Components:
Method of action:
Treatment option:
Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 02.04.2022
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Top 20 medicines with the same components:
Abba (Antibacterials)
Amoxicillin
The drug Augmentin® CP is indicated for the treatment of bacterial infections of the following localizations caused by microorganisms sensitive to the combination of amoxicillin with clavulanic acid:
respiratory tract infections, such as community-acquired pneumonia, exacerbation of chronic bronchitis, acute bacterial sinusitis, usually caused by Streptococcus pneumoniae (including penicillin-resistant strains), Haemophilus influenzae1, Moraxella catarrhalis1 and Streptococcus pyogenes
prevention of local infections after surgery in dentistry.
1 Некоторые штаммы этих бактерий продуцируют бета-лактамазы, что делает их нечувствительными к монотерапии амоксициллином.
Infections caused by amoxicillin-sensitive microorganisms can be treated with Augmentin ® CP, as amoxicillin is one of its active ingredients. The drug Augmentin® CP is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as beta-lactamase-producing microorganisms sensitive to the combination of amoxicillin with clavulanic acid.
The drug Augmentin® CP demonstrated efficacy against S. pneumoniae strains resistant to penicillin (strains with MPC ≥2 mg / L).
Drugs containing a combination of amoxicillin with clavulanic acid should be used in accordance with the Russian guidelines for antibiotic therapy and regional data on the sensitivity of pathogens to the combination of amoxicillin with clavulanic acid.
The sensitivity of bacteria to the combination of amoxicillin with clavulanic acid varies depending on the region and over time. Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples should be collected and analyzed for bacteriological sensitivity.
Respiratory tract infections (acute and chronic bronchitis, lobar and bronchopneumonia, pleural empyema, lung abscess, ear, nose and throat infections)
It is also used for the prevention of infections that are associated with major surgical operations on the gastrointestinal tract, in the pelvis, head and neck, on the heart, kidneys, and bile ducts.
Inside, washed down with water
Film-coated tablets
Adults and children over 12 years of age (body weight ≥40 kg)
Take 1 tablet. 2 times a day, every 12 hours.
The maximum daily dose of amoxicillin for adults is 6 g, for children-45 mg / kg / day.
The maximum daily dose of clavulanic acid for adults (in the form of potassium clavulanate) is 600 mg, for children-10 mg/kg / day.
The course of treatment — 5-14 days
Dosage for renal failure
Tablets 875/125 mg should be used only in patients with a creatinine Cl of more than 30 ml / min, and no dose adjustment is required.
Patients on peritoneal dialysis do not need to adjust the dose. Patients on hemodialysis may need to adjust the dose of the drug.
Powder for preparation of suspension for oral administration
Dose with a measuring spoon, taking into account that 5 ml of the finished suspension contains amoxicillin 400 mg/clavulanic acid 57 mg. Drink 0.5-1 cup of water.
The dose of Panclav 2X is prescribed by a doctor, taking into account the characteristics of the pathogen, localization and severity of the infection. The dosage regimen is set individually, depending on age, body weight (for children) and kidney function. The course of treatment — 5-14 days
For infections that require a long course of therapy (for example, osteomyelitis), exceeding the maximum recommended course of therapy of 14 days is possible only after a thorough assessment by the doctor of the patient's condition, the achieved and expected therapeutic effects and risks.
The maximum daily dose of amoxicillin for adults is 6 g, for children-45 mg / kg / day. The maximum daily dose of clavulanic acid for adults (in the form of potassium clavulanate) is 600 mg, for children-10 mg/kg / day.
Adults and children over 12 years of age (body weight ≥40 kg)
Standard dosage regimen for all indications:
2 scoops (800/114 mg) 2 times a day, every 12 hours.
