Tazolin
- ENG
- မြန်မာ
(Piperacillin Sodium & Tazobactam Sodium Injection)
- Name of the medicinal product
Piperacillin and Tazobactam for Injection USP
Zifam Tazolin 4.5 g (Piperacillin and Tazobactam for Injection USP)
Zifam Tazolin 225 g (Piperacillin and Tazobactam for Injection USP)
- Composition
Zifam Tazolin 4.5 g
Each vial contains:
Piperacillin Sodium USP equivalent to Piperacillin…………4 g
Tazolin Sodium USP equivalent to Tazobactam………………0.5 g
Zifam Tazolin 2.25 g
Each vial contains:
Piperacillin Sodium USP equivalent to Piperacillin…………. 2 g
Tazolin Sodium USP equivalent to Tazobactam………………0.25 g
Sterile dry powder injection.
- Description
Zifam Tazolin is an injectable antibacterial combination product consisting of the semi synthetic antibiotic piperacillin sodium and the beta lactamase inhibitor tazobactam sodium for intravenous administration.
Piperacillin, a broad spectrum, semisynthetic penicillin exerts bactericidal activity by Inhibition of both septum and cell wall synthesis.
Tazobactam is an inhibitor of many beta-lactamases, which commonly cause resistance to penicillins and cephalosporins.
Tazobactum extends the antibiotic spectrum of piperacillin to include many beta-lactamase-producing bacteria that have acquired resistance to piperacillin alone.
- Clinical particulars
5.1 Therapeutic indications
Zifam Tazolin (Piperacillin/Tazobactam) is indicated for the following infections in adults and children over 2 years of age:
Adults and adolescents
– Severe pneumonia including hospital-acquired and ventilator-associated pneumonia
– Complicated urinary tract infections (including pyelonephritis)
– Complicated skin and soft tissue infections (including diabetic foot infections)
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with any of the infections listed above.
Zifam Tazolin (Piperacillin/ Tozobactam) may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection.
Children 2 to 12 years of age
– Complicated intra-abdominal infections
Zifam Tazolin (Piperacillin/Tazobactam) may be used in the management of neutropenic children with fever suspected to be due to bacterial infection.
Consideration should be given to official guidance on the appropriate us of antibacterial agents.
5.2 Dosage and method of administration
Dosage
The dose and frequency of Zifam Tazolin (Piperacillin/Tazobactam) depends on the severity and localisation of the infection and expected pathogens.
Adult and adolescent patients
Infections
The usual dose is 4 g piperacillin / 0.5 g tazobactam given every 8 hours.
For Nosocomial pneumonia, bacterial infections in Neutropenia patients and other severe infections (As mentioned above) the recommended dose is 4 g piperacillin/ 0.5 g tazobactam administered every 6 hours.
The following table summarises the treatment frequency and the recommended dose for adult and adolescent patients by indication or condition:
| Treatment Frequency | Piperacillin/Tazobactam 4 g/ 0.5 g |
| Every 6 hours | Severe pneumonia |
| Neutropenic adults with fever suspected to be due to a bacterial infection | |
| Every 8 hours | Complicated urinary tract infections (including pyelonephritis) |
| Complicated intra-abdominal infections | |
| Skin and soft tissue infections (including diabetic foot infections) |
Renal impairment
Thie intravenous dosa should be adjusted to the degree of actual renal impairment as follows (each patient must be monitored closely for signs of substance toxicity. medicinal product dose and interval should be adjusted accordingly:
| Creatinine clearance (ml/min) | Piperacillin/Tazobactam (recommended dose) |
| >40 | No dose adjustment necessary |
| 20-40 | Maximum dose suggested: 4 g/ 0.5 g every 8 hours |
| <20 | Maximum dose suggested: 4 g/ 0.5 g every 12 hours |
For patients on haemodialysis, one additional dose of piperacillin / tazobactam 2g / 0.25 g should be administered following each dialysis period, because haemodialysis removes 30%50% of piperacillin in 4 hours.
Hepatic impairment
No dose adjustment is necessary.
Dose in early patients
No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 40 ml/min.
