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The most common infectious viruses and their virulence

TYPE OF VIRUS VIRULENCE (%)

Rhinovirus 30–50%

Coronavirus 10–15%

Influenza virus 5–15%

Metapneumovirus 5–10%

Respiratory Syncytial Virus (RSV) (Giant cell respiratory virus)5%

Parainfluenza 5%

Adeno- and enterovirus under 5%

Unknown 15–25%

Respiratory infections

(colds)

common cold is usually a virus-induced, acute

infection of the upper respiratory tract. This

A

type of respiratory infections are among the most

common diseases in modern industrial countries.

On the average adults suffer up to five times a year

a cold, preschoolers even eight to ten times. In most

cases the infections are caused by viruses and associated

with similar symptoms: shivering, sneezing,

runny nose, cough and fatigue. Since antibiotics work

only in the treatment of bacterial infections, applying

them in case of infections of viral origin, they might

remain ineffective.

Penetration of viruses

and bacteria in the body

Infections of the upper respiratory tract caused by

viruses or bacteria will not necessarily lead to illness

if the immune system is capable of effective defense

against pathogens, or the pathogens are hindered

at intruding the body by a barrier.

The main goal of a virus is to safeguard its own

propagation for which it requires a host cell. To

this end, it targets the cells in the oral mucosa and

attempts to dock to them. In case of a successful

attachment it penetrates the host cell membrane and

reprograms it to promote its own multiplication.

What do

Medistus ® Antivirus

lozenges contain?

Medistus ® Antivirus lozenges contain Kistosyn ® 200 extract.

Medistus ® Antivirus is a Class IIa medical device product.

Efficacy and safety have been tested according to the European Medical Device

Directive (93/42/EEC).

Infection risks

(pandemics)

Recently, infections by emerging viruses occur

more frequently and they seem to be independent

of seasons. These infections manifest themselves as

fever from 38 °C and with symptoms such as sore

throat, runny nose, cough, muscle and joint pains,

headache and diarrhea.

Real influenza has to be dealt with separately from

the other respiratory diseases related to cold. This

infection is a disease caused by various types of

influenza viruses and differs from other respiratory

diseases both in its epidemiological, clinical characteristics

and also in its impacts. In the spreading of

the pathogens there is a similarity to other respiratory

diseases, since the influenza virus is also spread

by respiratory tiny droplets that become airborne

when infected individuals cough or sneeze. But the

speed of its dissemination is significantly higher.

Active defense

against infection

The research of the last decades has unambiguously

demonstrated that in case of infection

pathogens (viruses, bacteria) dock to the carbohydrate

structures of the host cell membranes through

their proteins based on the so-called key-lock

principle. This process occurs in the oral and

pharyngeal mucous membranes. In the event this

docking process is successful, like a key opening

a lock the pathogens penetrate the host cell and

commence to multiply. The solution is compelling:

we have to impede pathogens in docking to the

host cells. Researchers of our times are engaged in

the constant pursuit of substances which possess

such potentials. Myriads of studies were conducted

on plant-based polyphenol compounds which

substantiate this so-called astringent effect.

The plant polyphenols and biopolymers that are

responsible for the defense reaction are abundant

in the Kistosyn ® 200 extract of Medistus ® Antivirus.

The Kistosyn ® 200 extract builds a protective

film over the throat mucous membranes. Viruses,

bacteria and other pathogens are hampered by this

physical barrier – assuming you apply the lozenges

preventively.

M edistus® Antivirus is a novel medical device

with an active ingredient complex containing

plant-based substances. The Kistosyn ® 200 extract

forms through its natural active substances a protective

film over the oral and pharyngeal mucosa.

This protective barrier leads to a physical (mechanical)

protection against viruses and bacteria causing respiratory

infections, which helps prevent their penetration

into body cells and their further propagation.

M edistus® Antivirus lozenges support through their

natural active substances the barrier function

of the oral and pharyngeal mucosa by forming

a natural film on it. As a result, the oral and pharyngeal

mucosa get moisturized and external irritations

can significantly be reduced. Due to this

physical effect resistance development is not possible.



Areas of application

In which cases shall Medistus ® Antivirus

be applied?

To support by physical means the natural barrier function of the oral and

pharyngeal mucosa against viruses and bacteria infecting the respiratory tract.

For the prevention of infectious and inflammatory airways diseases of viral

and bacterial origin by physical (mechanical) barrier formation on the oral

and pharyngeal mucosa.

