Propoflo

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Propoflo uses


For Animals Only

VETONE®

Propoflo CF

(propofol injectable emulsion)

Anesthetic Injection

Each mL contains 10 mg Propoflo

NADA 141-070

Emulsion for intravenous use in dogs and cats.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

VetOne® Propoflo CF (propofol) injection is a sterile, nonpyrogenic emulsion containing 10 mg/mL of Propoflo suitable for intravenous administration. Propoflo is chemically described as 2,6-diisopropylphenol and has a molecular weight of 178.28. Propoflo is very slightly soluble in water and is therefore formulated as a white, oil-in-water emulsion. Each mL contains Propoflo (10 mg), soybean oil (100 mg), glycerol (22.5 mg), egg yolk phospholipid (12 mg) and sodium metabisulfite (0.25 mg), with sodium hydroxide to adjust the pH. The Propoflo emulsion is isotonic and has a pH of 4.5-6.6.

INDICATIONS

VetOne® Propoflo CF (propofol) is an anesthetic injection for use in dogs and cats as follows:

1. As a single injection to provide general anesthesia for short procedures.

2. For induction and maintenance of general anesthesia using incremental doses to effect.

3. For induction of general anesthesia where maintenance is provided by inhalant anesthetics.

Induction of general anesthesia will usually be observed within 30 to 60 seconds after the end of administration (administration should take 60 to 90 seconds). The doses for induction and maintenance vary depending upon species and preanesthetics. The duration of anesthesia varies depending upon species, dose, and preanesthetics.

In dogs, the duration of anesthesia following the recommended induction dose (5.5 to 7.0 mg/kg without premedication) is generally 5 to 7 minutes. The duration of anesthesia after maintenance doses varies from 2 to 6 minutes following 1.1 mg/kg to 6 to 10 minutes following 3.3 mg/kg. Full standing recovery is generally observed within 10 to 20 minutes after the end of anesthesia, regardless of the duration of anesthesia. Recovery may be delayed in sighthounds or if preanesthetics are administered.

In cats, the duration of anesthesia following the recommended induction dose (8.0 to 13.2 mg/kg without premedication) is generally 5 to 12 minutes. The duration of anesthesia after maintenance doses varies from 5 to 7 minutes following 1.1 mg/kg to 12 to 18 minutes following 4.4 mg/kg. Full standing recovery is generally observed within 30 to 45 minutes after the end of anesthesia, regardless of the duration of anesthesia. Recovery may be delayed if preanesthetics are administered.

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DOSAGE AND ADMINISTRATION

Shake the vial thoroughly before opening. VetOne® Propoflo CF injection contains no antimicrobial preservatives. Strict aseptic techniques must always be maintained during handling since the vehicle is capable of supporting rapid growth of microorganisms.

Failure to follow aseptic handling procedures may result in microbial contamination causing fever, infection/sepsis, and/or other life-threatening illness. Do not use if contamination is suspected.

VetOne® Propoflo CF injection should be prepared for use just prior to initiation of each individual anesthetic procedure. The vial rubber stopper should be disinfected using 70% isopropyl alcohol. The entire contents of the vial should be drawn into sterile syringes immediately after vials are opened. Administration should commence promptly and be completed within 6 hours after the vials are opened. Any unused product should be discarded within 6 hours. Administer by intravenous injection only.

The emulsion should not be mixed with other therapeutic agents or injected into containers of infusion fluids prior to administration.

INDUCTION OF GENERAL ANESTHESIA

For induction, VetOne® Propoflo CF injection should be titrated against the response of the patient over approximately 60 to 90 seconds or until clinical signs show the onset of anesthesia.

If VetOne® Propoflo CF injection is injected too slowly (greater than 90 seconds), an inadequate plane of anesthesia can occur. If this occurs, an additional low dose (1.1 mg/kg) of Propoflo may be administered to facilitate intubation or the transition to inhalant maintenance anesthesia.

The average induction dose ranges and dosage rates for healthy dogs given Propoflo alone, or when Propoflo is preceded by a premedicant, are indicated in the following table (the Table is for guidance only; in practice, the dose should be based upon patient response):


Induction Dosage Guidelines for Dogs


Preanesthetic


Propoflo Induction Dose


Propoflo Rate of Administration


mg/kg


mg/lb


Seconds


mg/kg/min


mL/kg/min


None


5.5-7.0


2.5-3.2


60-90


3.7-7.0


0.37-0.70


Acepromazine


4.0-4.4


1.8-2.0


60-90


2.7-4.4


0.27-0.44


Xylazine


2.2-3.3


1.0-1.5


60-90


1.5-3.3


0.15-0.33


Oxymorphone


2.2-3.3


1.0-1.5


60-90


1.5-3.3


0.15-0.33


Medetomidine


2.2-2.8


1.0-1.3


60-90


1.5-2.8


0.15-0.28


The required dose of tranquilizers, sedatives, or analgesics administered as preanesthetic medications (listed below) may be lower than the label directions for their use as a single medication1.


