Haemodez-N (Solution) Instructions for Use
ATC Code
B05AA (Blood substitutes and plasma preparations)
Clinical-Pharmacological Group
Drug with detoxifying action for parenteral use
Pharmacotherapeutic Group
Electrolytes in combination with other drugs
Pharmacological Action
The action of the combination is due to the ability of low molecular weight polyvinylpyrrolidone to bind toxins circulating in the blood and rapidly remove them from the body. It most fully binds toxins circulating in the blood of patients with dysentery, salmonellosis, and food intoxications.
In burn disease, toxins formed during the first 4-5 days of the disease are almost completely inactivated; toxins formed at later stages are neutralized significantly weaker.
Toxins formed in the body of patients with acute radiation sickness are not bound, although their elimination from the body may be accelerated.
It helps to eliminate erythrocyte stasis in the capillaries, which develops during intoxication of any origin, leading to improved microcirculation. It enhances renal blood flow, increases glomerular filtration, and increases diuresis.
Pharmacokinetics
It is not metabolized in the body. It is rapidly excreted by the kidneys, 80% within 4 hours, and completely within 12-24 hours.
Indications
Shock (post-traumatic, postoperative, burn, hemorrhagic); intoxication (toxic diseases of the gastrointestinal tract, including dysentery, dyspepsia, salmonellosis; burn disease, radiation sickness and hemolytic disease, peritonitis, intestinal obstruction, thyrotoxicosis, liver diseases, sepsis, pneumonia; acute phase of myocardial infarction); toxemia of newborns; preeclampsia.
ICD codes
| ICD-10 code | Indication |
| A02 | Other salmonella infections |
| A03 | Shigellosis |
| A05 | Other bacterial food poisonings, not elsewhere classified |
| A09 | Other and unspecified gastroenteritis and colitis of infectious origin |
| A40 | Streptococcal sepsis |
| A41 | Other sepsis |
| B15 | Acute hepatitis A |
| B16 | Acute hepatitis B |
| B17 | Other acute viral hepatitis |
| B18 | Chronic viral hepatitis |
| E05 | Thyrotoxicosis [hyperthyroidism] |
| I21 | Acute myocardial infarction |
| J15 | Bacterial pneumonia, not elsewhere classified |
| K56.6 | Other and unspecified intestinal obstruction |
| K65.0 | Acute peritonitis (including abscess) |
| K70 | Alcoholic liver disease |
| K71 | Toxic liver disease |
| K73 | Chronic hepatitis, not elsewhere classified |
| K75 | Other inflammatory liver diseases |
| O10-O16 | Edema, proteinuria and hypertensive disorders during pregnancy, childbirth and the puerperium |
| P36 | Bacterial sepsis of newborn |
| P55 | Hemolytic disease of fetus and newborn |
| R54 | Acute intoxication |
| R57.0 | Cardiogenic shock |
| R57.1 | Hypovolemic shock |
| R57.2 | Septic shock |
| R57.8 | Other types of shock |
| T30 | Burns and corrosions of unspecified body region |
| T66 | Unspecified effects of radiation (radiation sickness) |
| T79.4 | Traumatic shock |
| ICD-11 code | Indication |
| 1A02 | Intestinal infections due to Shigella |
| 1A09.Z | Salmonella infection, unspecified |
| 1A1Z | Bacterial foodborne intoxications, unspecified |
| 1A40.Z | Infectious gastroenteritis or colitis, unspecified |
| 1E50.0 | Acute hepatitis A |
| 1E50.1 | Acute hepatitis B |
| 1E50.Z | Acute viral hepatitis, unspecified |
| 1E51.Z | Chronic viral hepatitis, unspecified |
| 1G40 | Sepsis without septic shock |
| 1G41 | Sepsis with septic shock |
| 4A85.00 | Drug hypersensitivity-induced liver disease |
| 5A02.Z | Thyrotoxicosis, unspecified |
| 8E61.0 | Radiation-induced brain injury |
| 8E61.1 | Radiation-induced spinal cord injury |
| BA41.Z | Acute myocardial infarction, unspecified |
| CA40.0Z | Bacterial pneumonia, unspecified |
