WHAT EXCIPIENTS ARE INCLUDED IN INFUKOL^® 6% SOLUTION FOR INFUSION?

Water for injections

WHAT IS INFUKOLL^® 6% SOLUTION FOR INFUSION INDICATED FOR?

Treatment and prevention of hypovolaemia and shock.

Normovolaemic haemodilution.

WHAT IS THE RECOMMENDED DOSAGE FOR INFUKOLL^® 6% SOLUTION FOR INFUSION?

HES must be administered intravenously.
Total dosage, duration and rate of infusion will depend upon the amount of blood lost and/or the haemodynamic status and general clinical condition of the patient. Dosage will need to be adjusted as necessary by monitoring the usual circulatory parameters e.g. blood pressure.

The risk of circulatory overload by too rapid rate of infusion or inappropriately large doses must be borne in mind.

Due to the risk for occurrence of an anaphylactic reaction, the first 10 ml - 20 ml of Infukoll^® 6 % should be infused slowly and under careful observation of the patient.

Maximum infusion rate:
The maximum rate of infusion should be adjusted to the clinical situation.

Patients with acute haemorrhagic shock: Up to 20 ml/kg bodyweight/hour (equivalent to 0.33 ml/kg BW/min).

In life-threatening situations: 500 ml as a rapid infusion (under pressure). The rates of infusion selected for perioperative indications and for burns and septic shock patients will usually be lower.

Maximum daily dosage:
A maximum daily dosage of 2 g/kg bodyweight/day of hydroxyethyl starch (HES) should not be exceeded. This corresponds to 33 ml/kg bodyweight/day of the 6 % solution (approximately 2,500 ml/day in a person of 75 kg).

Experience of treatment of more than 1-2 days is limited. In cases of longer treatment the daily doses have generally been lower. An increasing risk of undesirable effects with high cumulative doses (see section 4.8) should be considered.

Children:
There are no data concerning usage of Infukoll^® 6 % in children.

Administration to children should only be managed after careful benefit/risk assessment.

Further information:
Patients with primarily interstitial fluid losses must firstly be treated with crystalloids. After infusion of HES controls of serum electrolytes and fluid balance are required. Electrolytes must be administered as required. In all patients adequate fluid supply is essential. Renal function must be monitored during treatment (control of serum creatinine).

Because of the possibility of allergic (anaphylactic/anaphylactoid) reactions, appropriate monitoring of patients is necessary.(See section 4.4 of the SPC)

WHAT ARE THE CONTRA-INDICATIONS FOR THE USE OF INFUKOLL^® 6% SOLUTION
FOR INFUSION?

• Known hypersensitivity to hydroxyethyl starch
• Hypervolaemia
• Hyper-hydration (e.g. water intoxication)
• Hyperchloraemia (or hypernatriaemia)
• Congestive cardiac failure
• Pulmonary oedema
• Renal failure, with oliguria and anuria
• Cerebral haemorrhage
• Severe blood coagulation disorders
• Severe hepatic impairment

HOW DOES INFUKOLL^® 6% SOLUTION FOR INFUSION WORK?

The main risk of an acute overdose would be volume overload. In this case infusion must be stopped immediately and if necessary diuretics should be administered.

Hydroxyethyl starch is a mixture of several different substances with different degree of substitution and molecular weight. The elimination depends on molecular weight and degree of substitution. Molecules smaller than the renal threshold (60 000 Da – 70 000 Da) are eliminated via glomerular filtration. Larger molecules are degraded by a-amylase and are thereafter eliminated renally. The rate of degradation decreases with increased degree of substitution. The initial half-life in serum is approximately 6 hours. Approximately 50 % of a given dose is excreted into urine within 24 hours.

IS INFUKOLL^® 6% SOLUTION FOR INFUSION SUITABLE FOR USE IN WOMEN WHO ARE PREGNANT OR ARE BREASTFEEDING?

For Infukoll^® 6 % no clinical data on exposed pregnancies are available. No reproductive toxicological studies in animals with Infukoll^® 6 %  have been performed, but studies with similar hydroxyethyl starch products have caused vaginal bleeding and embryolethality during repeated treatment of test animals. Harmful embryo effects may occur with HES associated anaphylactic reactions in the pregnant mother. Infukoll^® 6 %  should only be used during pregnancy when the potential effects outweigh the potential risks to the embryo.

There is as yet no experience with usage of this product in nursing mothers

WHAT ACTION SHOULD BE TAKEN FOLLOWING AN OVERDOSE OF INFUKOLL^® 6% SOLUTION FOR INFUSION?

The main risk of an acute overdose would be volume overload. In this case infusion must be stopped immediately and if necessary diuretics should be administered.