Dahu a Brochure Final 814
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LONG-ACTING, HIGHLY
EFFECTIVE, REVERSIBLESino-implant (II) is a long-acting methodcurrently labeled for four years of use.Until removal is desired, no action fromthe user or routine clinical follow-up isrequired after initial insertion. Like otherimplants, Sino-implant (II) is one of themost effective contraceptive methodsavailable. It has an annual pregnancy rate
of less than 1 percent.After removal of the rods, there is no delayin a woman’s return to fertility. Womenwho discontinue use of Sino-implant(II) can expect pregnancy rates that arecomparable to women who are not usinga contraceptive method.
Sino-implant (II) has the same mechanismof action and amount of active ingredient
as other two-rod implants currentlyavailable on the market.
AFFORDABLE
CONTRACEPTIVE PROTECTIONAlthough contraceptive implants arepopular worldwide, their high costhas been a barrier to access in manycountries. Sino-implant (II) addressesthis problem. This high-quality implant costabout 50 percent less thanothers available.
ADVANTAGES FOR FAMILY
PLANNING PROGRAMS AND USERS
Globally, over 200 million women havean unmet need for safe and effectivecontraception. Access to long-actingcontraceptive methods helps couplesachieve their desired family size and can
help countries improve maternal andchild health.
CONTRACEPTIVE IMPLANTS
Sino-implant (II) is a subdermal contraceptive implant. The implant is a set of two flexible,
cylindrical rods made of medical-grade silicone elastomer. Each rod contains 75 mg of
levonorgestrel, the active ingredient, for a total of 150 mg. The implant is inserted just under
the skin of a women’s upper arm by a trained health care provider using a disposable trocar
as the insertion instrument.
2 SILICONEELASTOMERRODS
DISPOSABLETROCAR
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COMPANY PROFILE
Shanghai Dahua Pharmaceutical Co.,Ltd. — known as Dahua — is a trustedglobal leader in the production of safe,effective and long-acting contraceptiveimplants. Our goal is to promote thereproductive health of women worldwide.We are committed to quality, honesty andcustomer-driven service.
Established in 1991, Dahua is an
enterprise designated by the NationalPopulation and Family Planning
Commission of China (NPFPC) and theState Food and Drug Administration(SFDA) for the production ofcontraceptive products.
ONGOING QUALITY ASSURANCE
We are committed to ensuring the safety
and quality of our products. The currentmanufacturing facility opened in 2004 andwas designed and built to meet ChinaGood Manufacturing Practice (GMP)standards. We are GMP certified by theSFDA. In addition, we are ISO 9001 andISO 13485 certified.
We continually evaluate the quality ofthe final product through lot-release
testing conducted on each lot priorto distribution. These tests, based onmethods approved by the SFDA forlevonorgestrel silicone elastomer implants,include tests for the identification,quantification, and release of the activeingredient and for product sterility.
In addition, an independent qualityevaluation has been conducted since
2008 by FHI 360, a leading internationaldevelopment organization based in theU.S. with over 20 years of experiencewith quality testing of public healthproducts. This assessment has includedindependent lot-release testing as well asan extensive battery of tests on the activeingredient, final product, sterilization andpackaging conducted annually. The annualtesting uses standards from the United
States Pharmacopeia (USP), the BritishPharmacopoeia (BP), the International
Organization for Standardization (ISO),and the ASTM (formerly the AmericanSociety for Testing and Materials). Thefindings showed that Dahua demonstratesthe ability to consistently producea contraceptive implant that meetsinternational quality standards.
CE-MARKED DISPOSABLE TROCAR
Currently, Sino-implant (II) is distributedwith a disposable trocar with a CEmark, which is a mandatory conformitymark for medical devices in EuropeanUnion Member States. A disposabletrocar eliminates the need to clean theinstrument by autoclaving after each useand facilitates service delivery in low-resource settings where electricity is notalways available.
HIGH-QUALITY SERVICE DELIVERY
Essential elements of implantprovision include:
•
Proper counseling before insertion sothat users know about potential sideeffects, how to reliably access removalservices, and that implants do notprotect against HIV or other sexuallytransmitted infections
• High-quality insertion andremoval services
For more information about service
delivery considerations for implants, see:http://www.k4health.org/toolkits/implants
• Highly effective
• Long-acting
• Simple insertion
and removal
• No daily or monthly actionrequired from the user
• Discreet
• Reversible
• Limited side effects
• Appropriate for women who
wish to space or
limit births
• No delay in return to fertilityafter discontinuation
compared to women not
using contraception
• Low cost
Additional advantages of Sino-implant (II) include the following:
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SHANGHAI DAHUA PHARMACEUTICAL CO., LTD.
For information about orderingSino-implant (II), please contactone of our current distributors:
PHARM ACCESS AFRICA, LTD.(PAAL) E-MAIL: [email protected]: www.pharmaccessafrica.com
MARIE STOPES INTERNATIONAL
E-MAIL: [email protected]: www.mariestopes.org
DKT INTERNATIONAL E-MAIL: [email protected]: www.dktinternational.org
WomanCare Global E-MAIL: [email protected]: www.womancareglobal.org
For additional information about thetechnical assistance that FHI 360
provides under a Bill & Melinda Gatesgrant, please contact:
FHI 360 E-MAIL: [email protected]: http://www.fhi360.org/en/Research/Projects/sinoimplant.htm
REGISTRATIONS AND DISTRIBUTION
Sino-implant (II) is registered in over 20 countries worldwide and issold under a variety of trade names including Zarin, Femplant, Trust
and Simplant.We partner with distributors who work in countries around the world.Most distributors guarantee access to Sino-implant (II) at a low cost topublic and nonprofit sectors.
http://en.dahua-sh.com/SALES OFFICE ADDRESS:Room 301, Building 2Lane 425, Baotong RoadShanghai, 200071China
TEL.: +86-21-56637324.
COMPANY ADDRESS:3503 Changzheng HighwayChongming CountyShanghai, 202174China
TEL.: +86-21-59311132.E-MAIL: [email protected]