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Desmospray, Desmopressin Nasal Spray

*
Pharmacy Only: Prescription

  • Company:

    Ferring Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Desmopressin Acetate

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

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Updated on 04 June 2015

Reasons for updating

  • New SPC for new product

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

Updated on 04 June 2015

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 4.8 - 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: Updated from ‘Also contains 20 micrograms benzalkonium chloride per actuation’ to ‘1ml Desmospray contains 0.1mg benzalkonium chloride’


Section 4.2:
New 'General' section added - see SPC for information.
New 'Special Populations' section added - see SPC for information.


Section 4.4:

 

New text 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).”

“All patients and, when applicable, their guardians should be carefully instructed to adhere to the fluid restrictions.”

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

“There is some evidence from post-marketing data for the occurrence of severe hyponatraemia in association with the nasal spray formulation of desmopressin when it is used in the treatment of central diabetes insipidus.

Due to the presence of benzalkonium chloride this product may cause bronchospasm.”

Sentence update: “Precautions to avoid……and some antidiabetics of the sulfonylurea group particularly chlorpropamide..”



Section 4.5:
Sentence update: "Substances, which are known to induce SIADH, e.g.,…. as well as some antidiabetics of the sulfonylurea group particularly chlorpropamide,…”

New section:  “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
New section: "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 4.8
Full section update - see SPC

Sections 5.1, 5.2 adn 5.3: Full section updates - see SPC



 

Updated on 04 June 2015

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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

Section 2: Updated from ‘Also contains 20 micrograms benzalkonium chloride per actuation’ to ‘1ml Desmospray contains 0.1mg benzalkonium chloride’


Section 4.2:
New 'General' section added - see SPC for information.
New 'Special Populations' section added - see SPC for information.


Section 4.4:

 

New text 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).”

“All patients and, when applicable, their guardians should be carefully instructed to adhere to the fluid restrictions.”

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

“There is some evidence from post-marketing data for the occurrence of severe hyponatraemia in association with the nasal spray formulation of desmopressin when it is used in the treatment of central diabetes insipidus.

Due to the presence of benzalkonium chloride this product may cause bronchospasm.”

Sentence update: “Precautions to avoid……and some antidiabetics of the sulfonylurea group particularly chlorpropamide..”



Section 4.5:
Sentence update: "Substances, which are known to induce SIADH, e.g.,…. as well as some antidiabetics of the sulfonylurea group particularly chlorpropamide,…”

New section:  “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
New section: "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 4.8
Full section update - see SPC

Sections 5.1, 5.2 adn 5.3: Full section updates - see SPC



 

Updated on 15 August 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Remove the protection cap.
  • Control that the end of the tube inside the bottle is submerged in the liquid.
  • Re-prime the pump if the spray has not been used within the last week.
  • Once it has been primed, the pump delivers one dose each time pressure is applied.
  • The head must be tipped back slightly while inserting the applicator straight into the nostril.
  • When a higher dose is needed, spray alternatively into each nostril.
  • Replace cap after use and store the bottle in an upright position.

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

Free text change information supplied by the pharmaceutical company

Section 4.2:
addition of statement, "Please refer to Section 6.6 for instructions for use and handling"

Section 4.4:
- addition of statement "When used for the treatment of nocturia associated with multiple sclerosis, fluid intake must be limited to a minimum from 1 hour before until 8 hours after administration."
- sentence update as per indication: "When Desmospray is used in the treatment of nocturia associated with multiple sclerosis, periodic assessments should be made of blood pressure and weight to monitor the possibility of fluid overload."
- sentence update: "Treatment with desmopressin should be carefully adjusted interrupted during acute intercurrent illness characterized by fluid and/or electrolyte imbalance (such as systemic infections, fever, and gastroenteritis)."

Section 5.1:
Pharmacotherapeutic group adn ATC code added:

"Pharmacotherapeutic group: Vasopressin and analogues

ATC code: H01B A02"


Section 6.6:
Instructions for handling included:
"Instructions for use:

The patient should blow his/her nose before using the spray

  1. Remove the protection cap.
  2. Control that the end of the tube inside the bottle is submerged in the liquid.
  3. Re-prime the pump if the spray has not been used within the last week.
  4. Once it has been primed, the pump delivers one dose each time pressure is applied.
  5. The head must be tipped back slightly while inserting the applicator straight into the nostril.
  6. When a higher dose is needed, spray alternatively into each nostril.
  7. Replace cap after use and store the bottle in an upright position.

 

The spray bottle should always be stored in an upright position.

 

If there is any doubt concerning the correct intake of the dose, the spray should not be re-administered until the next scheduled dose.

 

In young children, administration should be under strict adult supervision to ensure the correct dosage."