Acepromazine


0.03-0.1


mg/kg


IM, SC, IV


Xylazine


0.25-0.5


mg/kg


IV


Xylazine


0.5-1.0


mg/kg


IM, SC


Oxymorphone


0.1-0.2


mg/kg


IM, SC, IV


Medetomidine


5.0-10.0


µg/kg


IM


The use of the drugs listed above as preanesthetics for dogs markedly reduces Propoflo requirements. As with other sedative hypnotic agents, the amount of phenothiazine, opioid, and/or alpha2-agonist premedication will influence the response of the patient to an induction dose of VetOne® Propoflo CF injection. The induction dose will also be influenced by the interval between the administration of premedication and induction, and by the rate of administration of Propoflo.

The average induction dose ranges and dosage rates for healthy cats given Propoflo alone, or when Propoflo is preceded by a premedicant, are indicated in the following table (the Table is for guidance only; in practice, the dose should be based upon patient response):


Induction Dosage Guidelines for Cats


Preanesthetic


Propoflo Induction Dose


Propoflo Rate of Administration


mg/kg


mg/lb


Seconds


mg/kg/min


mL/kg/min


None


8.0-13.2


3.6-6.0


60-90


5.3-13.2


0.53-1.32


Acepromazine


8.0-13.2


3.6-6.0


60-90


5.3-13.2


0.53-1.32


Butorphanol


8.0-13.2


3.6-6.0


60-90


5.3-13.2


0.53-1.32


Oxymorphone


8.0-13.2


3.6-6.0


60-90


5.3-13.2


0.53-1.32


Xylazine


7.0-12.0


3.2-5.5


60-90


4.7-12.0


0.47-1.20


The required dosage of tranquilizers, sedatives, or analgesics administered as preanesthetic medications (listed below) may be lower than the label directions for their use as a single medication1,8,9.


Acepromazine


0.03-0.1


mg/kg


IM, SC, IV


Butorphanol


0.1-0.4


mg/kg


IM, SC


Oxymorphone


0.1-0.4


mg/kg


IM, SC, IV


Xylazine


0.25-0.5


mg/kg


IV


Xylazine


0.5-1.0


mg/kg


IM, SC


The use of the drugs listed above as preanesthetics for cats may reduce Propoflo requirements. As with other sedative hypnotic agents, the amount of phenothiazine, opioid and/or alpha2-agonist premedication will influence the response of the patient to an induction dose of VetOne® Propoflo CF injection. The induction dose will also be influenced by the interval between the administration of premedication and induction, and by the rate of administration of Propoflo.

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MAINTENANCE OF GENERAL ANESTHESIA

A. Intermittent Propoflo Injections: Anesthesia can be maintained by administering Propoflo in intermittent IV injections. Clinical response will be determined by the amount, the rate of administration, and the frequency of maintenance injections. The following Tables are provided for guidance:


Maintenance Dosage Guidelines for Dogs


Preanesthetic


Propoflo Maintenance Dose


Propoflo Rate of Administration


mg/kg


mg/lb


Seconds


mg/kg/min


mL/kg/min


None


1.1-3.3


0.5-1.5


30-60


1.1-3.3


0.11-0.33


Acepromazine


1.1


0.5


30-60


1.1-2.2


0.11-0.22


Xylazine


1.1


0.5


30-60


1.1-2.2


0.11-0.22


Oxymorphone


1.1


0.5


30-60


1.1-2.2


0.11-0.22


Medetomidine


1.1


0.5


30-60


1.1-2.2


0.11-0.22


Repeated maintenance doses of Propoflo do not result in increased recovery times, indicating that the anesthetic effects of Propoflo are not cumulative in dogs.


