Dimethyl fumarate Mylan

Nchi: Umoja wa Ulaya

Lugha: Kiingereza

Chanzo: EMA (European Medicines Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
22-12-2023
Tabia za bidhaa Tabia za bidhaa (SPC)
22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma (PAR)
22-12-2023

Viambatanisho vya kazi:

dimethyl fumarate

Inapatikana kutoka:

Mylan Ireland Limited

ATC kanuni:

L04AX07

INN (Jina la Kimataifa):

dimethyl fumarate

Kundi la matibabu:

Immunosuppressants

Eneo la matibabu:

Multiple Sclerosis, Relapsing-Remitting

Matibabu dalili:

Dimethyl fumarate Mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Bidhaa muhtasari:

Revision: 4

Idhini hali ya:

Authorised

Idhini ya tarehe:

2022-05-13

Taarifa za kipeperushi

                                37
B. PACKAGE LEAFLET
Medicinal product no longer authorised
38
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIMETHYL FUMARATE MYLAN 120 MG GASTRO-RESISTANT HARD CAPSULES
DIMETHYL FUMARATE MYLAN 240 MG GASTRO-RESISTANT HARD CAPSULES
dimethyl fumarate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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
Dimethyl fumarate Mylan is and what it is used for
2.
What you need to know before you take Dimethyl fumarate Mylan
3.
How to take Dimethyl fumarate Mylan
4.
Possible side effects
5.
How to store Dimethyl fumarate Mylan
6.
Contents of the pack and other information
1.
WHAT DIMETHYL FUMARATE MYLAN IS AND WHAT IT IS USED FOR
WHAT DIMETHYL FUMARATE MYLAN IS
DIMETHYL FUMARATE MYLAN
is a medicine that contains the active substance
DIMETHYL FUMARATE
WHAT DIMETHYL FUMARATE MYLAN IS USED FOR
Dimethyl fumarate Mylan is used to treat relapsing-remitting multiple
sclerosis (MS) in patients aged
13 years and older.
MS is a long-term condition that affects the central nervous system
(CNS), including the brain and the
spinal cord. Relapsing-remitting MS is characterised by repeated
attacks (relapses) of nervous system
symptoms. Symptoms vary from patient to patient, but typically include
walking difficulties, feeling
off balance and visual difficulties (e.g. blurred or double vision).
These symptoms may disappear
completely when the relapse is over, but some problems may remain.
HOW DIMETHYL FUMARATE MYLAN WORKS
Dimethyl fumarate Mylan seems to work by stopping the body’s defence
system from damaging your
brain an
                                
                                Soma hati kamili

Tabia za bidhaa

                                1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules
Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate
Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant hard capsule (gastro-resistant capsule)
Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules
Blue-green and white gastro-resistant hard capsules, 21.7 mm in
length, printed with ‘MYLAN’ over
‘DF 120’ containing white to off-white enteric coated pellets.
Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules
Blue-green gastro-resistant hard capsules, 21.7 mm in length, printed
with ‘MYLAN’ over ‘DF 240’
containing white to off-white enteric coated pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dimethyl fumarate Mylan is indicated for the treatment of adult and
paediatric patients aged 13 years
and older with relapsing remitting multiple sclerosis (RRMS).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under supervision of a physician
experienced in the treatment of
multiple sclerosis.
Posology
The starting dose is 120 mg twice a day. After 7 days, the dose should
be increased to the
recommended maintenance dose of 240 mg twice a day (see section 4.4).
If a patient misses a dose, a double dose should not be taken. The
patient may take the missed dose
only if they leave 4 hours between doses. Otherwise the patient should
wait until the next scheduled
dose.
Medicinal product no longer authorised
3
Temporary dose reduction to 120 mg twice a day may reduce the
occurrence of flushing and
gastrointestinal adverse reactions. W
                                
                                Soma hati kamili

Bidhaa zinazofanana

Viambatanisho vya kazi dimethyl fumarate

dimethyl fumarate

ATC kanuni L04AX07

L04AX07

Mzalishaji au wazalishaji wadogowadogo Mylan Ireland Limited

Mylan Ireland Limited

INN (Jina la Kimataifa) dimethyl fumarate

dimethyl fumarate

Nyaraka katika lugha zingine

Taarifa za kipeperushi Taarifa za kipeperushi Kibulgaria 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kibulgaria 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kibulgaria 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kihispania 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kihispania 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kihispania 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kicheki 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kicheki 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kicheki 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kidenmaki 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kidenmaki 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kidenmaki 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kijerumani 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kijerumani 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kijerumani 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kiestonia 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kiestonia 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiestonia 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kigiriki 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kigiriki 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kigiriki 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kifaransa 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kifaransa 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kifaransa 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kiitaliano 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kiitaliano 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiitaliano 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kilatvia 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kilatvia 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kilatvia 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kilithuania 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kilithuania 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kilithuania 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kihungari 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kihungari 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kihungari 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kimalta 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kimalta 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kimalta 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kiholanzi 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kiholanzi 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiholanzi 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kipolandi 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kipolandi 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kipolandi 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kireno 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kireno 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kireno 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kiromania 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kiromania 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiromania 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kislovakia 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kislovakia 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kislovakia 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kislovenia 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kislovenia 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kislovenia 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kifinlandi 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kifinlandi 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kifinlandi 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kiswidi 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kiswidi 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kiswidi 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kinorwe 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kinorwe 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kiaisilandi 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kiaisilandi 22-12-2023
Taarifa za kipeperushi Taarifa za kipeperushi Kroeshia 22-12-2023
Tabia za bidhaa Tabia za bidhaa Kroeshia 22-12-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma Kroeshia 22-12-2023

Tafuta arifu zinazohusiana na bidhaa hii

Taadhari Dimethyl fumarate Mylan

Dimethyl fumarate Mylan

Tazama historia ya hati

Historia ya nyaraka Historia ya nyaraka

Dimethyl fumarate Mylan