Zacoldine Actions

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Consists of Acetaminophen, chlorpheniramine maleate, K sulphoguaiacolate, phenylephrine

Actions of Acetaminophen (Zacoldine) in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Pharmacology: Pain is a very common experience and analgesic drugs such as paracetamol plays an important role in providing general pain relief for both acute and chronic pain. Paracetamol is widely recommended as the initial drug of choice for the treatment of mild to moderate musculoskeletal pain and symptomatic osteoarthritis as it is regarded as having a more acceptable safety profile in chronic use than nonsteroidal anti-inflammatory drugs (NSAIDs).

Acetaminophen (Zacoldine) provides analgesic action via its inhibition activity on the central prostaglandin synthetase and its antipyretic action is thought to be due to selective inhibition of prostaglandin synthesis in the central nervous system (CNS).

Acetaminophen (Zacoldine) is readily absorbed from the upper small intestine, has absolute oral bioavailability (70-90%) and is extensively metabolized in the liver.

Pharmacokinetics: Acetaminophen (Zacoldine) formulation consists of a bilayer tablet containing 665 mg of paracetamol: One layer containing an immediate-release (IR) formulation and providing 31% of the total dose and a 2nd layer containing a sustained release (SR) formulation that provides the remaining 69% of the total dose.

Pharmacokinetics of Acetaminophen (Zacoldine) have been investigated in 2 pivotal biostudies. In the First study, Acetaminophen (Zacoldine) and Panadol tablets were compared in fed and fasted volunteers. Both were bioequivalent with respect to dose-corrected AUC(0-t) and AUC(0-inf) in both fed and fasted states. The bioavailability of paracetamol from Acetaminophen (Zacoldine) is not affected by food thus indicating that the formulation can be taken with or without food.

In the Second study, where Acetaminophen (Zacoldine) was again compared with Panadol; Acetaminophen (Zacoldine) showed a clear pattern of controlled release of paracetamol, and the formulations were bioequivalent based on the comparison of AUCs for the final 24 hours of the 48-hour dosing period. This shows that there is no additional accumulation of paracetamol from the Acetaminophen (Zacoldine) formulation. Besides that, steadier concentrations of paracetamol were achieved with Acetaminophen (Zacoldine). Thus, Acetaminophen (Zacoldine) may be particularly appropriate for patients who require repeat doses as it maintains a continuous therapeutic effect when taken every 8 hours (2 x 665 mg tablets per dose).

How should I take Acetaminophen (Zacoldine)?

Use Acetaminophen (Zacoldine) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take more of this medication than is recommended. An overdose of Acetaminophen (Zacoldine) can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you are treating a child, use a pediatric form of Acetaminophen (Zacoldine). Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label.

Acetaminophen (Zacoldine) made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of Acetaminophen (Zacoldine). Never mix and match dosing devices between infant formulations of Acetaminophen (Zacoldine).

You may need to shake the liquid before each use. Follow the directions on the medicine label.

The chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the Acetaminophen (Zacoldine) disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the Acetaminophen (Zacoldine) effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Stop taking Acetaminophen (Zacoldine) and call your doctor if:

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Acetaminophen (Zacoldine).

Store at room temperature away from heat and moisture.

Acetaminophen (Zacoldine) administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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Take exactly as directed on the label, or as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended.

Do not take more of this medication than is recommended. An overdose of Acetaminophen (Zacoldine) can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you are treating a child, use a pediatric form of Acetaminophen (Zacoldine). Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label.

Acetaminophen (Zacoldine) made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of Acetaminophen (Zacoldine). Never mix and match dosing devices between infant formulations of Acetaminophen (Zacoldine).

You may need to shake the liquid before each use. Follow the directions on the medicine label.

The chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the Acetaminophen (Zacoldine) disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the Acetaminophen (Zacoldine) effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Stop taking Acetaminophen (Zacoldine) and call your doctor if:

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Acetaminophen (Zacoldine).

Store at room temperature away from heat and moisture.

Acetaminophen (Zacoldine) pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.
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Mechanism of Action

The precise mechanism of the analgesic and antipyretic properties of Acetaminophen (Zacoldine) is not established but is thought to primarily involve central actions.

Pharmacodynamics

Acetaminophen (Zacoldine) has been shown to have analgesic and antipyretic activities in animal and human studies.

Single doses of Acetaminophen (Zacoldine) up to 3,000 mg and repeated doses of 1,000 mg every 6 hours for 48 hours have not been shown to cause a significant effect on platelet aggregation. Acetaminophen (Zacoldine) does not have any immediate or delayed effects on small-vessel hemostasis. Clinical studies of both healthy subjects and patients with hemophilia showed no significant changes in bleeding time after receiving multiple doses of oral Acetaminophen (Zacoldine).

