Desmospray, Desmopressin Nasal Spray
- Name:
Desmospray, Desmopressin Nasal Spray
- Company:
Ferring Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Print ViewKeyword Search SmPC
1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Ferring Ireland Limited
Company Products
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 4 June 2015 PIL
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 4 June 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 June 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 4.8 - 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 15 August 2012 PIL
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
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
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
- 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.
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 SmPC
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
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
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
- 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.
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 PIL
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
Updated on 18 August 2008 SmPC
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
Updated on 5 November 2007 PIL
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Free text change information supplied by the pharmaceutical company
Updated on 5 November 2007 SmPC
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
Updated on 31 October 2007 PIL
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 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 SmPC
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 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 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 15 May 2007 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 13 April 2007 PIL
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
Updated on 13 April 2007 PIL
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
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
Updated on 13 April 2007 SmPC
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
Updated on 13 June 2006 PIL
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
Updated on 13 June 2006 SmPC
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
Updated on 5 July 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 5 July 2005 PIL
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 PIL
Reasons for updating
- New SPC for medicines.ie
Updated on 27 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)