Translation of the instruction Mose

RETINOLUM ACETATE skin Solutio oleosa and oral 34.4 mg/ml

Instruction

On medical use of medicine

Retinolum acetate

(retinol acetate)

Ingredients:

Active ingredient: retinol (vit a);

Retinolum (in the form of acetate Retinolum) — 34.4 mg (100000 ME vitamins A) — 18–20 drops contains

1 ml of solution;

1 drop contains about 5000 ME of vitamin A;

excipient: soy oil.

Dosage form.

Solution skin and oral, oil.

Main physical and chemical properties: transparent oily liquid from light yellow till dark yellow color, without rancid taste; existence of a specific smell is allowed.

Pharmacotherapeutic group.

Plain medicaments of vitamin A. Retinolum (vitamin A). code atkh a11s a01.

Pharmacological properties.

Pharmacodynamics.

Vitamin A (Retinolum) belongs to group of oil-soluble vitamins.

Retinolum Drug acetate is an analog of natural vitamin A and is necessary for restoration of normal concentration of Retinolum in an organism. Vitamin A plays an important role in synthesis of protein, lipids, mucopolysaccharides, regulates balance of minerals.

Most specific function of vitamin A is ensuring processes of sight (photoreception). Retinolum participates in rhodopsin synthesis — the rhodopsin located in retina sticks.

Vitamin A modulates processes of differentiation of epithelial cells, participates in development of secretory glands, processes of keratinization, regeneration of mucous membranes and skins.

Vitamin A is necessary for

for normal functioning of closed glands and growth of an organism because it is synergist of somatomedins.

Vitamin A influences division of immunocompetent cells, synthesis of factors specific (immunoglobulin) and nonspecific (interferon, lysozyme) protection of an organism against infectious and other diseases, stimulates a myelopoiesis.

Retinolum increases glycogen level in a liver, stimulates producing trypsin and a lipase in digestive system; inhibits photochemical free radical reactions and oxidation of cysteine; activates inclusion of sulfates in components of connective tissue, cartilages, bones; satisfies the need for sulfocerebrosides and a myelin, providing carrying out and transfer of nervous impulses.

At a lack of vitamin A disturbances of twilight sight develop (night blindness) and an atrophy of an epithelium of a conjunctiva, a cornea, lacrimal glands. Degenerative dystrophic processes in airways (mucous membranes of a nasopharynx, adnexal bosoms, tracheas, bronchial tubes), in an urinogenital system (epithelium of a renal pelvis, ureters, a bladder, an urethra, a vagina, ovaries, uterine tubes and endometrium, seed bubbles and cords, a prostate), in digestive system are observed (mucous a digestive tract, sialadens, a pancreas). Vitamin A deficiency leads to disturbance of a trophicity of skin (hyperkeratosis), deterioration in growth and quality of hair and nails and also function grease and sweat glands. Besides, decrease in body weight and delay of growth of bones, decrease in synthesis of glucocorticoids and steroid hormones, disturbance of body resistance to infectious and other diseases is observed. The tendency to hole- and to a nephrolithiasis is noted.

Lack or excess of vitamin A of an organism of the woman can result

in anomaly of pre-natal fetation.

Retinolum possesses antineoplastic action which does not extend to not epithelial tumors.

Pharmacokinetics.

Biotransformation of Retinolum passes

in a liver, and then in the form of inactive metabolites he is brought by kidneys. Retinolum can partially be removed with bile and participate in enterogepatichesky circulation. Elimination of Retinolum happens slowly — in 3 weeks 34% of the accepted medicament dose are brought out of an organism.

acetate Accepted in Retinolum well is soaked up by

in upper parts of a small intestine. Then as a part of chylomicrons it is transported from an intestines wall in lymphatic system and through a chest channel gets to a blood stream. Transportation of retinolefir to blood is carried out by β-lipoproteids. The maximum level of ethers of vitamin A in blood serum is observed in 3 hours after reception. The place of deposition of vitamin A is the liver parenchyma where it collects in steady radio forms. Besides, the high content of vitamin A is defined in a pigmentary epithelium of a retina. This depot is necessary for regular delivery of external segments of sticks and flasks vitamin A.

Clinical characteristics.

Indication.

A-avitaminosis and and - hypovitaminosis, diseases of eyes (a pigmentary retinitis, a xerophthalmia, a hemeralopia, a superficial keratitis, defeat of a cornea, conjunctivitis, a pyoderma and eczematic defeat a century), in complex therapy:

• rickets;
• acute respiratory diseases, proceeding against the background of exudative diathesis;
• acute and chronic bronchopulmonary diseases;
• a hypotrophy;
• kollagenoz;
• at pathological processes of skin (frostbites, burns, wounds, an ichthyosis, a follicular dyskeratosis, a senile keratosis, a tuberculosis cutis, some forms of eczema, psoriasis);
• at inflammatory and ulcer and erosive damages of intestines;
• cirrhosis.

Contraindication.

Hypersensitivity to medicament components, acute and chronic nephrite, heart failure in a decompensation stage, cholelithiasis, chronic pancreatitis, a hypervitaminosis and, overdose of retinoids, a lipidemia, obesity, an alcoholism.

Interaction with other medicines and other types

Interactions

.

Estrogen increases risk of developing a hypervitaminosis And.

Retinolum acetate reduces anti-inflammatory action of glucocorticoids.

Retinolum acetate cannot be accepted at the same time with nitrites and holestiraminy as they break medicament absorption.

Retinolum acetate should not be applied together with other derivatives of vitamin A because of danger of overdose, development of a hypervitaminosis And.

Combination with vitamin E promotes acetate Retinolum preservation in an active form, to absorption from intestines and to emergence of anabolic effects.

Simultaneous use of liquid paraffin can break vitamin B absorption intestines.