Updated on 15 August 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Remove the protection cap.
  • Control that the end of the tube inside the bottle is submerged in the liquid.
  • Re-prime the pump if the spray has not been used within the last week.
  • Once it has been primed, the pump delivers one dose each time pressure is applied.
  • The head must be tipped back slightly while inserting the applicator straight into the nostril.
  • When a higher dose is needed, spray alternatively into each nostril.
  • Replace cap after use and store the bottle in an upright position.

Free text change information supplied by the pharmaceutical company

Section 4.2:
addition of statement, "Please refer to Section 6.6 for instructions for use and handling"

Section 4.4:
- addition of statement "When used for the treatment of nocturia associated with multiple sclerosis, fluid intake must be limited to a minimum from 1 hour before until 8 hours after administration."
- sentence update as per indication: "When Desmospray is used in the treatment of nocturia associated with multiple sclerosis, periodic assessments should be made of blood pressure and weight to monitor the possibility of fluid overload."
- sentence update: "Treatment with desmopressin should be carefully adjusted interrupted during acute intercurrent illness characterized by fluid and/or electrolyte imbalance (such as systemic infections, fever, and gastroenteritis)."

Section 5.1:
Pharmacotherapeutic group adn ATC code added:

"Pharmacotherapeutic group: Vasopressin and analogues

ATC code: H01B A02"


Section 6.6:
Instructions for handling included:
"Instructions for use:

The patient should blow his/her nose before using the spray

  1. Remove the protection cap.
  2. Control that the end of the tube inside the bottle is submerged in the liquid.
  3. Re-prime the pump if the spray has not been used within the last week.
  4. Once it has been primed, the pump delivers one dose each time pressure is applied.
  5. The head must be tipped back slightly while inserting the applicator straight into the nostril.
  6. When a higher dose is needed, spray alternatively into each nostril.
  7. Replace cap after use and store the bottle in an upright position.

 

The spray bottle should always be stored in an upright position.

 

If there is any doubt concerning the correct intake of the dose, the spray should not be re-administered until the next scheduled dose.

 

In young children, administration should be under strict adult supervision to ensure the correct dosage."

Updated on 18 August 2008

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Section 6.3  Shelf-life extended from 2 years to 3 years.
Section 10  Date of revision of text changed to May 2008.

Updated on 18 August 2008

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 6.3  Shelf-life extended from 2 years to 3 years.
Section 10  Date of revision of text changed to May 2008.

Updated on 05 November 2007

Reasons for updating

  • 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 6.6 (Instructions for Use and Handling) - Addition of sentence 'The spray bottle should always be stored in an upright position'

Updated on 05 November 2007

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

Section 6.6 (Instructions for Use and Handling) - Addition of sentence 'The spray bottle should always be stored in an upright position'

Updated on 31 October 2007

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 3 (pharmaceutical form): Inserted the phrase 'clear, colourless solution)
section 6. 6 (Instruction for Use/Handling): Removed the paragraph 'Instructions for use' and replaced with the phrase 'For further instructions for use, see section 4.2'

Updated on 31 October 2007

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

section 3 (pharmaceutical form): Inserted the phrase 'clear, colourless solution)
section 6. 6 (Instruction for Use/Handling): Removed the paragraph 'Instructions for use' and replaced with the phrase 'For further instructions for use, see section 4.2'

Updated on 15 May 2007

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 15 May 2007

Reasons for updating

  • Correction of spelling/typing errors

Updated on 13 April 2007

Reasons for updating

  • 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

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

Updated on 13 April 2007

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 13 April 2007

Reasons for updating

  • 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

Free text change information supplied by the pharmaceutical company

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

Updated on 13 April 2007

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

Free text change information supplied by the pharmaceutical company

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

Updated on 13 June 2006

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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 4.2 - Dosage has been reduced and extra warnings added
Section 4.3 - Contraindications added
Section 4.4 - Extra warnings and precautions added
Seciton 4.5 - Further information added re other medicinal products which may effect Desmospray
Section 4.6 - Further data added re use of Desmospray in pregnant women
Section 4.8 - More detail added re undesirable effects
Section 4.9 - Further guidance provided re overdose
Section 6.6 - Further guidance re correct use of Desmospray

Updated on 13 June 2006

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

Section 4.2 - Dosage has been reduced and extra warnings added
Section 4.3 - Contraindications added
Section 4.4 - Extra warnings and precautions added
Seciton 4.5 - Further information added re other medicinal products which may effect Desmospray
Section 4.6 - Further data added re use of Desmospray in pregnant women
Section 4.8 - More detail added re undesirable effects
Section 4.9 - Further guidance provided re overdose
Section 6.6 - Further guidance re correct use of Desmospray

Updated on 05 July 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 medical prescription which may be renewed (B)

Updated on 05 July 2005

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

Ferring Ireland Limited

Ferring Ireland Limited