DESMOPRESSIN Nasal spray, solution (2019)
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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