| DA91.Z | Unspecified obstruction of small intestine |
| DB30.Z | Unspecified obstruction of large intestine |
| DB94.Z | Alcoholic liver disease, unspecified |
| DB95.Z | Drug-induced or toxic liver disease, unspecified |
| DB97.2 | Chronic hepatitis, not elsewhere classified |
| DB97.Z | Inflammatory liver diseases, unspecified |
| DC50.0 | Primary peritonitis |
| DC50.2 | Peritoneal abscess |
| DC50.Z | Peritonitis, unspecified |
| DE2Z | Diseases of the digestive system, unspecified |
| JA2Z | Edema, proteinuria, or hypertensive disorders in pregnancy, childbirth or the puerperium, unspecified |
| KA60 | Fetal or neonatal sepsis |
| KA84.Z | Hemolytic disease of fetus or newborn, unspecified |
| MG2A | Frailty syndrome |
| MG40.0 | Cardiogenic shock |
| MG40.1 | Hypovolemic shock |
| MG40.Z | Shock, unspecified |
| NE11 | Burn of unspecified body region |
| NF00 | Exposure to radiation, not elsewhere classified |
| NF0A.4 | Traumatic shock, not elsewhere classified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Solution
The solution should be warmed to body temperature before administration.
The drug is administered intravenously by drip at a rate of 40-80 drops/min. The single dose depends on the patient’s age and the severity of intoxication. The initial dose for children is 2.5 ml/kg of body weight.
The maximum single dose depending on the patient’s age is presented in the table.
| Patient Age | Maximum Single Dose |
| Up to 1 year | 50 ml |
| 2-5 years | 70 ml |
| 6-9 years | 100 ml |
| 10-15 years | 200 ml |
| Adults | 400 ml |
The drug is administered 1-2 times/day depending on the severity of intoxication.
Adverse Reactions
Possible decrease in blood pressure, tachycardia, difficulty breathing (with rapid administration), allergic reactions of varying severity (up to the development of anaphylactic shock); infection at the injection site, thrombosis or phlebitis spreading from the infusion site.
Contraindications
Intracranial hypertension; hemorrhagic stroke; condition after traumatic brain injury; chronic heart failure stage IIb-III; respiratory failure; severe allergic reactions; thromboembolism; oliguria, anuria, acute nephritis; bronchial asthma; phlebothrombosis; hypersensitivity to the components of the combination.
Use in Pregnancy and Lactation
The possibility of use depends on the dosage form used.
Use in Renal Impairment
Contraindicated in acute nephritis.
Pediatric Use
Use is possible according to the dosage regimen.
Special Precautions
During treatment, monitoring of blood pressure and the patient’s condition is necessary.
Drug Interactions
For extensive burns, it is combined with the administration of plasma, albumin, gamma globulin.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for infusion: containers 200 ml, 250 ml, 400 ml or 500 ml
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
 |
Haemodez-N | Solution for infusion: containers 200 ml, 250 ml, 400 ml or 500 ml |
Dosage Form, Packaging, and Composition
Solution for infusion light yellow or yellow, transparent.
| 1 L | |
| Povidone (low molecular weight polyvinylpyrrolidone) medical low molecular weight with molecular weight 8000±2000 | 60 g |
| Sodium chloride | 5.5 g |
| Potassium chloride | 0.42 g |
| Calcium chloride hexahydrate | 0.5 g |
| Sodium bicarbonate | 0.23 g |
| Magnesium chloride hexahydrate | 0.005 g |
Excipients : water for injections – up to 1 L.
Ionic composition per 1 L:
Sodium ion – 96.85 mmol/L
Potassium ion – 5.63 mmol/L
Calcium ion – 2.28 mmol/L
Magnesium ion – 0.025 mmol/L
Chloride ion – 104.35 mmol/L
Bicarbonate ion – 2.74 mmol/L
Theoretical osmolarity – 219.37 mOsm/L
200 ml – single-dose polyethylene containers (1) – cardboard packs.
250 ml – single-dose polyethylene containers (1) – cardboard packs.