Pharmacokinetics

Distribution

The pharmacokinetics of Acetaminophen (Zacoldine) have been studied in patients and healthy subjects up to 60 years old. The pharmacokinetic profile of Acetaminophen (Zacoldine) has been demonstrated to be dose proportional in adults following administration of single doses of 500, 650, and 1,000 mg.

The maximum concentration (Cmax) occurs at the end of the 15 minute intravenous infusion of Acetaminophen (Zacoldine). Compared to the same dose of oral Acetaminophen (Zacoldine), the Cmax following administration of Acetaminophen (Zacoldine) is up to 70% higher, while overall exposure (area under the concentration time curve [AUC]) is very similar.

Pharmacokinetic parameters of Acetaminophen (Zacoldine) (AUC, Cmax, terminal elimination half-life [T½], systemic clearance [CL], and volume of distribution at steady state [Vss]) following administration of a single intravenous dose of 15 mg/kg in children and adolescents and 1,000 mg in adults are summarized in Table 5.

Table 5. Acetaminophen (Zacoldine) Pharmacokinetic Parameters
Subpopulations

Mean (SD)

AUC 0-6h

(mcg× h/mL)

C max (mcg/mL)

(h)

CL

(L/h/kg)

Vss

(L/kg)

Children

38 (8)

29 (7)

3.0 (1.5)

0.34 (0.10)

1.2 (0.3)

Adolescents

41 (7)

31 (9)

2.9 (0.7)

0.29 (0.08)

1.1 (0.3)

Adults

43 (11)

28 (21)

2.4 (0.6)

0.27 (0.08)

0.8 (0.2)

The concentrations of Acetaminophen (Zacoldine) observed in neonates greater than 32 weeks gestational age at birth treated with 12.5 mg/kg dose are similar to infants, children and adolescents treated with a 15 mg/kg dose, and similar to adults treated with a 1,000 mg dose.

At therapeutic levels, binding of Acetaminophen (Zacoldine) to plasma proteins is low (ranging from 10% to 25%). Acetaminophen (Zacoldine) appears to be widely distributed throughout most body tissues except fat.

Metabolism and Excretion

Acetaminophen (Zacoldine) is primarily metabolized in the liver by first-order kinetics and involves three principal separate pathways: Conjugation with glucuronide, conjugation with sulfate, and oxidation via the cytochrome P450 enzyme pathway, primarily CYP2E1, to form a reactive intermediate metabolite (N-acetyl-p-benzoquinone imine or NAPQI). With therapeutic doses, NAPQI undergoes rapid conjugation with glutathione and is then further metabolized to form cysteine and mercapturic acid conjugates.

Acetaminophen (Zacoldine) metabolites are mainly excreted in the urine. Less than 5% is excreted in the urine as unconjugated (free) Acetaminophen (Zacoldine) and more than 90% of the administered dose is excreted within 24 hours.

Actions of Chlorpheniramine maleate (Zacoldine) in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Chlorpheniramine maleate (Zacoldine) belongs to class of medications called antihistamines. It acts by blocking a natural chemical (histamine) that your body makes during an allergic reaction. Histamine is responsible for many symptoms of allergy.

How should I take Chlorpheniramine maleate (Zacoldine)?

This section provides information on the proper use of a number of products that contain cough and cold combinations. It may not be specific to Chlorpheniramine maleate (Zacoldine). Please read with care.

To help loosen mucus or phlegm in the lungs, drink a glass of water after each dose of this medicine, unless otherwise directed by your doctor.

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects.

For patients taking the extended-release capsule or tablet form of this medicine:

For patients taking the extended-release oral solution or oral suspension form of this medicine:

For patients taking a combination medicine containing an antihistamine and/or aspirin or other salicylate:

If a combination medicine containing aspirin has a strong vinegar-like odor, do not use it. This odor means the medicine is breaking down. If you have any questions about this, check with your pharmacist.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Keep the liquid form of this medicine from freezing. Do not refrigerate the syrup.

Chlorpheniramine maleate (Zacoldine) administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.

Chlorpheniramine maleate (Zacoldine) pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.

Chlorpheniramine maleate (Zacoldine) acts directly on both alpha- and, to a lesser degree, beta-adrenergic receptors. Through direct action on alpha-adrenergic receptors in the mucosa of the respiratory tract, pseudoephedrine produces vasoconstriction. Chlorpheniramine maleate (Zacoldine) relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors. Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect.

Actions of Phenylephrine (Zacoldine) in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.

