Mechanism of Action primobolan depot cycle – a semi-synthetic broad-spectrum antibiotic with activity against many Gram-positive and Gram-negative microorganisms. Meanwhile primobolan depot cycle susceptible to destruction of beta-lactamases, and therefore the spectrum of primobolan depot cycle activity not covered by the microorganisms which produce these enzymes. Clavulanic acid – inhibitor of beta-lactamases are structurally related penicillins, it has the ability to inactivate a wide range of beta-lactamase detected in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid has sufficient effectiveness against plasmid beta-lactamase, which often cause bacterial resistance, and less effective against chromosomal beta-lactamase 1 type. The presence of clavulanic acid in a preparation Augmentin ® protects primobolan depot cycle from degradation enzymes – beta-lactamases, allowing extend the antibacterial spectrum of primobolan depot cycle. Below is a combination of primobolan depot cycle with clavulanic acid activity in vitro . Bacteria usually sensitive to the combination of primobolan depot cycle with clavulanic acid Gram-positive aerobes Bacillus anthracis Enterococcus faecalis Gardnerella vaginalis Listeria monocytogenes Nocardia asteroides Streptococcus pneumoniae 1.2 Streptococcus pyogenes 1.2 Streptococcus agalactiae 1.2 group B Streptococcal Viridans 2 of Streptococcus spp. (other beta-hemolytic streptococci) 1.2 of Staphylococcus aureus (methicillin-sensitive) 1 of Staphylococcus saprophytics (methicillin-sensitive) Coagulase-negative staphylococci (methicillin sensitive) Gram-positive anaerobic bacteria of Clostridium spp. Peptococcus niger derived Peptostreptococcus magrtusPeptostreptococcus micros Peptostreptococcus spp. Gram-negative aerobes of Bordetella pertussis of Haemophilus influenzae 1 of Helicobacter pylori of Moraxella catarrhal of Neisseria gonorrhoeae of Pasteurella multocida of Vibrio cholerae Gram-negative anaerobic bacteria of Bacteroides fragilis of Bacteroides spp. Capnocytophaga spp. Eikenella corrodens by Fusobacterium nucleatum by Fusobacterium spp. of Porphyromonas spp . Prevotella spp . Other of Borrelia burgdorferi Leptospira icterohaemorrhagiae of Treponema pallidum bacteria, for which the likely acquired resistance to the combination of primobolan depot cycle with clavulanic acid Gram-negative aerobic Escherichia coli 1 of Klebsiella oxytoca of Klebsiella pneumoniae 1 of Klebsiella spp. the Proteus mirabilis the Proteus vulgaris the Proteus spp. of Salmonella spp. of Shigella spp. Gram-positive aerobes of Corynebacterium spp . of Enterococcus faecium bacteria having natural resistance to primobolan depot cycle with clavulanic acid Gram-negative aerobes of Acinetobacter spp. Citrobacter freundii of Enterobacter spp. Hafnia alvei of Legionella pneumophila Morganella morganii Providencia spp. of Pseudomonas spp. of Serratia spp. Stenotrophomonas maltophilia are of Yersinia enterocolitica Other of Chlamydia pneumoniae of Chlamydia psittaci of Chlamydia spp. Coxiella burnetii of Mycoplasma spp. 1 – for the clinical efficacy of these bacteria combination of primobolan depot cycle with clavulanic acid has been demonstrated in clinical trials. 2 – strains of these bacteria do not produce beta-lactamase. Sensitivity for primobolan depot cycle alone suggests a similar sensitivity to primobolan depot cycle combined with clavulanic acid.
Absorption Below are the results of studies of pharmacokinetics after intravenous bolus administration of the drug to healthy volunteers Augmentin ® at 500 mg + 100 mg (0.6 g), or 1000 mg + 200 mg (1D g).
