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Ciprofloxacin hydrochloride tablets


Compared to the and mg immediate-release tablets, the mg and mg XR tablets provide higher C max, but the 24‑hour AUCs are equivalent. Ciprofloxacin immediate-release tablets contain ciprofloxacin as the hydrochloride salt, and the XR tablets contain a mixture of the hydrochloride salt as the free base. Ciprofloxacin Hydrochloride is the hydrochloride salt form of ciprofloxacin, a fluoroquinolone related to nalidixic acid with antibacterial activity. Ciprofloxacin hydrochloride exerts its bactericidal effect by interfering with the bacterial DNA gyrase, thereby inhibiting the DNA synthesis and preventing bacterial cell growth.
Ciprofloxacin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body. It is used to treat different types of bacterial infections. Ciprofloxacin is also used to treat people who have been exposed to anthrax or certain types of plague.. Ciprofloxacin should be used only for infections that cannot be treated with a safer antibiotic. The tablets contain a combination of two types of ciprofloxacin drug substance, ciprofloxacin hydrochloride and ciprofloxacin betaine (base). Ciprofloxacin hydrochloride is 1-cyclopropylfluoro-1,4dihydrooxo(1-piperazinyl)quinolinecarboxylic acid hydrochloride. Ciprofloxacin tablets USP, mg are available as white to off-white, capsule shaped, biconvex film-coated tablets, with “ ”on one side and “CR ” .


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Even after the first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: Ciprofloxacin is passed into human breast milk. Side effects in more detail. Ciprofloxacin hydrochloride tablets Ципрофлоксацина гидрохлорида таблетки, покрытые оболочкой, 0,25 г (Ciprofloxacin hydrochloride filmcoated tablets 0,25 g). Фильтруемый список. Действующее вещество  Состав и форма выпуска. Фармакологическое действие. Показания препарата Ципрофлоксацина гидрохлорида таблетки, покрытые оболочкой, 0,25 г. Противопоказания. Побочные действия. Способ применения и дозы. Ciprofloxacin Hydrochloride Tablet назначается для лечения Бактериальная инфекция, Бактериальные инфекции и других состояний. Ciprofloxacin Hydrochloride Tablet содержит следующие активные ингредиенты: Ciprofloxacin Hydrochloride. Доступен в форме tablet form.  Ciprofloxacin Hydrochloride Tablet используется для лечения, контроля, предотвращения и улучшения следующих заболеваний, состояний и симптомов: Бактериальная инфекция. Бактериальные инфекции. Ciprofloxacin is an antibiotic belong to a group of drugs called fluoroquinolones. Learn about side effects, interactions and indications.  Generic Name: ciprofloxacin (oral) (SIP roe FLOX a sin) Brand Names: Cipro, Cipro XR, Proquin XR. Medically reviewed on Sep 10, Overview.

The efficacy of Ciprofloxacin for the treatment of acute pulmonary exacerbations in pediatric cystic fibrosis patients has not been established. In addition to the adverse reactions reported in pediatric patients in clinical trials, it should be expected that adverse reactions reported in adults during clinical trials or postmarketing experience may also occur in pediatric patients.

The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including Ciprofloxacin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure Table Hematologic—Eosinophilia, leukopenia, decreased blood platelets, elevated blood platelets, pancytopenia. Renal—Elevations of serum creatinine, BUN, crystalluria, cylindruria, and hematuria have been reported.

Other changes occurring were: Coadministration of Ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the coadministered drug.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother. A controlled prospective observational study followed women exposed to fluoroquinolones The reported rates of major congenital malformations were 2.

Rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the Ciprofloxacin exposed children. The malformation rates among live-born babies exposed to Ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. No specific patterns of congenital abnormalities were found.

The study did not reveal any clear adverse reactions due to in utero exposure to Ciprofloxacin. No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to Ciprofloxacin during pregnancy. Ciprofloxacin is excreted in human milk.

