DDAVP DESMOPRESSIN Solution for injection (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
DDAVP/Desmopressin Injection.
Qualitative and quantitative composition
Each 1ml ampoule contains Desmopressin acetate 4 micrograms per ml.
Pharmaceutical form
Solution for injection.
Therapeutic indications
DDAVP/Desmopressin Injection is indicated as follows : Diagnosis and treatment of cranial diabetes insipidus. To increase Factor VIII:C and Factor VIII:Ag in patients with mild to moderate haemophilia ...
Posology and method of administration
Treatment of Cranial Diabetes Insipidus By subcutaneous, intramuscular or intravenous injection. <u>Adults:</u> The usual dose is 1 to 4 micrograms given once daily. <u>Children and infants:</u> Doses ...
Contraindications
DDAVP/Desmopressin Injection is contraindicated in cases of: GENERAL: habitual and psychogenic polydipsia RENAL FUNCTION TESTING, TREATMENT OF LUMBAR PUNCTURE HEADACHE OR FIBRINOLYTIC RESPONSE TESTING: ...
Special warnings and precautions for use
GENERAL Precautions to prevent fluid overload must be taken in: conditions characterised by fluid and/or electrolyte imbalance patients at risk for increased intracranial pressure Care should be taken ...
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/Desmopressin injection leads to a prolonged duration of action with an increased risk of water retention and/or hyponatraemia. Treatment Although the treatment of hyponatraemia should ...
Pharmacodynamic properties
Desmopressin is a structural analogue of vasopressin in which the antidiuretic activity has been enhanced by the order of 10, while the vasopressor effect has been reduced by the order of 1500. The clinical ...
Pharmacokinetic properties
Following intravenous injection, plasma concentrations of Desmopressin follow a biexponential curve. The initial fast phase of a few minutes duration and with a half life of less than 10 minutes is thought ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections of the SPC.
List of excipients
Sodium Chloride EP Hydrochloric Acid EP Water for Injection EP
Incompatibilities
None known.
Shelf life
Shelf life of unopened ampoule: 48 months.
Special precautions for storage
To be stored in a refrigerator at 2°C to 8°C.
Nature and contents of container
Carton containing 10 1ml clear Type I glass ampoules. Each ampoule contains 1ml of a sterile, clear, colourless solution for injection.
Special precautions for disposal and other handling
As indicated under the posology and method of administration section.
Marketing authorization holder
Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
Marketing authorization number(s)
PL 03194/0002
Date of first authorization / renewal of the authorization
10th September 1998
Date of revision of the text
June 2011
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