactam is excreted in the form of its metabolite.

Impaired liver function

Although in patients with impaired liver function, the half-lives of piperacillin and tazobactam are increased (by 25 % and 18 %, respectively), dose adjustment is not required.

Indications:

Tazocin® is used to treat systemic and / or local bacterial infections caused by microorganisms susceptible to tazobactam and piperacillin.

Adults and children over 12 years:

- Lower respiratory tract infections;

- Urinary tract infections (complicated and uncomplicated);

- Intra-abdominal infections;

- Infections of the skin and soft tissues;

- Septicemia;

- Gynecological infections (including endometritis and adnexitis in the postpartum period):

- Bacterial infections in patients with neutropenia (in combination with aminoglycosides);

- Infections of bones and joints;

- Mixed infections (caused by Gram-positive / Gram-negative aerobic and anaerobic microorganisms).

Children aged from 2 before 12 years:

- Intra-abdominal infections;

- Infections against neutropenia (in combination with aminoglycosides).

Contraindications:

Hypersensitivity to piperacillin, tazobactam, beta-lactam preparations (including penicillins, cephalosporins), other components of the drug or to inhibitors of beta-lactamases.

Children age up to 2 years.

Carefully:

Severe bleeding (including history), cystic fibrosis (increased risk of hyperthermia and skin rash), pseudomembranous enterocolitis, childhood, pregnancy, lactation.

Renal failure (creatinine clearance below 20 ml / min). Patients on hemodialysis.
Joint use of high doses of anticoagulants.
Hypokalemia.

Pregnancy and lactation:

Pregnancy. There is insufficient data on the use of a combination of tazobactam and piperacillin or both active substances separately in pregnant women. Piperacillin and tazobactam penetrate the placental barrier. In pregnant women, the drug can be used only when the expected benefit to the mother exceeds the possible risk to the fetus.

Lactation period. Piperacillin in low concentrations is secreted with breast milk; the isolation of tazobactam in milk has not been studied. During the lactation period, the drug can be used only when the expected benefit to the mother exceeds the possible risk for a breastfed infant, or breastfeeding should be stopped for the duration of treatment.

Dosing and Administration:

Tazocin® is administered intravenously drip for at least 20-30 minutes.

Doses of the drug and the duration of treatment are determined by the severity of the infectious process and the dynamics of clinical and bacteriological indicators.

Adults and children over 12 years with normal renal function

The recommended daily dose is 12 g piperacillin / 1,5 g of tazobactam, which is divided for several administrations every 6-8 hours.

The total daily dose depends on the severity and localization of the infection. The daily dose can reach 18 g piperacillin / 2,25 g of tazobactam, which is divided for several administrations.

Children aged from 2 before 12 years

For neutropenia:

In children with a normal function of the nights and body weight, less than 50 kg with a fever resulting from neutropenia, the dose of Tazocin® is 90 mg (80 mg piperacillin / 10 mg tazobactam) per kilogram of body weight, which is administered every 6 hours in combination with the appropriate dose of aminoglycoside.

Children with a body weight of more than 50 kg Tazocin® is dosed in both adults and is administered in combination with a suitable dose of aminoglycoside.

With intra-abdominal infection: in children with body weight up to 40 kg and normal renal function, the recommended dose is 112,5 mg (100 mg piperacillin / 12.5 mg tazobactam) per kilogram body weight 8 hours.

Children with a body weight of more than 40 kg and normal kidney function apply the same dose as in adults.

Duration of treatment is from 5 before 14 days, in view of the fact that the administration of the drug is continued for at least a half- 48 hours after the disappearance of clinical signs of infection.

Impaired renal function

Patients with renal insufficiency or patients on hemodialysis, dose and frequency of administration should be adjusted for the degree of impaired renal function.

Recommended doses of the drug for adults and children (body weight> 50 kg) with renal failure

Creatinine clearance (ml / min)	Recommended doses of tazobactam and piperacillin
>40	Dose correction is not required
20-40	12 g /1,5 g / day 4 g / 0.5 g every 8 hours
<20	8 g / 1 g / day 4 g / 0.5 g every 12 hours

For patients on hemodialysis, the maximum daily dose is 8 g / 1 g piperacillin / tazobactam. In addition, since hemodialysis for 4 hours is displayed 30-50 % piperacillin, one additional dose should be used 2 g / 0.25 g piperacillin / tazobactam after each dialysis session.

