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1. Drug name
Talipool
2. Drug formula ingredients
Each vial contains:
Ascorbic Acid …………………………….... 100.0 mg
Thiamine HCl…………………………………. 3.81 mg
Pyridoxine HCl……………………………… 4.86 mg
Dexpanthenol……………………………….. 15.0 mg
Biotin ................................................................ ............. .60mcg
Vitamin A………………………………….. 3,300 IU
Ergocalciferol................................................…200 IU
Riboflavine-5'-Phosphate Sodium ................3.60 mg
Nicotinamide ……..………….…….….…..... 40.0 mg
dl-alpha-Tocopherol Acetate ...…….…...… 10.0 mg
Foli c acid……………………………… ....…400mcg
Excipients:: D-Mannitol, Polysorbate 80, polysorbate 20, Sodium hydroxyte
3. Dosage form
Lyophilized powder for injection.
4. Route of administration
Injection route.
5. Indications
Supplement necessary vitamins.
Prevent vitamin deficiency syndrome in the following patients: After surgery, severe burns, fractures or other cases related to trauma. Severe infections, coma.
6. Administration, dosage
Adults and children over 11 years old:
Add 5ml of distilled water for injection to the vial. Shake well to dissolve for a few seconds, then dilute with 500-1000ml of 5% Glucose solution or Ringer's solution (or LVP solution). (Large volume parenteral) ready-made).
Use 1 tube per day by intravenous infusion. This medicine is only used as prescribed by your doctor.
7. Contraindications
High doses of Vitamin A (more than 5,000 units/day) can cause fetal malformations in pregnant women, so do not use vitamin A in high doses, more than 5,000 units/day, for pregnant women. pregnant during the first 3 months of pregnancy or women of childbearing potential.
Do not use the drug in patients allergic to any ingredient of the drug.
8. Special warnings and precautions for use
Use the correct dose and route of administration.
After using the medicine, if you notice any unusual signs, stop taking the medicine and consult a doctor.
Inject intravenously as slowly as possible because injection may cause pain.
Once mixed, it should be stored in the refrigerator and used within 48 hours.
Vitamin A, Vitamin D and Riboflavin are very sensitive to light so the medicine should not be exposed to light for long periods of time. After several weeks of continuous treatment, tests should be done to avoid the accumulation of Vitamin A and Vitamin D causing toxicity. Before use, it must be dissolved with infusion solutions to avoid dizziness or drug shock. For children under 11 years old, the effects and safety of the drug have not been evaluated.
9. Fertility, pregnancy and lactation
High doses of Vitamin A (more than 5,000 units/day) can cause fetal malformations in pregnant women, so do not use vitamin A in high doses, more than 5,000 units/day, for pregnant women. pregnant during the first 3 months of pregnancy or women of childbearing potential.
10. Effects on ability to drive and use machines
The drug does not affect the ability to drive and operate machinery.
11. Drug interactions and incompatibilities
Do not combine with Acetazolamide, Sodium Chlorthiazide, Tetracycline HCl and alkaline solutions.
Not stable in the presence of calcium salts or chloride salts.
Some vitamins in medications antagonize vitamin K.
Do not dilute with solutions containing lipids.
12. Undesirable effects
Allergic reaction: itching or rash, swelling of the face or hands, swelling or itching in the mouth or throat, chest tightness, trouble breathing.
13. Overdose and treatment
There have been no reports of overdose when using the drug.
14. Pharmacodynamic properties
Vitamin C is needed for collagen formation, tissue reconstruction in the body and participates in a number of oxidation-reduction reactions. Vitamin C participates in the metabolism of phenylalanine, tyrosine, folic acid, norepinephrine, histamine, iron, and a number of drug metabolizing enzyme systems, in the use of carbohydrates, in the synthesis of lipids and proteins, in immune function, in liver function. resistance to infection, in preserving the integrity of blood vessels and in cellular respiration.
Vitamin A is a fat-soluble vitamin that is essential for vision, growth, and the development and maintenance of epithelia.
Ergocalciferol is vitamin D2. The main biological function of Vitamin D is to maintain normal calcium and phosphorus concentrations in plasma by increasing the efficiency of absorption of minerals in the diet, in the small intestine, and increasing the mobilization of calcium and phosphorus from bones into the blood. .
Thiamine has practically no pharmacological effect, even at high doses. Thiamine pyrophosphate, the physiologically active form of thiamin, is a carbohydrate metabolism coenzyme responsible for the carboxyl metabolism of alpha-ketoacids such as pyruvate and alpha-ketoglutarate and in the utilization of pentose in the hexose monophosphate cycle.
Riboflavin has no apparent effects when taken orally or injected. Riboflavin is converted into two co-enzymes, flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD), which are active co-enzymes required for tissue respiration.
Pyridoxine (Vitamin B6) participates in the synthesis of gamma-aminobutyric acid (GABA) in the central nervous system and participates in the synthesis of hemoglobulin.
Nicotinamide: In the body, nicotinamide functions after being converted into either nicotinamide adenine dinucleotide (NAD) or nicotinamide dinucleotide phosphate (NADP). NAD and NADP have a vital role in metabolism, as a coenzyme that catalyzes oxidation-reduction reactions necessary for cellular respiration, glycogenolysis, and lipid metabolism.
