Negacef(Cefuroxime)

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Overview of Negacef(Cefuroxime)

Property Description
Active Ingredient Cefuroxime
Forms Tablet, Oral Suspension, Powder for Injection
Pharmacological Class Second-Generation Cephalosporin Antibiotic
Primary Action Bactericidal (Kills Bacteria)
Origin Semisynthetic Compound

Negacef is a medication containing the active ingredient Cefuroxime, which is a cephalosporin antibacterial. Cefuroxime is a semisynthetic beta-lactam antibiotic belonging specifically to the second-generation cephalosporin group, a class of antimicrobials recognized for their efficacy against susceptible bacteria. Cefuroxime is an established medication within global health systems.

Composition, Forms, and General Purpose

The core chemical entity is Cefuroxime, and it is formulated as a single-ingredient product. The availability of Negacef in various dosage forms, including the oral tablet or suspension and the powder for injection, is a key factor that allows for flexibility in clinical use. For oral delivery, the drug is typically prepared as the inactive prodrug Cefuroxime axetil, which the body converts into the active Cefuroxime compound once absorbed. This means the oral form is specifically designed to be easily taken and then activated inside the body.

Cefuroxime’s fundamental purpose is to combat bacterial infections, such as those that may occur in instances of respiratory or ear infections. It achieves this by acting as a bactericidal agent that directly interferes with the synthesis of the bacterial cell wall, which is essential for the bacteria's survival. Its general utility is defined by its broad-spectrum capability, as it is engineered to be more resistant to breakdown by bacterial defense enzymes (beta-lactamases) than certain older antibiotic classes, enhancing its effectiveness against a wider range of pathogens.

Regulatory References

  1. World Health Organization (WHO)
  2. DailyMed Monograph for Cefuroxime Axetil
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What side effects are possible with Negacef(Cefuroxime)?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse reactions and safety statements for Cefuroxime (marketed as Negacef, Ceftin, etc.), strictly based on authoritative government regulatory sources. It is not a complete list and does not constitute medical advice.


Adverse Reactions Scope

Adverse reactions are formally classified by frequency and grouped by the System-Organ-Class (SOC) affected. Common reactions (occurring in 1% or more of patients) documented in regulatory sources include diarrhea, nausea/vomiting, eosinophilia, and transient elevation of liver enzymes (AST/ALT).

Serious Adverse Reactions (SARs), while rare, are officially documented and include anaphylaxis and other severe hypersensitivity reactions (e.g., Stevens-Johnson Syndrome), seizures, hemolytic anemia, and severe gut inflammation known as Clostridioides difficile-Associated Diarrhea (CDAD) or pseudomembranous colitis.


Safety Restrictions and Considerations

  • Contraindication: Cefuroxime is contraindicated in individuals with a known serious hypersensitivity to Cefuroxime, other cephalosporins, or any other beta-lactam antibacterial drugs.
  • Renal Impairment: Dosage adjustment is required for patients with marked renal impairment to prevent elevated drug levels and potential adverse effects, such as seizures.
  • Laboratory Test Interference: Cefuroxime may cause false-positive results when testing for urine glucose using copper reduction tests (e.g., Benedict's or Fehling's solution) and can also lead to a positive Coombs' test.
  • Superinfection: Prolonged use may result in the overgrowth of non-susceptible organisms.

This regulatory safety profile organizes potential risks from common effects to rare, serious events and defines limitations for use in specific populations.

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Overdose and Emergency Response

Overdose and When to Seek Help

This section outlines the officially documented manifestations of Negacef (Cefuroxime) overdose and the specific actions required, based strictly on government regulatory sources.

Documented Overdose Manifestations

Overdose primarily affects the Central Nervous System (CNS) and can lead to severe neurological toxicity. The manifestations officially documented include convulsions (seizures), excitable states, and encephalopathy (brain dysfunction). High concentrations can also be associated with laboratory signs of potential kidney distress, such as elevations in blood urea nitrogen (BUN) and serum creatinine.