Maintenance Dosage Guidelines for Cats


Preanesthetic


Propoflo Maintenance Dose


Propoflo Rate of Administration


mg/kg


mg/lb


Seconds


mg/kg/min


mL/kg/min


None


1.1-4.4


0.5-2.0


30-60


1.1-4.4


0.11-0.44


Acepromazine


1.1-4.4


0.5-2.0


30-60


1.1-4.4


0.11-0.44


Butorphanol


1.1-4.4


0.5-2.0


30-60


1.1-4.4


0.11-0.44


Oxymorphone


1.1-4.4


0.5-2.0


30-60


1.1-4.4


0.11-0.44


Xylazine


1.1-2.2


0.5-1.0


30-60


1.1-2.2


0.11-0.22


Acepromazine/Butorphanol


1.1-3.3


0.5-1.5


30-60


1.1-3.3


0.11-0.33


Acepromazine/Oxymorphone


1.1-3.3


0.5-1.5


30-60


1.1-3.3


0.11-0.33


Repeated maintenance doses of Propoflo may result in slightly increased recovery times, indicating that the anesthetic effects of Propoflo may be cumulative in cats.

B. Maintenance by Inhalant Anesthetics: Clinical trials using Propoflo have shown that it may be necessary to use a higher initial concentration of the inhalant anesthetic than is usually required following induction using barbiturate anesthetics, due to rapid recovery from VetOne® Propoflo CF injection.

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OVERDOSAGE

Rapid administration or accidental overdosage of VetOne® Propoflo CF injection may cause neurologic and cardiopulmonary depression. Respiratory arrest (apnea) may be observed. In cases of respiratory depression, stop drug administration, establish a patent airway, and initiate assisted or controlled ventilation with oxygen. Cardiovascular depression should be treated with plasma expanders, pressor agents, antiarrhythmic agents or other techniques as appropriate for the observed abnormality.

In feline safety studies using healthy cats and elevated doses of Propoflo, unexplained decreases in albumin, globulin, and total protein values were noted. Increases in bile acids and triglycerides were also noted and were probably due to the lipid content of the drug formulation. These transient changes were not clinically significant in healthy cats.

CONTRAINDICATIONS

VetOne® Propoflo CF injection is contraindicated in dogs and cats with a known hypersensitivity to Propoflo or its components, or when general anesthesia or sedation are contraindicated.

WARNINGS

Induction of anesthesia with VetOne® Propoflo CF injection is frequently associated with apnea and respiratory depression. Hypotension and oxygen desaturation can occur also, especially following rapid bolus administration. Apnea is observed less frequently following maintenance doses of VetOne® Propoflo CF injection when given as the sole maintenance agent, or when a maintenance dose is administered during inhalant anesthesia.

When using VetOne® Propoflo CF injection, patients should be continuously monitored and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available. The clinical use of Propoflo without available supplemental oxygen and artificial ventilation has not been adequately evaluated and is not recommended.

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PRECAUTIONS

1. VetOne® Propoflo CF injection contains no antimicrobial preservatives. Strict aseptic techniques must always be maintained during handling since the vehicle is capable of supporting rapid growth of microorganisms. Failure to follow aseptic handling procedures may result in microbial contamination causing fever, infection/sepsis, and/or other life-threatening illness. Do not use if contamination is suspected.

2. When using VetOne® Propoflo CF injection, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available. The clinical use of Propoflo without available supplemental oxygen and artificial ventilation has not been adequately evaluated and is not recommended.

3. Anesthesia effects: Careful monitoring of the patient is necessary when using VetOne® Propoflo CF injection as a maintenance anesthetic due to the possibility of rapid arousal. Apnea may occur following maintenance doses of VetOne® Propoflo CF injection.

Following induction, additional VetOne® Propoflo CF injection at the lower maintenance dose may be needed to complete the transition to inhalant maintenance anesthesia due to rapid recovery from Propoflo. Doses administered during the transition to inhalant anesthesia or during inhalant maintenance anesthesia may result in apnea.

4. Physiological effects: During induction of anesthesia, mild hypotension and increased heart rate may occur when VetOne® Propoflo CF injection is used alone.

5. Premedicants: Premedicants may increase the anesthetic or sedative effect of VetOne® Propoflo CF injection and result in more pronounced changes in systolic, diastolic and mean arterial blood pressures. The use of ketamine (an approved compound for restraint in cats) is not recommended as a preanesthetic prior to Propoflo due to an increased number of patients experiencing apnea.

6. Breeding animals: Adequate data concerning the safe use of VetOne® Propoflo CF injection in pregnant, lactating, and breeding dogs and cats have not been obtained. Propoflo crosses the placenta, and as with other general anesthetic agents, the administration of Propoflo may be associated with neonatal depression.

7. Puppies and Kittens: The use of Propoflo has not been evaluated in puppies or kittens.

8. Compromised or debilitated dogs and cats: Doses may need adjustment for geriatric or debilitated patients. The administration of VetOne® Propoflo CF injection to patients with renal failure and/or hepatic failure has not been evaluated. As with other anesthetic agents, caution should be exercised in dogs or cats with cardiac, respiratory, renal or hepatic impairment, or in hypovolemic or debilitated dogs and cats.