Children 2-12 years with renal insufficiency:

The pharmacokinetics of tazobactam and piperacillin in children with renal insufficiency has not been studied. Data on the doses of the drug with a combination of renal failure and neutropenia are absent. For children aged 2-12 years with renal insufficiency, it is recommended to adjust the dose of Tazocin® as follows:

Recommended doses of the drug for children (body weight < 50 kg) with renal failure

Creatinine clearance

Recommended doses of tazobactam and piperacillin

>50 ml / min

112,5 mg / kg (100 mg piperacillin / 12.5 mg tazobactam)

every 8 hours

<50 ml / min

78,75 mg / kg (70 mg piperacillin (8.75 mg tazobactam)

every 8 hours

Such a change in dose is only indicative. Each patient should be closely monitored for the timely detection of signs of an overdose. It is necessary to adjust the dose of the drug and the interval between its administration accordingly.

Impaired liver function

Dose adjustment if the liver function is not required.

Elderly patients

Correction of the dose to elderly patients is necessary only if they have a violation of kidney function.

Recommendations for the preparation of solution

Tazocin® is only used for intravenous administration!

The preparation is dissolved in one of the following solvents in accordance with the volumes indicated. The vial is rotated in a circular motion until the content is completely dissolved (with constant rotation, usually during 5 - 10 min.). The prepared solution is a colorless or pale yellow liquid.

Dosage / vial (piperacillin / tazobactam)	Required volume of solvent
2 g + 0,25 g	10 ml
4 g + 0,5 g	20 ml

Solvents used to dissolve the drug, compatible with Tazocin®:

0,9 % solution of sodium chloride; sterile water for injections;

5 % dextrose solution;

The prepared solution should then be diluted to the volume required for intravenous administration (for example, from 50 ml to 150 ml) with one of the following compatible solvents;

0,9 % solution of sodium chloride;

sterile water for injections (the maximum recommended volume - 50 ml);

5 % dextrose solution;

6 % saline solution of dextran;

Hartman's solution;

Ringer's acetate;

Ringer's acetate / malate;

Ringer's lactate solution.

The prepared solution should be used for 24 h after cooking at a temperature not higher than 25 ⁰C or during 48 h when stored at a temperature from 2 before 8 FROM.

Side effects:

The table lists the side effects classified by frequency according to the categories CIOMS (Council of International Medical Scientific Organizations):

Often: ≥ 10%

Often: ≥ 1 % and < 10 %

Infrequently: ≥ 0,1 % and < 1 %

Rarely: ≥ 0,01 % and < 0,1 %

Rarely: < 0,01 %

Frequency unknown: It is impossible to estimate the occurrence frequency of the phenomenon.

Superinfections	Often	Candidiasis*
Organs of hematopoiesis	Often	Thrombocytopenia, anemia *, positive Coombs direct test, increase in partial thromboplastin time
	Infrequently	Leukopenia, an increase in prothrombin time
	Rarely	Agranulocytosis, epistaxis
	Frequency unknown	Pancytopenia , neutropenia, purpura, increased bleeding time, hemolytic anemia , eosinophilia , thrombocytosis
The immune system	Frequency unknown	Anaphylactoid reaction , anaphylactic reaction , anaphylactoid shock , anaphylactic shock , hypersensitivity *
Metabolism	Often	Hypoalbuminemia, hypoproteinemia
Metabolism	Infrequently	Hypokalemia, hypoglycemia
Nervous system	Often	Headache, insomnia
Nervous system	Rarely	Convulsions
Cardiovascular system	Infrequently	Reduction of blood pressure, phlebitis, thrombophlebitis, "hot flashes" of blood to the skin of the face
Gastrointestinal tract	Highly often	Diarrhea
Gastrointestinal tract	Rarely	Pseudomembranous colitis, stomatitis
Hepatobiliary	Often	Increased activity of "liver" transaminases
system		(alanine aminotransferase (ALT), aspartate aminotransferase (ACT)), increased activity of alkaline phosphatase
	Infrequently	Hyperbilirubinemia
	Frequency	Hepatitis *, jaundice, increased activity
	unknown	gamma glutamyl transferase
Skin and subcutaneous	Often	Rashes, itchy skin
cellulose	Infrequently	Polymorphic exudative erythema , urticaria, maculopapular rash
	Rarely	Toxic epidermal necrolysis *
	Frequency	Stevens-Johnson syndrome *, bullous
	unknown	dermatitis
Musculoskeletal system	Rarely	Arthralgia, myalgia
Kidneys and	Often	Increase in the concentration of creatinine, urea in
urinary tract		blood serum
system	Frequency	Renal failure,
	unknown	tubulointerstitial nephritis *
Other	Often	Increased body temperature, local reactions (redness, condensation at the site of injection)
	Infrequently	Chills

