Multi Gyn® Active Gel by lindahy


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									                                                        Product Information

                                              Multi-Gyn® Active Gel

Name of product                                                           The test results show that the 2QR-complex effectively blocks the
                                                                         pathogenic microbes in a very short-time span and reaches its full
Multi-Gyn® Active Gel                                                    effect within 1 hour after application. The 2QR-complex is
(Product also known as ActiGel and Multi-Gyn Gel)                        sensitive to certain pathogens, but does not affect the Lactobacillus

Active ingredient: 2QR*                                                  Clinical Trails

A negatively charged polyhexasaccharide of mannose, galactose,           A pilot study to evaluate the efficacy of Multi-Gyn Actigel in the
glucose and uronic acids.                                                treatment of nonspecific vulvitis and vaginitis.
                                                                         No. of patients: 50
[CHO(CHOR)4(CH2OR0]n[CHO(CHOR)4COOM]m                                    Duration: 1 week
For n counts: 150<n<3500 and for m: 0<m<700,                             Results: 64% of participants reported positive results after one week
Giving a range in molecular weights of 30000 to approximately            of treatment.
550000 Dalton                                                            16 patients also reported no vaginal symptoms.
                                                                         Adverse Effects: None reported
*2QR, patented bio-active polysaccharides EP 1 323 738 A1, WO
03/055918                                                                Multi-Gyn Actigel in the Prevention and Treatment of Bacterial
                                                                         Vaginosis; an evidence based cytological evaluation.
Ingredients according to INCI declaration:
2QR, Aloe Barbadensis extract, Glycerin, Xanthan gum,                    No. of patients: 128
Galactoarabinan Polyglucoronic Acid Crosspolymer, Caprylyl               Duration: 1 week
Glycol.                                                                  Results: After treatment: 74% lactobacillus, 26% mixed flora, 78%
                                                                         relief of symptoms
                                                                         Adverse Effects: None reported
                                                                         Relief and prevention of Vaginal Complaints in
Multi-Gyn® Active Gel is a bio-adhesive gel for application to the       Post-menopausal women with Multi-Gyn Actigel.
vagina and vulva. The gel is transparent with a light amber colour.
The Bio-active gel contains Aloe Barbadenisis Gel, Glycerine (of         No. of patients: 68
herbal origin) and Xantham gum (plant origin) for viscosity.             Duration: 6 months
                                                                         Results: Decrease in all symptoms, improved pH and vaginal flora.
Pharmacology                                                             Adverse Effects: None reported

The Aloe Barbadensis gel, consists of a naturally occurring              Influence of Multi-Gyn Actigel on the vaginal pH
complex polysaccharide called Galactoarabinan Polyglucuronic
Acid Crosspolymer, also termed 2QR. The unique property of this          No. Of patients: 26
compound inhibits the adhesion mechanism of bacteria, by                 Duration: 4 hours
“entangling” the bacteria, and not allowing it to adhere to the host     Results: 6 women with an initial pH of 4 - 4.5 had no change after
tissue. By not allowing the bacteria to adhere to the host tissue, the   the use of Multi-Gyn Actigel; 20 women with an initial pH > 5
bacteria is not able to flourish and is naturally disposed of. These     showed a decrease in pH after the use of Multi-Gyn Actigel.
bacteria are entangled by the long chains of polysaccharides. This is
therefore a physical and not a (bio)chemical effect.                     Post Marketing

2QR was discovered in 1999 and BioClin developed a process by            Distributors in all countries are obligated to report any side effects.
which this compound in the Aloe Barbadensis gel can be filtered          One effect has been reported. On application, patients report a
out (molecular filtration) and concentrated. The compound can            slight stinging or burning sensation after application which is
therefore be quality controlled. 0.8mg/g ploymannose is the              transient within a few minutes. This sensation has been identified as
standard quality concentration used for the 2QR complex.                 a response to the different pH values. Multi-Gyn® Actigel has a pH
                                                                         of 4.1 - 4.3. Persons with bacterial vaginosis often have an
                                                                         abnormally high pH > 5. Also in cases of tissue damage, the mild
Clinical testing                                                         acidity may cause a burning sensation.

A special type of in vitro test model was developed to determine the     Indications
time-frame in which the blocking of the adhesive mechanism of the
pathogens takes place. Samples of the microbial flora were taken         Prevents and treats bacterial vaginosis
from human volunteers. The samples were prepared in the lab, and         Reduces unpleasant odour and discharge
several dilutions of the “2QR” active component were added. The          Has a direct soothing effect on itch and irritations
dilutions where selected based on the percentages as used in the         Provides direct relief of common vaginal discomforts
Multi-Gyn® Active Gel. A time schedule for analysis of efficacy          Counters yeast
was: 15minutes, 30minutes, 1 hour, 3 hours, 6 hours, 12 hours and        Restores physiological pH
24 hours.                                                                Optimizes the condition of the vaginal tissue and flora

Known or tested hypersensitivity to any of the ingredients.


If local intolerance develops, seek medical advise immediately.


No negative interactions have been reported.

Use in Pregnancy and Lactation

No negative undesirable effects during pregnancy nor lactation
have been reported

Adverse Reactions

No adverse reactions have been reported.

Dose and Administration

 Indication                         Dose and Administration
 Bacterial Vaginosis                Apply twice per day for a pe-
                                    riod of 5 days                      Not applicable
 Prevention of discharge, odour     Apply once every three days or
 and related symptoms of Bacte-     more if necessary                   Presentation
 rial Vaginosis                                                         Thin transparent gel, amber in colour.
 Vaginal discomforts such as        Apply once per day or until
 itch, irritations, sensitivity,    relief is desired                   Packaging
 redness and soreness
 Prevention of Thrush               Apply once every three days or      Aluminium tube, 50ml;
                                    more if necessary                   Applicator with cap;
In the case of discomforts of the outer vaginal area (vulva), you can
                                                                        Instructions for use.
apply Multi-Gyn® Active Gel by finger (always wash your hands
prior to doing so).
                                                                        Product Status

                                                                        CE registration as a Medical Device class 2a

                                                                        Date Of Approval

                                                                        Approved by the Therapeutic Goods Administration on: 28/10/2008
                                                                        ARTG Number: 156268


                                                                        Maximum 36 months

                                                                        Storage Conditions

                                                                        No special storage conditions are imposed.
                                                                        Temperatures below 0°C and above 50°C are
                                                                        not recommended.


                                                                        BioClin B.V. PO BOX 95, 2600AB, Delft, The Netherlands
Internal Use
For internal application, please use the applicator which is included
in the box. The use of the applicator allows for the gel to enter the   Advantage Health Care
vagina where it can act for a longer period of time. After you use      34 Percy Street Victoria, 3195, Australia
the applicator to apply the gel into the vagina, wash it with warm
water and place the cap on the applicator.

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