BD UnijectTM Auto-disable Prefillable Injection System Bridging the Gap

Transcription

1 BD UnijectTM Auto-disable Prefillable Injection System Bridging the Gap BD-Brochure_Uniject_e06.indd 1 10/06/ :27

2 What is the gap BD is trying to bridge? For developing countries, prefilled syringes are often perceived as too costly. It is one of the reasons why these countries mostly use vials. However, with vials, there is a greater risk of medication or dosing errors when compared to prefilled syringes. Moreover, their utilization requires trained healthcare workers. These issues can be solved by an economical Auto-disable Prefillable Injection System: BD Uniject. Current Issues/Gaps in Developing Markets u High Cost Prefilled syringes are often perceived as too costly for price sensitive drugs and markets.4,7 Use of multi-dose vials leads to doses being wasted i.e. higher per dose cost to the program. 1,3 u Medication & Dosing Errors7 Risk of over/under dose with vial usage. Risk of receiving the wrong drug/vaccine. u Injection Associated Infections1,3 Risk of cross contamination/transmission of blood borne pathogens through syringe reuse. Risk of needlestick injuries (preparation and administration). BD Uniject is linking innovative pharmaceutical drugs with people who need them in developing countries. This, in a Safe, Simple and Sensible way. BD-Brochure_Uniject_e06.indd /06/ :27

3 To bridge that gap, BD offers a Product that is Safe Simple Sensible. u Safe Benefits for the patients and frontline healthcare providers 2,3,4 How Safe and Sensible is BD Uniject TM? Features and Benefits. BD Uniject helps reduce medication and dosage error. 7 The unique, single dose design cannot be reused inadvertently or intentionally. 1,3 High patient comfort ensured by the advanced BD needle technology. 1,4 u Simple Benefits for medical programs 1,3,4,6 Enhances the distribution of an injection system with a compact profile. After training, may be used by non-professional healthcare workers, taking less time per injection in outreach programs that increases coverage. Reduced contaminated materials requiring disposal. u Sensible Benefits for pharmaceutical companies 5 An economical, low cost, entry level prefillable option. Enhanced product image and differentiation through a unique design. Reduced particulates in medication guaranteed by an elastomer and silicone free drug reservoir (sterilization ensured through gamma radiation). All-in-one construction simplifying logistics for filling (only a single packaging item to track). Unique configuration discourages counterfeiting. Minimized overfill and medication waste in a low-dead-space design. Prefilled drug reservoir Silicone and elastomer free to minimize drug interactions and particulates > Delivers the required dosage of medication to reduce waste and cost Transparent > i.e., easy, fast medication inspection Collapse after use > Not refillable and/or usable Valve disc Between the reservoir and the isolation barrier > Prevents refilling Double-pointed needle 1,4,6 Allows smooth piercing of the reservoir when activating BD Uniject TM syringe > High patient comfort level ensured by the advanced BD needle technology Port Connects the needle to the reservoir Needle assembly Consists of needle and hub Covered by the needle shield until injection How Simple is BD Uniject TM? Activation and Use. Remove BD Uniject TM System from secondary packaging Activate BD Uniject TM System Remove the needle shield Insert the needle into the patient Inject contents by squeezing the reservoir and discard BD Uniject TM System Do not reshield. Discard the used device according to established medical waste disposal procedures. Drug reservoir Port Close the gap Needle shield BD-Brochure_Uniject_e06.indd /06/ :27

4 Regulatory and Technical Support Standard Product Offering u Regulatory support BD can support your regulatory applications through a streamline process with some document available at your request. Provides a Technical Dossier (TD) or a Letter of Authorization (LoA) upon request to support the preparation of customer s regulatory files. Request your LoA and TD online in just a few clicks on: Assists in your responsive to the relevant regulatory authority if inquiry related to drug delivery system is requested by them. Provides documentation information to ease your approval process. BD Uniject System has been designed and tested to meet the standards of: WHO (World Health Organization) The US and European pharmacopoeia Product Type Catalog N Barrel Size Needle Length Needle Gauge BD Uniject ml 5/8 in 25 G BD Uniject ml 1 in 23 G TW BD Uniject ml 3/8 in 23 G TW BD Uniject ml 5/8 in 25 G BD Uniject ml 1 in 23 G TW BD Uniject ml 5/4 in 23 G TW u Technical support BD partners with you to understand your product manufacturing plans and works closely with your technical team and machine suppliers to: Advise pharmaceutical companies on new developments relative to BD Uniject Auto-Disable Prefillable Injection system. Provide assistance in technical questions before or during customer processing. Offer expertise and knowledge of pharmaceutical operations from the start-up phase to routine production. Provide a Technical Dossier upon request. Vol.1 ml Needle 3/8 in Vol. 0.5 ml Needle 5/8 in Vol. 1 ml Needle 1 in Vol. 1 ml Needle 5/4 in BD-Brochure_Uniject_e06.indd 7 10/06/ :27

5 BD Medical Pharmaceutical Systems References: 1. The BD Uniject injection system: Multi-country experience and evidence. Path, Childress_ Vaccines in the BD Uniject injection system, Path, Brooke_ HealthTech - Historical Profile, Path, Status Report on the BD Uniject Prefilled Injection Device, Path, Fleming_ BD Uniject technical manual, Edition 4, June Provider acceptability of Sayana Press: results from community health workers and clinic-based providers in Uganda and Senegal, Burke et al., Single dose versus multi dose vaccine vials for immunization programmes in developing countries, Bulletin of WHO 2003 BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company BD Europe 11, rue Aristide Bergès Le Pont de Claix France Phone: Fax: Becton Dickinson France S.A.S. Share capital: euros RCS Grenoble B United States 1 Becton Drive Franklin Lakes, NJ BD-Brochure_Uniject_e06.indd 8 10/06/ :27