TEST INSTRUCTIONS

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0 height="100%"><tr> <td valign="top" width=200 BGCOLOR="#C0C0C0" TEXT="#080000" background="18402c00excwnc.jpg"> <div> <I>"Birth Control Knowledge for a</I></div> <div> <I>Healthier World"</I></div> <bR> <div> <TABLE BORDER="0" CELLPADDING="2" CELLSPACING="0" WIDTH="95" BORDERCOLORLIGHT="#C0C0C0" BORDERCOLORDARK="#808080" FRAME="BOX" RULES="ALL" HSPACE="0" VSPACE="0" > <tR> <tD VALIGN=TOP HEIGHT= 46 WIDTH="91"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="46" ALIGN="bottom" WIDTH="91" HSPACE="0" VSPACE="0"></tD> </tR> </TABLE></div> <div> <I>GHO</I></div> <bR> <bR> <div> <A HREF="index.htm" TARGET="_top" TITLE="GLOBAL HEALTH OPTIONS"><U><B>HOME</B></U></A></div> <bR> <bR> <bR> <bR> <bR> </td> <td valign="top" BGCOLOR="#FFFFFF" TEXT="#080000"> <div> <FONT SIZE="5" COLOR="#333399" FACE="Algerian" ><I><B>GLOBAL  HEALTH  OPTIONS</B></I></FONT>     |   <A HREF="index.htm" TARGET="_top" TITLE="GLOBAL HEALTH OPTIONS"><U> HOME</U></A></div> <div> <B>TEST INSTRUCTIONS</B><B>   |   </B><A HREF="id52.htm" TARGET="_top" TITLE="PERSONA INSTRUCTION BOOKLET"><U>PERSONA INSTRUCTION BOOKLET</U></A></div> <div> <B><U>TEST INSTRUCTIONS</U></B></div> <bR> <div> <A HREF="#pharmatex_instr_" TITLE="TEST INSTRUCTIONS"><U><B>Pharmatex sponge Instructions</B></U></A></div> <div> <A HREF="#protectaid" TITLE="TEST INSTRUCTIONS"><U><B>Protectaid sponge Instructions</B></U></A></div> <bR> <bR> <DIV ALIGN="LEFT"></DIV> <div> <FONT SIZE="3" COLOR="#333399" FACE="Arial" ><B>PROTECTAID SPONGE INSTRUCTIONS</B></FONT><B> <A NAME="protectaid"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="1" ALIGN="bottom" WIDTH="1" HSPACE="0" VSPACE="0" ></A></B></div> <div> <B>Side A:</B></div> <div> <U><IMG SRC="23eb8810.jpg" border=0 width="696" height="897" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></U></div> <div> <B>Side B:</B></div> <div> <IMG SRC="246d7b80.jpg" border=0 width="727" height="952" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></div> <bR> <DIV ALIGN="LEFT"></DIV> <div> <B>PHARMATEX SPONGE INSTRUCTIONS</B></div> <div> <B> <A NAME="pharmatex_instr_"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="1" ALIGN="bottom" WIDTH="1" HSPACE="0" VSPACE="0" ></A></B></div> <div> <B><U><IMG SRC="218571a0.png" border=0 width="343" height="26" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></U></B></div> <div> Please read this notice carefully before using this medication.</div> <div> If you have any questions, if in doubt, ask for more information from your physician or pharmacist.</div> <div> Do not discard this notice, as you might need to refer to it again.</div> <bR> <div> <B>BRAND NAME</B></div> <div> <B>PHARMATEX</B><FONT SIZE="1" COLOR="#000080" FACE="Arial" ><B>R</B></FONT><B>, vaginal sponge.</B></div> <div> <B>QUALITATIVE AND QUANTITATIVE INGREDIENTS</B><FONT SIZE="4" COLOR="#000080" FACE="Arial" ><B> </B></FONT></div> <div> <U>Active ingredient</U> :</div> <div> Benzalkonium chloride........................................................................................................1.20 g</div> <div> <U>Inert ingredients</U> :citric acid, glycol and polyglycol stearates, lavender essence, purified water q.s.p. 100.00 g</div> <DIV ALIGN="LEFT"></DIV> <div> Each sponge is infused with 5 g of the mixture</div> <div> <B>DOSAGE FORM</B></div> <div> Vaginal sponge (box of 6).</div> <div> <B>THERAPEUTIC CLASS</B></div> <div> LOCAL CONTRACEPTIVE</div> <div> (G : genito-urinary system)</div> <div> <B>OPERATOR                                                                  MANUFACTURER</B></div> <bR> <div> <B><U>WHEN SHOULD THIS MEDICATION BE USED</U></B></div> <div> Local contraception.</div> <div> This method considerably diminishes the risk of pregnancy without completely eliminating it.</div> <div> The efficacy is dependent on closely following the instructions for use.