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REGIOCIT SOLUTION FOR HAEMOFILTRATION

Product Information

Registration Status: Active

SIN15513P

REGIOCIT SOLUTION FOR HAEMOFILTRATION is approved to be sold in Singapore with effective from 2018-07-19. It is marketed by BAXTER HEALTHCARE (ASIA) PTE LTD, with the registration number of SIN15513P.

This product contains Sodium Chloride 5.03 g/l, and Sodium Citrate 5.29g/l in the form of SOLUTION, STERILE. It is approved for INTRAVENOUS use.

This product is manufactured by Bieffe Medital S.p.A in ITALY.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

Sodium chloride, also known as salt, common salt, table salt or halite, is an ionic compound with the chemical formula NaCl, representing a 1:1 ratio of sodium and chloride ions. Sodium chloride is the salt most responsible for the salinity of seawater and of the extracellular fluid of many multicellular organisms. It is listed on the World Health Organization Model List of Essential Medicines.

Indication

This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. Also, designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives.

Mechanism of Action

Sodium and chloride — major electrolytes of the fluid compartment outside of cells (i.e., extracellular) — work together to control extracellular volume and blood pressure. Disturbances in sodium concentrations in the extracellular fluid are associated with disorders of water balance.

Pharmacokinetics

Absorption
Absorption of sodium in the small intestine plays an important role in the absorption of chloride, amino acids, glucose, and water. Chloride, in the form of hydrochloric acid (HCl), is also an important component of gastric juice, which aids the digestion and absorption of many nutrients.
Distribution
The volume of distribution is 0.64 L/kg.
Metabolism
The salt that is taken in to gastro intestinal tract remains for the most part unabsorbed as the liquid contents pass through the stomach and small bowel. On reaching the colon this salt, together with the water is taken in to the blood. As excesses are absorbed the kidney is constantly excreting sodium chloride, so that the chloride level in the blood and tissues remains fairly constant.Further more, if the chloride intake ceases, the kidney ceases to excrete chlorides. Body maintains an equilibrium retaining the 300gm of salt dissolved in the blood and fluid elements of the tissue dissociated into sodium ions and chloride ions.
Elimination

Toxicity

The rare inadvertent intravascular administration or rapid intravascular absorption of hypertonic sodium chloride can cause a shift of tissue fluids into the vascular bed, resulting in hypervolemia, electrolyte disturbances, circulatory failure, pulmonary embolism, or augmented hypertension. ( toxnet)

Active Ingredient/Synonyms

Sodium Chloride | Sodium Chloride |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.


Description

Sodium citrate is the sodium salt of citric acid. It is white, crystalline powder or white, granular crystals, slightly deliquescent in moist air, freely soluble in water, practically insoluble in alcohol. Like citric acid, it has a sour taste. From the medical point of view, it is used as alkalinizing agent. It works by neutralizing excess acid in the blood and urine. It has been indicated for the treatment of metabolic acidosis.

Indication

Used as an anticoagulant during plasmophoresis as well as a neutralizing agent in the treatment of upset stomach and acidic urine [FDA Label] [L788] [L789].

Mechanism of Action

Citrate chelates free calcium ions preventing them from forming a complex with tissue factor and coagulation factor VIIa to promote the activation of coagulation factor X [A19410] [A19411]. This inhibits the extrinsic initiation of the coagulation cascade. Citrate may also exert an anticoagulant effect via a so far unknown mechanism as restoration of calcium concentration does not fully reverse the effect of citrate [A19410]. Citrate is a weak base and so reacts with hydrochloric acid in the stomach to raise the pH. It it further metabolized to bicarbonate which then acts as a systemic alkalizing agent, raising the pH of the blood and urine [L790]. It also acts as a diuretic and increases the urinary excretion of calcium.

Pharmacokinetics

Absorption
Tmax of 98-130min [A19414].
Distribution
19-39L [A19414].
Metabolism
Citrate is metabolized to bicarbonate in the liver and plays a role as an intermediate in the citric acid cycle [A19419] [L795].
Elimination

Clearance

Total clearance of 313-1107mL/min [A19414].

Toxicity

Overdose toxicity is mainly due to alkalosis as well as tetany or depressed heart function due to lack of free calcium [L790].

Active Ingredient/Synonyms

Sodium citrate anhydrous | Sodium citrate, anhydrous | trisodium citrate anhydrous | Trisodium citrate, anhydrous | Sodium Citrate |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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