Bolus intravenous injection
|The active ingredients in the composition of
Augmentin drug ®
|Mean values of pharmacokinetic parameters|
(ug / ml)
(mg x hr / l)
in urine, 0-6% h
|primobolan depot cycle||500||32.2||1.07||25.5||66.5|
C max – the maximum plasma concentration.
T ½ – half-life.
The AUC – area under the curve “concentration-time”.
found in various tissues and interstitial fluid (in the gall bladder, abdominal tissue, skin, fat and muscle tissues, synovial and peritoneal fluids, bile, purulent discharge) Intravenously, the combination of primobolan depot cycle with clavulanic acid, therapeutic concentrations of primobolan depot cycle and clavulanic acid.
primobolan depot cycle and clavulanic acid have a low degree of binding to plasma proteins. Studies have shown that plasma protein binds about 13-20% of each of the components of the drug Augmentin ® . In animal studies found no accumulation of components of the drug Augmentin ® in any organ. primobolan depot cycle, like most penicillins, it passes into breast milk. The
breast milk can also be detected by trace amounts of clavulanic acid. Except for the possibility of diarrhea or candidiasis of the oral cavity mucous membranes, no other known adverse effects of primobolan depot cycle and clavulanic acid on the health of infants, breastfed. Reproduction studies in animals have shown that primobolan depot cycle and clavulanic acid penetrate the placental barrier. However, there was no evidence of negative effects on the fetus. The metabolism of 10-25% of the initial dose of primobolan depot cycle excreted by the kidneys in the form of inactive metabolites (penitsilloevoy acid). Clavulanic acid is extensively metabolized to 2,5-digadro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and excreted by the kidneys, the gastrointestinal tract (GIT), and the expired air as carbon dioxide. Excretion as other penicillins, primobolan depot cycle excreted mainly kidneys, whereas clavulanic acid – through both the renal and extrarenal mechanisms. Approximately 60-70% of primobolan depot cycle and 40-65% of clavulanic acid excreted by the kidneys in unchanged form in the first 6 hours after a single bolus injection of the drug Augmentin ® at a dose of 500 mg + 100 mg or 1000 mg + 200 mg. Simultaneous administration of probenecid slows excretion of primobolan depot cycle, but it does not slow renal excretion of clavulanic acid (see. “Interaction with other medicinal products” section).
Indications for use
The combination of primobolan depot cycle with clavulanic acid is indicated for the treatment of bacterial infections of the following locations, caused by susceptible to the combination of primobolan depot cycle with clavulanic acid microorganisms:
- Upper respiratory tract infection (including LOP tract infections), eg recurrent tonsillitis, sinusitis, otitis media, usually caused by pneumoniae of Streptococcus, of Haemophilus influenzae # , of Moraxella catarrhalis # and Streptococcus pyogenes.
- Lower respiratory tract infections such as acute exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia, typically caused by pneumoniae of Streptococcus, of Haemophilus influenzae# and catarrhalis of Moraxella # .
- Infections of the urinary tract, such as cystitis; urethritis, pyelonephritis, infection of female genital mutilation, usually caused by species of the family Enterobacteriaceae # (mainly coli of Escherichia # ), and saprophytics of Staphylococcus species of the genus of Enterococcus, and gonorrhea caused gonorrhoeae of Neisseria # .
- Infections of skin and soft tissues, often caused by Staphylococcus aureus *. Streptococcus pyogenes, and species of the genus Bacteroides # .
- Bone and joint infections, such as osteomyelitis, usually caused aureus Staphylococcus # , when necessary, may conduct long term therapy.
- Other mixed infection (eg, septic abortion, puerperal sepsis, intra-abdominal sepsis, septicemia, peritonitis, postoperative infection) in the framework of sequential therapy.
- Preparation Augmentin ® at a dosage of 1000 mg + 200 mg is also indicated for the prevention of postoperative infections in surgical procedures on the gastrointestinal tract, pelvic organs, the head and neck, heart, kidney, biliary tract, as well as the implantation of artificial joints.
