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HAEMODIALYSIS CONCENTRATE NKFS-03 (ACID) FOR BICARBONATE DIALYSIS

Product Information

Registration Status: Active

SIN11033P

HAEMODIALYSIS CONCENTRATE NKFS-03 (ACID) FOR BICARBONATE DIALYSIS is approved to be sold in Singapore with effective from 1999-07-19. It is marketed by B. BRAUN SINGAPORE PTE LTD, with the registration number of SIN11033P.

This product contains Acetic Acid 8.46g/l,Calcium Chloride 7.77g/l,Glucose 77.50g/l,Magnesium Chloride Hexahydrate 3.58g/l,Potassium Chloride 5.25g/l, and Sodium Chloride 216.19g/l in the form of SOLUTION. It is approved for HEMODIALYSIS use.

This product is manufactured by B BRAUN MEDICAL INDUSTRIES SDN BHD in MALAYSIA.

It is an Over-the-counter Medicine that can be freely obtained from any retailer

Product Reference
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Description

A benzothiazepine derivative with vasodilating action due to its antagonism of the actions of the calcium ion in membrane functions. It is also teratogenic.

Indication

For the treatment of Hypertension

Mechanism of Action

Possibly by deforming the channel, inhibiting ion-control gating mechanisms, and/or interfering with the release of calcium from the sarcoplasmic reticulum, diltiazem, like verapamil, inhibits the influx of extracellular calcium across both the myocardial and vascular smooth muscle cell membranes. The resultant inhibition of the contractile processes of the myocardial smooth muscle cells leads to dilation of the coronary and systemic arteries and improved oxygen delivery to the myocardial tissue.

Pharmacokinetics

Absorption
Diltiazem is well absorbed from the gastrointestinal tract but undergoes substantial hepatic first-pass effect.
Distribution
Metabolism
Diltiazem is metabolized by and acts as an inhibitor of the CYP3A4 enzyme.
Elimination

Toxicity

LD50=740mg/kg (orally in mice)

Active Ingredient/Synonyms

(+)-cis-5-[2-(dimethylamino)ethyl]-2,3-dihydro-3-hydroxy-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one acetate ester | (2S-cis)-3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one | (2S,3S)-5-(2-(dimethylamino)ethyl)-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydrobenzo[b][1,4]thiazepin-3-yl acetate | Acetic acid (2S,3S)-5-(2-dimethylamino-ethyl)-2-(4-methoxy-phenyl)-4-oxo-2,3,4,5-tetrahydro-benzo[b][1,4]thiazepin-3-yl ester | D-cis-diltiazem | Diltiazem | Diltiazemum | Diltiazem |


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

Calcium chloride is an ionic compound of calcium and chlorine. It is highly soluble in water and it is deliquescent. It is a salt that is solid at room temperature, and it behaves as a typical ionic halide. It has several common applications such as brine for refrigeration plants, ice and dust control on roads, and in cement. It can be produced directly from limestone, but large amounts are also produced as a by-product of the Solvay process. Because of its hygroscopic nature, it must be kept in tightly-sealed containers.

Indication

For the treatment of hypocalcemia in those conditions requiring a prompt increase in blood plasma calcium levels, for the treatment of magnesium intoxication due to overdosage of magnesium sulfate, and used to combat the deleterious effects of hyperkalemia as measured by electrocardiographic (ECG), pending correction of the increased potassium level in the extracellular fluid.

Mechanism of Action

Calcium chloride in water dissociates to provide calcium (Ca2+) and chloride (Cl-) ions. They are normal constituents of the body fluids and are dependent on various physiological mechanisms for maintenance of balance between intake and output. For hyperkalemia, the influx of calcium helps restore the normal gradient between threshold potential and resting membrane potential.

Toxicity

Too rapid injection may produce lowering of blood pressure and cardiac syncope. Persistent hypercalcemia from overdosage of calcium is unlikely because of rapid excretion.

Active Ingredient/Synonyms

Calcium chloride anhydrous | Calcium chloride, anhydrous | calcium(2+) chloride | Calcium 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

Glucose is a simple sugar (monosaccharide) generated during phosynthesis involving water, carbon and sunlight in plants. It is produced in humans via hepatic gluconeogenesis and breakdown of polymeric glucose forms (glycogenolysis). It circulates in human circulation as blood glucose and acts as an essential energy source for many organisms through aerobic or anaerobic respiration and fermentation.[A19399] It is primarily stored as starch in plants and glycogen in animals to be used in various metabolic processes in the cellular level. Its aldohexose stereoisomer, dextrose or D-glucose, is the most commonly occurring isomer of glucose in nature. L-glucose is a synthesized enantiomer that is used as a low-calorie sweetener and laxative.[T28] The unspecified form of glucose is commonly supplied as an injection for nutritional supplementation or metabolic disorders where glucose levels are improperly regulated.[L786] Glucose is listed on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system.