In general, α1-adrenergic receptors mediate contraction and hypertrophic growth of smooth muscle cells. α1-receptors are 7-transmembrane domain receptors coupled to G proteins, Gq/11. Three α1-receptor subtypes, which share approximately 75% homology in their transmembrane domains, have been identified: α1A (chromosome 8), α1B (chromosome 5), and α1D (chromosome 20). Phenylephrine (Zacoldine) appears to act similarly on all three receptor subtypes. All three receptor subtypes appear to be involved in maintaining vascular tone. The α1A-receptor maintains basal vascular tone while the α1B-receptor mediates the vasocontrictory effects of exogenous α1-agonists. Activation of the α1-receptor activates Gq-proteins, which results in intracellular stimulation of phospholipases C, A2, and D. This results in mobilization of Ca2+ from intracellular stores, activation of mitogen-activated kinase and PI3 kinase pathways and subsequent vasoconstriction. Phenylephrine (Zacoldine) produces its local and systemic actions by acting on α1-adrenergic receptors peripheral vascular smooth muscle. Stimulation of the α1-adrenergic receptors results in contraction arteriolar smooth muscle in the periphery. Phenylephrine (Zacoldine) decreases nasal congestion by acting on α1-adrenergic receptors in the arterioles of the nasal mucosa to produce constriction; this leads to decreased edema and increased drainage of the sinus cavities.

How should I take Phenylephrine (Zacoldine)?

Do not use if the solution turns brown or becomes cloudy.

To use:

For patients using the 2.5 or 10% eye drops:

Dosing

The dose of Phenylephrine (Zacoldine) will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Phenylephrine (Zacoldine). If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of Phenylephrine (Zacoldine), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For non-prescription strength eye drops, follow the package directions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Phenylephrine (Zacoldine) administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.

IV:

Hypotension/shock: May be administered via continuous infusion (after diluting). When administering as a continuous infusion, central line administration is preferred. IV infusions require an infusion pump.

Hypotension during anesthesia: Administer as an IV bolus over 20 to 30 seconds.

Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Initiate phentolamine (or alternative antidote). Apply dry warm compresses (Hurst 2004; Reynolds 2014).

Phentolamine: Dilute 5 to 10 mg in 10 to 20 mL NS and administer into extravasation site as soon as possible after extravasation; may readminister if patient remains symptomatic (Reynolds 2014).

Alternative to phentolamine: Nitroglycerin topical 2% ointment (based on limited data): Apply a 1-inch strip to the site of ischemia; may repeat every 8 hours as necessary (Reynolds 2014).

Phenylephrine (Zacoldine) pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.

Mechanism Of Action

Phenylephrine (Zacoldine) hydrochloride is an a-1 adrenergic receptor agonist.

Pharmacodynamics

Interaction of Phenylephrine (Zacoldine) with a1-adrenergic receptors on vascular smooth muscle cells causes activation of the cells and results in vasoconstriction. Following Phenylephrine (Zacoldine) hydrochloride intravenous administration, increases in systolic and diastolic blood pressures, mean arterial blood pressure, and total peripheral vascular resistance are observed. The onset of blood pressure increase following an intravenous bolus Phenylephrine (Zacoldine) hydrochloride administration is rapid, typically within minutes. As blood pressure increases following intravenous administration, vagal activity also increases, resulting in reflex bradycardia.

Phenylephrine (Zacoldine) has activity on most vascular beds, including renal, pulmonary, and splanchnic arteries.

Pharmacokinetics

Following an intravenous infusion of Phenylephrine (Zacoldine) hydrochloride, the observed effective halflife was approximately 5 minutes. The steady-state volume of distribution of approximately 340 L suggests a high distribution into organs and peripheral tissues. The average total serum clearance is approximately 2100 mL/min. The observed Phenylephrine (Zacoldine) plasma terminal elimination half-life was 2.5 hours.

Phenylephrine (Zacoldine) is metabolized primarily by monoamine oxidase and sulfotransferase. After intravenous administration of radiolabeled Phenylephrine (Zacoldine), approximately 80% of the total dose was eliminated within first 12 h; and approximately 86% of the total dose was recovered in the urine within 48 h. The excreted unchanged parent drug was 16% of the total dose in the urine at 48 h post intravenous administration. There are two major metabolites, with approximately 57 and 8% of the total dose excreted as m-hydroxymandelic acid and sulfate conjugates, respectively. The metabolites are considered not pharmacologically active.

Clinical Studies

The evidence for the efficacy of Phenylephrine (Zacoldine) is derived from studies of Phenylephrine (Zacoldine) hydrochloride in the published literature. The literature support includes 16 studies evaluating the use of intravenous Phenylephrine (Zacoldine) to treat hypotension during anesthesia. The 16 studies include 9 studies where Phenylephrine (Zacoldine) was used in low-risk (ASA 1 and 2) pregnant women undergoing neuraxial anesthesia during Cesarean delivery, 6 studies in non-obstetric surgery under general anesthesia, and 1 study in non-obstetric surgery under combined general and neuraxial anesthesia. Phenylephrine (Zacoldine) has been shown to raise systolic and mean blood pressure when administered either as a bolus dose or by continuous infusion following the development of hypotension during anesthesia.



References

  1. DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "ACETAMINOPHEN; ASPIRIN; CAFFEINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. NCIt. "Phenylephrine: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).

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