</div> <div> This method of contraception may be used by all women of childbearing age and especially:</div> <div> -if there is a temporary or absolute contraindication to the use of oral contraceptives or the Intrauterine Device;</div> <div> -after giving birth, while breastfeeding or during the pre-menopausal period ;</div> <div> -when a method of contraception is needed only occasionally ;</div> <div> -while using an oral contraceptive, if a pill is missed or taken later than the scheduled time : if this occurs, use both contraceptive methods for the remainder of the cycle.</div> <div> As a back-up method, when using the Intrauterine Device (especially if you are regularly taking certain medications, like an anti-inflammatory).</div> <bR> <div> <B><U>CAUTION !</U></B></div> <div> <B><U>WHEN NOT TO USE THIS MEDICATION</U></B></div> <div> -This medication SHOULD NOT BE USED if there is an allergy to benzalkonium chloride.</div> <div> -Unless otherwise advised by your physician, this medication should not be used at the same time as medications that are administered via the vaginal route (<I>especially during treatment with a vaginal antibiotic, antiviral or Estrogen medication)</I> nor should it be used at the same time while using soap.</div> <div> <B>Provision for use</B></div> <DIV ALIGN="LEFT"></DIV> <div> The contraceptive efficacy is dependent on the correct use.</div> <div> It is necessary to follow these instructions :</div> <div> -before sexual intercourse, insert a sponge all the way inside the<FONT SIZE="4" COLOR="#000080" FACE="Arial" > </FONT>vagina, regardless of what day of your menstrual cycle you are on;</div> <div> <B>-immediately before and after having sexual intercourse</B> do not wash or douche vaginally <B>with soap</B>, because the soapy water, even traces of it, can destroy the active ingredient. Only the external genital area should be washed, if desired, and only plain water should be used.</div> <div> -because of the presence of the benzalkonium chloride, stop using this product in case a genital lesion develops or becomes irritated.</div> <div> If it is necessary to undergo a vaginal treatment or to use a product that is administered via the vaginal route, wait until the end of the treatment to (re)start using the contraceptive sponge.</div> <div> <B>DRUG AND GENERAL INTERACTIONS</B></div> <div> <I>IN ORDER TO AVOID POSSIBLE INTERACTIONS especially with medications that are administered via the vaginal route and with soap, YOU SHOULD INFORM YOUR PHYSICIAN OR</I><FONT SIZE="4" COLOR="#000080" FACE="Arial" ><I> </I></FONT><I>YOUR PHARMACIST ABOUT ANY OTHER TREATMENTS THAT YOU ARE UNDERGOING. </I></div> <div> <B>PREGNANCY AND BREASTFEEDING</B></div> <div> <I>IN GENERAL, WHILE BREASTFEEDING, IT IS ADVISABLE TO NOTIFY YOUR PHYSICIAN OR YOUR PHARMACIST BEFORE USING ANY MEDICATION.</I></div> <div> _____________________________________________________________________________________________</div> <div> <B><U>HOW TO USE THIS MEDICATION</U></B></div> <div> <B>INDICATION FOR USE AND DOSAGE</B></div> <div> Use one sponge before sexual intercourse regardless of what day of your menstrual cycle you are on.</div> <bR> <div> <B>MODE AND ROUTE OF ADMINISTRATION</B></div> <div> Vaginal route.</div> <div> Remove the sponge from its protective box.</div> <div> Place your middle finger in the middle of the flat surface.</div> <div> With your other hand spread the vaginal lips, and then insert the sponge all the way up into the vagina, until it comes into contact with the cervix.</div> <div> The contraceptive protection is immediate and lasts for 24 hours.</div> <div> There is no need to replace the sponge during this period, even if<FONT SIZE="4" COLOR="#000080" FACE="Arial" > </FONT>you engage in additional acts of sexual intercourse.</div> <div> The sponge may be removed 2 hours after the last act of sexual intercourse.  In any case, the sponge must be removed after 24 hours after it was inserted.</div> <div> In case of difficulty with retrieving the sponge, squat (to decrease the depth of the vagina) and, with the middle and index fingers, pinch the sponge and remove it.