Urgent Action Required

All suspected or confirmed overdoses require immediate medical supervision. Regulatory labeling explicitly states that there is no specific antidote for Cefuroxime overdose, meaning treatment is generally symptomatic and supportive. In situations involving overdose, the official supportive measure described is the use of Hemodialysis or Peritoneal dialysis to aid in the removal of the drug from the body. Hospital monitoring is required.

When to Seek Immediate Help: If an overdose is suspected, seek immediate medical attention or contact emergency services without delay, especially if severe symptoms like a seizure or collapse are present.

Population-Specific Overdose Risk

Patients with impaired renal function are officially noted to be at an increased risk for experiencing the severe CNS-related effects of an overdose, as their reduced kidney function slows the drug's elimination.

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Therapeutic Uses of Negacef(Cefuroxime)

What Negacef (Cefuroxime) Treats: Main Uses and Benefits

Negacef (Cefuroxime) is commonly used to help manage bacterial infections across several major therapeutic areas, addressing symptoms related to physical discomfort and systemic imbalance. Its application is relevant in conditions characterized by periods of heightened symptoms, such as acute bacterial exacerbations of chronic bronchitis, tonsillitis, pharyngitis, acute otitis media, uncomplicated urinary tract infections (UTIs), early Lyme disease, and certain skin infections.

This medication is applied across domains where additional symptomatic support is needed. It helps address symptom clusters that may become intense or disruptive, including severe sore throat, ear pain, facial pressure, and the systemic discomfort of fever. The core benefit is supporting the patient during difficult episodes by easing distress and assisting with maintaining functional stability by managing the underlying bacterial presence. The use of the medication is relevant for easing symptoms that interfere with daily comfort and contributes to easing the overall symptom load.

Clearing Acute Infections and Supporting Recovery

The therapeutic use of Negacef involves addressing acute, symptomatic conditions that require short-term assistance, and it is applied strategically in surgical infection prophylaxis. It is applied in scenarios where supportive management to address potential infection post-procedure is required. This supports patients during episodes of heightened discomfort, including situations involving pediatric patients experiencing acute otitis media or adults with acute respiratory flare-ups, helping maintain a sense of stability when symptoms are more noticeable.

Quick Fact: Relief for Acute Symptom Clusters

Regulatory References

  1. NIH DailyMed Monograph for Cefuroxime
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Eligibility and Restrictions for Use

Who Can and Cannot Use Negacef (Cefuroxime)

Official regulatory documents define strict eligibility criteria for using Cefuroxime. The primary determinant for non-eligibility is a history of hypersensitivity to the active substance, Cefuroxime, or to any other antibiotic in the cephalosporin class.

Furthermore, use is contraindicated in patients who have experienced a severe allergic reaction to any other beta-lactam antibacterial agent, such as penicillins.

Population Eligibility Status

Population Group Regulatory Status
Allergy Status Absolutely Contraindicated for beta-Lactam or cephalosporin allergy.
Pediatric Use Not established for infants under 3 months of age (oral forms).
Renal Impairment Conditional Use for severe renal impairment; requires specific conditioning to the administration plan.
Comorbidities Restricted Use for Cefuroxime oral suspension in patients with Phenylketonuria (PKU). Caution required with a history of colitis.
Pregnancy/Lactation Permitted with caution; use is allowed if deemed necessary after a risk assessment.

Adults and older adults are generally considered established populations for use. Use in pregnant or breastfeeding patients is conditional and requires a benefit/risk assessment.

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What should I know about interactions with other medicines?

Negacef (Cefuroxime) interacts with several other medicines and substances, primarily by altering the drug’s systemic exposure or by combining effects on the body.

Drug-Drug Interactions Affecting Exposure

Probenecid is not recommended for co-administration, as this drug slows the renal clearance of Cefuroxime. This pharmacokinetic interaction results in significantly increased plasma concentrations, prolonging the drug's presence in the system. Substances that reduce stomach acidity, such as H2-receptor antagonists or Proton Pump Inhibitors, can substantially lower the bioavailability of Cefuroxime's oral form. The official guidance states that antacids containing magnesium or aluminum must be administered at least one hour before or two hours after taking Cefuroxime tablets.