Paediatric population (2-12 years of age)
Infections
The following table summarises the treatment frequency and the dose per body weight for paediatric patients 2-12 years of age by indication or condition:
| Dose per weight and treatment frequency | Indication/condition |
| 80 mg Piperacillin / 10 mg Tazobactam per kg body weight / every 6 hours | Neutropenic children with fever suspected to be due to bacterial infections* |
| 100 mg Piperacillin / 12.5 mg Tazobactam per kg body weight / every 8 hours | Complicated intra-abdominal infections* |
* Not to exceed the maximum 4 g/ 05 g per dosa over 30 minutes
Renal Impairment
The intravenous dose should be adjusted to the degree of actual renal impairment as follows (each patient must be monitored closely for signs of substance toxicity: medicinal product dose and interval should be adjusted accordingly):
Indication / condition
| Creatinine clearance (ml/min) | Piperacillin/Tazobactam (recommended dose) |
| >50 | No dose adjustment needed. |
| ≤50 | 70 mg piperacillin/ 8.75 mg tazobactam/ kg every 8 hours. |
For children on haemodialyis, one additional dese of 40 mg piperacillin / 5 mg tazobactam /kg should be administered following each dialysis period.
Use in children aged below 2 years
The safety and efficacy of Zifam Tazolin (Piperacillin/ Tazobactam) in children 0-2 years of age has not been established. No data from controlled clinical studies are available.
Treatment duration
The usual duration of treatment for most indications is in the range of 5-14 days. However, the duration of treatment should be guided by the severity of the infection the pathogen and the patient’s clinical and bacteriological progress.
Route of administration
Piperacillin/Tazobactam 4.5 g is administered by intravenous infusion (over 30 minutes),
Piperacillin/Tazobactam 2.25 g is administered by intravenous infusion (over 30 minutes).
For reconstitution instructions, see section 7.6.
5.3 Contraindications
Zifam Tazolin is contraindicated in patents with
- Hypersensitivity to the active substances or to any other penicillin-antibacterial agent.
- History of acute severe allergic reaction to any other beta-lactam active substances (eg. Cephalosporin, monobactam or carbapenem).
5.4 Special warnings and precautions for use
The selection of piperacillin/ tazobactam to treat an individual patient should take into account the appropriateness of using a broad-spectrum semi-synthetic penicillin based on factors such as the severity of the infection and the prevalence of resistance to other suitable antibacterial agents.
Before initiating therapy with Zifam Tazolin (Piperacillin/Tazobactam), careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, other beta-lactam agents (e.g. cephalosporin, monobactam or carbapenem) and other allergens.
Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid
[including shock]) reactions have been reported in patients receiving therapy with penicillins, including piperacillin / tazobactam: These reactions are more likely to occur in persons with a history of sensitivity to multiple allergens. Serious hypersensitivity reactions require the discontinuation of the antibiotic, and may require administration of epinephrine and other emergency measures, Antibiotic induced pseudomembranous colitis may be manifested by severe, persistent diarrhoea which may be life-threatening: The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. In these cases Zifam Tazolin (Piperacillin/Tazobactam) should be discontinued.
Therapy with Zifam Tazolin (Piperacillin/Tazobactam) may result in the emergence of resistant organisms, which might cause super-infections.
Bleeding manifestations have occurred in some patients receiving beta-lactam antibiotics. These reactions sometimes have been associated with abnormalities of coagulation tests, such as clotting time, platelet aggregation and prothrombin time, and are more likely to occur in patients with renal failure. If bleeding manifestations occur, the antibiotic should be discontinued and appropriate therapy instituted. Leucoopenia and neutropenia may occur, especially during prolonged therapy; therefore, periodic assessment of haematopoietic function should be performed.
As with treatment with other penicillins, neurological complications in the form of convulsions may occur when high doses are administered; especially in patients with impaired renal function.
Hypokalaemia may occur in patients with low potassium reserves or those receiving concomitant medicinal products that may lower potassium levels; periodic electrolyte determinations may be advisable in such patients.
5.5 Interaction with other medicinal products and other forms of interaction
Non-depolarising muscle relaxants (Vecuronium)
Due to their similar mechanisms of action, it is expected that the neuromuscular blockade produced by any of the non-depolarising muscle relaxants could be prolonged in the presence of piperacillin.
