The Go Medical Nasal Spray device is a hand-activated nasal spray for the delivery of medications or solutions to the nasal mucosa. The device is supplied empty and is intended to be filled prior to use.
The Nasal Spray device comes in two main variants, i.e. No-Lockout and Lockout variants. The Lockout variants are designed with 2-minute, 3-minute and 4-minute lockout times.
The general features for the Nasal Spray device include the following:
- Amber glass container minimises drug absorption and provides UV protection for drugs that are light-sensitive.
- Wide flanges enable easy pressing of the actuator to deliver a dose.
- Protective cap minimises contamination while the device is not being used.
In addition, the Lockout variant has a novel feature where Flow Control Tubing (FCT) is used to control the refilling rate into the dose chamber of the actuator. This essentially provides a lockout time between sprays as the dose chamber needs to be filled to sufficient volume before the spray will be fully atomised for effective delivery.
All Nasal Spray devices are supplied non-sterile.
Product History
The Nasal Spray device has been manufactured since 1997 and sold in Australia, Europe and the USA. The device has been registered on the ARTG (entry 159773) and has a CE Mark.
In the USA, the Nasal Spray is labelled as a Nasal Inhaler and is not classified as a medical device.
Intended Purpose
The Nasal Spray device is intended to deliver medication or other substances to the nasal passages for localized or systemic effects. The device delivers a controlled quantity of fluid in an atomized spray when administered by pressing the spray pump. The device is supplied empty and is intended to be filled prior to use. The Lockout variants have a flow restrictor to limit the volume per hour available to be delivered.
Device Variants
Nasal Spray PCA – No Lockout
| Device Name | Catalogue Number |
|---|---|
| Nasal Spray – No Lockout (5ml) Screw Top | NSS 000 |
| Nasal Inhaler – No Lockout (5ml) Screw Top | AAM 3000 |
| Nasal Spray – No Lockout (10ml) Screw Top | NSS 001 |
| Nasal Inhaler – No Lockout (10ml) Screw Top | AAM 3010 |
Nasal Spray PCA - Lockout
| Device Name | Catalogue Number |
|---|---|
| Nasal Spray PCA – 2 Minute Lockout (5ml) Screw Top | NSS 020 |
| Nasal Inhaler – 2 Minute Lockout (5ml) Screw Top | AAM 3002 |
| Nasal Spray PCA – 3 Minute Lockout (10ml) Screw Top | NSS 030 |
| Nasal Inhaler – 3 Minute Lockout (10ml) Screw Top | AAM 3003 |
| Nasal Spray PCA – 4 Minute Lockout (10ml) Screw Top | NSS 040 |
| Nasal Inhaler – 4 Minute Lockout (10ml) Screw Top | AAM 3004 |
Reference Material
The following papers report on the safely and clinical effectiveness of the Go Medical Nasal Spray device.
- Finn, J. et al., 2004. A randomised crossover trial of patient controlled intranasal fentanyl and oral morphine for procedural wound care in adult patients with burns. Burns : journal of the International Society for Burn Injuries, 30(3), pp.262–8. Available at: http://www.ncbi.nlm.nih.gov/pubmed/15082356
- Hallett, a et al., 2000. Patient-controlled intranasal diamorphine for postoperative pain: an acceptability study. Anaesthesia, 55(6), pp.532–9. Available at: http://www.ncbi.nlm.nih.gov/pubmed/10866715
- Lim, S., Paech, M.J., Sunderland, V.B., Roberts, M.J., Banks, S.L. & Rucklidge, M.W.M. 2003. Pharmacokinetics of Nasal Fentanyl. Journal of Pharmacy Practice and Research, 33(1), pp.59–63
- O'Neil G, Peach M, Wood F. Preliminary clinical use of a patient-controlled intranasal analgesia (PCINA) device. Anaesth Intens Care 1997; 25:408-412. Available at: http://www.ncbi.nlm.nih.gov/pubmed/9288385
- Paech, M.J. et al., 2003. A new formulation of nasal fentanyl spray for postoperative analgesia: a pilot study. Anaesthesia, 58(8), pp.740–4. Available at: http://www.ncbi.nlm.nih.gov/pubmed/12859464.
- Zeppetella, G., 2000. An assessment of the safety, efficacy, and acceptability of intranasal fentanyl citrate in the management of cancer-related breakthrough pain: a pilot study. Journal of pain and symptom management, 20(4), pp.253–8. Available at: http://www.ncbi.nlm.nih.gov/pubmed/11027906