DDAVP Desmopressin 100 micrograms/ml Nasal drops,solution

  • Name:

    DDAVP Desmopressin 100 micrograms/ml Nasal drops,solution

  • Company:
    info
  • Active Ingredients:

    Desmopressin Acetate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Summary of Product Characteristics last updated on medicines.ie: 19/10/2017
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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
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Medicine Name Desmotabs Melt 60 micrograms oral lyophilisate Active Ingredients Desmopressin Acetate
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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
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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 October 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4:

Sentence updates:
- "Patients should be warned to avoid ingesting water while swimming. and to discontinue DDAVP/Desmopressin Nasal Drops solution during an episode of vomiting and/or diarrhoea until their fluid balance is once again normal. "

- "
Treatment with desmopressin should be interrupted or carefully adjusted during acute intercurrent illness characterised by fluid and/or electrolyte imbalance (such as systemic infections, fever, gastroenteritis)."

Updated on 19 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 October 2015 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 4.4 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

Section 2: text reworded to state "1 ml contains 100 micrograms desmopressin acetate equivalent to 89 microgram desmopressin."

Section 4.2:  text reformatted.

 

New section, 'General' stating:

"The rhinyle tube has a graduated scale corresponding to 2.5 µg, 5 µg, 10 µg, 15 µg and 20 µg desmopressin acetate.

Method of administration: see instruction in sections 6.5 and 6.6.

Fluid restriction should be observed (see indication specific instructions in section 4.4).

In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain, and in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered.  When restarting treatment strict fluid restriction should be enforced (see section 4.4)."

 

New section ‘Special Populations’, see SPC.

 

Section 4.4:

Following sentences added:

 “Treatment without concomitant reduction of fluid intake may lead to water retention and/or hyponatraemia with or without accompanying warning signs and symptoms (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions).”

“Infants, elderly and patients with serum sodium levels in the lower range of normal may have an increased risk of hyponatraemia. “

“Precautions must be taken in patients at risk for increased intracranial pressure.”

“Desmopressin should be used with caution in patients with conditions characterised by fluid and/or electrolyte imbalance.”

 

Section 4.5:

Sentence update:Substances, which are known to induce SIADH, e.g., tricyclic antidepressants, selective serotonine reuptake inhibitors, chlorpromazine and carbamazepine, as well as some antidiabetics of the sulfonylurea group particularly chlorpropamide, may cause an additive antidiuretic effect leading to an increased risk of fluid retention/hyponatraemia (see section 4.4 Special Warnings and Precautions for Use).”

 

Sentence added: “It is unlikely that desmopressin will interact with drugs affecting hepatic metabolism, since desmopressin has been shown not to undergo significant liver metabolism in in vitro studies with human microsomes. However, formal in vivo interaction studies have not been performed. “

 


Section 4.6:

Sentence updated:Published data on a limited number of exposed pregnancies in women with diabetes insipidus (n=53) as well as data on exposed pregnancies in women with bleeding complications (n=216) indicate no adverse effects of desmopressin on pregnancy or on the health of the foetus/newborn child.”

Sentences added: “Animal reproduction studies have shown no clinically relevant effects on parents and offspring. In vitro analysis of human cotyledon models have shown that there is no transplacental transport of desmopressin when administered at therapeutic concentration corresponding to recommended dose. “


Section 4.7:

Text updated from “None” to “DDAVP/Desmopressin Nasal drops solution has no or negligible influence on the ability to drive and use machines.”


Section 4.8:

Full section update – see SPC


Section 5.1:

Full section update – see SPC


Section 5.2:

Full section update – see SPC


Section 5.3:

Full section update – see SPC

 

Updated on 19 June 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8: reporting of side effects information updated

Updated on 8 January 2014 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.5:
New sentence: The rhinyle tube has 5 dosing marks: 0.025 ml, 0.050 ml, 0.100 ml, 0.150 ml and 0.200 ml.

Section 6.6:
Sentence deleted:  The unnumbered mark between the end and the 0.05ml mark is approximately at the 0.025ml position.

Updated on 17 September 2007 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section10 
date changed to May 2007

Updated on 13 April 2007 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Primary Nocturnal Enuresis indication has been removed from all sections of the SPC

Updated on 19 July 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

All changes made due to assessment of renewal

Updated on 16 August 2005 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

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 medical prescription which may be renewed (B)

Updated on 9 June 2005 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 25 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)