| Dossier: | Ctd |
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| GMP: | Chinese GMP |
| Transport Package: | Free |
| Specification: | 100mg/10ml |
| Trademark: | Sinolead |
| Origin: | China |
| Samples: |
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| Customization: |
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| Generic Name | Propofol Injection Emulsion 100mg/10ml |
| Strength | 100mg/10ml |
| Packing | 5amps/box |
| Origin | China |
This product is a white "oil in water" isotonic water-soluble emulsion for intravenous injection, containing 10mg propofol per mL, pre-filled in the syringe.
Diprivan is a short-acting intravenous anesthetic used to induce and maintain general anesthesia.
Diprivan may be used to enhance sedation in supervised adult patients undergoing mechanical ventilation.
Diprivan can also be used for awake sedation during surgery and diagnosis.
Usage and dosage:
A. Adults
Induction of general anesthesia
Diapril and propofol can induce anesthesia by slow intravenous infusion or drip. For patients who have and have not been dosed before surgery, it is recommended that diprivan be administered intravenously gradually (40mg every 10 seconds in a normal healthy adult) while the patient's response is observed until clinical signs indicate that anesthesia is working. Most adult patients younger than 55 years of age require about 1.5 to 2.5mg/kg of diprivan, and a smaller rate of administration (20 to 50mg /min) can reduce the total dose required. Beyond this age, demand generally decreases. In patients with ASA3 and 4, the rate of administration should be slower (about 20mg every 10 seconds).
Maintenance of general anesthesia
Diprivan, given by continuous infusion or repeated single injection, can maintain the depth required for anesthesia.
Continuous infusion
The rate of administration required varies significantly from patient to patient, and generally ranges from 4 to 12mg/kg per hour to maintain a satisfactory anesthetic effect.
Repeat with a single injection
If repeated single dose technique is used, doses of 25mg to 50mg can be given each time depending on clinical need.
Enhance sedation during monitoring
The use of the "Diprifusor" TCI system for diprivan infusion is not recommended for intensive care patients.
When used as a sedative in an intensive care patient undergoing artificial ventilation, continuous infusion of dipropofol is recommended. The infusion rate should be adjusted according to the depth of sedation required, and usually the infusion rate range of 0.3 to 4.0mg/kg per hour should be able to obtain satisfactory sedation.
Conscious sedation during surgery and diagnosis.
Diprivan infusion with the "Diprifusor" TCI system is not recommended for awake sedation.
Awake sedation during surgery and diagnosis should be individualized and administered progressively according to the patient's clinical response.
Most patients need 0.5 to 1mg/kg. About 1 to 5 minutes to initial anesthesia.
Sedation is maintained with diprivan to maintain the required level of sedation. Most patients need 1.5 to 4.5mg/kg per hour. In addition to the infusion, if the depth of sedation needs to be deepened, 10 to 20mg can be injected at one time. The rate and dose of administration should be reduced in patients with ASA3 and 4.
B. Elderly patients
Diprivan and propofol should be administered gradually to observe the patient's response, and the dose of Diprivan required for induction of anesthesia in patients older than 55 years and for use as awake sedation for surgery and diagnosis may be lower.
C. Children
The "Diprifusor" TCI system for diprivan infusion is not recommended for children.
Induction of general anesthesia
Diprivan is not recommended for children under 3 years of age.
When used for induction of anesthesia in children, diprivan is recommended to be administered slowly until clinical signs indicate that anesthesia is effective, and the dose should be adjusted according to age and/or body weight. In most patients over 8 years of age, induction of anesthesia requires about 2.5mg/kg of diprivan. Below this age, the amount of medication required may be larger. Lower doses are recommended for children with ASA3 and 4.
Maintenance of general anesthesia
Diprivan is not recommended for children under 3 years of age.
Diprivan, given by infusion or repeated single injection, is able to maintain the depth required for anesthesia. The rate of administration required varies significantly from patient to patient, and usually a rate of 9 to 15mg/kg per hour is sufficient to achieve a satisfactory anesthetic effect.
Enhance sedation during monitoring
Diprivan is not recommended as a pediatric sedative because its safety and effectiveness have not been proven.
Serious adverse reactions (including death) have been reported for unregistered indications, but a direct correlation with diprivan has not been established. These reports usually occur in children with respiratory tract infections, and doses are given in excess of the recommended dose for adults.
Conscious sedation during surgery and diagnosis.
It is not recommended for sedation in children, as safety and efficacy are not known.
Matters needing attention:
Diprivan should be administered by a trained anesthesiologist or intensive care unit physician. The respiratory tract should be kept open during the medication, and artificial ventilation, oxygen supply and other resuscitation equipment should be available. Diapril and propofol should not be administered by a surgeon or diagnostic surgeon.
When diprivan is used for awake sedation during surgery and diagnosis, watch closely for early signs of hypotension, airway obstruction, and oxygen scarcity.
After general anesthesia, the patient must be fully recovered before discharge. It is rare for diprivan to be administered with a period of postoperative unconsciousness, sometimes accompanied by an increase in muscle tone. This is sometimes preceded by a period of recovery and sometimes not. Although patients can wake up on their own, unconscious patients still need to be cared for.
Diprivan should be used with the same caution as other intravenous anesthetics in patients with heart, respiratory, kidney, or liver damage or in patients with reduced or weakened circulation.
Diprivan lacks the activity to disarm the vagus nerve and has been linked to reports of bradycardia (occasionally heavier) and cardiac arrest. Intravenous anticholinergics should be considered before induction of anesthesia or during anesthesia maintenance, especially if vagal tension appears to predominate or when diapril is used in combination with other drugs that may cause bradycardia.
When diprivan is used on epileptic patients, there may be a risk of convulsions.
Caution should be exercised with diprivan in patients with lipid metabolism disorders and in other situations where caution must be exercised with fat milk.
In patients considered to be at particular risk of fat overload, it is recommended to monitor blood lipid levels when administering dipropofol. If monitoring indicates that fat is being improperly removed from the body, the dose of diprivan should be adjusted accordingly. If the patient is receiving an intravenous fat milk at the same time, the dosage should be reduced to take into account the amount of fat given in the diprivan formulation, i.e., 1.0 ml of Diprivan contains about 0.1 g of fat.
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