# Some members of this genus microorganisms produce beta-lactamase, which makes them insensitive to amoxycillin (see. Also “Pharmacological properties”).
Infections caused by susceptible to primobolan depot cycle microorganisms may be treated with the drug Augmentin ® , as primobolan depot cycle is one of its operating substances. Augmentin ® is also indicated for the treatment of mixed infections caused by pathogens susceptible to primobolan depot cycle and microorganisms that produce beta-lactamase susceptible to primobolan depot cycle combination with clavulanic acid.
The sensitivity of the bacteria to a combination of primobolan depot cycle with clavulanic acid varies from region to region and over time . Where possible, it should be taken into consideration by local sensitivity data. If necessary, collect samples and microbiological analysis bacteriological sensitivity.
Contraindications for use
- Hypersensitivity to primobolan depot cycle, clavulanic acid, other components of the drug; beta-lactam antibiotics (e.g. penicillins, cephalosporins) history;
- jaundice prior episodes or abnormal liver function with the combination of primobolan depot cycle with clavulanic acid in the anamnesis.
preparation is Augmentin ® should be used with caution in patients with hepatic impairment and renal impairment (creatinine clearance less than 30 ml / min).
Pregnancy and lactation Pregnancy In studies of reproductive function in animals, oral and parenteral administration of Augmentin drug ® did not cause any teratogenic effects. In a single study in women with premature rupture of membranes, it was found that the prophylactic therapy of the drug may be associated with an increased risk of necrotising enterocolitis in neonates. Like all medicines, Augmentin ®is not recommended for use during pregnancy except in cases where the application of the expected benefit to the mother outweighs the potential risk to the fetus. Lactation The drug Augmentin ® can be used during breastfeeding. Except for the possibility of diarrhea or candidiasis of the oral mucosa associated with penetration in the breast milk of trace amounts of the active ingredients of this preparation, no other adverse effects in infants who are breastfed, were observed. In case of adverse effects in infants who are breastfed, it is necessary to stop it.
Dosing and Administration
The dosage regimen set individually depending on the age, body weight, renal function of the patient, and the severity of infection. Treatment should not be continued for more than 14 days without revising the clinical situation.
Preparation Augmentin ® is not intended for intramuscular injection (due to instability at the concentration that could be administered intramuscularly). Doses are given based on the content of active substances. primobolan depot cycle and clavulanic acid Adults and children over 12 years of age or 40 kg body weight and more infections are mild to moderate severity : a dose of 1000 mg + 200 mg every 8 hours.Severe infections : the dose of 1000 mg + 200 mg every 4-6 hours. Prophylaxis in surgery interventions lasting less than 1 h : a dose of 1000 mg + 200 mg at the time of induction of anesthesia. The interventions lasting more than 1 hour: 1 dose of 1000 mg + 200 mg during the induction of anesthesia and further to 4 doses of 1000 mg + 200 mg over 24 hours.
Special groups of patients Children For children weighing less than 40 kg the dose calculated according to body weight. In children under 3 months of drug Augmentin ® should be administered only slow infusion for 30-40 minutes. Under 3 months weighing less than 4 kg 25 mg of primobolan depot cycle and clavulanic acid 5 mg per 1 kg of body weight every 12 hours. Under 3 months, weighing 4 kg to 25 mg of primobolan depot cycle and 5 mg of clavulanic acid per 1 kg of body weight every 8 hours. from 3 months to 12 years with a body weight less than 40 kg to 25 mg of primobolan depot cycle and 5 mg of clavulanic acid per 1 kg of body weight every 6-8 hours depending on the severity of the infection. elderly patients do not require correction dosing regimen, dosing in adults patients. patients with impaired renal function correction dosing regimen is based on the maximum recommended dose of primobolan depot cycle.