Indication

Glucose pharmaceutical formulations (oral tablets, injections) are indicated for caloric supply and carbohydrate supplementation in case of nutrient deprivation. It is also used for metabolic disorders such as hypoglycemia.[L787]

Mechanism of Action

Glucose supplies most of the energy to all tissues by generating energy molecules ATP and NADH during a series of metabolism reactions called glycolysis. Glycolysis can be divided into two main phases where the preparatory phase is initiated by the phosphorylation of glucose by hexokinase to form glucose 6-phosphate.[A19402] The addition of the high-energy phosphate group activates glucose for the subsequent breakdown in later steps of glycolysis and is the rate-limiting step. Products end up as substrates for following reactions, to ultimately convert C6 glucose molecule into two C3 sugar molecules. These products enter the energy-releasing phase where the total of 4ATP and 2NADH molecules are generated per one glucose molecule. The total aerobic metabolism of glucose can produce up to 36 ATP molecules. These energy-producing reactions of glucose are limited to D-glucose as L-glucose cannot be phosphorylated by hexokinase.[T35] Glucose can act as precursors to generate other biomolecules such as vitamin C. It plays a role as a signaling molecule to control glucose and energy homeostasis. Glucose can regulate gene transcription, enzyme activity, hormone secretion, and the activity of glucoregulatory neurons. The types, number, and kinetics of glucose transporters expressed depends on the tissues and fine-tunes glucose uptake, metabolism, and signal generation to preserve cellular and whole body metabolic integrity.[A19401]

Pharmacokinetics

Absorption
Polysaccharides can be broken down into smaller units by pancreatic and intestinal glycosidases or intestinal flora. Sodium-dependent glucose transporter SGLT1 and GLUT2 (SLC2A2) play predominant roles in intestinal transport of glucose into the circulation.[A19395] SGLT1 is located in the apical membrane of the intestinal wall while GLUT2 is located in the basolateral membrane, but it was proposed that GLUT2 can be recruited into the apical membrane after a high luminal glucose bolus allowing bulk absorption of glucose by facilitated diffusion.[A19400] Oral preparation of glucose reaches the peak concentration within 40 minutes and the intravenous infusions display 100% bioavailability.[A19406]
Distribution
The mean volume of distribution after intravenous infusion is 10.6L.[A19407]
Metabolism
Glucose can undergo aerobic oxidation in conjunction with the synthesis of energy molecules. Glycolysis is the initial stage of glucose metabolism where one glucose molecule is degraded into two molecules of pyruvate via substrate-level phosphorylation. These products are transported to the mitochondria where they are further oxidized into oxygen and carbon dioxide.[A19402]
Elimination

Clearance

The mean metabolic clearance rate of glucose (MCR) for the 10 subjects studied at the higher insulin level was 2.27 ± 0.37 ml/kg/min at euglycemia and fell to 1.51±0.21 ml/kg/ at hyperglycemia. The mean MCR for the six subjects studied at the lower insulin level was 1.91 ± 0.31 ml/kg/min at euglycemia.[A19408]

Toxicity

Oral LD50 value in rats is 25800mg/kg. The administration of glucose infusions can cause fluid and solute overloading resulting in dilution of the serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. Hypersensitivity reactions may also occur including anaphylactic/anaphylactoid reactions from oral tablets and intravenous infusions.[L786]

Active Ingredient/Synonyms

aldehydo-D-glucose | Anhydrous dextrose | D-Glucose in linear form | D-glucose, anhydrous | D(+)-Glucose | Dextrose anhydrous | Dextrose, anhydrous | Glucose | Glucose anhydrous | Glucose, anhydrous | D-glucose |


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.



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

A white crystal or crystalline powder used as an electrolyte replenisher, in the treatment of hypokalemia, in buffer solutions, and in fertilizers and explosives.

Indication

For use as an electrolyte replenisher and in the treatment of hypokalemia.

Mechanism of Action

Supplemental potassium in the form of high potassium food or potassium chloride may be able to restore normal potassium levels.

Pharmacokinetics

Absorption
Potassium is a normal dietary constituent and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine.
Distribution
Metabolism
Elimination

Toxicity

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, of if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment, and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

Active Ingredient/Synonyms

[KCl] | Chlorid draselny | Chloride of potash | Kaliumchlorid | KCl | Monopotassium chloride | Muriate of potash | Sylvite | Potassium 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 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.

References

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

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