The amount of Ciprofloxacin absorbed by the nursing infant is unknown. Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls. Ciprofloxacin is indicated for the treatment of cUTI and pyelonephritis due to Escherichia coli in pediatric patients 1 to 17 years of age.

The risk-benefit assessment indicates that administration of Ciprofloxacin to pediatric patients is appropriate [see Dosage and Administration 2. Ciprofloxacin is indicated in pediatric patients from birth to 17 years of age, for treatment of plague, including pneumonic and septicemic plague due to Yersinia pestis Y.

Efficacy studies of Ciprofloxacin could not be conducted in humans with pneumonic plague for feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals. The risk-benefit assessment indicates that administration of Ciprofloxacin to pediatric patients is appropriate [ s ee Indications and Usage 1. Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Ciprofloxacin.

This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing Ciprofloxacin to elderly patients especially those on corticosteroids.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. No alteration of dosage is necessary for patients greater than 65 years of age with normal renal function.

However, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients [ s ee Dosage and Administration 2. In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using Ciprofloxacin with concomitant drugs that can result in prolongation of the QT interval for example, class IA or class III antiarrhythmics or in patients with risk factors for torsade de pointes for example, known QT prolongation, uncorrected hypokalemia [ s ee Warnings and Precautions 5.

Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction [ s ee Dosage and Administration 2. In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in Ciprofloxacin pharmacokinetics have been observed. The pharmacokinetics of Ciprofloxacin in patients with acute hepatic insufficiency, have not been studied.

In the event of acute overdosage, reversible renal toxicity has been reported in some cases. Empty the stomach by inducing vomiting or by gastric lavage. Observe the patient carefully and give supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria and administration of magnesium, aluminum, or calcium containing antacids which can reduce the absorption of Ciprofloxacin.

Adequate hydration must be maintained. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of Ciprofloxacin, USP is 1-cyclopropylfluoro-1,4-dihydrooxo 1-piperazinyl quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:.

Ciprofloxacin film-coated tablets are available in mg, mg and mg Ciprofloxacin equivalent strengths. Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch maize , purified water, silicon dioxide, talc, and titanium dioxide.

Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology Ciprofloxacin maximum serum concentrations C max and area under the curve AUC are shown in the chart for the mg to 1, mg dose range Table Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Mean concentrations 12 hours after dosing with mg, mg, or mg are 0. The serum elimination half-life in subjects with normal renal function is approximately 4 hours.

Serum concentrations increase proportionately with doses up to 1, mg. A mg oral dose given every 12 hours has been shown to produce an AUC equivalent to that produced by an intravenous infusion of mg Ciprofloxacin given over 60 minutes every 12 hours.

A mg oral dose given every 12 hours has been shown to produce an AUC at steady-state equivalent to that produced by an intravenous infusion of mg given over 60 minutes every 8 hours. A mg oral dose results in a C max similar to that observed with a mg intravenous dose.

A mg oral dose given every 12 hours produces an AUC equivalent to that produced by an infusion of mg Ciprofloxacin given every 12 hours Table Avoid concomitant administration of Ciprofloxacin with dairy products like milk or yogurt or calcium-fortified juices alone since decreased absorption is possible; however, Ciprofloxacin may be taken with a meal that contains these products.

After oral administration, Ciprofloxacin is widely distributed throughout the body. Tissue concentrations often exceed serum concentrations in both men and women, particularly in genital tissue including the prostate. Ciprofloxacin has also been detected in lung, skin, fat, muscle, cartilage, and bone.

Low levels of the drug have been detected in the aqueous and vitreous humors of the eye. The metabolites have antimicrobial activity, but are less active than unchanged Ciprofloxacin. Coadministration of Ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the coadministered drug [see Contraindications 4.

The urinary excretion of Ciprofloxacin is virtually complete within 24 hours after dosing. Thus, active tubular secretion would seem to play a significant role in its elimination.