|Creatinine clearance> 30 mL / min||correction mode is not required.|
|Creatinine clearance 10-30 ml / min||The initial dose of 1000 mg + 200 mg + 500 mg further 100 mg 2 times a day.|
|Creatinine clearance <10 mL / min||The initial dose of 1000 mg + 200 mg + 500 mg further 100 mg every 24 hours.|
|Creatinine clearance> 30 mL / min||correction mode is not required.|
|Creatinine clearance 10-30 ml / min||25 mg + 5 mg per 1 kg two times a day.|
|Creatinine clearance <10 mL / min||25 mg + 5 mg per 1 kg every 24 hours.|
Patients on dialysis
correction dosing regimen is based on the maximum recommended dose of primobolan depot cycle. Adults Initially administered one dose of 1000 mg + 200 mg, more than 500 mg + 100 mg every 24 hours and an additional 500 mg + 100 mg at the end of hemodialysis (to compensate for the reduction levels of amoxycillin and clavulanic acid in blood plasma). Children 25 mg of primobolan depot cycle and 5 mg of clavulanic acid per 1 kg of body weight every 24 hours and an additional 12.5 mg of primobolan depot cycle and clavulanic acid 2.5 mg per 1 kg of body weight at the end of hemodialysis . (to compensate for the reduction of primobolan depot cycle and clavulanic acid levels in blood plasma) and a further 25 mg of primobolan depot cycle and 5 mg of clavulanic acid per 1 kg of body weight per day, patients with impaired liver function treatment is carried out with caution; regularly to monitor liver function. It is not enough data to changes in recommendations dose in these patients.
Dosing bolus drug Augmentin ® may be administered as a slow intravenous injection duration of 3-4 minutes directly into a vein or via a catheter. The contents of one vial are diluted in 20 ml of water for injection, a total volume of 20.9 ml. During cooking, the solution can take on a pink color, which disappears later. Ready solution can have color from colorless to light straw. The resulting solution should be entered within 20 minutes after dilution. Infusion introduction of drug Augmentin ® is administered by intravenous infusion over 30-40 minutes. A solution prepared as described above for bolus without immediately added to 100 ml of one of the infusion solutions in the table below.
|Infusion solutions||Stability Period
at 25 ° C
|Water for injections||4|
|Sodium chloride 0.9%||4|
|sodium lactate solution for intravenous administration||4|
|Ringer’s lactate solution for Hartman||3|
The solution is prepared at room temperature and can be stored under the same conditions, with the infusion should be completed before the expiry of the period specified in the table above. The solution may be stored at 5 ° C for 8 hours. To this solution, prepared as described above for bolus injection, is added to a precooled bottle with 100 ml of water for infusion, or 100 ml 0.9% sodium chloride solution.
The solutions were stored at 5 ° C, must be entered immediately upon reaching room temperature.
the stability of the combination of primobolan depot cycle with clavulanic acid solution depends on the concentration. If necessary, the use of more concentrated solutions during the stability of the solution will change accordingly.
Any remaining amount of the solution must be discarded.
Vials product Augmentin ® not intended for repeated use.
