Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
Active ingredients: Poly (0-2-hydroxyethyl) starch, Sodium chloride
Injection solution for IV infusion
This medicine is a recommended volume replacement:
- for the treatment of mild to moderate hypovolemia during shock, haemorrhagic, toxi-infectious, traumatic or burns,
- for normovolemic hemodilution.
This solution should not be used as a substitute for blood or plasma.
Dosage PENTASTARCH 6% 6% / 0.9% Solution for infusion 500 ml bag
PENTASTARCH 6% solution for infusion should be administered intravenously strict.
The therapeutic limits are fixed by the dilution effect. Take into account that the intravascular volume effect is greater than the infused dose.
Close monitoring of the infusion rate and amount will prevent circulatory overload.
The first 10 to 20 milliliters of solution should be infused slowly, carefully monitoring the patient to detect the onset of an anaphylactic reaction as soon as possible.
The daily dose and infusion rate should be adjusted according to the patient's circulatory failure status, age, body weight and hemodynamic status.
In adults, the dosage generally administered is between 500 ml and 1000 ml.
The usual dosage usually does not exceed 1500 ml / day or 20 ml per kg of body weight per day for a 70 kg patient. However, added to other colloid substances, the maximum dose will depend on the volume of circulating blood and hematocrit.
In patients without cardiovascular or pulmonary risk, the solution should only be used when the hematocrit is greater than 30%.
- Maximum daily dosage:
The maximum daily dosage is 33 ml / kg body weight / day or 2500 ml / 75 kg / day. In case of treatment over several days, the maximum daily dosage should be reduced to take into account the effects of dilution and hemostasis.
- Maximum infusion rate:
Do not exceed the maximum infusion rate of 20 ml / kg / h, ie 1500 ml of this solution for a 75 kg subject.
- Duration of administration:
Administration over several days is only indicated in exceptional cases. Note that the risk of adverse reactions increases with the total dose. If this infusion solution is used repeatedly, the coagulation parameters should be carefully monitored.
- Recommendations for the treatment of hypovolemia and shock:
Unless otherwise specified, the usual daily volume should be less than 33 ml / kg of body weight per day or 2500 ml / 75 kg / day. The maximum infusion rate should be less than 20 ml / kg / h or 1500 ml / 75 kg / h. Administration over several days is only indicated in exceptional situations.
- Recommendations for normovolemic hemodilution:
Unless otherwise specified, it is recommended, prior to the surgical procedure, to withdraw blood from the donor and simultaneously substitute it with a 6% Pentastarch infusion at a ratio of 1/1. The hematocrit should not be less than 30% after administration. Repeated use is possible if the initial hematocrit is within the normal range and is not less than 30% after treatment.
In general, 2 to 3 x 500 ml of blood are replaced with 2 to 3 x 500 ml of solution at a 1000 ml infusion rate for 15-30 minutes.
- Use in children:
The safety and efficacy of PENTASTARCH 6% Infusion Solution in children have not been established.
- In the elderly subject:
No specific modification of the dosage is necessary. Instructions for use and handling and for proper use are given in the Instructions for Use, Handling and Disposal section.
Administration of PENTASTARCH 6% solution for infusion is contraindicated in the following cases:
- known hypersensitivity to hydroxyethyl starches;
- severe congestive heart failure or cardiac decompensation, pulmonary edema, state of hyperhydration or circulatory overload;
- severe bleeding disorders (with the exception of life-threatening emergencies);
- patients with chronic renal failure with oliguria or anuria during hemodialysis;
- intracranial hemorrhage;
- Hereditary or acquired hemostasis disorders, in particular hemophilia and Willebrand disease known or suspected;
- late pregnancy (work): There is no data available on the use of PENTASTARCH 6% solution for infusion in pregnant women. No animal reproduction studies have been conducted with this solution, however animal studies with analogous hydroxyethyl starches have shown signs of vaginal bleeding and adverse effects on the embryo after repeated use. . In addition, the risk of anaphylactic reaction resulting in fetal brain damage is increased. PENTASTARCH 6% solution for infusion should not be administered to pregnant women or during labor during epidural anesthesia because of the risk of death or serious neurological sequelae in the child.
NOT RECOMMENDED :
Breast-feeding: Breast-feeding should be discontinued because it is not known whether PENTASTARCH 6% hydroxyethyl starch solution for infusion is excreted in breast milk.
Side effects Pentastarch 6%
PENTASTARCH 6% solution for infusion forms a macromolecular complex with the amylase (by which it is degraded) and produces an increase in serum amylase level up to three days post-infusion. This can alter the results of the blood count and therefore, in particular, hinder the diagnosis of pancreatitis. This hyperamylasemia has no pathological consequence.
The following side effects have been reported:
- anaphylactoid reactions, ranging from simple erythema to the development of circulatory disorders, shock, bronchospasm, respiratory and / or cardiac arrest. Rare cases of itching have been reported. If an intolerance reaction occurs, stop the infusion immediately and give appropriate treatment.
- Respiratory reactions, including pulmonary edema of non-cardiac origin, bronchospasm and respiratory arrest. They are usually mild but can be serious and life threatening. Close monitoring of the patient is necessary and resuscitation measures should be immediately available.
- Haemostasis disorders characteristic of von Willebrand disease, with increased BPT and bleeding time, and decreased levels of VIIIc / vWF complex observed with other hydroxyethyl starches of the same weight especially when the 6% hydroxyethyl starch infusion solution is administered at a high dosage over several consecutive days.
- Cardiovascular reactions such as: bradycardia, tachycardia, pulmonary edema and rarely hypotension with consequent cardiac arrest have also been reported. They are usually mild but can be serious and life threatening. Close monitoring of the patient is necessary and resuscitation measures should be immediately available.
- Impaired hepatic function (initially in the form of poor general health) and / or onset or worsening of portal hypertension have been reported during prolonged and repeated use with hydroxyethyl starches of the same molecular weight but having a higher degree of substitution.
- Various reactions . Other reactions such as chills, paresthesia, headache, lipothymia, vomiting, erythema, hypertrophy of the submaxillary and parotid glands, muscle pain and peripheral edema of the lower limbs have been reported. Skin reactions with persistent and reversible itching (pruritus) have been reported. These reactions are easily controlled by discontinuing treatment and, if necessary, administering an antihistamine.