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SPC, UK: DDAVP/Desmopressin Injection (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Ferring Pharmaceuticals Ltd
Διεύθυνση :
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
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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. Adults: The usual dose is 1 to 4 micrograms given once daily. Children and infants: Doses from 0.4 micrograms ...

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