ml3660-6-medistussalesfolder-dec2021-1643893442-514

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.
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.
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.
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.
Medistus ® Antivirus lozenges can be used for the prevention
of infectious and inflammatory respiratory
diseases of viral and bacterial origin by physical
(mechanical) barrier formation on the oral and
pharyngeal mucosa.

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).
The Kistosyn ® 200 extract contained in Medistus ® Antivirus lozenges 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.

Areas of application
In which cases shall Medistus ® Antivirus be applied?
For the prevention of infectious and inflammatory
respiratory diseases of viral and bacterial origin
by physical (mechanical) barrier formation
on the oral and pharyngeal mucosa.
Recommended use on places
with high risk of infection
travel
public
transportation
education
waiting
rooms
shopping
event

Efficacy study/1
Efficacy study about the antiviral effect
of Medistus ® Antivirus against H1N1 and H2N2 viruses
The antiviral effect of Medistus ®
Antivirus lozenges against the
common seasonal flu (H1N1) was
succesfully tested in an accredited,
highly recognised German test
laboratory. 1
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. 2
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.

Efficacy study/2 3
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
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.
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
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/3
Efficacy study about the antiviral effect of Medistus ®
Antivirus against the surrogate enveloped virus MVA
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%
80%
60%
40%
20%
10%
0%
100.00
Initial virus
load of the
test solution
Medistus
solution
<0.1
Residual virus
concentration
under high load
(OECD)
Medistus
solution
0.00
Residual virus
concentration
with artifical
saliva
These test results clearly support and confirm the antiviral effect of Medistus ®
Antivirus lozenges against enveloped viruses that may cause epidemics.

Efficacy study/4
Medistus ® Antivirus in-vitro test results against
the SARS-Related Coronavirus 2 (SARS-CoV-2)
In proving the broad antiviral and antibacterial
activity of Medistus ® Antivirus another
milestone has been laid in January 2021.
Pursuant to the recent laboratory test results
performed by an FDA registered, industry
leader laboratory in the USA according
to the ASTM E 1052 standard, Medistus ®
Antivirus demonstrated a significant antiviral
activity against SARS-CoV-2 in-vitro,
showing a viral titer reduction up to 99.8%
at the longest exposure time of 30 minutes.
The study report 7 reads the following
conclusion:
Under the conditions of this investigation and in
the presence of a 1% fetal bovine serum
organic soil load, Medistus ® Antivirus lozenge
(Lot 0C0906), diluted 200mg/ml defined as
2.0g of test substance + 10mL of artificial saliva,
demonstrated a 68.4% reduction in viral titer
following a 120 second exposure time, a 90.0%
reduction in viral titer following a 5 minute
exposure time, 99.4% reduction in viral titer
following a 10 minute exposure time, 99.0%
reduction in viral titer following a 20 minute
exposure time, and a 99.8% reduction in viral
titer following a 30 minute exposure time to
SARS-Related Coronavirus 2 as compared to
the titer of the corresponding virus controls.
The log reductions in viral titer were 0.50 log 10
,
1.00 log 10
, 2.25 log 10
, 2.00 log 10
, and 2.75 log 10
respectively.
The result shows that even after 10 minutes
exposure time, a 99.4% percent reduction in
the viral titer could be achieved. Due to the
long mucoadhesion time of Medistus ® Antivirus
lozenges, demonstrated in a laboratory test
performed by the German Food Technology
Institute 8 , all exposure times between 120 sec
and 30 minutes can be regarded as a period in
which the active ingredients are able to exert
their effects.
The results of the SARS-CoV-2 in-vitro
test are in line and confirm once again
the broad in-vitro antiviral activity of
Medistus ® Antivirus lozenges demonstrated
by the in-vitro virucidal activity test against
MVA surrogate enveloped virus in 2020.
The broad antiviral effect of Medistus ®
Antivirus lozenges against respiratory
viruses that may cause epidemics is
clearly supported by the results
of several successful in-vitro tests.

How to use Medistus ® Antivirus lozenges?
Dosage:
Adults dissolve one lozenge slowly in the mouth 3 to 6 times
a day.
Children older than 12 years (and with at least 25 kg body
weight) dissolve one lozenge slowly in the mouth 3 times a day.
Children older than 6 years of age dissolve one lozenge slowly
in the mouth once daily.
If there is no improvement 2 - 3 days after starting using
Medistus ® Antivirus lozenges or if the symptoms worsen
significantly (e.g. in case of fever), a physician should be
consulted.
Overdose:
Excessive overdosing of Medistus ® Antivirus lozenges may
lead to laxative effects due to the content of sugar substitutes
(sorbitol and maltitol).
Pregnancy and breast-feeding:
In the absence of sufficient data, the use of this product during
pregnancy and breast-feeding is not recommended.
Interactions with other medical devices and other forms
of interaction
To avoid interaction with other medications, leave a 2-hour
interval between the intakes or a physician should be consulted.
Possible side effects
There are no known side effects.
Warnings:
Do not take Medistus ® Antivirus lozenges if you are allergic
(hypersensitivity reactions) to Cistus criticus, Buchu leaves,
Chinese blackberry leaves, gum arabic, peppermint flavour
or any of the other ingredients of this medical device.
Use of lozenges in children is only recommended starting
from 6 years of age. The lozenges may pose a choking risk
for children when unable to dissolve them in the mouth.
For further instructions always read the instructions for use.
What do Medistus ® Antivirus lozenges contain?
One lozenge contains 840 mg Kistosyn ® 200 extract
(composed of Gum arabic, Cistus creticus extract, Buchu leaf
extract, Chinese blackberry leaf extract).
Other ingredients: maltodextrin, maltitol, sorbitol, ascorbic acid,
citric acid, apricot flavour, blackcurrant flavour, medium chain
triglycerides, stevia extract, peppermint oil, purified water.
Contains menthol and cineol as components of the buchu leaf
extract.
No preservatives and colorants. Sugar-free, gluten-free and
lactose-free.
Store in a dry place. Do not store above 25°C.
Made in Germany
License owner: Innopharm GmbH, Hauptplatz 1, A-7350 Oberpullendorf / Austria
Distributor: VitaPlus Ltd., Dunavirág u. 2-6., 1. torony 5. em., H-1138 Budapest / Hungary
www.medistusantivirus.com
1
BioTeSys GmbH: In-vitro Studie zur Untersuchung des Effekts von Lutschpastillen auf die Viruslast. BTS 1114/2017. Datum: 13.11.2017. Esslingen/Germany
2
http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
3
BioTeSys GmbH: In vitro Studie zur Untersuchung des Effekts von Lutschpastillen auf die Bakterienadhärenz an Epithelzellen. BTS1259/18. Datum: 06.09.2018.
Esslingen/Germany
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.
7
„Evaluation of Antiviral Properties of a Product Using a Virucidal Suspension Assay, Protocol Number: INNOO7122920.SARS2.” Revised report date. April 13,
2021.Analytical Lab Group MIDWEST 1285 Corporate Center Dr, Ste 110 Eagan, MN 55121
8
Mucoadhesionstest der Medistus Antivirus Lutschtabletten, Bericht 13/01/2021, Deutsches Institut für Lebensmitteltechnik e.V., Quakenbrück / Germany