Emosint (Solution) Instructions for Use

Marketing Authorization Holder

Kedrion S.p.A. (Italy)

Manufactured By

Biologici Italia Laboratories, S.r.l. (Italy)

ATC Code

H01BA02 (Desmopressin)

Active Substance

Desmopressin (Rec.INN registered by WHO)

Dosage Forms

	Emosint	Injection solution 4 mcg/0.5 ml: amp. 10 pcs.
		Injection solution 20 mcg/1 ml: amp. 10 pcs.
		Injection solution 40 mcg/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution transparent, colorless, free from visible mechanical inclusions.

Excipients : sodium chloride, chlorobutanol, hydrochloric acid 0.1M, water for injections.

0.5 ml – ampoules of colorless glass (5) – trays (2) – cardboard packs.

* international nonproprietary name recommended by WHO – Desmopressin.

Injection solution transparent, colorless, free from visible mechanical inclusions.

Excipients : sodium chloride, chlorobutanol, hydrochloric acid 0.1M, water for injections.

1 ml – ampoules of colorless glass (5) – trays (2) – cardboard packs.

* international nonproprietary name recommended by WHO – Desmopressin.

Injection solution transparent, colorless, free from visible mechanical inclusions.

Excipients : sodium chloride, chlorobutanol, hydrochloric acid 0.1M, water for injections.

1 ml – ampoules of colorless glass (5) – trays (2) – cardboard packs.

* international nonproprietary name recommended by WHO – Desmopressin.

Clinical-Pharmacological Group

Vasopressin analog. Antidiuretic

Pharmacotherapeutic Group

Remedy for diabetes insipidus

Pharmacological Action

Hemostatic agent. Synthetic analog of 8-arginine vasopressin, possesses the properties of the natural antidiuretic hormone.

The hemostatic effect is due to the ability of desmopressin to increase the concentration of coagulation factor VIII in blood plasma and to promote the release of plasminogen activator in the blood.

Pharmacokinetics

Data on the pharmacokinetics of the drug Emosint are not provided.

Indications

• Hemophilia A (mild and moderate forms);
• Von Willebrand disease type I;
• Preoperative preparation of patients with von Willebrand disease;
• Preparation of uremic patients with prolonged bleeding time for invasive procedures.

ICD codes

Dosage Regimen

Emosint is prescribed at a dose of 0.3 mcg/kg of body weight per day.

Emosint can be administered subcutaneously or intravenously by drip, after dissolving in physiological saline (for body weight less than 10 kg, it is recommended to use 10 ml of physiological saline, for body weight more than 10 kg – 50 ml of physiological saline). The drug is administered intravenously slowly, over 15-30 minutes. Repeated administration of the drug is possible no earlier than after 48 hours.

Adverse Reactions

From the cardiovascular system transient headache; rarely – facial flushing, swelling, increased blood pressure, slight decrease in blood pressure with a corresponding increase in heart rate, thrombosis.

From the digestive system nausea, moderately severe abdominal pain.

From water-electrolyte metabolism rarely – overhydration, hyponatremia.

Allergic reactions in isolated cases – anaphylactic reactions.

Other moderately severe vaginal pain; rarely – burning at the injection site.

Contraindications

• Von Willebrand disease type II;
• Inhibitor form of hemophilia A;
• Hemophilia B;
• Arterial hypertension;
• Chronic nephritis;
• Anuria;
• Edema syndrome of various origins;
• Chronic heart failure;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The safety of using the drug Emosint during pregnancy and lactation has not been established, therefore its use is possible only if the expected benefit to the mother outweighs the possible risk to the fetus and breastfed infant.

Use in Renal Impairment

The drug is contraindicated in chronic nephritis, anuria, edema syndrome of various origins.

Special Precautions

Emosint should be prescribed with caution in bronchial asthma, with a history of epilepsy, migraine, tendency to thrombosis.

When using Emosint, it is necessary to control the volume of fluid consumed, especially in young and elderly patients, to prevent overhydration and hyponatremia.

When using Emosint, it is also necessary to control diuresis, because due to the antidiuretic effect, the drug can retain fluid in the body.

Repeated administration of the drug less than 48 hours later may reduce its effectiveness.

The drug is effective when the activity of blood coagulation factor VIII is more than 5%, therefore it is necessary to monitor the level of coagulation factor VIII in the blood.

During intravenous administration, heart rate should be monitored.

Effect on ability to drive vehicles and mechanisms

Emosint does not affect the ability to drive vehicles and mechanisms.

Overdose

Symptoms intensification of the manifestations of side effects.

Treatment there is no specific antidote. In case of overdose, it is necessary to adjust the dose of the drug or temporarily stop its use.

Drug Interactions

With simultaneous use of Emosint with chlorpropamide, clofibrate, indomethacin, an enhancement of the antidiuretic effect is observed; with simultaneous use with glibutide, carbamazepine – a weakening.

Emosint potentiates the action of hypertensive drugs.

Storage Conditions

The drug should be stored in a light-protected place at a temperature from 2°C (35.6°F) to 8°C (46.4°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.