Concomitant use of vitamin A and anticoagulants enhances tendency to bleedings.

Feature of use.

Drug is taken under observation of the doctor. at prolonged use of Retinolum of acetate it is necessary to control biochemical indicators and a blood clotting time.

At treatment of disturbance of twilight sight (night blindness) of Retinolum acetate should be applied with Riboflavinum, niacin.

to apply

With care at the heavy damages of a gepatobiliarny system, diseases which are followed by disturbance of blood clotting.

is not recommended to use medicament during long therapy by tetracyclines.

Retinolum should be accepted in 1 hour prior to or in 4–6 hours after reception of a holestiramin.

Drug has property to collect and is long to be in an organism. Women who accepted high doses of Retinolum can plan pregnancy not earlier than in 6–12 months. It is connected with the fact that during this time there is a risk of maldevelopment of a fruit under the influence of the high content of vitamin A in an organism.

For normal absorption of vitamin A a necessary condition is presence of fats in food.

Alcohol abuse and tobacco breaks absorption of medicament from a digestive tract.

Medicine contains soy oil. In the presence of an allergy to peanut or soy it is not necessary to take this drug.

Use during pregnancy or feeding by a breast.

medicament is contraindicated to

In view of a high dose of vitamin A in this dosage form for intake during pregnancy or feeding by a breast.

Ability to influence speed of response at control of motor transport or other mechanisms.

is not present

Data on influence of medicament on ability to drive the car or to work with difficult mechanisms.

Route of administration and doses.

acetate to appoint

Retinolum inside in 10–15 minutes after a meal and outwardly. 1 drop contains about 5000 me vitamin A.

contains

1 ml of medicament 100000 ME (18–20 drops) vitamin A.

When determining doses of medicament to recognize what the highest single dose of vitamin A makes for adults 50000 ME. The highest daily dose for adults is equal to 100000 ME. Therapeutic doses of vitamin A in avitaminosis easy and moderate severity make for adults up to 33000 ME in day. It is for this purpose better to use medicament in dosage forms of a dragee or capsules (1 dragee on 10 mg or 1 capsule a day). In skin diseases and also in a pigmetny retinitis, a xerophthalmia, a hemeralopia the daily dose of vitamin A makes 50000–100000 ME (at the same time to appoint Riboflavinum ( _{2 vitamin B} ) in a daily dose of 0.02 g).

affected areas after hygienic cleaning to grease

At defeats of a surface of skin (ulcers, burns, frostbites) with solution and to cover with a gauze bandage (5–6 times a day with reduction of number of appliques to one in process of epithelization). At the same time to appoint medicaments inside. For prevention of formation of concrements to establish preventive doses, proceeding from the daily need of a human body for vitamin A. Treatment term — from 10 days to 1 month.

Children.

Inside to children not to use medicament in this dose.

Overdose.

Symptoms: dizziness; confusion of consciousness, diarrhea, heavy dehydration of an organism, irritability; generalized rash with the subsequent krupnosloyny peeling beginning with a face; bleeding of gums, dryness and an ulcer of a mucous membrane of an oral cavity, peeling of lips, sharply painful palpation of long tubular bones owing to subperiostal hemorrhages.

Acute and chronic hypervitaminosis And is followed by a severe headache, temperature increase, drowsiness, vomiting, a disorder of vision (doubling in eyes), xeroderma, joint and muscles pain, emergence of a nevus pigmentosus, increase in the sizes of a liver and spleen, jaundice, change of a picture of blood, loss of forces and appetite. In hard cases convulsive attacks, warm weakness and hydrocephaly develop.

Treatment: symptomatic as the antagonist to appoint thyroxine, use of ascorbic acid, vitamin E is rational.

Side reactions.

Long reception of high doses of vitamin A can cause development of a hypervitaminosis and.

from nervous system and sense bodys: fast fatigue, drowsiness, slackness, irritability, headache, loss of a dream, spasm, discomfort, intraocular hypertensia, disorder of vision.

from digestive system: loss of appetite, degrowth of a body, nausea, it is very rare — vomiting. Exacerbation of diseases of a liver, increase in activity of transaminases and alkaline phosphatase is possible.

from an urinary system: pollakiuria, nocturia, polyuria.

from the haematogenic system: hemolytic anemia.

from a musculoskeletal system: changes on roentgenograms of bones, gait disorder, morbidity of bones of the lower extremities.

Allergic reactions: cracks of skin of lips, yellow-orange spots on soles, palms, on the site of a nasolabial triangle; hypodermic hypostasis; in some cases in the first day of use there can be pruritic spotty and papular rash that demands medicament withdrawal; itching; erythema and rash; dry skin; dryness in a mouth; temperature increase; hyperaemia of the person with the subsequent peeling.

Others: hair loss, disturbance of a menstrual cycle, abdominal pain, afta, photosensitivity, hypercalcemia.

or at temporary cancellation of medicine the by-effects pass

With reduction of a dose independently.

In skin diseases the use of high medicament doses after 7–10 days of treatment can be followed by aggravation of local inflammatory reaction which does not demand additional treatment and weakens further. This effect is connected with miyelo- and immunopromoting effect of drug.

Expiration date.

2 years.

Storage conditions.

to Store

in original packing at a temperature not higher than 25 wasps.

Out of children's reach.

Packing.

On 10 ml in the bottles enclosed in a pack.

Category of release.

Without prescription.

Producer.

PJSC vitaminy.

Location of the producer and its address of the place of implementation of activity.

20300, Ukraine, Cherkassk region, Uman, st. of a Lenin spark, 31.

Applicant.

PJSC vitaminy.

Location of the applicant and/or applicant's representative.

20300, Ukraine, Cherkassk region, Uman, st. of a Lenin spark, 31.