* side effects revealed during post-registration studies.

Overdose:

Symptoms of overdose are nausea, vomiting, diarrhea, increased neuromuscular excitability and convulsions. Depending on the clinical manifestations, symptomatic treatment is prescribed. To reduce high concentrations of piperacillin or tazobactam in the serum, hemodialysis can be prescribed.

Interaction:

Joint use of the drug Tazocin® with probenecid increases the half-life and reduces the renal clearance of both piperacillin and tazobactam, but the maximum plasma concentrations of both drugs remain unchanged. He The pharmacokinetic interaction between the drug Tazocin® and vancomycin was detected.

Piperacillin, including when combined with tazobactam, did not have a significant effect on the pharmacokinetics of tobramycin both in patients with preserved renal function and in patients with mild to moderate renal impairment. The pharmacokinetics of piperacillin, tazobactam and metabolites also did not significantly change when tobramycin was used.

The simultaneous use of the drug Tazocin® and vecuronium bromide may result in a longer lasting neuromuscular blockade caused by the latter (a similar effect can be observed with a combination of piperacillin with other non-depolarizing muscle relaxants).

When used simultaneously with the drug Tazocin® heparin, indirect anticoagulants or other drugs that affect the blood coagulation system, including the function of platelets, it is necessary to more often monitor the state of the blood coagulation system.

Piperacillin may delay the excretion of methotrexate (in order to avoid a toxic effect, it is necessary to control the concentration of methotrexate in the blood serum).

Impact on the results of laboratory and other diagnostic studies.

During the application of the drug Tazocin®, a false positive test result for glucose in the urine is possible using a method based on the reduction of copper ions. Therefore, it is recommended to carry out a test based on the enzymatic oxidation of glucose.

There is evidence that patients receiving the drug Tazocin®, false-positive results of the test for galactomannan produced by the test systems of Bio-Rad (Platelia Aspergillus ELISA). Cross reactions with nonaspergillous polysaccharides and polyfuranoses have been reported in the application of the test Platelia Aspergillus.

Thus, in patients receiving tazobactam and piperacillin, should be critical of the positive results of the test for galactomannan and recheck using other diagnostic methods.

Joint use with aminoglycosides.

When mixing solutions of Tazocin® and aminoglycosides it is possible to inactivate them, therefore it is recommended to administer these preparations separately.In situations where joint use is preferred, solutions of the preparation of Tazocin® and aminoglycosides must be prepared separately. For introduction, you only need to use V-shaped catheter. If all of the above conditions are met, Tazocin® can be administered with V-like catheter only with the aminoglycosides indicated in the table:

Aminoglycoside

Tazocin®,

dose

Tazocin®, volume solvent (ml)

Aminoglycoside

concentration⁺

(mg / ml)

Compatible

solvent

Amikacin

2 g +0,25 g,

4 g + 0,5 g

50, 150

1,75-7,5

0,9 % solution of sodium chloride or 5 % dextrose solution

Gentamicin

2 g +0,25 g, 4 g + 0,5 g

50, 150

0,7 - 3,32

0,9 % solution of sodium chloride or 5 % dextrose solution

+ The dose of aminoglycoside depends on the weight, the nature of the infection (serious or life threatening) and kidney function (creatinine clearance).

Pharmaceutical compatibility with other drugs

Tazocin® should not be mixed in a single syringe or dropper with other drugs other than gentamicin, amikacin, and the aforementioned solvents, as there is no compatibility data.

When using Tazocin® together with other antibiotics, the drugs should be administered separately.