Dexpanthenol is a derivative of D-pantothenic. In humans, an exogenous source of pantothenic acid is required for the intermediary metabolism of carbohydrates, proteins and lipids. Pantothenic acid is also necessary for normal epithelial function.
dl- a-Tocopherol Acetate is a synthetic Vitamin E, vitamin E is also used as an antioxidant Biotin is a vitamin necessary for the activity of enzymes that transport carboxyl units and attach carbon dioxide and is needed for many functions. metabolic ability.
Folic acid is a B vitamin. In the body, folic acid is reduced to tetrahydrofolate, which is a coenzyme of many metabolic processes, including the synthesis of purine or pyrimidine nucleotides; thus affecting DNA synthesis.
Cyanocobalamine is Vitamin B12 that is essential for all hematopoietic tissues, small intestine, and uterus. Vitamin B12 deficiency also causes nerve fiber demyelination.
15. Pharmacokinetic properties
- Vitamin C: Normal vitamin C concentration in plasma is about 10-20micrograms/ml. Widely distributed in tissues in the body. About 25% of vitamin C in plasma is combined with proteins. Some vitamin C is converted into inactive substances including ascorbic acid-2 sulfate and oxalic acid which are excreted in the urine.
- Vitamin A: stored in the liver, excreted through urine and feces. The normal concentration of vitamin A in plasma is from 300-600 micrograms/liter.
- Vitamin D: because Vitamin D is lipid soluble, it is concentrated in chyme microsomes, and absorbed by the lymphatic system. Vitamin D and its metabolites circulate in the blood bound to specific alpha globulin. The half-life of vitamin D is 19-25 hours, but the drug is stored for a long time in fatty tissues. Vitamin D is metabolized in the liver; Excreted mainly through bile and feces, only small amounts appear in urine. Some types of vitamin D may be secreted into milk.
- Thiamin: Thiamin is distributed into most tissues and milk. The minimum requirement of Thiamin is 1mg daily. When absorbed at this level, there is little or no thiamine excreted in the urine. When absorption exceeds the minimum requirement, Thiamin stores in the first tissues are saturated. The excess amount will then be eliminated through urine as intact Thiamine molecules.
- Riboflavin: riboflavin metabolites are distributed throughout body tissues and into milk. Small amounts are stored in the liver, spleen, kidneys and heart. Excreted mainly through the kidneys, but also through feces. Riboflavin does cross the placenta and is excreted in milk.
- Pyridoxine: mostly stored in the liver, partly in muscles and brain, mainly eliminated through the kidneys in the form of metabolism. The amount taken in, if it exceeds daily needs, is largely excreted unchanged.
- Nicotinamide: widely distributed into tissues in the body. The elimination half-life of the drug is about 4.5 minutes. Nicotinamide is metabolized in the liver. After usual doses of nicotinamide, only small amounts of nicotinamide are excreted in the urine in unchanged form; However, when large doses are used, the amount of drug excreted unchanged will increase.
- Dexpanthenol: normal serum pantothenate concentration is 100micrograms/ml or more. Dexpanthenol is easily converted into pantothenic acid, which is widely distributed in body tissues. The highest concentrations are found in the liver, adrenal glands, heart, and kidneys. Breast milk from a breastfeeding baby, fed a normal diet, contains about 2 micrograms of pantothenic acid in 1 ml. About 70% of an oral pantothenic acid dose is excreted unchanged in the urine and about 30% in the feces.
- dl- atocopherol: widely distributed into all tissues and accumulated in adipose tissue. Some vitamin E is metabolized in the liver and excreted in the urine, while most of the dose is slowly excreted into the bile. Vitamin E enters milk, but very little passes through the placenta.
- Biotin: binds mainly to plasma proteins. The drug appears in urine mainly as intact biotin and to a lesser extent as the metabolites bis-norbiotin and biotin sulfoxide.
- Folic acid: distributed throughout the body. The drug is stored mainly in the liver and is actively concentrated in the cerebrospinal fluid. Every day about 4-5 micrograms are excreted through urine. Folic acid crosses the placenta and is present in breast milk.
- Cyanocobalamin: after absorption, vitamin B12 binds to transcobalamin II and is removed from the plasma for preferential distribution into the liver parenchyma. The liver is where vitamin B12 is stored for other tissues. About 2 micrograms of cobalamin are excreted into bile every day, of which 50-60% are cobalamin derivatives that cannot be reabsorbed.
16. Packaging specifications
Box of 10 bottles with instructions for use.
17. Storage conditions, expiration date, and quality standards of the drug
Storage conditions: Cool and dry place, protected from light, temperature not exceeding 30 o C.
Expiry date: 36 monthsfrom the date of manufacture.
Quality standards of drugs: IN HOUSE
18. Name and address of the drug manufacturing facility
Euro Santé Pharmaceutical Joint Stock Company
Song Cung industrial site, Dong Thap commune, Dan Phuong district, Hanoi city, Vietnam.
