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Logo HAES-steril 6%
HAES-steril 10%

STANDARD PRODUCT INFORMATION
This information is taken from the "Scientific Product Information" brochure which is based upon the documentation under which HAES-steril
®has been approved in the Federal Republic of Germany.

The information contained in the Standard Product Information may differ with regard to national approved indications, contra-indications, side effects, etc.

HAES-steril
® is not necessarily the registered trademark under which the HydroxyEthyl Starch formulation (HES) from FRESENIUS AG is marketed in your country.

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

HAES-steril 6%
HAES-steril 10%

6% hydroxyethyl starch (HES 200/0.5) in isotonic sodium chloride solution
10% hydroxyethyl starch (HES 200/0.5) in isotonic sodium chloride solution

COMPOSITION:
1 litre contains:
- Medicinal active ingredients:
Poly (0-2-hydroxyethyl) starch 60.00 g /100.00 g,
Degree of substitution 0.40-0.55,
Average moleculare weight Mw: 200.000,
- Active ingredients: Sodium chloride 9.00 g,
Na+: 154 mmol/L, Cl- : 154 mmol/L
- Other ingredients: Sodium hydroxide, Hydrochloric acid, water,
Titration acidity: < 1 mmol NaOH/L,
Theoretical osmolarity: 308 mosm/L,
pH value: 3.5-6.0

INDICATIONS:
Therapy and prophylaxis of volume deficiency (hypovolemia) and shock (volume replacement therapy) in connection with: (Surgery) (haemorrhagic shock), (Injuries) (traumatic shock), (Infections) (septic shock), (Burns) (burn shock). Saving of donor blood during surgery e.g. acute normovolaemic haemodilution = ANH. (HAES-steril 6%)
Therapeutic dilution of blood (Haemodilution)

CONTRA-INDICATION:
Severe congestive heart failure (cardiac insufficiency), Renal failure (serum creatinine > 2 mg/dL and > 177 µmol/L), Severe coagulation disturbances (except in life-threatening emergencies), Excess fluid overload (hyperhydration) and severe lack of fluid (dehydration). Bleeding of the brain (cerebral haemorrhage), Starch allergy.

There are no data available as yet with regard to use during pregnancy and breastfeeding, nor in children. To be administered only where indication is vital during early pregnancy. Serum creatinine levels should be monitored at the beginning of therapy. Daily monitoring of the fluid balance and renal retention values is essential with limit-value creatinine values (1.2-2.0 mg/dL and 106-177 µmol/L, compensatory renal insufficiency). Despite normal serum creatinine values, pathological urine findings can indicate existing compensatory renal damage. In such cases daily serum creatinine values should be monitored daily. Where serum cratinine values and urine test results are normal, monitoring of renal retention values 1-2 times daily is essential in a therapy of several days duration. Sufficient supply of fluid (2-3 liters of fluid per day) must be ensured. Particular care must be taken with pulmonary oedema or chronic liver diseases.

SIDE EFFECTS:
The product may lead to anaphylactoid reactions in isolated cases. In the event of intolerance reactions (see table) infusion is to be discontinued immediately and the standard emergency measures initiated:

Clinical symptoms and degree of severity Stop
of
Emergency measures
I. Skin reactions   Antihistamines
II. Tachycardia
Drop in blood pressure, Vertigo, Nausea, Vomiting
Infusion Positioning Antihistamines + corticosteroids e.g. 120 mg prednisolone i.v.
III. Shock
Bronchospasm

IV. Respiratory and cardiac arrest
Alarm Positioning Resuscitation
1. Adrenaline 0.05–0.1 mg i.v. +
2. Corticosteroids e.g. prednisolone 1.0–2.0 g i.v.
3. Infusion e.g. albumin 5%

Long-term, daily administration of HAES-steril
® 6% or HAES-steril® 10% in medium and high doses frequently causes an almost untreatable itching. This can still occur weeks after ending the therapy, persist over months and could be strained for the patient. Only in a rare number of cases were pains in the kidney area reported. In such cases, infusion is to be discontinued immediately, sufficient fluid supplied and the serum creatinine values monitored closely. In higher doses, a prolongation of bleeding time can occur due to the dilution effect but clinically-relevant haemorrhage is not triggered. The fall in haematocrit and the dilution of the plasma proteins should be monitored.
Notes: The concentration of serum amylase can rise under administration of hydroxyethyl starch (interference with the diagnosis pancreatitis). A regular control of serum ionogramm and fluid balance is necessary.

Interactions with other drugs: No intereactions with other drugs known to date.

Notes: Should mixing with other drugs be necessary, 100% hygienic injection, thorough mixing, and above all, compability must be ensured.

Dosage and route of application: For Intravenous Infusion. The initial 10-20 mL of HAES-steril
® 6% or HAES-steril® 10% are to be infused slowly, keeping the patient under close observation (due to possible anaphylactoid reactions).
The daily dose and rate of infusion are to be determined according to blood loss and hemoconcentration. The effect of dilution limits the therapeutic application.

The use of colloidal plasma expanders in patients without cardiovascular or pulmonary risks is limited by a hematocrit of 30%. Oberloading of the circulatory system from too rapid and too high dosage must be avoided.

