DDAVP/Desmopressin 4 micrograms/ml Solution for Injection

  • Name:

    DDAVP/Desmopressin 4 micrograms/ml Solution for Injection

  • Company:
    info
  • Active Ingredients:

    Desmopressin Acetate

  • Legal Category:

    Product subject to restricted prescription (C)

Summary of Product Characteristics last updated on medicines.ie: 19/7/2018

Click on this link to Download PDF directly

Ferring Ireland Limited

Ferring Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Cortiment 9mg prolonged release tablets Active Ingredients Budesonide
Medicine Name DDAVP Desmopressin 100 micrograms/ml Nasal drops,solution Active Ingredients Desmopressin Acetate
Medicine Name DDAVP/Desmopressin 4 micrograms/ml Solution for Injection Active Ingredients Desmopressin Acetate
Medicine Name Desmospray, Desmopressin Nasal Spray Active Ingredients Desmopressin Acetate
Medicine Name Desmotabs Melt 120 micrograms oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name Desmotabs Melt 240 micrograms oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name Desmotabs Melt 60 micrograms oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name FIRMAGON 120 mg powder and solvent for solution for injection Active Ingredients degarelix acetate
Medicine Name FIRMAGON 80 mg powder and solvent for solution for injection Active Ingredients degarelix acetate
Medicine Name Glypressin 1 mg Powder and Solvent for Solution for Injection Active Ingredients Terlipressin acetate
Medicine Name Glypressin 1 mg/ 8.5 ml solution for injection Active Ingredients Terlipressin acetate
Medicine Name Gonapeptyl Depot 3.75 mg powder and solvent for suspension for injection Active Ingredients triptorelin acetate
Medicine Name Lutinus 100 mg Vaginal Tablets Active Ingredients Progesterone
Medicine Name Menopur 1200IU powder and solvent for solution for injection Active Ingredients Menotrophin
Medicine Name Menopur 600IU powder and solvent for solution for injection Active Ingredients Menotrophin
Medicine Name Menopur 75IU Powder and Solvent for Solution for Injection. Menotrophin (HMG) Active Ingredients Menotrophin
Medicine Name Noqturina 25 microgram oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name Noqturina 50 microgram oral lyophilisate Active Ingredients Desmopressin
Medicine Name Nordurine 0.1 mg Tablets Active Ingredients Desmopressin Acetate
Medicine Name Nordurine 0.2mg Tablets Active Ingredients Desmopressin Acetate
Medicine Name Pabal 100 micrograms/ml solution for injection Active Ingredients Carbetocin
Medicine Name Pentasa 1 g Prolonged-release Tablets Active Ingredients Mesalazine
Medicine Name Pentasa 1 g Suppositories Active Ingredients Mesalazine
Medicine Name Pentasa 10 mg/ml Rectal Suspension Active Ingredients Mesalazine
Medicine Name Pentasa 500 mg Prolonged Release Tablets Active Ingredients Mesalazine
1 - 0 of 35 items.Total: Infinity pages

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 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 26 May 2015 SmPC

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 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

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 SmPC

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 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

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 PIL

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 SmPC

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 PIL

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 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to restricted prescription (C)

Updated on 26 May 2003 SmPC

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