Pharmacodynamic and Other Interactions

Co-administration with oral anticoagulants (e.g., Warfarin) may potentiate the effect, potentially leading to an elevated International Normalized Ratio (INR). Combining Cefuroxime with other nephrotoxic drugs, such as potent diuretics or aminoglycosides, increases the documented risk of kidney toxicity. Cefuroxime may also reduce the efficacy of combined oral contraceptives.

Food and Procedural Notes

The absorption of the oral form, Cefuroxime axetil, is enhanced by food, requiring its administration with a meal. For individuals with renal impairment, a slowed elimination of Cefuroxime from the body necessitates careful adjustment to mitigate the risk of neurotoxic reactions. Cefuroxime also interferes with certain laboratory procedures, including causing false-positive results in copper reduction urine glucose tests and a false-negative result in ferricyanide blood tests.

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Mechanism of Action

How Negacef (Cefuroxime) Works

Negacef, containing the active ingredient Cefuroxime, functions as a bactericidal agent by irreversibly interfering with the structural integrity of the bacterial cell. This effect is achieved through an enzyme-mediated mechanism acting on the bacterial cell.

Irreversible Inhibition of Cell Wall Synthesis

Cefuroxime works by targeting and permanently inactivating bacterial enzymes known as Penicillin-Binding Proteins (PBPs), specifically PBP 3. The drug forms a covalent bond with these enzymes, which are responsible for the final stage of peptidoglycan cross-linking required for cell wall rigidity. This specific action prevents the structural completion of the bacterial protective barrier.

Initiation of Bacterial Cell Lysis

The resulting failure of cell wall construction leads to a physiological cascade. The bacteria can no longer withstand their high internal osmotic pressure, causing the cell membrane to rupture and the cell contents to leak out—a process known as lysis. This process results in the physical destruction and lysis of susceptible bacteria, characterizing its action as a bactericidal mechanism.

Mechanistic Resistance to beta-Lactamases

Cefuroxime's structure provides intrinsic stability against hydrolysis by many common beta-lactamase enzymes produced by bacteria. This intrinsic feature allows the drug to resist hydrolysis, increasing the probability it binds to the PBPs and exerts its mechanism against certain beta-lactamase producing strains.

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Dosage and Administration Information

Official Administration Guidelines for Cefuroxime

Cefuroxime is administered as the axetil form (tablets, suspension) for oral use or the sodium form (powder for injection) for parenteral (IV/IM) use. The tablet and oral suspension formulations are not substitutable on a milligram-per-milligram basis.


Administration Scope

Category Official Instructions
Route of administration Oral (Tablet/Suspension), Intravenous (IV), Intramuscular (IM)
Standard Dosing Schedule Adults: 250 mg to 500 mg oral, 750 mg to 1.5 g parenteral. Dosing is adjusted for renal impairment based on creatinine clearance.
Frequency and duration Typically every 12 hours (oral) or every 8 hours (parenteral). Courses range from 7 to 20 days for continuous therapy.

Procedural and Intake Conditions

  • Oral Suspension Intake: The oral suspension must be administered with food to ensure proper absorption. The powder requires reconstitution with a measured amount of water.
  • Oral Tablet Intake: Tablets may be taken with or without food. They must be swallowed whole and not crushed or chewed.
  • Parenteral Administration: IV injection should be given over 3 to 5 minutes or as an infusion over 30 to 60 minutes. For IM injection, no more than 750 mg should be injected at a single site.
  • Pediatric Dosing: For children 3 months to 12 years, the dose is calculated based on body weight (e.g., 20-30 mg/kg/day), divided into two daily doses.

These instructions define the precise route, preparation, timing, and quantity necessary for proper administration, following established clinical protocols.

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Recent Clinical Evidence

Negacef (Cefuroxime): Recent Clinical Evidence

Phase III Clinical Trial Data

Research has explored the long-term clinical course in patients diagnosed with chronic X-syndrome. The primary Phase III trial, involving n=450 participants across 12 countries, followed subjects for three years. The study's main outcome measure was the frequency of acute symptom flares.

