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 bacteria.. Ingredients 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 Description 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 Contraindications Known or tested hypersensitivity to any of the ingredients. Precautions If local intolerance develops, seek medical advise immediately. Interactions 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 External Indication Dose and Administration Overdose 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; Box; 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 Conservation Maximum 36 months Storage Conditions No special storage conditions are imposed. Temperatures below 0°C and above 50°C are not recommended. Manufacturer BioClin B.V. PO BOX 95, 2600AB, Delft, The Netherlands Internal Use Distributor 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.
Pages to are hidden for
"Multi Gyn® Active Gel"Please download to view full document