DDAVP/Desmopressin 4 micrograms/ml Solution for Injection *

  • Company:

    Ferring Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to restricted prescription (C)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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

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 4.4Full 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

Change to product name: update document title to align with SPC name

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

Change to product name: update document title to align with SPC name

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

Section 4.5 - Updated Interactions to include NSAIDS
Section 4.8 - Updated Undesirable effects to include allergic skin reactions, severe general rections, rare cases of emotional disorders including aggression in children.

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

Section 4.5 - Updated Interactions to include NSAIDS
Section 4.8 - Updated Undesirable effects to include allergic skin reactions, severe general rections, rare cases of emotional disorders including aggression in children.

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

Change to section 9 (Date of Renewal of Authorisation): Changed to Date of first authorisation: 17th February 1977.  Date of last renewal: 17th February 2007 

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

Change to section 9 (Date of Renewal of Authorisation): Changed to Date of first authorisation: 17th February 1977.  Date of last renewal: 17th February 2007 

Updated on 27 August 2007

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

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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

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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

Updated on 26 June 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

Legal category:Product subject to restricted prescription (C)

Updated on 26 May 2003

Reasons for updating

  • New SPC for medicines.ie