DDAVP/Desmopressin 4 micrograms/ml Solution for Injection
- Name:
DDAVP/Desmopressin 4 micrograms/ml Solution for Injection
- Company:
Ferring Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to restricted prescription (C)
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Ferring Ireland Limited
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 19 July 2018 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to restricted prescription (C)
Updated on 26 May 2015 SPC
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 PIL
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 SPC
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 PIL
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 PIL
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Free text change information supplied by the pharmaceutical company
Updated on 16 October 2007 SPC
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 27 August 2007 PIL
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Updated on 27 August 2007 SPC
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 June 2005 SPC
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 PIL
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 PIL
Reasons for updating
- New SPC for medicines.ie
Updated on 26 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to restricted prescription (C)
Updated on 26 May 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to restricted prescription (C)
Updated on 26 May 2003 PIL
Reasons for updating
- New SPC for medicines.ie