Oral anticoagulants
During simultaneous administration of heparin, oral anticoagulants and other substances that may affect the blood coagulation system including thrombocyte function, appropriate coagulation tests should be performed more frequently and monitored regularly.
Methotrexate
Piperacillin may reduce the excretion of methotrexate; therefore, serum levels of methotrexate should be monitored in patients to avoid substance toxicity.
Probenecid
As with other penicillins, concurrent administration of probenecid and piperacillin/ tazobactam produces a longer half-life and lower renal clearance for both piperacillin and tazobactam; however, peak plasma concentrations of either substances are unaffected.
Aminoglycosides
Piperacillin, either alone or with tazobactam, did not significantly alter the pharmacknetics of tobramycin in subjects with normal renal function and with mild or moderate renal impairment. The pharmacokinetics of piperacillin, tazobactam, and the M1 metabolite were also not significantly altered by tobramycin administration.
The inactivation of tobramycin and gentamicin by piperacillin has been demonstrated in patients with severe renal impairment.
Vancomycin
No pharmacokinetic interactions have been noted between piperacillin/ tazobactam and vancomycin.
Effects on laboratory tests
Non-enzymatic methods of measuring urinary glucose may lead to false-positive results, as with other penicillins. Therefore, enzymatic urinary glucose measurement is required under Zifam Tazolin (Piperacillin/Tazobactam) therapy. A number of chemical urine protein measurement methods may lead to false-positive results. Protein measurement with dip sticks is not affected.
The direct Coombs test may be positive.
Bio-Rad Laboratories Platelia Aspergillus ElA tests may lead to false-positive results for patients receiving Zifam Tazolin (Piperacillin/Tazobactam)
Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus ElA test have been reported.
Positive test results for the assays listed above in patients receiving Zifam Tazolin (Piperacillin/Tazobactam) should be confirmed by other diagnostic methods.
Geriatric Use
Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal insufficiency.
5.6 Fertility, pregnancy and lactation Pregnancy
There are no or a limited amount of data from the use of Zifam Tazolin (Piperacillin/Tazobactam) in pregnant women. Studies in animals have shown developmental toxicity, but no evidence of teratogenicity, at doses that are maternally toxic. Piperacillin and tazobactam cross the placenta. Piperacillin / tazobactam should only be used during pregnancy if clearly indicated, i.e. only if the expected benefit outweighs the possible risks to the pregnant woman and foetus.
Breast-feeding
Piperacillin is excreted in low concentrations in human milk; tazobactam concentrations in human milk have not been studied. Women who are breast feeding should be treated only if the expected benefit outweighs the possible risks to the woman and child.
Fertility
A fertility study in rats showed no effect on fertility and mating after intraperitoneal administration of tazobactam or the combination piperacillin / tazobactam.
5.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
5.8 Undesirable effects
The most commonly reported adverse reactions occurring in to 10 patients in 100) are diarrhea, vomiting, nausea and rash.
In the following table, adverse reactions are listed by system organ class and preferred term. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
| System Organ Class | Common ≥ 1/100 to <1/10 | Uncommon ≥1/1,000 to <1/100 | Rare ≥1/10,000 to <1/1,000 | Very rare (<1/10,000) |
| Infections and infestations | Candidal superinfection | |||
| Blood and lymphatic disorders | Leukopenia, neutropenia, thrombocytopenia | Anaemia, haemolytic anaemia, purpura, epistaxis, bleeding time prolonged, eosinophilia | Agranulocytosis, pancytopenia, activated partial thromboplastin time prolonged, Coombs direct test positive, thrombocythemia | |
| Immune system disorders | Hypersensitivity | Anaphylatic/ anaphylatoid reaction (including shock) | ||
| Metabolism and nutrition disorders | Hypokalaemia, blood glucose decreased, blood albumin decreased, blood protein total decreased | |||
| Nervous system disorders | Headache, insomnia | |||
| Vascular disorders | Hypotension, thrombophlebitis, phlebitis | flushing | ||
| Gastrointestinal disorders | Diarrhoea, vomiting, nausea, jaundice, stomatitis | Constipation, dyspepsia | Pseudo-membranous colitis, abdominal pain | |
| Hepatobiliary disorders | Alanine aminotransferase increased, aspartate aminotransferase increased | Hepatitis, blood bilirubin increased, blood alkaline phosphatase increased, gamma-glutamyl transferase increased | ||
| Skin and subcutaneous tissue disorders | Rash, including maculopapular rash | Urticaria, pruritus | Erythema multiforme, dermatitis bullous, exanthema | Toxic epidermal necrolysis, Stevens-Johnson syndrome |
| Musculoskeletal and connective tissue disorders | Arthralgia, myalgia | |||
| Renal and urinary disorders | Blood creatinine increased | Renal failure, tubulointerstitial nephritis | Blood urea increased | |
| General disorders and administration site conditions | Pyrexia, injection-site reaction | Chills |
Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.
