Raminovet
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Questions & Answers
Side Effects & Adverse Reactions
Induction of anesthesia with RapinovetTM 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 RapinovetTM injection when given as the sole maintenance agent, or when a maintenance dose is administered during inhalant anesthesia.
When using Rapinovet™ 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.
SIDE EFFECTS:
The primary side effect of RapinovetTM injection in dogs 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 RapinovetTM 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:
•Respiratory: panting, reverse sneezing, cyanosis • Musculoskeletal: paddling during recovery, tremors, tenseness, movements, fasciculations. •Cardiovascular: bradycadia, hypotension, cyanosis, tachycardia, premature ventricular contractions •Central Nervous System: .excitation, opisthotonus, seizure •Injection Site: pain during injection •Gastrointestinal: emesis/retching •Other: rubbing at face or nose during recovery, vocalization during recovery, chewing or licking the injection site during recovery.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
RapinovetTM (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
History
There is currently no drug history available for this drug.
Other Information
Rapinovet™ (propofol) injection is a sterile, nonpyrogenic emulsion containing 10mg/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.
Sources
Raminovet Manufacturers
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Bayer Healthcare Llc
![Raminovet (Profol) Injection, Emulsion [Bayer Healthcare Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Raminovet | Bayer Healthcare Llc
Shake the vial thoroughly before opening.
RapinovetTM 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.
Rapinovet™ 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 ANETHESIA:
For induction, RapinovetTM 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 RapinovetTM 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
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 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 medication.1
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 IMThe 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 RapinovetTM 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 on patient response).
Induction Dosage Guidelines for Cats
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 medication.1,8,9
Acepromazine 0.03-0.1mg/kg
IM,SC,IV
Butorphanol 0.1-0.4mg/kg
IM, SC
Oxymorphone 0.1-0.4mg/kg
IM,SC,IV
Xylazine 0.25-0.5mg/kg
IV
Xylazine 0.5-1.0mg/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 RapinovetTM 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 OF GENERAL ANESTHESIA:
A. Intermittent Propofol Injections: Anesthesia can be maintained by administering propofol 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
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
Preanesthetic
Propofol Maintenance Dose
Propofol Rate of Administration
mg/kg
mg/lb
seconds
mg/kg/min
mL/kg/min
None
1.1-4.4
05.-2.0
30-60
1.1-4.4
0.11-0.44
Acepromazine
1.1-4.4
05.-2.0
30-60
1.1-4.4
0.11-0.44
Butorphanol
1.1-4.4
05.-2.0
30-60
1.1-4.4
0.11-0.44
Oxymorphone
1.1-4.4
05.-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/
Butorphanol1.1-3.3
0.5-1.5
30-60
1.1-3.3
0.11-0.33
Acepromazine/
Oxymorphone1.1-3.3
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.
B. Maintenance by Inhalant Anesthetics: Clinical trials using propofol 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 RapinovetTM injection.
OVERDOSAGE:
Rapid administration or accidental overdosage of RapinovetTM 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.
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