Abidec Multivitamin Drops
2. Qualitative and quantitative composition
Abidec Multivitamin Drops incorporates 1333 IU retinol (as vitamin A palmitate), 400 IU ergocalciferol solution, zero.4 mg thiamine hydrochloride, 0.8 mg riboflavin, 0.8 mg pyridoxine hydrochloride, 8 mg nicotinamide, and forty mg ascorbic acid in every 0.6 ml dose.
Three. Pharmaceutical form
A yellow to orange brown oral drops solution which darkens upon storage, with a few cloudiness.
4. Clinical particulars
4.1 Therapeutic symptoms
Abidec Multivitamin Drops is indicated for the prevention of diet deficiencies and for the maintenance of regular boom and health for the duration of the early years of infancy and formative years; multivitamin supplement.
4.2 Posology and method of management
Adults and youngsters over 12 years:
Not suitable.
Children aged 1 to twelve years:
Oral. One 0.6 ml dose taken day by day.
Maximum each day dose: zero.6 ml
Children beneath 1 12 months:
Oral. One 0.3 ml dose taken every day.
Maximum every day dose: zero.3 ml
The Elderly:
Not suitable
Hepatic/renal disorder
Normal dosage is suitable.
4.3 Contraindications
Abidec Multivitamin Drops is contraindicated in people with acknowledged allergy to the product or any of its additives including peanut oil.
Abidec Multivitamin Drops consists of Arachis oil (peanut oil) and need to now not be taken by means of patients acknowledged to be allergic to peanut. As there's a likely dating between allergy to peanut and allergic reaction to Soya, sufferers with Soya hypersensitive reaction need to also avoid Abidec Multivitamin Drops.
Four.Four Special warnings and precautions for use
When prescribing Abidec Multivitamin Drops, as with every multi-nutrition arrangements, allowance should be made for nutrients acquired from different sources.
While youngsters are taking Abidec Multivitamin Drops no other vitamin supplement containing nutrients A and D need to be taken except under scientific supervision.
This multivitamin supplement need to not take delivery of to infants who are receiving extra than 500mls of method milk according to day to avoid exceeding the safe upper limit of Vitamin A.
Excessive dosage of diet A and D may also result in hypervitaminoses. Due allowance must constantly be made for intake of these vitamins from different resources.
Patients with rare hereditary troubles of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency need to now not take this medicine.
Four.5 Interaction with other medicinal merchandise and other types of interaction
None.
Four.6 Pregnancy and lactation
Not indicated.
4.7 Effects on ability to pressure and use machines
None recognized
Four.Eight Undesirable effects
Vitamin A palmitate
Adverse effects are extraordinarily uncommon at each day doses of much less than nine mg (16363.6 iu).
Ergocalciferol (Vitamin D2)
The handiest known damaging results of vitamin D occur while excessive doses are taken. Adverse effects are not predicted at the amount present in Abidec Multivitamin Drops.
Ascorbic Acid (C), Nicotinamide, Pyridoxine (B6), Riboflavin (B2) & Thiamine (B1)
These water soluble nutrients are commonly non toxic compounds with a huge margin of protection, the extra amounts being hastily excreted in the urine. Adverse results arenot expected on the portions present in Abidec Multivitamin Drops.
Four.9 Overdose
Symptoms and signs
Abidec Multivitamin Drops consists of ranges of nutrients which present little threat in overdose.
Vitamin A palmitate
Acute administration of excessive doses of diet A can cause headache, nausea, vomiting and irritability. In toddlers acute toxicity can cause temporary hydrocephalus. All these results disappear inside 24 hours of taking retinol.
Ergocalciferol (Vitamin D2)
Excessive doses of nutrition D, 60 000 gadgets consistent with day, can result in hypercalcaemia and hypercalciuria. Adverse consequences of hypercalcaemia may additionally encompass muscle weak point, apathy, headache, anorexia, nausea and vomiting, hypertension and cardiac arrhythmias.
Thiamine hydrochloride (Vitamin B1)
When taken orally, thiamine is non-poisonous. If massive doses are ingested they're no longer stored by means of the frame however excreted unchanged with the aid of the kidneys.
Riboflavin (Vitamin B2)
Riboflavin has been discovered to be practically non-poisonous.
Pyridoxine hydrochloride (Vitamin B6)
Acute doses much less than 500mg in keeping with day appear like secure. Excessive doses may additionally lower serum folate concentrations. Sensory neuropathy has been defined with continual dosing of 2 hundred mg day by day.
Nicotinamide
A single big overdose of nicotinamide is not going to have extreme ill outcomes, though transient abnormalities of liver feature would possibly arise.
Ascorbic acid (Vitamin C)
Ascorbic acid isn't always saved to a terrific quantity with the aid of the body, any excess quantities are removed in the urine. Ascorbic acid is notion to emerge as toxic at chronic doses in excess of 6 g.
Treatment
Treatment ought to be supportive and symptomatic.
Five. Pharmacological houses
5.1 Pharmacodynamic homes
Vitamin A palmitate
Vitamin A plays an essential function inside the feature of the retina, the boom and feature of epithelial tissue, bone growth, reproduction and embryonic improvement.
Ergocalciferol (Vitamin D2)
Vitamin D is a regulator of both calcium and phosphate homeostasis.
Thiamine hydrochloride (Vitamin B1)
Vitamin B1 is vital for proper carbohydrate metabolism and plays an crucial role within the decarboxylation of alpha keto acids.
Riboflavin (Vitamin B2)
Riboflavin is important for the utilisation of electricity from food. It is a component of co-enzymes which play an essential function in oxidative/ reductive metabolic reactions. Riboflavin is also vital for the functioning of pyridoxine and nicotinic acid.