9. Sighthounds: VetOne® Propoflo CF injection induction followed by inhalant anesthetic agents produced satisfactory anesthesia and recovery times in sighthounds. Propoflo alone in 6 greyhounds and 7 non-greyhounds showed satisfactory, but longer recovery times in the greyhounds (averages of 47 and 18 minutes, respectively).2 In a Propoflo pharmacokinetics study, greyhounds had higher Propoflo levels in plasma, a lower volume of distribution, slower total body clearance rates, and longer recovery times than did mixed-breed dogs. The elimination half-life was similar in both groups.3

10. Arrhythmogenicity: In one study in dogs, Propoflo increased myocardial sensitivity to the development of epinephrine-induced ventricular arrhythmias in a manner similar to other anesthetics.4

11. Consecutive day treatment: Heinz bodies increased dramatically in cats following repeat administration of Propoflo on consecutive days and were associated with decreases in RBC count and hematocrit. Large numbers of Heinz bodies can lead to hemolytic anemia.5,6 In one study in cats, treatment with Propoflo once a day for 3 days led to a marked increase in Heinz bodies. Treatment for 5 or more consecutive days resulted in generalized malaise and/or facial edema; clinical signs of illness resolved within 24 to 48 hours after cessation of Propoflo.

12. Concurrent medication: No significant adverse interactions with commonly used drugs have been observed.

13. Perivascular administration: Perivascular administration does not produce local tissue reaction.

HUMAN USER SAFETY

Not for human use. Keep out of reach of children.

VetOne® Propoflo CF injection should be managed to prevent the risk of diversion, through such measures as restriction of access and the use of drug accountability procedures appropriate to the clinical setting. Rare cases of self-administration of Propoflo have been reported, including dose-related fatalities.

Preventive care should be taken to avoid self-administration; for example, use of a guarded needle until the moment of injection is recommended. Symptoms of self-administration may include cardiovascular and/or respiratory depression. Anaphylaxis to Propoflo may occur during its first use, especially in patients with a history of drug allergy.7 In the event of accidental self-administration, seek medical attention immediately.

Contact of this product with skin, eyes, and clothes should be avoided. If contact occurs, skin and eyes should be liberally flushed with water for 15 minutes. If irritation develops and continues, consult a physician.

Initial arousal following Propoflo anesthesia can be extremely rapid. Caution should be used at this time in manipulations involving the mouth, such as removing an endotracheal tube.

ADVERSE REACTIONS

The primary side effect of VetOne® Propoflo CF injection is respiratory depression and apnea. Apnea was observed in 20% of the dog cases in the clinical trial. Apnea was observed in 1.4% of the cat cases in the clinical trial. All apnea cases responded satisfactorily to oxygen supplementation and/or controlled ventilation.

Apnea lasting less than 1 minute in healthy dogs or cats may cause no harm. Animals breathing atmospheric air that become apneic may show signs of cerebral damage after 2 minutes. Animals breathing 100% oxygen that become apneic may not show signs of cerebral damage for 5 to 8 minutes. Ventricular arrhythmias may occur secondary to hypoxia induced by apnea.

The primary side effect of VetOne® Propoflo CF injection in cats is paddling during recovery. Paddling was observed in 11% of the cat cases in the clinical trial.

Other transient side effects in dogs or cats are observed infrequently or rarely:

CLINICAL PHARMACOLOGY

After a single dose, Propoflo blood level profiles are characterized by a rapid distribution phase and a rapid elimination phase. The liver is the main site of metabolism with the major portion of metabolites being excreted in urine. No change in pharmacokinetics occurs after multiple daily dosing in dogs. Concomitant medication may affect the pharmacokinetics of either Propoflo or other medications.

In dogs, VetOne® Propoflo CF injection has been used in association with acepromazine, atropine, glycopyrrolate, halothane, isoflurane, medetomidine, oxymorphone, and xylazine. No pharmacological incompatibility has been encountered.

In cats, VetOne® Propoflo CF injection has been used in association with acepromazine, atropine, glycopyrrolate, butorphanol, oxymorphone, xylazine, and halothane. No pharmacological incompatibility has been encountered.

To report suspected adverse drug events, call 1-888-621-0189. For technical assistance go to www.ivaoes.com. To obtain a copy of the Safety Data Sheet (SDS) go to www.mwivet.com.

For additional information about adverse drug experience reporting for animal drugs, Contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinarySafetyHealth.

STORAGE

Store between 4 – 25°C (40-77°F). Do not freeze.