Adverse events reported below are listed in accordance with the defeat of the organs and systems of organs and frequency of occurrence. The frequency is defined as follows: very common ( > 1/10), common ( > 1/100 and <1/10), uncommon ( > 1/10000 and <1/100), rare ( > 1/10000, and <1 / 1000), very rare (<1/10 000, including isolated cases). Frequency categories were formed on the basis of clinical trials of the drug and post-marketing surveillance. Adverse events The incidence of infectious and parasitic diseases often: candidiasis of the skin and mucous membranes. Violations of the blood and lymphatic system Rare: Reversible leucopenia (including neutropenia), reversible thrombocytopenia. Very rare : reversible agranulocytosis and reversible hemolytic anemia, prolonged bleeding time and prothrombin time; eosinophilia, thrombocytosis, anemia. Violations by the immune system Very rare: angioneurotic edema, anaphylactic reactions, a syndrome similar to serum sickness, allergic vasculitis.Disorders of the nervous system Uncommon: dizziness, headache. Very rare: convulsions. Seizures may occur in patients with impaired renal function, as well as in those receiving high doses of insomnia drug, agitation, anxiety, behavioral changes. Violations by vessels Rare: thrombophlebitis at the injection site. Violations of the gastrointestinal tract is often diarrhea . Uncommon: nausea, vomiting, diarrhea rastrojstva. Very rarely. antibiotic-associated colitis (including pseudomembranous and hemorrhagic (see section “Special instructions and precautions”), less common when parenterally administered Augmentin drug ® . Violations of the liver and biliary tract Uncommon:. a moderate increase in the activity of aspartate aminotransferase and / or alanine aminotransferase (ACT and / or ALT) This phenomenon has been observed in patients receiving therapy with any penicillin antibiotics, but its impact on the clinical condition of the patient is unknown. Very rare: hepatitis and cholestatic jaundice . These phenomena are observed in patients receiving therapy with antibiotics penicillin and cephalosporins. Increased activity of alkaline phosphatase, hyperbilirubinemia. Adverse effects of the liver were observed mainly in males and elderly patients and may be associated with prolonged therapy. These signs and symptoms are usually encountered in the process or from the end of therapy, however, may not occur in some cases, for several weeks completion of therapy. Adverse events are generally reversible. Adverse events of the liver can be severe, in extremely rare cases, there have been reports of deaths.In almost all cases, these were patients with a serious comorbidity or patients receiving both potentially hepatotoxic drugs. Violations of the skin and subcutaneous tissue disorders Uncommon: skin rash, pruritus, urticaria. Rare:. Poliformnaya erythema Very rare: Stevens-Johnson syndrome, toxic . epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis In case of skin allergies treatment with Augmentin ® should be discontinued. Violations of the kidney and urinary tract Very rare: interstitial nephritis, crystalluria (see “Overdose” section.).
Overdose Symptoms Symptoms of the gastrointestinal tract may occur, and fluid and electrolyte balance. Described amoksitsillinovaya crystalluria, in some cases, lead to the development of renal failure (see. Section “Special instructions and precautions in the application”). Convulsions may occur in patients with impaired function or kidneys in patients receiving high doses of the drug after intravenous administration of large doses of primobolan depot cycle it may precipitate in the urinary catheters. Therefore, regular checks should be carried out patency of urinary catheters. Treatment of Symptoms from ZHKT- symptomatic therapy, focusing on the normalization of water and electrolyte balance. primobolan depot cycle and clavulanic acid may be removed from the bloodstream by dialysis.
Interaction with other medicinal products
Concomitant use of the drug Augmentin ® and probenecid is not recommended. Probenecid decreases the tubular secretion of primobolan depot cycle, and therefore the simultaneous use of the drug Augmentin ® and probenecid may increase and persistence in the blood concentration of primobolan depot cycle but not of clavulanic acid.
Simultaneous use of allopurinol and primobolan depot cycle can increase the risk of allergic skin reactions. Currently no data in the literature on the concomitant use of primobolan depot cycle with clavulanic acid and allopurinol.
Penicillins are able to slow down the excretion of methotrexate by inhibiting its tubular secretion, so the simultaneous use of the drug Augmentin ® and methotrexate may increase the toxicity of methotrexate.As with other antibacterial drugs, drug Augmentin ® may affect the intestinal microflora, resulting in decreased absorption of estrogen from the blood and reduce the effectiveness of combined oral contraceptives. The presence of clavulanic acid in a preparation Augmentin ® can lead to non-specific binding of immunoglobulin G and albumin to the cell membrane of red blood cells which can lead to false positive reactions in the sample Coombs. The literature describes the rare cases of increased international normalized ratio (MHO) of patients in the combined use of warfarin and acenocoumarol or primobolan depot cycle. If necessary, co-administration of Augmentin drug ® with anticoagulants prothrombin time or MHO should be carefully monitored in the appointment or revocation of the drug Augmentin ® , anticoagulants dose adjustment may be required for oral administration.
