Fortox powder for solution for injection

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Viambatanisho vya kazi:

clostridium botulinum toxin type A

Inapatikana kutoka:

Huons BioPharma Global Co.

ATC kanuni:

M03AX01

INN (Jina la Kimataifa):

clostridium botulinum toxin type A

Kipimo:

100IU

Dawa fomu:

powder for solution for injection

Vitengo katika mfuko:

glass vial

Dawa ya aina:

Prescription

Idhini hali ya:

Registered

Idhini ya tarehe:

2022-11-17

Taarifa za kipeperushi

FORTOX
®
100 UNITS
Powder for Solution for Injection
_Botulinum Toxin Type A _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What FORTOX is and what it is used for
2. What you need to know before you use FORTOX
3. How to use FORTOX
4. Possible side effects
5. How to store FORTOX
6. Contents of the pack and other information
1. WHAT FORTOX IS AND WHAT IT IS USED FOR
FORTOX
contains
the
active
substance
Botulinum
toxin
type
A.
It
is
used
for
temporary
improvement in the appearance of moderate to severe vertical lines
between the eyebrows seen at
maximum frown (glabellar lines) when the severity of the facial lines
has an important psychological
impact in adult patients.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FORTOX
Do not use FORTOX
• if you are allergic (hypersensitive) to botulinum toxin type A or
any of the other ingredients of this
medicine (listed in section 6);
• if you have an infection or inflammation at the proposed injection
sites;
• if you have myasthenia gravis or Eaton Lambert Syndrome (chronic
diseases affecting the muscles).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using FORTOX:
• if you have ever had problems with swallowing or food or liquid
accidentally going into your lungs;
• if you are over 65 years of age and have other serious illnesses;
• suffer from certain diseases affecting your nervous system (such
as amyotrophic lateral sclerosis or
motor neuropathy);
• if you have significant weakness or wasting of the muscles which
your d

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FORTOX
100 Units
Powder for Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Botulinum toxin
*
type A, 100 Units/vial.
*
from _Clostridium botulinum _
Botulinum toxin units are not interchangeable from one product to
another.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
FORTOX product appears as a thin white deposit that may be difficult
to see on the base of the vial.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FORTOX is indicated for the temporary improvement in the appearance of
moderate to severe vertical
lines between the eyebrows seen at maximum frown (glabellar lines)
when the severity of the above
facial lines has an important psychological impact in adults below 65
years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Botulinum toxin units are not interchangeable from one product to
another. Doses recommended in
Units are different from other botulinum toxin preparations.
METHOD OF ADMINISTRATION
FORTOX should only be administered by physicians with appropriate
qualifications and expertise in the
treatment and the use of the required equipment.
THIS PRODUCT IS FOR SINGLE USE ONLY AND ANY UNUSED SOLUTION SHOULD BE
DISCARDED.

An injection volume of approximately 0.1 mL is recommended. A decrease
or increase in the
FORTOX dose is possible by administering a smaller or larger injection
volume. The smaller the
injection volume the less discomfort and less spread of toxin in the
injected muscle occurs. This is of
benefit in reducing effects on nearby muscles when small muscle groups
are being injected.
For instructions on reconstitution of the powder for solution for
injection, handling and disposal of vials
please refer to section 6.6.
REFER TO SPECIFIC GUIDANCE FOR INDICATION DESCRIBED BELOW.
Generally valid optimum dose levels and number of injection sites per
muscle have not been established
for indication. In these cases, individual treat