EMB-Fatol 1g/10ml concentrate for solution for infusion vials

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Ethambutol hydrochloride

Tersedia dari:

Imported (Germany)

Kode ATC:

J04AK02

INN (Nama Internasional):

Ethambutol hydrochloride

Dosis:

100mg/1ml

Bentuk farmasi:

Solution for infusion

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Diproduksi oleh:

SW Pharma GmbH

Indikasi Terapi:

treatment of tuberculosis

Ringkasan produk:

BNF:

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
EMB-FATOL
® 1.0 G
, CONCENTRATE FOR THE PREPARATION OF A SOLUTION FOR INFUSION
For use in adults, adolescents and children
Active substance: Ethambutol dihydrochloride
WHAT IS IN THIS LEAFLET
1.
What EMB-Fatol
®
1.0 g is and what it is used for
2.
What you need to know before you take EMB-Fatol
®
1.0 g
3.
How to take EMB-Fatol
®
1.0 g
4.
Possible side effects
5.
How to store EMB-Fatol
®
1.0 g
6.
Contents of the pack and other information
1.
WHAT EMB-FATOL
® 1.0 G IS AND WHAT IT IS USED FOR
EMB-Fatol
®
1.0 g is a medicine for the treatment of tuberculosis.
EMB-Fatol
®
1.0 g is used in adults, adolescents and children, where oral use is
impossible or where a
resorption disorder is known,
-
for the treatment of all forms and stages of pulmonary tuberculosis
and tuberculosis of other
organs with a pathogen sensitivity against ethambutol, always in
combination with other
antimycobacterially active drugs.
-
for empirical therapy in the initial phase of standard tuberculosis
treatment in initially unclear
resistance situations or in cases requiring retreatment.
-
for use in the scope of modified tuberculosis therapy regimes in the
case of proven
resistance against one or several of the standard combination
partners.
The quickest possible readjustment to an oral therapy is to be aimed
for.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EMB-FATOL
® 1.0 G
DO NOT TAKE EMB-FATOL
® 1.0 G
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.
-
if you are allergic to ethambutol or any of the othe

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
EMB-FATOL 1.0 G, concentrate for preparation of a solution for
infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Ethambutol dihydrochloride
One 10 ml bottle contains 1.0 g Ethambutol dihydrochloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for preparation of a solution for infusion
Clear, colourless concentrate for preparation of a solution for
infusion
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EMB-Fatol 1.0 g concentrate for preparation of a solution for infusion
is used for the treatment of
tuberculosis in patients where oral use is impossible or where a
resorption disorder is known.
EMB-Fatol is used in adults, adolescents and children.
-
for the treatment of all forms and stages of pulmonary tuberculosis
and extrapulmonary tu-
berculosis with a pathogen sensitivity against ethambutol, always in
combination with other
antimycobacterially active drugs.
-
for empirical therapy in the initial phase of standard tuberculosis
treatment in initially unclear
resistance situations or in cases requiring retreatment.
-
for use in the scope of modified tuberculosis therapy regimes in the
case of proven re-
sistance against one or several of the standard combination partners.
The quickest possible readjustment to an oral therapy is to be aimed
for.
The generally accepted guidelines on the appropriate use of
antimicrobial active substances in the
administration of EMB-Fatol 1.0 g concentrate for preparation of a
solution for infusion must be
observed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ethambutol is one of the standard tuberculosis therapeutics and is
always applied in the context of
a combination therapy.
The choice of tuberculosis therapy regime and the applied combination
partners is based on the local
resistance situation, on the results of the resistance tests of the
patient isolate in question as well as
the patient's reliability and willingness for cooperation
(complia