Ayendi 720micrograms/actuation nasal spray

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diamorphine hydrochloride

Available from:

Wockhardt UK Ltd

ATC code:

N07BC06

INN (International Name):

Diamorphine hydrochloride

Dosage:

720microgram/1dose

Pharmaceutical form:

Spray

Administration route:

Nasal

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5012727907550 5012727912653

Patient Information leaflet

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Wockhardt UK Limited
Ayendi common leaflet
105742/4
n-a
420 x 148mm
chris.jenney
1
10/08/2016
678658
42
6pt (Main Body) / 7pt (Variables)
UK
English
42
PACKAGE LEAFLET: INFORMATION FOR THE USER
AYENDI 1600 MICROGRAM/ACTUATION NASAL SPRAY
AYENDI 720 MICROGRAM/ACTUATION NASAL SPRAY
Diamorphine hydrochloride
(referred to as Ayendi Nasal Spray
throughout this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor
or pharmacist.
-
This medicine has been prescribed only for you.
Do not pass it on to others. It may harm them even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Ayendi Nasal Spray is and what it is used for
2. What you need to know before you are given Ayendi
Nasal Spray
3. How you will be given Ayendi Nasal Spray
4. Possible side effects
5. How to store Ayendi Nasal Spray
6. Contents of the pack and other information
1. WHAT AYENDI NASAL SPRAY IS AND WHAT IT IS USED
FOR
Ayendi Nasal Spray is used in hospital emergency
departments for the relief of severe pain caused by
accidental

Summary of Product characteristics

OBJECT 1
AYENDI 720MICROGRAM/ACTUATION NASAL SPRAY
Summary of Product Characteristics Updated 23-Feb-2017 | Wockhardt UK
Ltd
1. Name of the medicinal product
Ayendi 720microgram/actuation Nasal Spray
2. Qualitative and quantitative composition
Each bottle contains diamorphine 72mg (8ml bottle)/144mg (17ml bottle)
as diamorphine hydrochloride
(equivalent to 720microgram in each 50microlitre spray following
reconstitution).
When reconstituted the spray contains 0.02% benzalkonium chloride.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Powder and diluent for reconstitution for nasal spray, solution
AFTER RECONSTITUTION
_Nasal spray, solution_
A clear, colourless to pale straw coloured solution
BEFORE RECONSTITUTION
_Nasal spray, powder for solution_
A white to off-white, freeze-dried powder.
_Diluent_ _for reconstitution_
Clear, colourless 0.5%w/v preserved saline solution.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of acute severe nociceptive pain in children and
adolescents 2 to 15 years of age in a
hospital setting. Ayendi Nasal Spray should be administered in the
emergency setting by practitioners
experienced in the administration of opioids in children and with
appropriate monitoring.
4.2 Posology and method of administration
The 720micrograms/actuation Nasal Spray is only suitable for children
weighing between 12kg and less
than 30kg. For patients from 30kg to 50kg the 1600micrograms/actuation
Nasal Spray should be used.
_Posology_
The dose should not be repeated.
Patients should be dosed according to weight.
CHILD WEIGHT
(KG)
APPROX AGE (YEARS)
NO OF SPRAYS
DOSE ADMINISTERED
12 – <18
2-5
2
1.44mg
18 – <24
5-8
3
2.16mg
24 - <30
8-10
4
2.88mg
_Method of administration_
Ayendi Nasal Spray is for nasal use only.
A NEW TIP SHOULD BE USED FOR ANY NEW PATIENT TO AVOID RISK OF
MICROBIAL CONTAMINATION AND SOILING
OF THE TIP.
Ensure that the dip tube remains in the solution during priming and
re-priming to avoid air entering the
pump spray and affecting dose uniformi