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Dicynonum 250 mg / 2 ml 10s solution for injection in ampoules




The instruction for medical use

of Ditsinon® medicine

the Trade name
of Ditsinon®

the International unlicensed

name Etamsylate Dosage Form Solution for injections of 250 mg / 2 ml

contain Structure of 2 ml of solution:
active agent – etamsylate of 250 mg,
excipients: sodium metabisulphite, Natrii hydrocarbonas, water for injections.

The description
Transparent colourless solution practically without visible particles.

Vitamin K group and other haemo statics. Other system haemo statics
Code of automatic telephone exchange: B02BX01

the Pharmacological

Pharmacokinetics Later properties of intravenous administration etamsylate begins to work quickly (within from 5 to 15 minutes). The maximum action is reached in one hour. Its action continues within 4 – 6 hours, and then gradually stops. After intravenous administration of 500 mg the peak concentration in plasma is reached 10 minutes (50 mkg/ml) later
Etamsylate passes through a placenta and is removed with milk.
About 85% of the entered dose are removed with urine in not changed look within the first day.
The semi-elimination period is about 2 hours of plasma of intravenously entered etamsylate.
The pharmacodynamics
Dicynonum is gemostatiky. Its haemo static action is based on acceleration of the first phase of a hemostasis – stimulation of interaction between an endothelium and thrombocytes. Dicynonum protects an endothelium, increases adhesion of thrombocytes to the damaged vascular walls, in particular capillaries, reduces permeability of walls of capillaries, inhibits biosynthesis of prostaglandins which cause disaggregation and a vazodilatation and, therefore, increase permeability of capillaries. Thanks to effect of drug the bleeding time considerably is shortened and decreases a loss of blood.
Dicynonum has no vasoconstrictive properties. It does not affect neither a fibrinolysis, nor the normal mechanism of fibrillation therefore it has no thrombogenic effect. Dicynonum inhibits action both hyaluronidase, and a histamine, reducing these hyperpermeability of capillaries in various diseases, for example, at inflammations. Dicynonum considerably reduces the frequency of intra ventricular bleeding in a brain at babies with a low weight at the birth. Frequency of a cerebral hemorrhage at children whose mothers received drug was much lower in comparison with children whose mothers did not receive this medicine.

– prevention and a stop of bleedings in time and after surgeries in otolaryngology, gynecology, obstetrics, urology, stomatology, ophthalmology and plastic surgery
– prevention and a stop of capillary bleedings of various etiology and localization: a hamaturia, a metrorrhagia, primary menorrhagias, menorrhagias at the women using intrauterine contraceptives, nasal bleeding, bleeding of gums
– in a neonatology: prevention of periventrikulyarny bleeding at premature children

the Route of administration and doses
the Ampoule of drug contains solution, ready for use, for injections. If drug mixes up with normal saline solution, it should be used immediately. Drug should not mix up with other drugs in one syringe.
Use for adults
the Optimum daily dose at adults makes 10-20 mg/kg/days divided into 3-4 receptions in the form of an intramuscular or slow intravenous injection.
From 1 to 2 ampoules of Dicynonum intramusculary or intravenously 3 – 4 times a day are in most cases entered. Intravenously medicine has to is entered slowly.

Before operation enter into surgeries intravenously or intramusculary 1-2 ampoules in one hour prior to the surgical procedure.
During operation enter 1-2 ampoules intravenously, the dose can be repeated.
After operation each 6 hours before disappearance of risk of developing bleeding enter 1-2 ampoules.
In pediatrics
the Daily dose makes 10-15 mg/kg of body weight divided into 3-4 receptions.
In a neonatology (up to 28 days from the birth)
Dicynonum has to is entered intramusculary or intravenously on 12.5 mg/kg of body weight (0.1 ml = 12.5 mg). Treatment should be begun within the first two hours after delivery. The drug should be administered as the vasoprotective remains microcirculation disturbance so far, and it is not normalized.
Contents of an ampoule can also locally be applied by treatment by it of a sterile gauze napkin and imposing on the bleeding wound, for example at skin transplants or odontectomy.

Side effects
Can arise the following passing and subtle side effects:
– the headache, dizziness
– hyperaemia of the person
– passing skin rashes
– nausea, pains in the field of epigastrium
– paresthesias in legs
– passing increase in systolic arterial blood pressure after intravenous administration, however acceptances of special measures is not required
– venous thrombosis from the women taking the drug before surgery on

the Contraindication vagina
– hypersensitivity to any of drug components
– hypersensitivity to sodium sulfite in the anamnesis
– a hemoblastosis at children (lymphatic and myeloid leukemia, an osteosarcoma)
– a sharp porphyria

Medicinal interactions
Solution for an injection should not mix up with drugs, the compatibility with which was not established. Solution for an injection is incompatible with solutions, containing hydrogenkarbonat and sodium lactate.
Interactions with other medicines are not known.

It is necessary to appoint the special instructions This Medicine with care in the presence in the anamnesis at patients of thrombosis or thrombembolia or hypersensitivity to medicines. Dicynonum contains sulfites because of what it is also required to be careful at introduction by his patient with bronchial asthma and an allergy.
Before an initiation of treatment it must be kept in mind that drug is inefficient at patients with thrombocytopenia.
Because at children to whom Dicynonum for prevention of bleeding was appointed at sharp lymphoblastoid and and a miyeloblastny leukosis and an osteosarcoma, weighting of a state was noted, some authors consider use of drug in these cases contraindicated.

Pregnancy and a lactation
Safety of use of drug at pregnancy is not established. Dicynonum should be applied at pregnancy only in individual cases if it is considered necessary when the potential advantage for mother exceeds potential risk for the child.
Mothers have to stop breastfeeding during treatment.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to driving by motor transport and control of mechanisms.

Cases of overdose are not revealed.

A form of release and packing
In ampoules on 2 ml No. 10, No. 50 in a cardboard pack together with the instruction for medical use.

To Store storage conditions at a temperature not above 25 °C, in the place protected from light.
To store out of children’s reach!

Not to use a period of storage of 5 years after the expiry date specified on packing.

Prescription status
According to the prescription

the Lek of Pharmasyyutikals Producer of of,

Verovshkova 57, 1526 Ljubljana, Slovenia

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