DDAVP/Desmopressin 4 micrograms/ml Solution for Injection
*Company:
Ferring Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 July 2018
File name
DDAVP Desmopressin 4ugml Sol for inj SPC_in line with license dated 12 7 2018.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 2: reworded. Sodium content added.
Section 4.2: Special populations added along with other minor updates
Section 4.3: Full section update, see SPC
Section 4.4: Full section update, see SPC
Section 4.5: Full section update, see SPC
Section 4.6: Full section update, see SPC
Section 4.7: updated to
“DDAVP/Desmopressin Injection has no or negligible influence on the ability to drive and use machines.”
Section 4.8: full section update. Summary of the safety profile added. Table of reported ADRs fully updated. Refer to SPC.
Section 4.9: text updated to:
“Symptoms
Overdose of DDAVP/Desmopressin Injection leads to a prolonged duration of action with an increased risk of water retention and hyponatraemia.
Treatment
The treatment of hyponatraemia should be individualised and can include discontinuation of DDAVP/Desmopressin treatment, fluid restriction and symptomatic treatment.”
Section 5.1, 5.2 and 5.3: Full section update, see SPC
Section 6.4: Text updated to:
“Keep container in the outer carton in order to protect from light.”
Section 6.6: text added:
“For intravenous infusion, the dose should be diluted in 50 ml of 0.9% sodium chloride for injection.”
Updated on 26 May 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 26 May 2015
Reasons for updating
- Change to product name
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 4.8: Update to include new HPRA contact information
Updated on 26 May 2015
Reasons for updating
- Change to product name
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Free text change information supplied by the pharmaceutical company
Section 4.8: Update to include new HPRA contact information
Updated on 14 October 2008
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 14 October 2008
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Updated on 16 October 2007
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 16 October 2007
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Free text change information supplied by the pharmaceutical company
Updated on 27 August 2007
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 27 August 2007
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Updated on 27 June 2005
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 27 June 2005
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to restricted prescription (C)
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Updated on 26 May 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to restricted prescription (C)
Updated on 26 May 2003
Reasons for updating
- New SPC for medicines.ie