5.9 Overdose
Symptoms
Symptoms & overdose include nausea, vomiting and diarrhoea. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure).
Treatment
In the event of an overdose, piperacillin/ tazobactam treatment should be discontinued. No specific antidote is known. Treatment should be supportive and symptomatic. according to the patient’s clinical presentation.
Excessive serum concentrations of either piperacillin or tazobactam may be reduced by haemodialysis.
6.0 Pharmacological properties
6.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, Combinations of penicilins incl. beta-lactamase inhibitors; ATC code: J01C R05.
Mechanism of action
Piperacillin, a broad spectrum, semisynthetic penicillin exerts bactericidal activity by inhibition of both septum and cell wall synthesis. Tazobactam, a beta-lactam structurally related to penicillins, is an inhibitor of many beta-lactamases, which commonly cause resistance to penicillins and cephalosporins, but it does not inhibit AmpC enzymes or metallo beta-lactamases. Tazobactam extends the antibiotic spectrum of piperacillin to include many beta-lactamase-producing bacteria that have acquired resistance to piperacillin alone.
Pharmacokinetic / Pharmacodynamic relationship
The time above the minimum inhibitory concentration (T>MIC) is considered to be the major pharmacodynamic determinant of efficacy for piperacillin.
Mechanism of resistance
The two main mechanisms of resistance to piperacillin/ tazobactam are:
- Inactivation of the piperacillin component by those beta-lactamases that are not inhibited by tazobactam: beta-lactamases in the Molecular class B, C and D. In addition, tazobactam does riot provide protection against extended-spectrum beta-lactamases (ESBLs) in the Molecular class A and D enzyme groups.
- Alteration of penicillin-binding proteins (PBPs), which results in the reduction of the affinity of piperacillin for the molecular target in bacteria Additionally, alterations in bacterial membrane permeability, as well as expression of multi-drug efflux pumps, may cause or contribute to bacterial resistance to piperacillin / tazobactam, especially in Gram-negative bacteria
Breakpoints
EUCAST Clinical MIC Breakpoints piperacillin/ tazobactam (2009-12-02, v 1). For susceptibility testing purposes, the concentration of tazobactam is fixed at 4 mg/l
| Pathogen | Species-related breakpoints (S≤/R>) | Pathogen | Species-related breakpoints (SS/R>) |
| Enterobacteriaceae | 8/16 | Gram-negative and Gram-positive anaerobes | 8/16
|
| Pseudomonas | 16/16 | Non-species related breakpoints | 4/16
|
The susceptibility of streptococcal is Inferred from the penicillin susceptibility.
The susceptibility of staphylococci is inferred from the oxacillin susceptibility.
Susceptibility
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
| Groupings of relevant species according to piperacillin/tazobactam susceptibility | |||
| Commonly Susceptible Species | |||
| Aerobic G (+)ve micro-organisms | Aerobic G (-)ve micro-organisms | Aerobic G (+)ve micro-organisms | Aerobic G (-)ve micro-organisms |
| E. faecalis | C. koseri | C. species | B. fragilis group |
| L. monocytogenes | H. influenza | E. species | F. species |
| Staphylococcus aureus, methicillin-susceptible | M. catarrhalis | P. species | P. species |
| Staphylococcus species, coagulase negative, methicillin-susceptible | P. mirabilis | P. species | |
| Streptococcus pyogenes | |||
| Group B streptococci | |||
| Species for which acquired resistance may be a problem | |||
| Aerobic G (+) ve micro-organism | Aerobic G (-) ve micro-organism | E. species | P. vulgaris |
| E. faecium | A. baumannii | E. coli | P. ssp. |
| S. pneumonia | B. cepacian | K. pneumonia | P. aeruginosa |
| S. viridans groups | C. freundii | M. morganii | S. species |
| Inherently Resistant Organisms | |||
| Aerobic G (+) ve micro-organism | Aerobic G (-) ve micro-organism | Other micro-organisms | |
| C. jeikeium | L. species | C. pneumonia | |
| S. maltophilia | Mycoplasma pneumonia | ||
| · Species showing natural intermediate susceptibility.