400 ml – single-dose polyethylene containers (1) – cardboard packs.
500 ml – single-dose polyethylene containers (1) – cardboard packs.
200 ml – single-dose polyethylene containers (12) – cardboard boxes (for hospitals).
200 ml – single-dose polyethylene containers (15) – cardboard boxes (for hospitals).
200 ml – single-dose polyethylene containers (24) – cardboard boxes (for hospitals).
200 ml – single-dose polyethylene containers (30) – cardboard boxes (for hospitals).
250 ml – single-dose polyethylene containers (12) – cardboard boxes (for hospitals).
250 ml – single-dose polyethylene containers (15) – cardboard boxes (for hospitals).
250 ml – single-dose polyethylene containers (24) – cardboard boxes (for hospitals).
250 ml – single-dose polyethylene containers (30) – cardboard boxes (for hospitals).
400 ml – single-dose polyethylene containers (12) – cardboard boxes (for hospitals).
400 ml – single-dose polyethylene containers (15) – cardboard boxes (for hospitals).
400 ml – single-dose polyethylene containers (24) – cardboard boxes (for hospitals).
400 ml – single-dose polyethylene containers (30) – cardboard boxes (for hospitals).
500 ml – single-dose polyethylene containers (12) – cardboard boxes (for hospitals).
500 ml – single-dose polyethylene containers (15) – cardboard boxes (for hospitals).
500 ml – single-dose polyethylene containers (24) – cardboard boxes (for hospitals).
500 ml – single-dose polyethylene containers (30) – cardboard boxes (for hospitals).
Solution for infusion: 200 ml bottles 1 or 28 pcs., 400 ml bottles 1 or 15 pcs.
Marketing Authorization Holder
Dalkhimpharm, JSC (Russia)
Dosage Form
|
Haemodez-N | Solution for infusion: 200 ml bottles 1 or 28 pcs., 400 ml bottles 1 or 15 pcs. |
Dosage Form, Packaging, and Composition
Solution for infusion transparent, light yellow or yellow.
| 100 ml | |
| Povidone (low molecular weight polyvinylpyrrolidone) medical low molecular weight with molecular weight 8000±2000 | 6 g |
| Sodium chloride | 550 mg |
| Potassium chloride | 42 mg |
| Calcium chloride | 50 mg |
| Sodium bicarbonate | 23 mg |
| Magnesium chloride anhydrous | 500 mcg |
Excipients : water for injections.
200 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard packs.
200 ml – bottles (28) – cardboard boxes.
400 ml – bottles (15) – cardboard boxes.
Solution for infusion: bottle 200 ml or 400 ml
Marketing Authorization Holder
Kursk Biofactory – Firm "BIOK", FSUE (Russia)
Dosage Form
|
Haemodez-N | Solution for infusion: bottle 200 ml or 400 ml |
Dosage Form, Packaging, and Composition
Solution for infusion transparent, light yellow or yellow.
| 100 ml | |
| Povidone (low molecular weight polyvinylpyrrolidone) medical low molecular weight with molecular weight 8000±2000 | 6 g |
| Sodium chloride | 550 mg |
| Potassium chloride | 42 mg |
| Calcium chloride | 50 mg |
| Sodium bicarbonate | 23 mg |
| Magnesium chloride anhydrous | 500 mcg |
Excipients : water for injections.
200 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard packs.
Solution for infusion: bottle 100 ml, 200 ml or 400 ml
Marketing Authorization Holder
Maxpharm, JSC (Russia)
Dosage Form
|
Haemodez-N | Solution for infusion: bottle 100 ml, 200 ml or 400 ml |
Dosage Form, Packaging, and Composition
Solution for infusion transparent, light yellow or yellow.
| 100 ml | |
| Povidone (low molecular weight polyvinylpyrrolidone) medical low molecular weight with molecular weight 8000±2000 | 6 g |
| Sodium chloride | 550 mg |
| Potassium chloride | 42 mg |
| Calcium chloride | 50 mg |
| Sodium bicarbonate | 23 mg |
| Magnesium chloride anhydrous | 500 mcg |
Excipients : water for injections.