Although bile concentrations of Ciprofloxacin are several fold higher than serum concentrations after oral dosing, only a small amount of the dose administered is recovered from the bile as unchanged drug. This may arise from either biliary clearance or transintestinal elimination. Pharmacokinetic studies of the oral single dose and intravenous single and multiple dose forms of Ciprofloxacin indicate that plasma concentrations of Ciprofloxacin are higher in elderly subjects older than 65 years as compared to young adults.

These differences are not considered clinically significant [ s ee Use in Specific Populations 8. In patients with reduced renal function, the half-life of Ciprofloxacin is slightly prolonged. Dosage adjustments may be required [see Use in Specific Populations 8. The kinetics of Ciprofloxacin in patients with acute hepatic insufficiency, have not been fully studied.

The AUC values were These values are within the range reported for adults at therapeutic doses. Histamine H 2 -receptor antagonists. Histamine H 2 -receptor antagonists appear to have no significant effect on the bioavailability of Ciprofloxacin. The serum concentrations of Ciprofloxacin and metronidazole were not altered when these two drugs were given concomitantly. In a pharmacokinetic study, systemic exposure of tizanidine 4 mg single dose was significantly increased C max 7-fold, AUC fold when the drug was given concomitantly with Ciprofloxacin mg twice a day for 3 days.

Concomitant administration of tizanidine and Ciprofloxacin is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine [ see Contraindications 4. Careful monitoring of clozapine associated adverse reactions and appropriate adjustment of clozapine dosage during and shortly after coadministration with Ciprofloxacin are advised. Following concomitant administration of a single oral dose of 50 mg sildenafil with mg Ciprofloxacin to healthy subjects, the mean C max and mean AUC of sildenafil were both increased approximately two-fold.

Use sildenafil with caution when coadministered with Ciprofloxacin due to the expected two-fold increase in the exposure of sildenafil upon coadministration of Ciprofloxacin. In clinical studies it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP 1A2 isozyme such as fluvoxamine, may result in a 5-fold increase in mean AUC and a 2.

In a study conducted in 9 healthy volunteers, concomitant use of 1. Although lidocaine treatment was well tolerated at this elevated exposure, a possible interaction with Ciprofloxacin and an increase in adverse reactions related to lidocaine may occur upon concomitant administration. Metoclopramide significantly accelerates the absorption of oral Ciprofloxacin resulting in a shorter time to reach maximum plasma concentrations.

No significant effect was observed on the bioavailability of Ciprofloxacin. The clinical significance of this interaction has not been determined. The mechanism of action of fluoroquinolones, including Ciprofloxacin, is different from that of penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines; therefore, microorganisms resistant to these classes of drugs may be susceptible to Ciprofloxacin. Resistance to fluoroquinolones occurs primarily by either mutations in the DNA gyrases, decreased outer membrane permeability, or drug efflux.

In vitro resistance to Ciprofloxacin develops slowly by multiple step mutations. Resistance to Ciprofloxacin due to spontaneous mutations occurs at a general frequency of between less than 10 -9 to 1x10 There is no known cross-resistance between Ciprofloxacin and other classes of antimicrobials.

The following in vitro data are available, but their clinical significance is unknown. However, the efficacy of Ciprofloxacin in treating clinical infections due to these bacteria has not been established in adequate and well-controlled clinical trials.

Gram-positive bacteria Staphylococcus haemolyticus methicillin-susceptible isolates only Staphylococcus hominis methicillin-susceptible isolates only. Gram-negative bacteria Acinetobacter lwoffi Aeromonas hydrophila Edwardsiella tarda Enterobacter aerogenes Klebsiella oxytoca Legionella pneumophila Pasteurella multocida Salmonella enteritidis Vibrio cholera e Vibrio parahaemolyticus.

Vibrio vulnificus Yersinia enterocolitica. When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drug products used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens.

These reports should aid the physician in selecting an antibacterial drug product for treatment. Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations MICs. These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds.