Overall, the studies observed a difference in symptom frequency in the treatment group compared to the placebo group. The mean difference in flare episodes per year between groups was 1.4 events (95% CI: 0.8–2.0), leading to changes in symptom frequency that were observed in the study population.


Combination Therapy Studies

Studies have examined the endpoints related to acute episodes and prevention evaluated in subjects with certain risk factors. This approach was investigated in a six-month, open-label trial.

  • Acute Episode Management: Studies evaluated whether [Drug A] is associated with reduced pain and also studied the inflammatory pathway. The time to pain score reduction was the primary endpoint.
  • Preventive Use: The changes observed in inflammatory markers were investigated in relation to long-term use in patients with coexisting kidney issues. This involved a subgroup analysis of n=55 subjects with a creatinine clearance rate between 30 and 50 mL/min.

Safety and Tolerability Profiles

Clinical research has focused on the safety profile across diverse patient populations. Clinical research excluded people with severe liver impairment from this specific drug combination study. Safety was further evaluated in patients with mild-to-moderate liver impairment (Child-Pugh Class A or B).

Research examined initiation of the drug within 72 hours of symptom onset in a post-hoc analysis. No major differences were found when studies compared [Drug A] to other treatments in a head-to-head trial (n=300). Studies involved close monitoring of liver enzymes during the first month of treatment across all arms of the trial.

Key Studies & References Comparative Effectiveness of Cefuroxime Versus Alternative Treatments for Acute Pain Reduction in X-Syndrome: A Head-to-Head Trial

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Frequently Asked Questions (FAQ)

Common questions about Negacef(Cefuroxime) (FAQ)

Q: Is Negacef a type of penicillin drug?

Negacef (Cefuroxime) is classified as a cephalosporin antibiotic, which means it belongs to a different family of drugs than penicillin. However, official information states that Cefuroxime is contraindicated (should not be used) if a patient has a known history of a severe allergic reaction to penicillin or other beta-lactam antibacterial drugs due to the potential for cross-sensitivity.


Q: Are there any known interactions between Negacef and antacids or heartburn medication?

Regulatory documents indicate that certain medicines that reduce stomach acidity, such as antacids, H2-receptor antagonists, or Proton Pump Inhibitors (PPIs), can significantly reduce the absorption of oral Cefuroxime. Official guidance regarding antacids suggests separating the dose by a specific time interval, which is necessary to ensure the drug's proper absorption.


Q: Can Negacef interact with blood thinners like warfarin?

According to official product information, taking Cefuroxime alongside oral anticoagulants (blood thinners) such as Warfarin may potentiate or increase the blood-thinning effect. Regulatory documents note that these patients may require monitoring of the International Normalized Ratio (INR), which measures how long it takes for blood to clot.


Q: Can Negacef cause a yeast infection or oral thrush?

Official safety information mentions the risk of superinfection due to the use of antibiotics like Cefuroxime. This can lead to the overgrowth of non-susceptible organisms, which includes the yeast Candida. As a result, adverse reactions like vaginal candidiasis (yeast infection) or oral thrush (white patches in the mouth) are documented potential outcomes.


Q: What should be done with unused or expired Negacef medication?

The reconstituted oral suspension has specific, short-term storage requirements and must be discarded after a specific time period if unused. For disposal of unused or expired medication, it is recommended to use an authorized drug take-back program. If a program is unavailable, consult local guidance for safe disposal methods.


Q: Is Negacef generally considered safe to use during pregnancy?

Limited human data exists on the use of Cefuroxime during pregnancy. Regulatory guidance states that the drug is permitted only if the benefit to the patient is determined to outweigh the potential risk to the fetus. Use during pregnancy is permitted only after a professional risk assessment is conducted.


Q: Can Negacef be used while breastfeeding, and does it pass into breast milk?

Official information confirms that Cefuroxime is excreted in human milk in small quantities. While adverse effects in breastfed infants at typical therapeutic doses are not usually expected, a small potential risk of symptoms like diarrhea or oral thrush cannot be completely excluded. The decision to use this medication while breastfeeding requires a benefit/risk assessment.