Children from 2 to 12 years (body weight ≥40 kg)
25 mg / kg | 13-21 kg | 2-6 years old | 2.5 ml 2 times a day |
22-40 kg | 7-12 years old | 5 ml 2 times a day | |
45 mg / kg | 13-21 kg | 2-6 years old | 5 ml 2 times a day |
22-40 kg | 7-12 years old | 10 ml 2 times a day |
Children from 3 months to 3 years old
5 kg | 0.8 ml 2 times a day | 1.4 ml 2 times a day |
6 kg | 0.9 ml 2 times a day | 1.7 ml 2 times a day |
7 kg | 1.1 ml 2 times a day | 2 ml 2 times a day |
8 kg | 1.3 ml 2 times a day | 2.3 ml 2 times a day |
9 kg | 1.4 ml 2 times a day | 2.5 ml 2 times a day |
10 kg | 1.6 ml 2 times a day | 2.8 ml 2 times a day |
11 kg | 1.7 ml 2 times a day | 3.1 ml 2 times a day |
12 kg | 1.9 ml 2 times a day | 3.4 ml 2 times a day |
The daily dose for children older than 3 months and up to 12 years (body weight ≥40 kg) is 25-45 mg/kg / day (based on amoxicillin), divided into two doses, every 12 hours.Low doses of the drug (25 mg/kg/day) are used to treat skin and soft tissue infections, as well as recurrent tonsillitis. High doses of the drug (45 mg / kg / day) are used to treat diseases such as otitis media, sinusitis, lower respiratory tract and urinary tract infections. The duration of treatment of acute uncomplicated otitis media is 5-7 days, in children-7-10 days.
Children and adults with renal insufficiency
If the creatinine Cl is less than 30 ml / min, the drug at this dose is not recommended
Preparation of suspension for oral administration
In the bottle with the powder, gradually add water to the mark (distilled water or boiled and cooled) and shake until the powder is evenly wet (about 30 c). If the level of the prepared suspension is below the label on the bottle label, re-add water to the label and shake.
The finished suspension must be shaken before each meal.
Important! Если прием препарата пропущен, следует как можно скорее принять таблетку (или суспензию), не дожидаясь времени следующего приема. Далее соблюдать равные промежутки времени между приемами — по 12 ч. You should never take a double dose to make up for a missed medication!
Inside.
To optimize absorption, the drug should be taken at the beginning of a meal.
Treatment should not last more than 14 days without reviewing the clinical situation.
Tablets of the drug Augmentin® The SRS have a dividing groove that allows them to be broken in half for ease of ingestion, but not to reduce the dose: both halves must be taken simultaneously. The recommended dose of the drug is 2 tablets. 2 times a day.
Adults (16 years and older). Инфекции дыхательных путей: 2 табл. 2 раза в день в течение 7–10 дней, включая следующие заболевания:
- community-acquired pneumonia — 2 tables. 2 times a day for 7-10 days
- exacerbation of chronic bronchitis — 2 tables. 2 times a day for 7 days
- acute sinusitis of bacterial etiology — 2 tables. 2 times a day for 10 days.
Prevention of local infections after surgical dental interventions: 2 tables. 2 times a day for 5 days starting 3 hours after the intervention.
Special patient groups
Children under 16. Не применяется.
Elderly patients. Не требуется коррекция режима дозирования.
Patients with impaired renal function. Не требуется коррекция режима дозирования при Cl креатинина ≥30 мл/мин. Не рекомендуется назначение препарата пациентам с Cl креатинина <30 мл/мин.
Patients on hemodialysis. Не рекомендуется.
Impaired liver function. Лечение проводят с осторожностью; регулярно осуществляют мониторинг функции печени. Недостаточно данных для рекомендации режима дозирования для данной группы пациентов.
IV is administered slowly, for 3-4 minutes, no later than 20 minutes after dissolution. For the infusion, 600 mg of the substance is dissolved in 50 ml of the infusion solution or 1.2 g of the substance in 100 ml of the solution. The duration of the drip infusion is 30-40 minutes. The drug can be administered in various infusion solutions, except for glucose (dextrose) solution.
Adults and children over 12 years of age: 1.2 g every 8 hours, with more severe infections, the interval between injections is reduced to 6 hours.
Children from 3 months to 12 years: 30 mg / kg every 8 hours, with more severe infections, the interval between injections is reduced to 6 hours.
Children under 3 months: 30 mg / kg every 12 hours in premature infants and newborns, then the interval between injections is reduced to 8 hours.
30 mg of the intravenous drug contains 25 mg of amoxicillin and 5 mg of clavulanic acid.
In surgical practice, Abba (Antibacterials)is used to protect against infection during surgery. Adults are given 1.2 g intravenously before anesthesia, if the intervention lasts more than an hour. The course of treatment can be extended for several days if the risk of infection was increased during the intervention. The drug should also be used in postoperative treatment.
With reduced renal function: adults with mild insufficiency (Creatinine Cl > 30 ml / min) there is no need to reduce the dosage
Treatment of adults and children can last 14 days, after which it is necessary to decide whether to continue antibacterial therapy or cancel it.