The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation.

Standardized susceptibility test procedures require the use of laboratory controls to monitor the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test.

Eight in vitro mutagenicity tests have been conducted with Ciprofloxacin, and the test results are listed below:. Results from photo co-carcinogenicity testing indicate that Ciprofloxacin does not reduce the time to appearance of UV-induced skin tumors as compared to vehicle control.

Hairless Skh-1 mice were exposed to UVA light for 3. In this model, mice treated with Ciprofloxacin alone did not develop skin or systemic tumors. The clinical significance of these findings to humans is unknown.

Ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested [see Warnings and Precautions 5. Damage of weight bearing joints was observed in juvenile dogs and rats.

This dose was also not associated with arthrotoxicity after an additional treatment-free period of 5 months. In another study, removal of weight bearing from the joint reduced the lesions but did not totally prevent them. Crystalluria, sometimes associated with secondary nephropathy, occurs in laboratory animals dosed with Ciprofloxacin.

This is primarily related to the reduced solubility of Ciprofloxacin under alkaline conditions, which predominate in the urine of test animals; in man, crystalluria is rare since human urine is typically acidic. These effects are considered to be related to histamine release, since they are partially antagonized by pyrilamine, an antihistamine.

In rhesus monkeys, rapid intravenous injection also produces hypotension but the effect in this species is inconsistent and less pronounced. In mice, concomitant administration of nonsteroidal anti-inflammatory drugs such as phenylbutazone and indomethacin with quinolones has been reported to enhance the CNS stimulatory effect of quinolones.

Ocular toxicity seen with some related drugs has not been observed in Ciprofloxacin-treated animals. The primary objective of the study was to assess musculoskeletal and neurological safety. Patients were evaluated for clinical success and bacteriological eradication of the baseline organism s with no new infection or superinfection at 5 to 9 days post-therapy Test of Cure or TOC.

The Per Protocol population had a causative organism s with protocol specified colony count s at baseline, no protocol violation, and no premature discontinuation or loss to follow-up among other criteria. The clinical success and bacteriologic eradication rates in the Per Protocol population were similar between Ciprofloxacin and the comparator group as shown below.

Ciprofloxacin pharmacokinetics have been evaluated in various human populations. The mean peak serum concentration achieved at steady-state in human adults receiving mg orally every 12 hours is 2. The mean trough serum concentration at steady-state for both of these regimens is 0. In a study of 10 pediatric patients between 6 and 16 years of age, the mean peak plasma concentration achieved is 8. Long-term safety data, including effects on cartilage, following the administration of Ciprofloxacin to pediatric patients are limited.

Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication.

The minimal inhibitory concentration MIC of Ciprofloxacin for the anthrax strain used in this study was 0. In the animals studied, mean serum concentrations of Ciprofloxacin achieved at expected T max 1 hour post-dose following oral dosing to steady-state ranged from 0.

Mean steady-state trough concentrations at 12 hours post-dose ranged from 0. More than 9, persons were recommended to complete a minimum of 60 days of antibacterial prophylaxis against possible inhalational exposure to B. Ciprofloxacin was recommended to most of those individuals for all or part of the prophylaxis regimen. Some persons were also given anthrax vaccine or were switched to alternative antibacterial drugs.

No one who received Ciprofloxacin or other therapies as prophylactic treatment subsequently developed inhalational anthrax. The number of persons who received Ciprofloxacin as all or part of their post-exposure prophylaxis regimen is unknown. Mean peak serum concentrations of Ciprofloxacin achieved at the end of a single 60 minute infusion were 3.

All trough concentrations Day 2, Day 6 and Day 10 were less than 0. Circulating Ciprofloxacin concentration was below 0. It became culture negative on Day 2 of treatment, but had a resurgence of low grade bacteremia on Day 6 after treatment initiation.