Protection on places

with high risk of infection

travel

waiting

rooms

public

transportation

shopping

education

event

Efficacy study/1 1

Adhesion of Staphylococcus aureus

bacteria to bronchial epithelial cells

Number of adhesive bacteria after the incubation

time compared to each other

(control solution versus Medistus ® solution)

3.0

2.5

2.0

1.5

1.0

0.5

0

control

solution

Medistus ®

solution

Adhesion of Streptococcus pneumoniae

bacteria to bronchial epithelial cells

Number of adhesive bacteria after the incubation

time compared to each other

(control solution versus Medistus ® solution)

0.10

0.09

0.08

0.07

0.06

0.05

0.04

0.03

0.02

0.01

0.00

control

solution

Medistus ®

solution

In vitro tests were performed on the adhesion

of Staphylococcus aureus bacteria to bronchial

epithelial cells. It was investigated whether

Medistus ® Antivirus lozenges affect

the adhesion of bacteria to cells, resulting

in preventing or reducing the infection.

For this purpose, one line of cells (BEAS-2B

human bronchial epithelium) was incubated with

bacteria (2.9x10 6 CFU / ml – 3.0x10 6 CFU / ml)

for an hour with the solution of Medistus ®

Antivirus lozenges, whereas another line of

cells and bacteria did not receive any treatment.

After the test period and the rinse of the nonadhesive

bacteria, the number of adhesive

germs was determined by the lysis

of the epithelial cells.

Result: On the cell layer treated with

Medistus ® Antivirus solution, the bacterial

adhesion decreased by 95% compared

to the untreated cell layer.

The same method was used to test the adhesion

of Streptococcus pneumoniae bacteria to

bronchial epithelial cells. The initial germ number

used for the incubation was set in this case to

1.7x10 6 CFU / ml – 1.9x10 6 CFU / ml.

The determination of the number of adhesive

germs after the test period delivered an

outstanding result.

Result: On the cell layer treated with

Medistus ® Antivirus solution, no living

streptococcus bacteria could be detected

after the one-hour incubation.

The test results clearly

indicate the powerful effect of

Medistus ® Antivirus lozenges

in inactivating bacteria.



Efficacy study/2

Efficacy study about the antiviral effect

of Medistus ® Antivirus against H1N1 and H2N2 viruses

Efficacy study/3

Efficacy study about the antiviral effect of Medistus ®

Antivirus against the surrogate enveloped virus MVA

The antiviral effect of Medistus ®

Antivirus lozenges against the

common seasonal flu (H1N1) was

succesfully tested in an accredited,

highly recognised German test

laboratory. 2

The test was performed according

to DIN EN 14476. The viruses in

the mucosa were mixed with a solution

of Medistus ® Antivirus lozenges.

The study included both normal and

OECD heavy load conditions. 3

Medistus ® Antivirus proved exceptionally

effective against the common flu virus.

The results show clearly that both in

clean and OECD heavy load conditions

H1N1 viruses got inactivated in just 15

seconds.

After the very successful test against

common flu, Medistus ® Antivirus

lozenges were put to a more severe test:

the most tenacious Asian avian flu type

H2N2 (duck) was merged in the

mucosa. This virus type is extremely

resistant due to its strong capsid

(protein coat). Even in such an adverse

environment, Medistus ® Antivirus could

inactivate the virus in 5 minutes in

clean conditions. When applying

a heavy load with a protein mix

according to OECD guidelines,

Medistus ® Antivirus lozenges could

reduce the virus count by 3 log units in

only 10 minutes. (Remark: Since

Medistus ® Antivirus lozenges exert

their effect in the mouth well beyond

the guideline test limits, the assumption

is well supported that even the tenacious

avian flu virus gets completely

inactivated in real life conditions.)

The test results clearly indicate the powerful effect of Medistus ® Antivirus

lozenges in inactivating influenza viruses.

The antiviral activity of Medistus ® Antivirus

lozenges has been demonstrated in several

previous in-vitro tests. In 2020, the virucidal

activity of the lozenges was tested against

the MVA virus in accordance with the requirements

of DIN EN 14476 by an accredited

laboratory in Germany. 4

The Modified Vaccinia Virus Ankara (MVA) is

a type of vaccine virus which was developed in

vaccine research. It is widely applied as

a surrogate virus representing all enveloped

viruses to replace these in in-vitro tests.