· Species for which high-resistance rates (more than 50%) have been observed in one or more areas/ countries/ regions within the EU. · All methicillin-resistant staphylococci are resistant to piperacillin/ tazobactam. |
|||
6.2 Pharmacokinetic properties
Absorption
The peak piperacillin and tazobactam concentrations after 4 / 0.5 g administered over 30 minutes by intravenous infusion are 298 4g/ml and 34 ug/mi respectively.
Distribution
Both piperacillin and tazobactam are approximately 30% bound to plasma proteins. The protein binding of either piperacillin or tazobactam is unaffected by the presence in other compound, protein binding of the tazobactam metabolite is negligible. Piperacillin / tazobactam is widely distributed in tissues and body fluids including intestinal mucosa, gallbladder, lung bile, and bone. Mean tissues concentrations are generally 50 to 100% of those in plasma : Distribution into cerebrospinal fluid is low in subjects with non-inflamed meninges, as with other penicillins.
Biotransformation
Piperacillin is metabolised to a minor microbiologically active desethyl metabolite. Tazobactam is metabolised to a single metabolite that has been found to be micro-biologically inactive.
Elimination
Piperacillin and tazobactam are eliminated via the kidney by glomerular filtration and tubular secretion. Piperacillin is excreted rapidly as uncharged substance, with 68% of the administered dose appearing in the urine.
Tazobactam and its metabolite are eliminated primarily by renal excretion, with 80% of the administered dose appearing
as unchanged substance and the remainder as the single metabolite, Piperacillin, tazobactam, and desethyl piperacillin are also secreted into the bile. Following single or multiple doses of piperacillin / tazobactam to healthy subjects, the plasma half-life of piperacillin and tazobactam ranged from 0.7 to 1.2 hours and was unaffected by dose or duration of infusion. The elimination half-lives of both piperacillin and tazobactam are increased with decreasing renal clearance.
There are no significant changes in piperacillin pharmacokinetics due to tazobactam. Piperacillin appears to slightly reduce the clearance of tazobactam.
Special populations
The half-life of piperacillin and of tazobactam increases by approximately 25% and 18%, respectively, in patients with hepatic cirrhosis compared to healthy subjects. The halj-life of piperacillin and tazobactam increases with decreasing creatinine clearance. The increase in half-life is two-fold and four-fold for piperacillin and tazobactam, respectively, at creatinine clearance below 20 ml/min compared to patients with normal renal function. Haemodialysis removes 30% to 50% of piperacillin/ tazobactam, with an additional 5% of the tazobactam dose removed as the tazobactam metabolite. Peritoneal dialysis removes approximately 6% and 21% of the piperacillin and tazobactam doses, respectively, with up to 18% of the tazobactam dose removed as the tazobactam metabolite.
Paediatric population
In a population PK analysis, estimated clearance for 9 month-old to 12 year-old patients was comparable to adults, with a population mean (SE) value of 5.64 (0.34) mi/min/kg. The piperacillin clearance estimate is 80% of this value for paediatric patients 2-9 months of age. The population mean (SE) for piperacillin volume of distribution is 0.243 (0.011) I/kg and is independent of age.
Elderly patients
The mean half-life for piperacillin and tazobactam were 32% and 55% longer, respectively, in the elderly compared with younger subjects. This difference may be due to age-related changes in creatinine clearance.