Inside, before or during meals. Adults and children over 12 years of age: moderate infections - 375 mg (1 table) 3 times a day
In case of impaired renal function, adults:
More than 30 | No changes |
10–30 | 375-750 mg every 12 hours |
Less than 10 | No more than 625 mg every 24 hours |
hypersensitivity to amoxicillin, clavulanic acid, other components of the drug, beta-lactam antibiotics (for example, penicillins, cephalosporins) in the anamnesis
previous episodes of jaundice or impaired liver function when using a combination of amoxicillin with clavulanic acid in the anamnesis.
With caution: нарушения функции печени.
Hypersensitivity to penicillin antibiotics, infectious mononucleosis, lymphocytic leukemia.
The adverse events presented below are listed according to the lesion of organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often - ≥1/10
Infectious and parasitic diseases: часто — генитальный монилиаз, кожно-слизистый кандидоз.
From the blood and lymphatic system: редко — обратимая лейкопения (включая нейтропению) и тромбоцитопения; очень редко — обратимые агранулоцитоз и гемолитическая анемия, увеличение времени кровотечения и ПВ.
On the part of the immune system: очень редко — ангионевротический отек, анафилактические реакции, синдром, сходный с сывороточной болезнью, аллергический васкулит.
From the nervous system: нечасто — головокружение, головная боль; очень редко — обратимые гиперактивность, судороги.
From the gastrointestinal tract: очень часто — диарея; часто — тошнота, абдоминальные боли; нечасто — рвота, расстройства пищеварения; очень редко — колиты, индуцированные приемом антибиотиков (включая псевдомембранозный колит и геморрагический колит), черный «волосатый» язык.
From the liver and biliary tract: нечасто — умеренное повышение активности ACT и/или АЛТ. Данное явление наблюдается у пациентов, получающих терапию бета-лактамными антибиотиками, однако клиническая значимость его неизвестна; очень редко — гепатит и холестатическая желтуха. Данное явление наблюдается у пациентов, получающих терапию антибиотиками пенициллинового ряда и цефалоспоринами.
Adverse events from the liver are observed mainly in men and elderly patients and may be associated with long-term therapy.
The listed signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. Adverse events are usually reversible. Adverse events from the liver can be severe, in extremely rare cases, there have been reports of fatal outcomes. In almost all cases, these were patients with serious comorbidities or patients receiving potentially hepatotoxic drugs at the same time.
From the skin and subcutaneous tissues: нечасто — сыпь, зуд, крапивница; редко — многоформная эритема; очень редко — синдром Стивенса-Джонсона, токсический эпидермальный некролиз, буллезный эксфолиативный дерматит, острый генерализованный экзантематозный пустулез. В случае возникновения любых аллергических реакций лечение препаратом Аугментин® СР необходимо прекратить.
From the kidneys and urinary tract: очень редко — интерстициальный нефрит, кристаллурия.
Dyspeptic phenomena (nausea, vomiting, diarrhea), allergic reactions (erythema, rash).
Symptoms: there may be symptoms from the gastrointestinal tract and violations of the water-electrolyte balance. Amoxicillin crystalluria is described, which in some cases led to the development of renal failure (see "Special instructions").
Treatment: симптомов со стороны ЖКТ — симптоматическая терапия, уделяя особое внимание нормализации водно-электролитного баланса. Амоксициллин и клавулановая кислота могут быть удалены из кровотока путем гемодиализа.
Symptoms: nausea, diarrhea, vomiting.
Treatment: symptomatic
Amoxicillin is a broad-spectrum semi-synthetic antibiotic with activity against many Gram-positive and Gram-negative microorganisms. At the same time, amoxicillin is susceptible to destruction by beta-lactamases, and therefore the spectrum of activity of amoxicillin does not extend to microorganisms that produce this enzyme.
Clavulanic acid, a beta-lactamase inhibitor structurally related to penicillins, has the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid has sufficient efficacy against plasmid beta-lactamases, which most often cause bacterial resistance, and is less effective against type 1 chromosomal beta-lactamases, which are not inhibited by clavulanic acid.
The presence of clavulanic acid in the preparation Augmentin® protects amoxicillin from destruction by beta — lactamase enzymes, which allows you to expand the antibacterial spectrum of amoxicillin.