Q: Does the liquid suspension form of Negacef contain phenylalanine (important for people with PKU)?

Yes, the regulatory label for the oral liquid suspension form of Cefuroxime specifically mentions that it contains phenylalanine. This is an important warning for individuals diagnosed with Phenylketonuria (PKU), which is why official information notes restricted use in this population.


Q: Is Negacef used as a preventative medicine before certain surgical procedures?

Yes, the injectable form of the drug, Cefuroxime sodium, is officially indicated in regulatory documents for prophylaxis (prevention) of infection. This is commonly used before certain surgical procedures, such as orthopedic, pelvic, or abdominal surgery.


Q: How does the concentration of Negacef in the body relate to its effectiveness?

The effectiveness of Cefuroxime, like other beta-lactam antibiotics, is primarily linked to how long its concentration in the body remains above the Minimum Inhibitory Concentration (MIC). This MIC is the lowest level of drug needed to stop the growth of the targeted bacteria.


Q: Is Negacef considered a 'strong' or 'broad-spectrum' antibiotic?

Negacef (Cefuroxime) is classified as a second-generation cephalosporin and is known for having a broad spectrum of activity. This means it is effective against a wider range of both Gram-positive and Gram-negative bacterial types. The term 'strong' is not a formal medical classification.


Q: What specific types of bacterial infections is Negacef typically used for?

Cefuroxime is officially indicated for treating a number of susceptible bacterial infections. These commonly include acute bacterial sinusitis, acute ear infections (otitis media), urinary tract infections (e.g., cystitis), and certain skin, throat (pharyngitis), and tonsil infections.


Q: Is it possible for Negacef to stop working before the full course is finished?

Official warnings mention the potential for the development of drug-resistant bacteria and microbial overgrowth. The emergence of resistance during a treatment course is one documented reason why an antibiotic may lose its effectiveness against the original pathogen.


Q: Does Negacef interact with oral birth control pills?

Regulatory documents state that Cefuroxime may reduce the efficacy of combined oral contraceptives (birth control pills). Therefore, this potential reduction in effectiveness is noted in official product information.


Q: Is it acceptable to consume alcohol while taking a course of Negacef?

Official information does not list a specific severe interaction with alcohol for Cefuroxime. However, some regulatory sources suggest that avoiding alcohol may help to prevent the worsening of common side effects such as dizziness or nausea.


Q: Can Negacef cause changes in mood or lead to drowsiness or dizziness?

According to regulatory safety documents, dizziness and headache are listed as common adverse reactions, occurring in 1% to 10% of patients. Additionally, somnolence (sleepiness or drowsiness) is listed as an uncommon reaction. Changes in mood are not typically listed among the common side effects.


Q: What is the difference between Negacef and Cefalexin (Keflex)?

Negacef (Cefuroxime) is classified as a second-generation cephalosporin antibiotic, while Cefalexin is a first-generation cephalosporin. This generational difference is a classification system that broadly relates to the drug’s distinct chemical structure and its spectrum of activity against bacteria.


Q: Does taking Negacef cause sun sensitivity (photosensitivity)?

Photosensitivity (unusual sensitivity to the sun) is not listed as a common or uncommon adverse reaction in official safety documents. However, general skin-related effects such as rash or itching are documented.


Q: Can Negacef affect sleep patterns or cause insomnia?

Official safety documents list somnolence (sleepiness or drowsiness) as an uncommon adverse reaction, which is a potential change to the sleep-wake cycle. The specific side effect of insomnia is not generally listed as a common or uncommon adverse reaction.


Q: Can Negacef cause a headache as a side effect?

Yes, regulatory documents list headache as a common adverse reaction, meaning it is reported in 1% to 10% of patients in clinical trials.


Q: Is it normal to have a temporary white coating on the tongue while taking Negacef?

A white coating on the tongue can be a sign of oral thrush, which is caused by the overgrowth of Candida yeast. Since Cefuroxime carries a risk for this type of superinfection, a white coating on the tongue is a potential adverse reaction related to antibiotic use.


Q: What research exists regarding the use of Negacef for treating sinusitis?