Race
No difference in piperacillin or tazobactam pharmacokinetics was observed between Asian (n=9) and Caucasian (n=9) healthy volunteers who received single 4 g/ 0.5 g
6.3 Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and genotoxicity. Carcinogenicity studies have not been conducted with piperacillin/ tazobactam. A fertility and general reproduction study in rats using intraperitoneal administration of tazobactam or the combination piperacillin / tazobactam reported a decrease in litter size and an increase in fetuses with ossification delays and variations of ribs, concurrent with maternal toxicity. Fertility of the F1 generation and embryonic development of F2 generation were not impaired. Teratogenicity studies using intravenous administration of tazobactam or the combination piperacillin / tazobactam in mice and rats resulted in slight reductions in rat fetal weights at maternally toxic doses but did not show teratogenic effects. Peri/postnatal development was impaired (reduced pup weights, increase in stillbirths, increase in pup mortality) concurrent with maternal toxicity after intrapertoneal administration of tazobactam or the combination piperacillin/ tazobactam in the rat.
7.0 Pharmaceutical particulars
7.1 List of excipients*
None
7.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section reconstituted solution
This product must not be mixed or co-administrated with any aminoglycoside. The mixing of beta-lactam antibiotics with an aminoglycoside in vitro can result in substantial inactivation of the aminoglycoside.
Piperacillin/ tazobactam should not be mixed with other substances in a syringe or infusion bottle since compatibility has not been established.
Piperacillin / tazobactam should be administered through an infusion set separately from any other drugs unless compatibility is proven.
Due to chemical instability, piperacillin / tazobactam should not be used in solutions containing only sodium bicarbonate.
Lactated Ringer’s (Hartmann’s) solution is not compatible with piperacillin/ tazobactam.
Piperacillin/ tazobactam should not be added to blood products or albumin hydrolysates.
7.3 Shelf life
Unopened: 24 Months
Storage/Stability: Reconstitute conventional vials with 5 ml of compatible diluent per gram of piperacillin. Shake well until dissolved. Use single dose vials immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (25°C) or after 48 hours if stored at refrigerated temperature (2°C to 8°C [36°F to 46° F]).
Stability in the IV bags has been demonstrated for up to 24 hours at room temperature and up to one week at refrigerated temperature. Stability in an ambulatory IV infusion pump has been demonstrated for a period of 12 hours at room temperature.
7.4 Storage
Unopened vial to be stored below 25°C in a dry place protected from light.
Keep out of reach of children.
7.5 Nature and contents of container
Zifam Tazolin 4.5 g
Zifam Tazolin 2.25 g
Glass vial of 30 ml with water for injection BP.
Glass vial of 20 ml with water for injection BP.
2 x 10ml Twist type Plastic bottles.
1 x 10ml Twist type Plastic bottles.
7.6 Special precautions for disposal and other handling
The reconstitution and dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discoloration
prior to administration. The solution should only be used if the solution is clear and free from particles.
Intravenous use
Reconstitute each vial with the volume of solvent shown in the table below
Shake well until dissolved.
Compatible reconstituted diluents: These Include 0.9% Sodium Chloride for injection, Sterile Water for injection, Dextrose 5%, Bacteriostatic Saline/Parabens, Bacteriostatic
Water/Parabens, Bacteriostatic Saline/Benzyl Alcohol, Bacteriostatic Water/Benzyl Alcohol.
Lactated Ringer’s solution is nol compatible. Dilute to at least 50 ml to 150 ml. Administer over a period of = 30 minutes.
Sterilized water for injection BP to be added to vial
Content of vial
2 x 10 ml
4.5 g (4 g piperacillin and 0.5 g tazobactam)
2.25 g (2 g piperacillin and 0.25 g tazobactam)
1 x 10 ml
The reconstituted solutions may be further diluted to the desired volume (e.g, 50 ml to 150 ml) with one of the following compatible solvents:
- sodium chloride 9 mg/ml (0.9 %) solution in water for injection;
- glucose 50 mg/ml (5 %) solution in water for injection;
- dextran (grade 40) 60 mg/ml (6%) solution in sodium chloride 9 mg/ml (0.9%) solution.
Any unused product or waste material should be disposed in accordance with local requirements.
For single use only. Discard any unused solution.
Manufactured by:
Zifam Pyrex Myanmar Co., Ltd.
Lot C6, Zone-A, Thilawa SEZ, Thanlyin and Kyaut Tan Township, Yangon, Myanmar.
Product of
Zifam Pinnacle Pty.Ltd
The Healthcare Group
Updated on 9/Feb/2024