In patients receiving mycophenolate mofetil at the beginning of the use of primobolan depot cycle and clavulanic acid, there was a decrease concentration of the active metabolite – mycophenolic acid before receiving the next dose of approximately 50%. Changes in concentrations observed prior to administration of the drug, can not accurately reflect the general changes in mycophenolic acid concentration. Pharmaceutical incompatibility drug Augmentin ® should not be mixed with blood products, other protein-containing fluids such as protein hydrolysates or with intravenous lipid emulsions. In an application with aminoglycosides antibiotics should not be mixed in the same syringe or in one bottle for intravenous fluids, because in such conditions aminoglycosides inactivated. The solution of the drug Augmentin ®should not be mixed with solutions containing dextrose, dextran or sodium bicarbonate.
Special instructions and precautions for use
Before starting treatment with Augmentin ® is necessary to collect detailed history concerning previous hypersensitivity reactions to penicillins, cephalosporins or other substances that cause an allergic reaction in the patient.
We describe the serious and occasionally fatal hypersensitivity (anaphylactic reaction) to penicillins. The risk of these reactions is greatest in patients with a history of hypersensitivity reactions to penicillins.In the event of an allergic reaction, you must stop treatment with Augmentin ® and start appropriate alternative therapy.
In severe anaphylactic reactions should be immediately administered to the patient epinephrine. It may also require oxygen therapy, intravenous corticosteroids and airway management, including intubation.
In the case of suspected infectious mononucleosis drug Augmentin ® should not be used as in patients with the disease primobolan depot cycle can cause morbilliform skin rash, making it difficult to diagnose the disease. Long-term treatment with Augmentin ® may lead to an excessive proliferation of non-susceptible organisms.
We describe the cases of pseudomembranous colitis with antibiotics, the severity of which may range from mild to life-threatening. Thus, it is important to diagnose patients who develop diarrhea during or after the use of antibiotics. If the diarrhea is prolonged or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient should be examined.
In general, the drug Augmentin ® is well tolerated and has a characteristic of all penicillins low toxicity. During long-term therapy with Augmentin ® is recommended to periodically assess the function of the kidneys, liver and blood formation.
Patients treated with the combination of primobolan depot cycle with clavulanic acid together with indirect (oral) with anticoagulants, in rare cases, reported an increase in prothrombin time (increase MHO). The joint appointment of indirect (oral) anticoagulation with a combination of primobolan depot cycle with clavulanic acid is necessary to monitor the relevant parameters. To maintain the desired effect of oral anticoagulants may require correction of the dose.
In patients with impaired renal dose function Augmentin ® should be reduced according to creatinine clearance (see. Section “Dosage and administration”).
The presence of clavulanic acid in the preparation of Augmentin ® may lead to non-specific binding of immunoglobulin G and albumin to the cell membrane of red blood cells which can lead to false positive reactions in the sample Coombs. If necessary, parenteral administration of high doses of the drug Augmentin ® in patients who are on a diet low in salt, should take into account the presence of sodium ions in the preparation.
In patients with reduced urine output crystalluria occurs very rarely, predominantly with parenteral therapy with Augmentin ® . During the administration of high doses of primobolan depot cycle is recommended to take plenty of fluids and to maintain an adequate urine output in order to reduce the probability of formation of primobolan depot cycle crystals (see. “Overdose” section).
Admission Augmentin drug ® inside leads to the high content of primobolan depot cycle in the urine, which can cause false-positive results when determining glucose in urine (e.g., Benedict sample Fehling test). In this case, use glyukozoksidantny method for determining the concentration of glucose in urine.
Abuse and drug dependence
were no drug dependence, addiction and euphoric reactions associated with the use of the drug Augmentin ® .
Effects on ability to drive vehicles, machinery
Since the drug may cause dizziness, it is necessary to warn patients about safety precautions while driving or working with moving machinery.
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