DDAVP/Desmopressin 4 micrograms/ml Solution for Injection *
Pharmacy Only: Prescription

  • 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

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

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 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 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 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 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