Shake well before use. Discard opened vial with care. Within 6 hours after opening, any withdrawn unused product should be discarded safely.

HOW SUPPLIED

VetOne® Propoflo CF injection is supplied in cartons of five-20 mL vials containing 10 mg Propoflo per mL.

REFERENCES

1. Thurman JC, Tranquilli WJ, Benson GJ, eds. Preanesthetics and anesthetic adjuncts. In: Lumb and Jones’ Veterinary Anesthesiology. 3rd ed; 1996: chap8.

2. Robertson SA, Johnson S, Beemsterboer J. Cardiopulmonary, anesthetic and postanesthetic effects of intravenous infusions of Propoflo in greyhounds and non-greyhounds. Am J Vet Res 53:1027- 1032: 1992.

3. Zoran DL, Riedesel DH, Dyer DC. Pharmacokinetics of Propoflo in mixed-breed dogs and greyhounds. Am J Vet Res 54:755-760: 1993.

4. Kamibayashi T, Hayashi Y, Sumikawa K, Yamatodani A, Kawabata K, Yoshiya I. Enhancement by Propoflo of epinephrine-induced arrhythmias in dogs. Anesthesiology 75:1035-1040 1991.

5. Bush BM. Interpretation of laboratory results for small animal clinicians. Blackwell Science: 1996.

6. Andress JL, Day TK, Day DG. The effects of consecutive day Propoflo anesthesia on feline red blood cells. Veterinary Surgery 24:277-282:1995.

7. Laxenaire MC, Mata-Bermejo E, Moneret-Vautrin DA, Gueant JL. Life-threatening anaphylactoid reactions to Propoflo (DIPRIVAN®). Anesthesiology 77:275-280: 1992.

8. Plumb D. Veterinary Drug Handbook 2nd ed. pp. 455-458: 1995.

9. Branson, KR, Gross ME, Booth NH, Adams RH, ed. Veterinary Pharmacology and Therapeutics 7th ed., pp. 299-300: 1995.

Net Contents: 20 mL

Made in Italy

Distributed by: MWI

Boise, ID 83705

www. VetOne.net

Rev 09/16

Front and Back Panel

NDC 13985-740-20

5 x 20 mL

VETONE®

Propoflo CF

(propofol injectable emulsion)

Anesthetic Injection

Each mL contains 10 mg Propoflo

CAUTION: Federal law restricts this drug to use by or on the

order of a licensed veterinarian

NADA 141-070. Approved by FDA

FOR USE IN ANIMALS ONLY

V1 505846 Net Contents: 5 X 20 mL

Left Side Panel

Emulsion for intravenous use in dogs and cats.

Read package insert for complete product information.

Use strict aseptic technique. Contains no preservative.

Begin use promptly after removing entire vial contents.

Discard appropriately within 6 hours after opening.

Do not use if contamination is suspected.

Each mL contains Propoflo (10 mg), soybean oil (100 mg),

glycerol (22.5 mg), egg yolk phospholipid (12 mg) and

sodium metabisulfite (0.25 mg), with sodium hydroxide to

adjust pH. The Propoflo emulsion is isotonic and has a pH of

4.5-6.6.

Store between 4°C-25°C (40°-77°F). Do not freeze.

Shake well before use.

Made in Italy

Distributed by: MWI

Boise, ID 83705

www. VetOne.net

Rev. 09/16

Right Side Panel

For intravenous use in dogs and cats.

Uses: VetOne® Propoflo CF (propofol injectable emulsion)

is an injectable anesthetic for use in dogs and cats as

follows:

1. As a single injection to provide general anesthesia

for short procedures.

2. For induction and maintenance of general

anesthesia using incremental doses to effect.

3. For induction of general anesthesia where

maintenance is provided by inhalant anesthetics.

Read package insert for complete product information.

Contains no antimicrobial preservative.

Shake well before use. Remaining contents of a vial

should be discarded safely within 6 hours after opening.

Store between 4°C-25°C (40°-77°F). Do not freeze.

Propoflo pharmaceutical active ingredients containing related brand and generic drugs:


Propoflo available forms, composition, doses:


Propoflo destination | category:


Propoflo Anatomical Therapeutic Chemical codes:


Propoflo pharmaceutical companies:


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References

  1. Dailymed."PROPOVAN (PROPOFOL) INJECTION, EMULSION [MWI/VETONE]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."PROPOFOL: 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/dailym... (accessed August 28, 2018).
  3. "propofol". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Propoflo?

Depending on the reaction of the Propoflo after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Propoflo not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Propoflo addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Propoflo, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Propoflo consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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