Rapanofal by is a Animal medication manufactured, distributed, or labeled by Ivaoes, Llc, Corden Pharma Spa In Breve Corden Pharma Spa, Si Group, Inc.. Drug facts, warnings, and ingredients follow.
Rapanofal® (propofol) injection is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration. Propofol is chemically described as 2,6- diisopropylphenol and has a molecular weight of 178.28. Propofol is very slightly soluble in water and is therefore formulated as a white, oil-in-water emulsion. Each mL contains propofol (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 propofol emulsion is isotonic and has a pH of 4.5-6.6.
Rapanofal® (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.
Shake the vial thoroughly before opening.
Rapanofal® 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.
Rapanofal® 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.
For induction, Rapanofal® 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 Rapanofal® 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 propofol 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 propofol alone, or when propofol 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 |
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Preanesthetic |
Propofol Induction Dose |
Propofol 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 propofol 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 Rapanofal® 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 propofol.
The average induction dose ranges and dosage rates for healthy cats given propofol alone, or when propofol 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 |
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Preanesthetic |
Propofol Induction Dose |
Propofol 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 propofol 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 Rapanofal® 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 propofol.
Maintenance Dosage Guidelines for Dogs |
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Preanesthetic |
Propofol Maintenance Dose |
Propofol 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 propofol do not result in increased recovery times, indicating that the anesthetic effects of propofol are not cumulative in dogs.
Maintenance Dosage Guidelines for Cats |
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Preanesthetic |
Propofol Maintenance Dose |
Propofol 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 propofol may result in slightly increased recovery times, indicating that the anesthetic effects of propofol may be cumulative in cats.
Rapid administration or accidental overdosage of Rapanofal® 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 propofol, 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.
Induction of anesthesia with Rapanofal® 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 Rapanofal® injection when given as the sole maintenance agent, or when a maintenance dose is administered during inhalant anesthesia.
When using Rapanofal® 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 propofol without available supplemental oxygen and artificial ventilation has not been adequately evaluated and is not recommended.
Not for human use. Keep out of reach of children.
Rapanofal® 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 propofol 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 propofol 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 propofol anesthesia can be extremely rapid. Caution should be used at this time in manipulations involving the mouth, such as removing an endotracheal tube.
The primary side effect of Rapanofal® 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 Rapanofal® 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:
After a single dose, propofol 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 propofol or other medications.
In dogs, Rapanofal® injection has been used in association with acepromazine, atropine, glycopyrrolate, halothane, isoflurane, medetomidine, oxymorphone, and xylazine. No pharmacological incompatibility has been encountered.
In cats, Rapanofal® 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. To obtain a copy of the Safety Data Sheet (SDS) or for technical assistance go to www.ivaoes.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.
Net Contents: 20 mL
NDC: 86064-001-20
Mfd. In Italy For:
Ivaoes Animal Health
Miami, FL 33130
Rev 06/18
Front and Back Panel
NDC: 86064-001-20
Net Contents: 5 x 20 mL
Rapanofal®
(propofol injectable emulsion)
Anesthetic Injection
Each mL contains 10 mg propofol
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
IVAOES
ANIMAL HEALTH
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 propofol (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 propofol 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 for Ivaoes Animal Health, Miami, FL 33130 Rev 06/18
Right Side Panel
For intravenous use in dogs and cats.
Uses: Rapanofal® (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.
RAPANOFAL
propofol injection, emulsion |
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Labeler - Ivaoes, Llc (080126338) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Corden Pharma Spa In Breve Corden Pharma Spa | 338725627 | MANUFACTURE |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Si Group, Inc. | 079452195 | API MANUFACTURE |
Mark Image Registration | Serial | Company Trademark Application Date |
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RAPANOFAL 87179594 5252445 Live/Registered |
IVAOES, LLC 2016-09-22 |