dahu a brochure final 814

8/12/2019 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



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:



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]

dahu a brochure final 814

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