Enveloped viruses include any virus that is

surrounded by a lipoprotein envelope (peplon)

that makes viruses more resistant to environmental

influences and helps them adapt to

the host cell. All viruses which pose a threat

of global epidemics affecting the human

population, are enveloped viruses such

as influenza viruses, herpes viruses, HIV,

ZIKA, Ebola virus, and SARS coronaviruses

(SARS-CoV). 5

The purpose of the in vitro test was to verify

the effectiveness of Medistus ® Antivirus

lozenges against enveloped viruses causing

upper respiratory infections under laboratory

conditions. The MVA virus used for testing is

a generally accepted surrogate in professional

communities and official bodies as surrogate

virus for enveloped viruses. 6

During the laboratory test, the solution of the

soft lozenges mixed with artificial saliva was

tested by two methods. First, by the so-called

“Clean conditions” method, in which the

virucidal effect of the test substance is measured

without adding interfering substances.

The other applied testing method was the test

according to “OECD conditions” which is performed

under high load conditions by adding

proteins, mucin and yeast to the test solution.

The inclusion of proteins and yeasts pose an

aggravating testing condition. It interferes

with the mechanism of action of Medistus ®

Antivirus soft lozenges by reducing its efficacy,

yet producing results close to real ‘in vivo’

conditions.

The number of residual viruses was counted

in the same intervals in both test methods. In

the “clean conditions” method, the virucidal

effect of Medistus ® Antivirus soft lozenges were

clearly confirmed in only 5 minutes. It reduced

the initial virus load by 4 log 10

and inactivated

all viruses.

Under OECD conditions with high protein,

mucin and yeast load, Medistus ® Antivirus

reduced the original virus concentration by

3.5 log 10

after 5 minutes and by 3.67 log 10

in 10 minutes. This translates into a virus load

reduction > 99.9% in 10 minutes contact time.

Decrease of MVA virus number

in the test solution (%)

100.00

100%

80%

60%

40%

20%

10%

0% Virus number

in the solution %

<0.01

OECD

load %

0.00

Normal

test %

These test results clearly support and confirm the antiviral effect of Medistus ®

Antivirus lozenges against enveloped viruses that may cause epidemics.



Dosage instructions, type and duration of

application

When, how often and how long shall

Medistus ® Antivirus be applied?

In case of exposure to infections.

For protection at increased risk of airways

infection of viral and bacterial origin.

Adults: Dissolve a lozenge slowly in the

mouth 3 to 6 times a day.

Children older than 12 years (and of at least

25 kg body weight): Dissolve a lozenge

slowly in the mouth 3 times a day.

Children older than 6 years: Dissolve a

lozenge slowly in the mouth once a day.

Please note

Suitable for children older than 6 years.

Side effects

There are no side effects known.

Counter indications

There are no counter indications known.

Interactions

To avoid interactions, in case of taking medicines

orally, please leave a pause of 2 hours

between the intakes or consult your doctor.

Notes and information concerning the shelf

life of the medical device product Medistus ®

Antivirus

The lozenges shall be used up until the “use by”

date marked on the box.

Ingredients

Active ingredient: Kistosyn ® 200 extract

Other ingredients: maltitol, sorbitol, purified

water, ascorbic acid, citric acid, flavor,

vegetable oil, stevia extract, peppermint oil.

No preservatives and colorants.

Sugar, gluten and lactose free.

Store in a cool and dry place, under 25 °C.

Keep out of reach of children.

Made in Germany

License owner: Innopharm GmbH, Hauptplatz 1, A-7350 Oberpullendorf / Austria

Distributor: VitaPlus Ltd., Csillaghegyi út 19-21., H–1037 Budapest / Hungary

www.medistusantivirus.com

1

BioTeSys GmbH: In vitro Studie zur Untersuchung des Effekts von Lutschpastillen auf die Bakterienadhärenz an Epithelzellen. BTS1259/18.

Datum: 06.09.2018. Esslingen/Germany

2

BioTeSys GmbH: In-vitro Studie zur Untersuchung des Effekts von Lutschpastillen auf die Viruslast. BTS 1114/2017.

Datum: 13.11.2017. Esslingen/Germany

3

http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm

4

BioTeSys GmbH: Virucidal activity of the lozenge Medistus Antivirus against Modified vaccinia virus Ankara, 16.06.2020, Esslingen / Germany

5

For more information, see Fauquet, C.M. et al., Eds .: Virus Taxonomy, eighth report of the international committee on taxonomy of viruses.

Elsevier Academic Press, San Diego, 2005

6

„Activity against enveloped viruses can be claimed when MVA = Modified Vaccinia virus Ankara is tested in a (modified) EN 14675 test.”

Guidance on the Biocidal Products Regulation Volume II Efficacy - Assessment and Evaluation (Parts B + C) Version 3.0 April 2018.

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