Delayed release of amoxicillin in Augmentin® CP allows you to maintain the sensitivity of those strains of S. pneumoniae in which resistance to amoxicillin is due to penicillin-binding proteins (penicillin-resistant S. pneumoniae, or PRSP).
Below is the activity of the combination of amoxicillin with clavulanic acid in vitro.
Bacteria usually sensitive to the combination of amoxicillin with clavulanic acid
Gram-positive airbags: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus pneumoniae1,2, Streptococcus pyogenes1,2, Streptococcus agalactiae1,2, Viridans group streptococci2, Streptococcus spp. (other beta-hemolytic streptococci)1,2, Staphylococcus aureus (sensitive to methicillin)1, Staphylococcus saprophyticus (methicillin-sensitive), coagulase-negative staphylococci (methicillin-sensitive).
Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae1, Helicobacter pylori, Moraxella catarrhalis1, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.
Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.
Gram-positive anaerobes: Clostridium spp., Peptostreptococcus spp., including Peptococcus niger, Peptostreptococcus magnus, Peptostreptococcus micros.
Gram-negative anaerobes: Bacteroides spp., including Bacteroides fragilis, Capnocytophaga spp., Eikenella corrodens, Fusobacterium spp., including Fusobacterium nucleatum, Porphyromonas spp., Prevotella spp.
Bacteria that are likely to have acquired resistance to the combination of amoxicillin with clavulanic acid
Gram-negative aerobes: Escherichia coli1, Klebsiella spp., including Klebsiella oxytoca, Klebsiella pneumoniae1, Proteus spp., including Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp.
Gram-positive airbags: Corynebacterium spp., Enterococcus faecium.
Bacteria that are naturally resistant to the combination of amoxicillin and clavulanic acid
Gram-negative aerobes: Acinetobacter spp., Citrobacter freundii, Enterobacter spp., Hafnia alvei, Legionella pneumophila, Morganella morganii, Providencia spp., Pseudomonas spp., Serratia spp., Stenotrophomonas maltophilia, Yersinia enterocolitica.
Other: Chlamydia spp., including Chlamydia pneumoniae, Chlamydia psittaci, Coxiella burnetii, Mycoplasma spp.
1 Для данных видов микроорганизмов клиническая эффективность комбинации амоксициллина с клавулановой кислотой была продемонстрирована в клинических исследованиях.
2 Штаммы этих видов бактерий не продуцируют бета-лактамазы. Чувствительность при монотерапии амоксициллином позволяет предполагать аналогичную чувствительность к комбинации амоксициллина с клавулановой кислотой.
Resistance
Cross-resistance. Амоксициллин непосредственно демонстрирует перекрестную резистентность с другими бета-лактамными антибиотиками, а также комбинацией бета-лактамных антибиотиков с ингибиторами бета-лактамаз и цефалоспоринами.
Mechanisms of resistance. Клавулановая кислота защищает амоксициллин от разрушающего действия бета-лактамаз. Замедленное высвобождение действующих веществ препарата Аугментин® СР повышает эффективность амоксициллина в отношении микроорганизмов, резистентность которых обусловлена модификацией пенициллинсвязывающих белков.
Bactericidal against a wide range of gram-positive and gram-negative microorganisms, aerobic and anaerobic pathogens (including those strains that have developed resistance to beta-lactam antibiotics due to the production of beta-lactamases).
Active against aerobic gram-positive bacteria (including beta-lactamase-producing strains): Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes
Clavulanic acid suppresses types II, III, IV and V of beta-lactamases, is inactive against type I beta-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high tropicity to penicillinases and forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases.
Suction
Both active ingredients of the drug Augmentin ® CP, amoxicillin and clavulanic acid, are well soluble in aqueous solutions with a physiological pH value, are quickly and completely absorbed from the gastrointestinal tract after oral administration. The absorption of active substances is optimal in the case of taking the drug at the beginning of a meal.
The pharmacokinetic parameters of amoxicillin and clavulanic acid after taking 2 tablets of the drug Augmentin are shown below® CP by healthy volunteers at the beginning of a meal.
Table 1
Average values of pharmacokinetic parameters
Amoxicillin | ||||||
Abba (Antibacterials) 1000 mg 62.5 mg×2 | 2000 | 5,9 (49,4) | 17 | 1,5 | 71,6 | 1,27 |
Clavulanic acid | ||||||
Abba (Antibacterials) 1000 mg 62.5 mg×2 | 125 | Not defined | 2,05 | 1,03 | 5,29 | 1,03 |
1 Для бактерий с МПК 4 мг/л.