Terminal blood culture in this animal was negative. Kelly DJ, et al. Serum concentrations of penicillin, doxycycline, and Ciprofloxacin during prolonged therapy in rhesus monkeys. J Infect Dis ; Friedlander AM, et al. Postexposure prophylaxis against experimental inhalational anthrax.

Advise patients to stop taking Ciprofloxacin tablets if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug. Inform patients that antibacterial drugs including Ciprofloxacin tablets should only be used to treat bacterial infections. They do not treat viral infections for example, the common cold.

When Ciprofloxacin tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may 1 decrease the effectiveness of the immediate treatment and 2 increase the likelihood that bacteria will develop resistance and will not be treatable by Ciprofloxacin tablets or other antibacterial drugs in the future.

Administration with Food, Fluids, and Concomitant Medications. Inform patients to drink fluids liberally while taking Ciprofloxacin tablets to avoid formation of highly concentrated urine and crystal formation in the urine. Inform patients that antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine should be taken at least two hours before or six hours after Ciprofloxacin tablets administration.

Ciprofloxacin tablets should not be taken with dairy products like milk or yogurt or calcium-fortified juices alone since absorption of Ciprofloxacin may be significantly reduced; however, Ciprofloxacin tablets may be taken with a meal that contains these products. Drug Interactions Oral Antidiabetic Agents. Inform patients that hypoglycemia has been reported when Ciprofloxacin and oral antidiabetic agents were coadministered; if low blood sugar occurs with Ciprofloxacin tablets, instruct them to consult their physician and that their antibacterial medicine may need to be changed.

Therefore, approval for these conditions was based on efficacy studies conducted in animals. Read this Medication Guide before you start taking Ciprofloxacin tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about Ciprofloxacin tablets?

Ciprofloxacin tablets , a fluoroquinolone antibacterial medicine, can cause serious side effects. If you get any of the following serious side effects while you take Ciprofloxacin tablets, you should stop taking Ciprofloxacin tablets immediately and get medical help right away.

The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including Ciprofloxacin tablets. Seizures have been reported in people who take fluoroquinolone antibacterial medicines, including Ciprofloxacin tablets. Tell your healthcare provider if you have a history of seizures before you start taking Ciprofloxacin tablets.

CNS side effects may happen as soon as after taking the first dose of Ciprofloxacin tablets. Worsening of myasthenia gravis a problem that causes muscle weakness. Fluoroquinolones like Ciprofloxacin tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Tell your healthcare provider if you have a history of myasthenia gravis before you start taking Ciprofloxacin tablets.

Do not take ciprofloxacin with dairy products such as milk or yogurt, or with calcium- fortified juice. You may eat or drink these products with your meals, but do not use them alone when taking ciprofloxacin. They could make the medication less effective. Using caffeine while taking ciprofloxacin can increase the effects of the caffeine. Antibiotic medicines can cause diarrhea , which may be a sign of a new infection.

If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine. Ciprofloxacin could make you sunburn more easily.

Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen SPF 30 or higher when you are outdoors. Tell your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun. Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Get emergency medical help if you have signs of an allergic reaction to ciprofloxacin hives , difficult breathing, swelling in your face or throat or a severe skin reaction fever, sore throat , burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling.

Ciprofloxacin can cause serious side effects, including tendon problems, side effects on your nerves which may cause permanent nerve damage , serious mood or behavior changes after just one dose , or low blood sugar which can lead to coma.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. Side effects in more detail. Some medicines can make ciprofloxacin much less effective when taken at the same time. If you take any of the following medicines, take your dose 2 hours before or 6 hours after you take the other medicine.

This list is not complete. Other drugs may interact with ciprofloxacin, including prescription and over-the-counter medicines, vitamins , and herbal products. Not all possible drug interactions are listed here. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use ciprofloxacin only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Adequate hydration must be maintained. Fluoroquinolone antibiotics can cause serious or disabling side effects that may not be reversible. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Ciprofloxacin hydrochloride tablets
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