DDAVP MELT Oral lyophilisate (2011)
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Περιεχόμενα
Name of the medicinal product
DDAVP Melt 60 micrograms oral lyophilisate. DDAVP Melt 120 micrograms oral lyophilisate. DDAVP Melt 240 micrograms oral lyophilisate.
Qualitative and quantitative composition
Each unit contains 60, 120 or 240 micrograms desmopressin (as acetate). For excipients, see 6.1.
Pharmaceutical form
Oral lyophilisate. <u>DDAVP Melt 60 micrograms oral lyophilisate:</u> White, round, oral lyophilisate marked with a drop shaped figure on one side. <u>DDAVP Melt 120 micrograms oral lyophilisate:</u> White, ...
Therapeutic indications
DDAVP Melt is indicated for the treatment of vasopressin-sensitive cranial diabetes insipidus or in the treatment of post-hypophysectomy polyuria/polydipsia.
Posology and method of administration
DDAVP Melt is for sublingual use. Treatment of diabetes insipidus Dosage is individual in diabetes insipidus but the total daily sublingual dose normally lies in the range of 120 micrograms to 720 micrograms. ...
Contraindications
DDAVP Melt is contraindicated in cases of cardiac insufficiency and other conditions requiring treatment with diuretic agents. Before prescribing DDAVP Melt, the diagnoses of psychogenic polydipsia and ...
Special warnings and precautions for use
Care should be taken with patients who have reduced renal function and/or cardiovascular disease. In chronic renal disease the antidiuretic effect of DDAVP Melt would be less than normal. Precautions to ...
Interaction with other medicinal products and other forms of interaction
Substances which are known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine and carbamazepine, may cause an additive antidiuretic effect leading ...
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
None.
Undesirable effects
Side-effects include headache, stomach pain and nausea. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including ...
Overdose
An overdose of DDAVP Melt leads to a prolonged duration of action with an increased risk of water retention and/or hyponatraemia. Treatment Although the treatment of hyponatraemia should be individualised, ...
Pharmacodynamic properties
Pharmacotherapeutic group: vasopressin and analogues ATC code: H01BA02 In its main biological effects, DDAVP does not differ qualitatively from vasopressin. However, DDAVP is characterised by a high antidiuretic ...
Pharmacokinetic properties
The overall mean systemic bioavailability of desmopressin administered sublingually as Melts at doses of 200, 400 and 800 micrograms is 0.25% with a 95% confidence interval of 0.21%-0.31%. The C<sub>max ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Gelatin Mannitol Citric acid, anhydrous
Incompatibilities
Not applicable.
Shelf life
48 months.
Special precautions for storage
Store in the original package in order to protect from moisture and light.
Nature and contents of container
PVC/Polyamide/Aluminium/Polyamide/PVC blisters. Top foil consists of Paper/Polyester teraphthalate/Aluminium/heat seal lacquer. Strips of 10 oral lyophilisates in packs of 100 oral lyophilisates.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
Marketing authorization number(s)
DDAVP Melt 60 micrograms oral lyophilisate PL 03194/0091 DDAVP Melt 120 micrograms oral lyophilisate PL 03194/0092 DDAVP Melt 240 micrograms oral lyophilisate PL 03194/0093
Date of first authorization / renewal of the authorization
19<sup>th</sup> January 2006
Date of revision of the text
June 2011
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