C Due to the chemical instability of Tazocin®, it should not be used in conjunction with solutions containing sodium hydrogen carbonate.

Tazocin® should not be added to blood products or albumin hydrolysates

Special instructions:

Before starting treatment with Tazocin®, the patient should be interviewed in detail in order to identify possible reactions of a heightened sensitivity in the anamnesis, including those associated with penicillins or cephalosporins. Severe allergic reactions are more likely to develop in patients with increased sensitivity to several allergens. Such reactions require the discontinuation of the drug and the use of epinephrine (Adrenaline) and other emergency measures.

Patients taking the drug Tazocin®, there have been cases of severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. In case of the appearance of a rash, patients should be carefully monitored and in case of progression of symptoms, the drug should be stopped.

The pseudomembranous colitis caused by antibiotics can be manifested by severe, prolonged diarrhea, which poses a threat to life.Pseudomembranous colitis can develop both during antibiotic therapy and after its completion. In such cases, immediately stop the administration of Tazocin® and prescribe appropriate therapy (for example, vancomycin, metronidazole orally). Preparations that inhibit peristalsis are contraindicated.

In the treatment with Tazocin®, especially prolonged, it is possible to develop leukopenia and neutropenia, therefore it is necessary to periodically monitor the peripheral blood.

Patients with renal insufficiency or patients on hemodialysis, dose and frequency of administration should be adjusted for the degree of impaired renal function.

In a number of cases (most often in patients with renal insufficiency), there appears to be increased bleeding and a concomitant change in the laboratory parameters of the blood coagulation system (clotting time, platelet aggregation and prothrombin time). When bleeding occurs, it is necessary to cancel the treatment with the drug and prescribe the appropriate therapy.

It should be borne in mind the possibility of the emergence of resistant microorganisms that can cause superinfection,especially with prolonged course of treatment with Tazocin®. Patients should be carefully observed during therapy. In case of development of superinfection, adequate measures should be taken.

As with the use of other penicillin drugs, against the background of therapy with Tazocin®, neurological complications, manifested by convulsions, may develop. These reactions are most often observed when the drug is used in high doses, especially in patients with impaired renal function.

This preparation contains 2,79 mEq. (64 mg) of sodium per gram of piperacillin, which can lead to a general increase in sodium intake in patients. In patients suffering from hypokalemia or receiving drugs that promote the excretion of potassium, during the period of treatment with Tazocin®, hypokalemia may develop (it is necessary to check the electrolyte content in the blood serum regularly).

No experience in children under 2 years of age.

Effect on the ability to drive transp. cf. and fur:

Studies of the effect of the drug Tazocin® on the ability to drive a car and engage in potentially dangerous activities that require increased concentration and speed of psychomotor reactions have not been carried out.

When there are undesirable phenomena from the central nervous system (convulsions) should refrain from performing these activities.

Form release / dosage:Lyophilizate for the preparation of a solution for intravenous administration 2 g + 0,25 g, 4 g + 0,5 in

Packaging:

By 2 g of piperacillin monohydrate and 0,25 g of tazobactam in vials of colorless glass (type 1) capacity 30 ml, sealed with a butyl rubber stopper and rolled up with an aluminum cap provided with a plastic tear-off cap with a smooth surface or with an engraved inscription "FLIP OFF".

Po 12 vials (with a cardboard separator between two rows of vials) together with instructions for use in a cardboard box.
By 4 g of piperacillin monohydrate and 0,5 g of tazobactam in vials of colorless glass (type 1) capacity 70 ml, sealed with a butyl rubber stopper and rolled up with an aluminum cap provided with a plastic tear-off cap with a smooth surface or with an engraved inscription "FLIP OFF". Po 12 vials (with a cardboard separator between two rows of vials) together with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not higher than 25 ° C out of the reach of children.

Shelf life:

3 of the year.

He apply after the expiry date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N009976

Date of registration:25.05.2009

The owner of the registration certificate: Pfizer Inc. Pfizer Inc. USA

Manufacturer: & nbsp

WYETH LEDERLE, S.p.A. Italy

Representation: & nbspPfizer H. Si. Pi. CorporationPfizer H. Si. Pi. Corporation

Information update date: & nbsp11.03.2015

Illustrated instructions

Instructions

Tazocin® (Tazocin®)