2 Т>МПК, ч (%) — время (в процентах от временного интервала между дозами), в течение которого концентрация препарата в крови выше МПК для конкретного возбудителя.
The drug Augmentin® CP has a unique pharmacological profile, the T>MPC index characteristic of this drug is not achieved when taking tablets with immediate release of active substances containing a combination of amoxicillin and clavulanic acid.
Distribution
As with the intravenous administration of a combination of amoxicillin and clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are created in various tissues and interstitial fluid (gallbladder, abdominal tissue, skin, adipose and muscle tissue, synovial and peritoneal fluid, bile, purulent discharge).
Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that about 25% of the total amount of clavulanic acid and 18% of amoxicillin in the blood plasma binds to plasma proteins.
In animal studies, no accumulation of the components of the drug Augmentin was found® CP in any body.
Amoxicillin, like most penicillins, can be detected in breast milk. Trace amounts of clavulanic acid were also found in breast milk. With the exception of the possibility of diarrhea and candidiasis of the oral mucosa, no other negative effects of amoxicillin and clavulanic acid on the health of infants fed with breast milk are known.
Studies of reproductive function in animals when taking the drug Augmentin® CP showed that amoxicillin and clavulanic acid penetrate the placental barrier. However, there was no negative effect on the fetus.
Metabolism
10-25% of the initial dose of amoxicillin is excreted by the kidneys as an inactive metabolite (penicillic acid). Clavulanic acid undergoes intensive metabolism to 2,5-dihydro-4 - (2-hydroxyethyl) - 5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butane-2-one and is excreted by the kidneys, through the gastrointestinal tract, and with exhaled air in the form of carbon dioxide.
Output
Like other penicillins, amoxicillin is mainly excreted by the kidneys, while clavulanic acid is excreted through both the renal and extrarenal mechanisms.
Studies have shown that, on average, about 60-70% of amoxicillin and about 40-65% of clavulanic acid is excreted unchanged by the kidneys.
Simultaneous administration of probenecid slows the elimination of amoxicillin, but does not slow the elimination of clavulanic acid (see "Interaction").
The pharmacokinetics of amoxicillin and clavulanic acid are similar. After intravenous administration at doses of 1200 mg and 600 mg, the Cmax of amoxicillin was 105.4 mcg / ml and 32.2 mcg/ml, respectively, and clavulanic acid was 28.5 mcg/ml and 10.5 mcg / ml, respectively. The connection with plasma proteins: amoxicillin — 17-20%, clavulanic acid — 23-30%. Both components are metabolized in the liver: amoxicillin - 10% of the administered dose, clavulanic acid-50%. T1 / 2 after intravenous administration at a dose of 1.2 g and 600 mg — 0.9 and 1.07 hours for amoxicillin, 0.9 and 1.12 hours-for clavulanic acid, respectively. It is mainly excreted by the kidneys (glomerular filtration and tubular secretion): 50-78% and 25-40% of the dose of amoxicillin and clavulanic acid, respectively, is excreted unchanged during the first 6 hours after administration
- Penicillins in combinations
Simultaneous use of the drug Augmentin® CP and probenecid are not recommended. Probenecid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of the drug Augmentin® CP and probenecid can lead to an increase and persistence in the blood concentration of amoxicillin, but not clavulanic acid.
Concomitant use of allopurinol and amoxicillin may increase the risk of skin allergic reactions. Currently, there is no data in the literature on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol.
Penicillins are able to slow the elimination of methotrexate from the body by inhibiting its tubular secretion, so the simultaneous use of the drug Augmentin® CP and methotrexate may increase the toxicity of methotrexate.
Like other antibacterial drugs, the drug Augmentin® CP can affect the intestinal microflora, leading to a decrease in the absorption of estrogens from the gastrointestinal tract and a decrease in the effectiveness of combined oral contraceptives.
The literature describes rare cases of increased MHO in patients with the combined use of acenocumarol or warfarin and amoxicillin. If necessary, simultaneous administration or withdrawal of the drug Augmentin® CP with PV or MHO anticoagulants should be carefully monitored, and the dose of anticoagulants for oral administration may need to be adjusted.
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