Recommended dosage for the therapy and prophylaxis of volume deficiency (hypovolemia) and shock (volume replacement therapy)
Unless otherwise prescribed according to volume needs:

HAES-steril® 6% HAES-steril® 10%
Maximum daily dose: Maximum daily dose: 
33 mL/kg BW/day 20 mL/kg BW/day 
( ^ 2500 mL/75 kg BW/day) ( ^ 1500 mL/75 kg BW/day) 
( ^ 2.0 g HES/kg BW/day) ( ^ 2.0 g HES/kg BW/day) 
Maximum rates of infusion: Maximum rates of infusion: 
20 mL/kg BW/hour 20 mL/kg BW/hour 
( ^ 1500 mL/75 kg BW/hour) ( ^ 1500 mL/75 kg BW/hour) 
( ^ 1.2 g HES (kg BW/hour) ( ^ 2.0 g HES (kg BW/hour) 

Recommended dosage for reduction of donor blood during surgery (acute normovolaemic haemodilution = ANH) (HAES-steril
® 6%)
Unless otherwise prescribed, substitution of autologous blood immediately prior to surgery at target haematocrit values after ANH not below 30%. Substitution at a ratio of 1:1 (HAES-steril
® 6%/blood)

Daily dose: 2-3 x 500 mL (HAES-steril® 6%)
Blood-letting: 2-3 x 500 mL (autologous blood)
Infusion rates: 1000 mL/15-30 min.
Blood withdrawal rates 1000 mL/15-30 min.

Recommended dosage for haemodilution therapy:
Aim of the haemodilution therapy is the haematocrit decrease. Administration could be done isovolemic (with blood-letting) or hypervolemic (without blood-letting) with low (250 mL), medium (500 mL) or high dosage (2 x 500 mL)

daily dose: 250 mL/day (low)
  500 mL/day (medium)
  2 x 500 mL/day (high)
Infusion rates: 250 mL in 0.5-2 hours
  500 mL in 4-6 hours
  2 x 500 mL in 8-24 hours
Note: In the literature, a correlation between dose and frequency of itching in patients with otoneurological disorders, such as sudden deafness, tinnitus ("ringing in the ear"), or acoustic trauma, has been described. In such cases it is advisable to reduce the dose to a maximum of 500 mL/day (HAES-steril® 6%) or 250 mL/day (HAES-steril® 10%). This will reduce the risk of itching as a side-effect. It should also be ensured that the patient has an adequate fluid intake.

Duration of application: Therapy and prophylaxis of volume deficiency (hypovolaemia) and shock (volume replacement therapy). There is no pharmacological or clinical evidence to give cause for concern with regard to a repeated application of HAES-steril
® 6% or HAES-steril® 10%. The duration and extent of the treatment are to be determined according to the duration and extent of the hypovolemia. Reduction of donor blood during surgery (acute normovolaemic haemodilution = ANH). ANH is usually performed once prior to surgery if the expected blood loss makes the use of donor blood derivatives probable. Repeated use of HAES-steril® 6% is possible if the initial haematocrit is within the normal range.

Haemodilution therapy: The haemodilution therapy with HAES-steril
® 6% or HAES-steril® 10% is recommended for 10 days.

HAES-steril
® 6% must not be used after the expiry date!
Only use when the solution is clear and the container is undamaged!
Keep out of the reach of children!



Further Information:
Description of HAES-steril
®6% and HAES-steril®10%:
Hydroxyethyl starch (HES) is manufactured from amylopectin, and is characterized by molecular weight, degree of substitution and plattern of substitution. The average molecular weight Mw is approx. 200,000 dalton, and the degree of substitution is approx. 0.5 i.e. approx. 5 hydroxyethyl groups are present in 10 glucose units of the amylopectin skeleton, mainly in position C2. The C2/C2 ratio is 5:1. The main chains in HES (poly(0-2-hydroxyethyl) starch) are made up of alpha 1.4-linked glucose units and branched via alpha-1.6-bonds. On basis of its close structural relationship to glycogen a high somatic tolerance and only a low risk of anaphylactoid reactions may be anticipated for HAES-steril
® 6%. HAES-steril® 6% is characterized by the high stability of the solution, and does not flocculate in the event of temperature fluctuations.

Effects of HAES-steril
®6%: Following the infusion of HAES-steril® 6% (500 mL/15 min) in hypovolemic test subjects, there is an increase in plasma volume equivalent to approx. 100% of the volume infused over approx. 4-8 hours. Thus, HAES-steril® 6% brings about an improvement in the circulation and microcirculation over a period of at least 4-8 hours. HAES-steril® 6% is degraded continuously by serum amylase and eliminated predominantly via the kidneys approx. 47% appear in the urine within 24 h, and 10% can still be detected in the plasma.

Effects of HAES-steril
®10%: Following the infusion of HAES-steril® 10% (500 mL/15 min) in hypovolemic test subjects, there is an increase in plasma volume equivalent to approx. 145% of the volume infused over approx. 1 hour and approx. 100% over another 2 hours.
HAES-steril
® 10% brings about an improvement in the circulation and microcirculation over a period of at least 4-8 hours. HAES-steril® 10% is degraded continuously by serum amylase, and eliminated predominantly via the kidneys, approx. 54% appear in the urine within 24 h, and 10% can still be detected in the plasma.

PRESENTATION:
1 x 250 mL glass bottles
1 x 250 mL PE bags
1 x 500 mL glass bottles
1 x 500 mL PE bottles
1 x 500 mL PE bags
Hospital packs: 10 bottles or bags

Supplied by:
INTRAMED DIVISION OF PHARMACARE LTD.

PHARMACOLOGICAL CLASSIFICATION:
A 8.4

CONTENTS:
Each 100 mL contains 60 g or 100 g
Hydroxyethyl Starch 200/0,5 (respectively) in normal saline.

REGISTRATION NUMBERS:
HAES-steril
® 6% 27/8.4/0154
HAES-steril
® 10% 27/8.4/0154

PRESENTATION:
Available in 250 mL and 500 mL containers.

Further information or references available from:
Intramed (Division of Pharmacare Ltd),
Druggists Park, Woodlands Drive,
Woodmead,
Sandton.

Tel: (011) 239-3400
Fax: (011) 239-3472

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