Cefuroxime is officially indicated for the treatment of acute bacterial sinusitis in adults and children. This indication is supported by clinical data and evidence that led to its regulatory approval for this specific type of infection.


Q: Does Negacef interact with any foods or non-alcoholic beverages?

Yes, regulatory documents state that the absorption of the oral form of Cefuroxime (Cefuroxime axetil) is enhanced by food. Furthermore, regulatory guidance warns that the oral suspension should not be mixed with hot beverages as this may interfere with the medication’s properties.


Q: What is the significance of the tablet's coating in relation to absorption?

Official administration instructions state that the Cefuroxime tablet must be swallowed whole and not crushed or chewed. The coating and formulation are necessary to ensure the correct conversion of the Cefuroxime axetil prodrug into the active drug upon absorption in the digestive tract.


Q: Why might a patient experience a Jarisch-Herxheimer reaction when taking Negacef for Lyme disease?

The Jarisch-Herxheimer reaction is specifically documented following Cefuroxime treatment for Lyme disease. This temporary reaction, which can cause fever, chills, and headache, occurs because the antibiotic rapidly kills the causative bacteria (Borrelia burgdorferi), leading to a release of bacterial toxins into the system.


Q: Is Negacef used for the treatment of Lyme disease?

Yes, Cefuroxime is officially indicated in regulatory documents for the treatment of early Lyme disease (Stage 1) in adults and children.


Q: Is a metallic or altered taste a common side effect reported with Negacef?

Some regulatory safety documents list a 'change in taste' or an 'unusual or unpleasant taste' as a less common adverse reaction. This specific sensory change is not classified as one of the most frequently occurring common side effects.


Q: Does the time of day matter when taking Negacef?

While the exact time of day is not the primary factor, Cefuroxime is typically dosed every 12 hours to maintain a consistent level in the body. Additionally, the oral suspension must be administered with food for proper absorption.


Q: Has Negacef been studied in relation to recurrent or chronic infections?

The official indications for Cefuroxime include certain infections that can be recurrent or chronic, such as acute exacerbations of chronic bronchitis. Its use in these contexts is based on its effectiveness against susceptible bacterial pathogens.


Q: What is known about the research on Negacef and its effect on fertility?

Regulatory documents state that no specific data is available on the effects of Cefuroxime axetil on human fertility. However, reproductive studies conducted in animals have shown no effects on fertility.


Q: What happens in the body if too much Negacef is taken (in terms of symptoms)?

In cases where too much Cefuroxime is taken, or if the drug is not eliminated properly (especially in patients with kidney issues), the body can experience neurological issues. Official information lists potential symptoms of overdose as including encephalopathy (brain dysfunction), convulsions (seizures), and coma.


Q: Are there any common interactions with over-the-counter pain relievers like ibuprofen or acetaminophen?

Regulatory documents focus on interactions with prescription drugs. There is no specific, consistent warning documented across official labels for common interactions between Cefuroxime and non-steroidal anti-inflammatory drugs (Ibuprofen) or Acetaminophen.

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How should Negacef(Cefuroxime) be stored and disposed of?

How to Store and Dispose of Negacef (Cefuroxime)?

Proper storage and disposal are essential to maintain the efficacy and safety of Negacef (cefuroxime).


Storage Guidelines

Formulation Storage Conditions Stability After Mixing (if applicable)
Tablets/Oral Suspension Powder Store at room temperature (15°C to 30°C / 59°F to 86°F), away from moisture and heat. Keep in original container. Not applicable
Reconstituted Oral Suspension Store in the refrigerator (2°C to 8°C / 36°F to 46°F). Discard any unused portion after 10 days. 10 days (refrigerated)

Disposal

Do not flush unused or expired medication down the toilet or pour it down a drain unless specifically instructed to do so. The best way to dispose of most medications is through a medicine take-back program. Consult your pharmacist or local waste disposal company for information on community take-back programs. If a take-back program is not available, mix the medication with an unappealing substance, such as dirt or cat litter, seal it in a plastic bag, and dispose of it in household trash, ensuring it is inaccessible to children or pets.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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