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DESMOPRESSIN Nasal spray, solution (2019)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης Ferring Pharmaceuticals Ltd
Διεύθυνση Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
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Περιεχόμενα

Name of the medicinal product

Desmopressin Spray 10 Micrograms/dose, nasal spray, solution.

Qualitative and quantitative composition

1 ml of nasal spray, solution contains: 100 micrograms desmopressin acetate trihydrate corresponding to 89 micrograms desmopressin. One actuation of 0.1 ml delivers 10 micrograms of desmopressin acetate ...

Pharmaceutical form

Nasal spray, solution. Clear colourless solution.

Therapeutic indications

Treatment of vasopressin-sensitive central diabetes insipidus. Diagnostic test of the renal concentrating capacity.

Posology and method of administration

For nasal use. Before application blow the nose. Place nozzle inside the nostril and press once. One actuation delivers a dose of 10 micrograms desmopressin acetate trihydrate. If higher doses are prescribed ...

Contraindications

Hypersensitivity to desmopressin or any of the excipients listed in section 6.1. Primary polydipsia and polydipsia due to alcohol abuse. Hyponatraemia or risk of developing hyponatraemia. Cardiac insufficiency ...

Special warnings and precautions for use

Desmopressin should be used with caution in patients with coronary heart disease, hypertension and severe hypertension or fluid and electrolyte imbalance (such as patients with renal impairment or cystic ...

Interaction with other medicinal products and other forms of interaction

Clofibrate, chlorpromazine, carbamazepine, tricyclic anti-depressants, serotonin reuptake inhibitors and non steroidal antiinflammatory medicinal products (NSAIDs) may enhance the antidiuretic effect of ...

Pregnancy and lactation

Pregnancy Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus indicate rare cases of malformations in children treated during pregnancy. To date, no other relevant epidemiological ...

Effects on ability to drive and use machines

No studies on the effect of Desmopressin Spray on the ability to drive and use machines have been performed. Desmopressin has no known effect on the ability to drive and use machines.

Undesirable effects

The following undesirable effects of desmopressin were recorded from clinical studies and postmarketing experience. Adverse reactions are listed according to the following categories: Very common: > 1/10 ...

Overdose

An overdose prolongs the antidiuretic effect and subsequently increases the risk of hyperhydration. Therefore, symptoms such as increase in body weight, headache, nausea, gastrointestinal cramps and in ...

Pharmacodynamic properties

Pharmacotherapeutic group: Posterior pituitary lobe hormones, Vasopressin and analogues. ATC code: H01BA02 Desmopressin is a synthetic analogue of the natural human neurohypophyseal hormone L-arginine ...

Pharmacokinetic properties

After intranasal administration of desmopressin, the maximum plasma concentration is attained after about 50 minutes. The plasma half-life is 2-3 hours. Desmopressin is excreted via the kidneys. After ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and toxicity to reproduction. Impairment of renal function, with a rise in serum ...

List of excipients

Citric acid, monohydrate Disodium phosphate dihydrate Sodium chloride Purified water

Incompatibilities

Not applicable.

Shelf life

Shelf life: 18 months. Shelf life after first opening: 4 weeks.

Special precautions for storage

Store in the original package. Do not store above 25°C. Store in upright position.

Nature and contents of container

Type I amber glass bottle fitted with a metering pump composed of polypropylene, polyethylene and thermoplastic components secured with a snap on system. Pack sizes: 6 ml.

Special precautions for disposal and other handling

No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Aspire Pharma Limited, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Marketing authorization number(s)

PL 35533/0145

Date of first authorization / renewal of the authorization

08/04/2007

Date of revision of the text

15/01/2019

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