100 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard packs.
Solution for infusion: bottle 200 ml or 400 ml
Marketing Authorization Holder
Mosfarm LLC (Russia)
Dosage Form
|
Haemodez-N | Solution for infusion: bottle 200 ml or 400 ml |
Dosage Form, Packaging, and Composition
Solution for infusion transparent, light yellow or yellow.
| 100 ml | |
| Povidone (low molecular weight polyvinylpyrrolidone) medical low molecular weight with molecular weight 8000±2000 | 6 g |
| Sodium chloride | 550 mg |
| Potassium chloride | 42 mg |
| Calcium chloride | 50 mg |
| Sodium bicarbonate | 23 mg |
| Magnesium chloride anhydrous | 500 mcg |
Excipients : water for injections.
200 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard packs.
Solution for infusion: bottle 250 ml 1 or 28 pcs., bottle 400 ml 1 or 15 pcs.
Marketing Authorization Holder
N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)
Dosage Form
|
Haemodez-N | Solution for infusion: bottle 250 ml 1 or 28 pcs., bottle 400 ml 1 or 15 pcs. |
Dosage Form, Packaging, and Composition
| Solution for infusion | 100 ml |
| Povidone (low molecular weight polyvinylpyrrolidone) medical low molecular weight with molecular weight 8000 | 6 g |
| Sodium chloride | 550 mg |
| Potassium chloride | 42 mg |
| Calcium chloride hexahydrate | 50 mg |
| Magnesium chloride hexahydrate | 500 mcg |
| Sodium bicarbonate | 23 mg |
250 ml – polyethylene bottles (1) – polyethylene bags.
Solution for infusion: bottle 200 ml 1 or 28 pcs., bottle 400 ml 1 or 15 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Contact Information
BIOKHIMIK JSC (Russia)
Dosage Form
|
Haemodez-N | Solution for infusion: bottle 200 ml 1 or 28 pcs., bottle 400 ml 1 or 15 pcs. |
Dosage Form, Packaging, and Composition
Solution for infusion transparent, light yellow or yellow in color.
| 100 ml | |
| Povidone (polyvinylpyrrolidone) low molecular weight medical with molecular weight 8000±2000 | 6 g |
| Sodium chloride | 550 mg |
| Potassium chloride | 42 mg |
| Calcium chloride | 50 mg |
| Magnesium chloride anhydrous | 500 mcg |
| Sodium bicarbonate | 23 mg |
| Osmolarity | 214 mosm |
Excipients : water for injections.
200 ml – bottles for blood substitutes (1) – cardboard packs.
200 ml – bottles for blood substitutes (28) – cardboard boxes.
400 ml – bottles for blood substitutes (1) – cardboard packs.
400 ml – bottles for blood substitutes (15) – cardboard boxes.
Solution for infusion: bottle 100 ml, 200 ml, 250 ml, 400 ml or 500 ml 1 pc.
Marketing Authorization Holder
Mir Chemical and Pharmaceutical Concern, LLC (Russia)
Manufactured By
NPC Eskom, PJSC (Russia)
Dosage Form
|
Haemodez-N | Solution for infusion: bottle 100 ml, 200 ml, 250 ml, 400 ml or 500 ml 1 pc. |
Dosage Form, Packaging, and Composition
Solution for infusion transparent, light yellow or yellow in color.
| 100 ml | |
| Povidone (polyvinylpyrrolidone) low molecular weight medical with molecular weight 8000±2000 | 6 g |
| Sodium chloride | 550 mg |
| Potassium chloride | 42 mg |
| Calcium chloride | 50 mg |
| Sodium bicarbonate | 23 mg |
| Magnesium chloride anhydrous | 500 mcg |
Excipients : water for injections.
100 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.
250 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard packs.
500 ml – bottles (1) – cardboard packs.
100 ml – bottles (28) – cardboard packs.
200 ml – bottles (28) – cardboard packs.
400 ml – bottles (15) – cardboard packs.
![Haemodez-N [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Haemodez-N [Solution] 2")