</div> <div> Right after having sexual intercourse, if cleaning is desired, only<FONT SIZE="4" COLOR="#000080" FACE="Arial" > </FONT>plain water and only the external genital area should be cleaned. </div> <div> Caution: while the sponge is in place inside the vagina, bathing (in the bathtub, the sea, the swimming pool) must be avoided because of the risk of the water diluting the spermicide.</div> <bR> <DIV ALIGN="LEFT"></DIV> <div> <B><IMG SRC="220fa7b0.png" border=0 width="250" height="123" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></B></div> <div> <TABLE BORDER="0" CELLPADDING="2" CELLSPACING="1" WIDTH="402" BORDERCOLORLIGHT="#C0C0C0" BORDERCOLORDARK="#808080" FRAME="BOX" RULES="ALL" HSPACE="0" VSPACE="0" > <tR> <tD VALIGN=TOP HEIGHT= 141 WIDTH="224"><div> 1. Your anatomy.</div> <div> 2. If you want to insert it while standing up lift one leg up and rest the leg on a stand.</div> <div> 3. Insert the sponge all the way inside the vagina.</div> </tD> <tD VALIGN=TOP><NOBR><div> <IMG SRC="22479740.png" border=0 width="121" height="116" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></div> <bR> </NOBR></tD> </tR> </TABLE></div> <div> <B><U>SIDE EFFECTS</U></B></div> <div> <I>LIKE ALL MEDICATIONS, IN CERTAIN PEOPLE THIS PRODUCT MAY CAUSE EFFECTS THAT CAN BE MORE OR LESS IRRITATING:</I> possible allergy.</div> <div> <I>INFORM YOUR PHYSICIAN OR PHARMACIST ABOUT ANY SIDE EFFECTS NOT MENTIONED IN THIS NOTICE.</I></div> <bR> <div> <B><U>STORAGE</U></B></div> <div> <B>DO NOT USE PAST THE EXPIRATION DATE PRINTED ON THE OUTSIDE OF THE BOX.</B></div> <bR> <div> <B>SPECIAL STORAGE PRECAUTIONS</B></div> <div> Store at a temperature below 25'C (77'F).</div> <bR> <div> Authorized medicine n<FONT SIZE="1" COLOR="#000080" FACE="Arial" >0</FONT></div> <div> Non Remb. S<FONT SIZE="1" COLOR="#000080" FACE="Trebuchet MS" >é</FONT>c.Soc.  326 922.8 (box of 6 vaginal sponges)</div> <div> <B><U>NOTICE REVISION DATE</U></B></div> <div> December 1998.</div> <div> <B>ADDENDUM</B></div> <div> The 1<FONT SIZE="1" COLOR="#000080" FACE="Arial" >st</FONT> year failure rate is 18.9% with typical use and 0.4% with perfect use.*</div> <div> Until more studies are available, this vaginal sponge should not be used to protect against Sexually Transmitted Infections, including HIV, the virus that causes AIDS.</div> <div> *<U>References: </U> </div> <div> Mauck CK et al.<B> </B><I>A phase I comparative study of contraceptive vaginal films containing benzalkonium chloride and nonoxynol-9. Postcoital testing and colposcopy.</I><B> </B>Contraception 1997 Aug;56(2):89-96<FONT SIZE="1" COLOR="#000080" FACE="Arial" > </FONT><FONT SIZE="1" COLOR="#333399" FACE="Arial" ><A HREF="http://www.biam2.org/www/Spe5817.html" TARGET="_top" TITLE="http://www.biam2.org/www/Spe5817.html"><U><U>http://www.biam2.org/www/Spe5817.html</U></U></A></FONT></div> <bR> <bR> <div> <B>On the side of the box:</B></div> <div> _________________________________________________________________________________________________</div> <bR> <div> <IMG SRC="22840aa0.png" border=0 width="320" height="170" ALIGN="BOTTOM" HSPACE="0" VSPACE="0">                                     <IMG SRC="22c6a9d0.png" border=0 width="106" height="157" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></div> <div> <B>Indication</B><B>: </B>local contraception.</div> <div> <B>Instructions for use:</B> in reclining position, insert the sponge all the way inside the vagina before sexual intercourse.To insert the sponge in a standing position, carefully read the notice.  The protection is immediate and lasts for 24 hours.  Right after sexual intercourse, if cleaning is desired, use only plain water and only clean the external genital area.</div> <div> <B>Keep out of the reach of children.</B></div> <div> <B>Before use, carefully read the enclosed notice.</B></div> <div> <B>Storage precautions: </B>store at a temperature below 25'C (77'F).</div> <div> ________________________________________________________________________________________________</div> <bR> <bR> <bR> <bR> <DIV ALIGN="LEFT"></DIV> <div> Copyright 2001-2004 GHO.  All rights reserved.</div> <bR> <bR> <bR> </td> </tr></table></body>