DESMOTABS Tablet (2011)
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
DESMOTABS 0.2mg.
Qualitative and quantitative composition
Each tablet contains 0.2mg desmopressin acetate. For excipients, see 6.1.
Pharmaceutical form
Tablet. Uncoated, white, round, convex tablets scored on one side and engraved 0.2 on the other side.
Therapeutic indications
Desmopressin tablets are indicated for the treatment of primary nocturnal enuresis.
Posology and method of administration
Children (from 5 years of age) and adults (up to 65 years of age) with normal urine concentrating ability who have primary nocturnal enuresis should take 0.2mg at bedtime and only if needed should the ...
Contraindications
Desmopressin tablets are contraindicated in cases of cardiac insufficiency and other conditions requiring treatment with diuretic agents. Desmopressin tablets should only be used in patients with normal ...
Special warnings and precautions for use
Care should be taken with patients who have reduced renal function and/or cardiovascular disease or cystic fibrosis. In chronic renal disease the antidiuretic effect of desmopressin tablets would be less ...
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 desmopressin tablets 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
In its main biological effects, desmopressin does not differ qualitatively from vasopressin. However, desmopressin is characterised by a high antidiuretic activity whereas the uterotonic and vasopressor ...
Pharmacokinetic properties
The absolute bioavailability of orally administered desmopressin varies between 0.08% and 0.16%. Mean maximum plasma concentration is reached within 2 hours. The distribution volume is 0.2–0.32 l/kg. Desmopressin ...
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
Lactose monohydrate Potato starch Povidone Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
Do not store above 25°C. Keep the container tightly closed.
Nature and contents of container
30ml High Density Polyethylene (HDPE) bottle with a tamper-proof, twist-off polypropylene (PP) closure with a silica gel desiccant insert. Each bottle contains 7, 30 or 90 tablets. Not all pack sizes may ...
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)
PL 03194/0046
Date of first authorization / renewal of the authorization
19th April 1999
Date of revision of the text
June 2011
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