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Analogue of ampicillin, is a semisynthetic antibiotic with essentially the all patients who present agar (Biokar®) were prepared and sterilized according to the manufacturers’ instructions. Another drug and may not reflect the rates.

Serum sample and one bone sample were available from differs from the organisms found in the sputum 6), negative control group: neither infected nor treated animals. Our lives.

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Amoxicillin Sodium 1g Powder for Solution for Injection. Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 250mg. Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 500mg. Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 1g.

Amoxicillin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): • Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms) • Acute exacerbations of chronic bronchitis. • Bacteremia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Amoxicillin is also indicated for the treatment and prophylaxis of endocarditis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. The dose of Amoxicillin that is selected to treat an individual infection should take into account: • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) • The severity and the site of the infection.

• The age, weight and renal function of the patient; as shown below. The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible.

Some infections require longer periods of treatment (see section 4.4 regarding prolonged therapy).

Severe infections of the ear, nose and throat (such as mastoiditis peritonsillar infections, epiglottis and sinusitis when accompanied by severe systemic signs and symptoms.

750 mg to 2 g every 8 hours, or 2 g every 12 hours, maximum of 12 g/day.

750 mg to 2 g every 8 hours, or 2 g every 12 hours, maximum of 12 g/day. 1 g to 2 g every 4 to 6 hours, maximum of 12 g/day. Lyme disease (see section 4.4) Late stage (systemic involvement): 2 g every 8 hours.

Bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed in section 4.1.

1 g to 2 g every 4, 6 or 8 hours, maximum of 12 g/day.

*Consideration should be given to the official treatment guidelines for each indication. Children 3 months and children MIC) is considered to be the major determinant of efficacy for amoxicillin.

The main mechanisms of resistance to amoxicillin are: • Inactivation by bacterial beta-lactamases.

• Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.

Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria.

MIC

breakpoints for amoxicillin are those of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) version 5.0.

MIC breakpoint (mg/L) Susceptible ? Staphylococcus spp. Gram positive anaerobes except Clostridium difficile 8.

1 Wild type Enterobacteriaceae are categorised as susceptible to aminopenicillins. Some countries prefer to categorise wild type isolates of E.

When this is the case, use the MIC breakpoint S ? 0.5 mg/L. 2 Most staphylococci are penicillinase producers, which are resistant to amoxicillin. Methicillin resistant isolates are, with few exceptions, resistant to all beta-lactam agents.

3 Susceptibility to amoxicillin can be inferred from ampicillin.

4 The susceptibility of streptococcus groups A, B, C and G to penicillins is inferred from the benzylpenicillin susceptibility.

5 Breakpoints relate only to non-meningitis isolates. For isolates categorised as intermediate to ampicillin avoid oral treatment with amoxicillin.

Susceptibility inferred from the MIC of ampicillin.

6 Breakpoints are based on intravenous administration. Beta-lactamase positive isolates should be reported resistant. 7 Beta lactamase producers should be reported resistant.

8 Susceptibility to

amoxicillin

can be inferred from benzylpenicillin. 9 The breakpoints are based on epidemiological cut-off values (ECOFFs), which distinguish wild-type isolates from those with reduced susceptibility. 10 The non-species related breakpoints are based on doses of at least 0.5 g x 3or 4 doses daily (1.5 to 2 g/day).

The prevalence of 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. In vitro susceptibility of micro-organisms to Amoxicillin. Beta-hemolytic streptococci (Groups A, B, C and G) Listeria monocytogenes. Species for which acquired resistance may be a problem.

Inherently resistant organisms † Enterococcus faecium † Acinetobacter spp.

(many strains of Bacteroides fragilis are resistant).

† Natural intermediate susceptibility in the absence of acquired mechanism of resistance.

? Almost all S.aureus are resistant to amoxicillin due to production of penicillinase.

In addition, all methicillin-resistant strains are resistant to amoxicillin. The pharmacokinetic results for studies in which amoxicillin was administered to groups of healthy volunteers given as a bolus intravenous injection are presented below. Peak serum conc (?g/ml) Urinary recovery (%, 0 to 6 h ) About 18% of total plasma amoxicillin is bound to protein and the apparent volume of distribution is around 0.3 to 0.4 l/kg. Following intravenous administration, amoxicillin has been found in gall bladder, abdominal tissue, skin, fat, muscle tissues, synovial and peritoneal fluids, bile and pus.

Amoxicillin does not adequately distribute into the cerebrospinal fluid. From animal studies there is no evidence for significant tissue retention of drug-derived material.

Amoxicillin, like most penicillins, can be detected in breast milk (see section 4.6). Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to up to 10 to 25% of the initial dose. The major route of elimination for amoxicillin is via the kidney.

Amoxicillin has a mean elimination half-life of approximately one hour and a mean total clearance of approximately 25 l/hour in healthy subjects.

Approximately 60 to 70% of the amoxicillin is excreted unchanged in urine during the first 6 hours after administration of a single 250 mg or 500 dose of amoxicillin. Various studies have found the urinary excretion to be 50 to 85% for amoxicillin over a 24 hour period. Concomitant use of probenecid delays amoxicillin excretion (see section 4.5).

Following oral administration of amoxicillin to healthy males and female subjects, gender has no significant impact on the pharmacokinetics of amoxicillin. The elimination half-life of amoxicillin is similar for children aged around 3 months to 2 years and older children and adults.

For very young children (including preterm newborns) in the first week of life the interval of administration should not exceed twice daily administration due to immaturity of the renal pathway of elimination.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. The total serum clearance of amoxicillin decreases proportionately with decreasing renal function (see section 4.2). Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.

Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.

Carcinogenicity studies have not been conducted with amoxicillin.

Amoxicillin should not be mixed with blood

products

, other proteinaceous fluids such us protein hydrolysates or with intravenous lipid emulsions.

If prescribed concomitantly with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because of loss of activity of the aminoglycoside under these conditions. Amoxicillin and aminoglycoside injections should be administered at separate sites. Amoxicillin should not be mixed with ciprofloxacin.

Amoxicillin solutions should not be mixed with infusions containing dextran or bicarbonate. Reconstituted solutions should be administered immediately after preparation.

Vials

containing 250mg or 500mg of amoxicillin sodium for injection in packs of 10 vials. Vials containing 1g of amoxicillin sodium for injection in single packs. All solutions should be shaken vigorously before injection and administered immediately after reconstitution.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Amoxicillin Sodium 250mg Powder for Solution for Injection - PL 29831/0010. Amoxicillin Sodium 500mg Powder for Solution for Injection - PL 29831/0012.

Amoxicillin Sodium 1g Powder for Solution for Injection - PL 29831/0011. On Friday February 22, Good Morning Britain ran a piece on the use of dogs in medical research. In the studio was Professor Nic Wells from the Royal Veterinary College who explained how he uses dogs in his research.

Opposing him in the studio was actor Peter Egan, and anti-vivisection scientific advisor Andre Menache was shown on a screen live from Paris.



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