Etasylsunny 250/2ml solution for IV injection
Composition:
Active ingredient: Etamsylate 250 mg/ 2ml .
Excipients: antioxidant (E223): 0.8 mg, water for injection qs 2 ml
Pharmaceutical form and amount of active ingredient per unit:
Solution for injection in Ampoule of (2 ml).
Each Ampoule contains 250 mg Etamsylate.
Indications / Applications:
Preoperative, peroperative and postoperative prophylaxis of capillary bleeding in all delicate procedures or highly perfused tissues: otorhinolaryngology, gynecology, obstetrics, urology, odonto-stomatology, ophthalmology, plastic and reconstructive surgery. Treatment of capillary bleeding, regardless of their location or cause. Prevention of periventricular haemorrhage in preterm infants.
Dosage / Application:
Adults and adolescents:
Preoperative: 1-2 ampoules IV or IM Etasylsunny 250 an hour before the procedure.
Peroperatively: 1-2 ampoules IV, repeat if necessary.
Postoperative: 1-2 ampoules Etasylsunny 250 every 4-6 hours, as long as there is a risk of hemorrhage.
Emergencies, depending on the severity of the case: 1-2 ampoules IV or IM. then every 4-6 hours, as long as there is a risk of hemorrhage.
Local therapy: soaking a compress with the contents of an ampoule and thus cover the bleeding stove, insert after tooth extraction one-soaked swab into the alveolus. If necessary, repeat it again later. It can be combined with the parenteral treatment.
Children
Half the adult dose.
Neonatology: 10 mg per kg body weight (0.1 mL = 12.5 mg) was injected intramuscularly within 2 hours after birth, then every 6 hours for 4 days.
Contraindications:
* Acute porphyria.
* Bronchial asthma, proven hypersensitivity to sulphite.
* Hypersensitivity (allergy) to any of the ingredients.
Pregnancy / lactation:
There are no clinical data on use in pregnant women are available.
Studies on animals show that it have no direct or indirect toxic effects on the pregnancy, the development of the embryo, the fetus or the newborn.
In pregnancy general caution is applied.
Since no information on excretion in breast milk are available, women should not breast-feed during treatment with Etasylsunny 250
Properties / Effects:
Mechanism of action:
Etamsylate is a synthetic Antihaemorrhagic and vascular protective agent that acts on the first phase of hemostasis (interaction between endothelial cells and platelets). By shortening the bleeding time, and reduction of the blood loss. Etamsylate is not act as vasoconstrictor, it has no effect on the fibrinolysis and does not change the plasma clotting factors.
Pharmacokinetics
After IV or IM injection : A dose level of 500 mg Etamsylate after 1 hour is a maximum plasma concentration of approximately 30-50 mg / ml.
Distribution
Etamsylate is approximately 90% bound to plasma proteins. Etamsylate exceeds Placental shrinkage. The concentrations in maternal blood and in umbilical cord blood are similar. It is not known whether Etamsylate is excreted in human milk.
Metabolism
Etamsylate is with little biotransformation.
Excretion
80% of the dose is excreted mainly unchanged in the urine. The plasma half-life is an average of 2 hours. Approximately 85% of the dose was excreted within the first 24 hours in the urine.
Pharmacokinetics in special clinical situations
It is not known if the pharmacokinetic properties of Etamsylate in patients with disorders in the kidney and / or liver function are changed.
Stability :
Do not store above 30°C
The drug should be used only until the expiration of the pack with “EXP” date specified.
Storage
The drug has to be stored in the original container at room temperature and protected from light. The Etasylsunny 250 ampoules in case of discoloration not apply.
Packs
presented in a Carton box containing colorless neutral glass (type I) 5,50 ampoules of 2ml solution + inner leaflet
Manufacturer
Sunny Pharmaceutical
Badr City-100 Acre zone-piece No.37&38
Cairo,Egypt
SUMMARY OF PRODUCT CHARACTERISTICS for FERCAYL
Sunnypyramid Injection Qualitative and quantitative composition
SUNNYFUNGAL NAME OF THE MEDICINAL PRODUCT
Peptrelif Injection 50 mg/2ml NAME OF
FERMED 20 mg .Name of the
Etasylsunny 250/2ml solution for IV injection
