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[Name of Veterinary Medicinal Product]
Generic name: Propo fol Injection
English Name: Pro pofol Injection
Chinese pinyin: Bingbofen Zhusheye
[Ingredient] Prop ofol
[Description] This product is white milky liquid.
[Pharmacological Effect]
Pharmacodynamics
P ropofol injection is an intravenous sedative hypnotic agent
for use in the induction and maintenance of anesthesia.
Induction of anesthesia will usually be observed within 75-120 seconds after the beginning of propofo l administration. The duration of anesthesia following the recommended induction
doses averages 6.7 minutes in dogs. Recommended maintenance doses for anesthesia
in unpremedicated dogs, animals premedicated with acepromazine, and dogs
premedicated with a combination of acepromazine/oxymor phone results in anesthesia
lasting an average of 3.68, 3.80 and 5.43 minutes, respectively, after each
maintenance dose. Recovery from propo fol is rapid; full standing recovery is
generally observed within 20 minutes. The use of certain premedication may result in
prolonged recovery.
Pharmacokinetics
After propofo l is intravenously administered to a dog, the plasma protein binding rate
is high. Propof ol can be quickly distributed in vivo. With its high lipophilicity,
prop ofol can crosse the blood-brain barrier and placental barrier. It can be secreted by
milk, metabolized as inactive conjugate in the liver and excreted by kidney.
Interactions with other medicinal drugs
P ropofol has been used in association with atropine, glycopyrrolate, acepromazine,
xylazine, o xymorphone, halothane and isoflurane. No pharmacological
incompatibility has been observed.
[Indications]
Prop ofol is used in dogs for induction of anesthesia.
[Dosage and Administration]
The dose is calculated on prop ofol basis.When Pr opofol is given alone intravenously,
a dose of 5.5mg/kg of body weight of dog over a period of 40 to 60 seconds is
recommended.When propof ol is preceded by a premedicant, the dose and rate shouldbe based upon the following table or patient response
Preanesthetic
Propo fol Induction Dose
(mg/kg)
Rate of Administration
(Seconds) mg/kg/min
mL/kg/min
None
5.5
40~60
5.5~8.3
0.55~0.83
Acepromazine
3.7
30~50
4.4~7.4
0.44~0.74
Acepromazine
/Oxy morphone
2.6
30~50
3.1~5.2
0.31~0.52
[Contraindications]
Propofo l injection is contraindicated in dogs with a known hypersensitivity to
propof ol or its components, or when general anesthesia or sedation are
contraindicated.
[Adverse Reactions]
1. Rapid bolus administration or overdosage of prop fol may cause undesirable
cardiorespiratory depression including hypotension and oxygen desaturation.
2. Other transient side effects are observed infrequently or rarely in dogs: depression,
gastrointestinal reaction, cardiovascular inhibition and seizures, etc.
[Precautions]
1. When using pro pofol, dogs should be continuously monitored and facilities for the
maintenance of a patent airway, artificial ventilation, and oxygen supplementation
must be immediately available. Careful monitoring of the patient is necessary when
using propof ol as a maintenance anesthetic due to the possibility of rapid arousal.
Apnea may occur following maintenance doses of prop ofol. Following induction,
additional prop ofol may be needed to complete the transition to inhalant maintenance
anesthesia due to rapid recovery from pro pofol. Doses administered during the
transition to inhalant anesthesia may result in apnea. Pro pofol has also been used
during inhalant maintenance anesthesia to increase anesthetic depth. Pro pofol used
during inhalant maintenance may result in apnea.
2. This drug shall be used by a licensed veterinarian.
3. Shake well before use. Only the product with uniform solution and an intact
container can be available.
4. Propo fol contains no antimicrobial preservatives. Strict aseptic techniques must
always be maintained during handling. Do not use if contamination is suspected.
5. Administer by intravenous injection only. Once propo fol has been opened, vial
contents should be drawn into sterile syringes; each syringe should be prepared for
single patient use only. Unused product should be discarded within 6 hours. Theemulsion should not be mixed with other therapeutic agents prior to administration.
6. Premedicants may increase the anesthesia or sedative effect of pr opofol and result
in more pronounced changes in systolic, diastolic and mean arterial blood pressures.
7. The use of propo fol in pregnant and breeding dogs has not been evaluated.
Pro pofol crosses the placenta and, as with other general anesthetic agents, the
administration of pro pofol may be associated with neonatal depression.
8. Pro pofol has not been evaluated in dogs less than 10 weeks of age.
9. Doses may need adjustment for geriatric or debilitated patients. The administration
of propo fol to patients with renal failure and/or hepatic failure has not been evaluated.
As with other anesthetic agents, caution should be exercised in dogs with cardiac,
respiratory, renal or hepatic impairment, or in hypovolemic or debilitated dogs.
10. Pro pofol induction and maintenance produced satisfactory anesthesia in
sighthounds, however, recoveries are delayed.
11. Propofo l increased myocardial sensitivity to the development of
epinephrine-induced ventricular arrhythmias in a manner similar to other anesthetics.
In the clinical study, transient ventricular arrhythmias associated with prop ofol were
observed in 2 of 145 animals induced and maintained on pr opofol.
12. Perivascular administration for dogs does not produce local tissue reaction.
13. Not for human use. Keep out of the reach of children.
14. Rare cases of self-administration have been reported, including fatalities.
Propo fol 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.
15. Exercise caution to avoid accidental self-injection. Overdose is likely to cause
cardiorespiratory depression. Remove the individual from the source of exposure and
seek medical attention. Respiratory depression should be treated by artificial
ventilation and oxygen.
16. Hypersensitivity reactions to prop ofol, including anaphylaxis, may occur in some
individuals who are also allergic to muscle relaxants. Use this drug with caution and
avoid the allergic reaction.
17. Avoid inhalation and direct contact of this product with skin, eyes, and clothes. In
case of contact, eyes and skin should be liberally flushed with water for 15 minutes.Consult a physician if irritation persists.
18. Do not freeze.
[Strength] 10ml:100mg
[Package] 5 ampoules/box
[Storage] Preserve in a closed container at 2~25ºC. Do not freeze.
[Shelf life ] 36 months
[Product License No.] Veterinary Drug No. 191377109
[Manufacturer]
Guangdong Jiabo Pharmaceutical Co., Ltd.
Manufacturing address: Bio-Pharmaceutical Park, High & New Technology Industries
Development Zone, Qingyuan City, Guangdong Province
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