Medicinal Products

ELOHES 6% Solution for infusion Carton 15 Pockets PVC 500 ml

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
Active ingredients: Hydroxyethyl starch
laboratory: Fresenius Kabi France

Injection solution for IV infusion
All forms

Indication

The indications of this hydroxyethyl starch solution are as follows:
- treatment of acute circulatory failure:
. during shock conditions: hypovolemic, haemorrhagic, toxi-infectious, traumatic,
. or during extensive burns;
- normovolemic hemodilution;
- Plasma exchanges, in association with albumin.

Dosage ELOHES 6% Solution for infusion Cardboard 15 Pockets PVC 500 ml

Dosage:
- The first day of treatment: the dose administered is strictly limited to 33 ml / kg / 24 hours (2 g / kg / day of hydroxyethyl starch), or 2500 ml for a patient of 75 kg.
- The 2nd and 3rd days of treatment: the dose administered should not exceed 20 ml / kg / 24 hours (1.2 g / kg / day of hydroxyethyl starch) or 1500 ml for a patient of 75 kg.
- The duration of treatment will be three days maximum.
The maximum cumulative dose administered will not exceed 80 ml / kg.
In the therapeutic indication : "Plasma exchanges in association with albumin", it is preferable to envisage only three exchanges at most in the same patient.
Mode of administration :
Strict intravenous route.
The dosage and the infusion rate should be appropriate to the clinical and cardiovascular status of the patient.
Blood pressure and possibly hemodynamic monitoring will be performed to avoid any risk of vascular overload.
The amount and rate of infusion depends on the intensity of the volume loss.

Against indications

CONTRAINDICATED:
This product should not be administered in the following situations:
- known hypersensitivity to hydroxyethyl starches;
- circulatory overload;
- chronic renal failure patients undergoing hemodialysis;
- constitutional or acquired haemostasis disorders, in particular, known or suspected haemophilia and von Willebrand disease;
- severe hepatic insufficiency;
- late pregnancy (at delivery): this product should not be used at the end of pregnancy. In particular, during delivery with analgesia or epidural anesthesia, do not use as a preventive measure (hypotension induced by anesthesia) because of a risk of death or severe neurological sequelae for the child. In fact, by analogy with accidents reported with other filling solutions, there is a risk of acute fetal distress in case of maternal anaphylactic or anaphylactoid reaction.
NOT RECOMMENDED :
Breast-feeding: In the absence of a specific study, it is not advisable to use this product during breastfeeding.

Elohes side effects

The following side effects have been observed:
- Anaphylactoid reactions : ranging from a simple erythema to the appearance of circulatory disorders, shock, bronchospasm and respiratory and / or cardiac arrest.
Rare cases of itching have been reported.
In case of intolerance reaction, the infusion will be stopped immediately and appropriate treatment will be given.
In case of shock, bronchospasm, the appropriate resuscitation procedures consist of the administration of adrenaline, corticosteroids.
In case of cardiac arrest, the appropriate resuscitation procedures are ventilation, cardiac massage, infusion of a 4% albumin solution.
- Disturbances of haemostasis : von Willebrand disease, resulting in prolongation of the TCA, bleeding time and a decrease in the levels of the VIIIc / vWF complex, were highlighted; especially in the case of treatment lasting longer than 24 hours and / or a cumulative dose greater than 80 ml / kg.
- Impairment of the general condition, hepatic dysfunction and / or the onset or aggravation of portal hypertension have been reported, particularly during prolonged use (see warnings and precautions for use ).
- A transient increase in amylase is usual.
It results from the formation of a complex between the product and the amylase whose elimination is delayed.

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