Pyridoxine hydrochloride (Vitamin B6)
Vitamin B6 is a constituent of the co-enzymes, pyridoxal pyrophosphate and pyridoxamine phosphate, both of which play an important position in protein metabolism.
Nicotinamide
Nicotinamide is an essential element of co-enzymes accountable for proper tissue breathing.
Ascorbic acid (Vitamin C)
Ascorbic acid is a water soluble diet and a powerful antioxidant.
It is a cofactor in numerous organic processes, inclusive of the metabolism of folic acid, amino acid oxidation and the absorption and transport of iron.
It is likewise required for the formation, upkeep and restore of intercellular cement cloth. Ascorbic acid is important in the defence towards contamination, the regular functioning of T-lymphocytes and for the effective phagocytic interest of leucocytes. It additionally protects cells towards oxidation damage to important molecules.
5.2 Pharmacokinetic properties
Absorption
Vitamins A, B1, B2, B6, C, D2 and nicotinamide are well absorbed from the gastro-intestinal tract.
Distribution
The nutrients present in Abidec Multivitamin Drops are extensively dispensed to all tissues within the body.
Metabolism and removal
Vitamin A palmitate
Vitamin A palmitate is hydrolysed within the intestinal lumen to retinol which is then absorbed. Retinol circulates inside the blood sure to retinol binding protein which protects it from glomerular filtration. The complicated circulates to goal tissues wherein the vitamin is released, permeates the cell and binds intracellularly to cellular retinol binding protein. Of the absorbed retinol 20 - 50 % is both conjugated or oxidised to various products and excreted over a count of days within the urine and faeces, whilst the remainder is stored. This stored retinol is steadily metabolised via the liver and peripheral tissues.
Ergocalciferol (Vitamin D2)
Vitamin D circulates within the blood associated with vitamin D binding protein. It is saved in fats deposits. Ergocalciferol is hydroxylated in the liver and gut to twenty-five-hydroxy colecalciferol that is then in addition metabolised inside the kidney to the active form 1,25-dihydroxycolecalciferol and different hydroxylated metabolites. Ergocalciferol and its metabolites are excreted in large part in bile with eventual elimination inside the faeces, with only small amounts of a number of the metabolites appearing in the urine.
Thiamine hydrochloride (Vitamin B1)
Thiamine has a plasma half existence of 24 hours and isn't always stored to any first rate quantity within the frame. Excess ingested thiamine is excreted inside the urine as either the unfastened diet or as the metabolite, pyrimidine.
Riboflavin (Vitamin B2)
Following absorption riboflavin is converted into the co-enzymes: flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD).
Riboflavin isn't always stored in body tissues to any extraordinary volume and amounts in extra of the body's necessities are excreted inside the urine largely unchanged.
Pyridoxine hydrochloride (Vitamin B6)
The half of lifestyles of pyridoxine tiers from 15 - 20 days. Once absorbed vitamin B6 is transformed to its lively co-enzyme form pyridoxal five-phosphate. Muscle is the foremost storage site for pyridoxal 5-phosphate. It is degraded in the liver to 4-pyridoxic acid that is eliminated via the kidneys.
Nicotinamide
Nicotinamide is comfortably taken up into tissues and utilised for the synthesis of the co-enzyme forms nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP). Nicotinamide is degraded in the liver and different organs to a number of products which might be excreted within the urine, the most important metabolites being n-methyl-2-pyridone-5-carboxamide and n-methylnicotinamide.
Ascorbic acid (Vitamin C)
Ascorbic acid reaches a maximum plasma concentration four hours following oral administration and then there may be speedy urinary excretion. Following oral administration 60 % of the dose is excreted in 24 hours either as ascorbic acid or its metabolite dihydroascorbic acid.
Pharmacokinetics in Renal Impairment
There have been no precise studies of Abidec Multivitamin Drops in renal impairment.
Pharmacokinetics within the Elderly
Not suitable.
5.3 Preclinical safety facts
Mutagenicity
There is insufficient facts to determine the mutagenic potential of the energetic elements. However very large doses of nutrition C are claimed to be mutagenic.
Carcinogenicity
There is insufficient information to decide the carcinogenic capacity of the energetic substances.
Teratogenicity
High doses of diet D are regarded to be teratogenic in experimental animals, but direct evidence for that is missing in people.
The teratogenicity of nutrition A in animals is widely recognized, each high and coffee stages of the vitamin bring about defects. But the importance of this for humans is in dispute. Synthetic versions of diet A (Isotretinoin and Etretinate) were shown to be powerful teratogens. There is inadequate records to decide the teratogenic ability of the other lively ingredients.
Fertility
Not appropriate.
6. Pharmaceutical details
6.1 List of excipients
Sodium hydroxide
Sugar (mineral water grade)
Refined peanut oil (a provider for Vitamin A palmitate)
Polysorbate 60
Purified water
Nitrogen, Oxygen free
6.2 Incompatibilities
None known.
6.Three Shelf lifestyles
18 months after manufacture.
Once opened use within four weeks.
6.4 Special precautions for storage
Do now not keep above 25°C. Keep bottle inside the outer carton.
6.Five Nature and contents of container
Abidec Multivitamin Drops are presented in an amber Type III glass bottle, with Tamper-obvious Polypropylene cap or ROPP aluminium cap containing a PET/ Aluminium/ Polyethylene/ Expanded Polyethylene laminated wad.
One or 25 ml bottles are enclosed in a broadcast cardboard carton with one polyethylene / polystyrene syringe graduated at 0.3 ml and 0.6 ml. Alternatively, cartons containing a 25 ml bottle and polyethylene / polystyrene syringe can be cut back wrapped to offer a p.C. Size of fifty ml.
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