Minaxen 50mg Capsules

Negara: Malta

Bahasa: Inggris

Sumber: Malta Medicines Authority

Bahan aktif:

MINOCYCLINE

Tersedia dari:

Delorbis Pharmaceuticals Limited 17 Athinon Str, Ergates Industrial Area, 2643 Ergates, PO Box 28629, 2081 Lefkosia, Cyprus

Kode ATC:

J01AA08

INN (Nama Internasional):

MINOCYCLINE 50 mg

Bentuk farmasi:

HARD CAPSULE

Komposisi:

MINOCYCLINE 50 mg

Jenis Resep:

POM

Area terapi:

ANTIBACTERIALS FOR SYSTEMIC USE

Status otorisasi:

Authorised

Tanggal Otorisasi:

2006-08-29

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MINAXEN 50 MG CAPSULES
Minocycline (as Minocycline hydrochloride)
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 Minaxen is and what it is used for
2.
What you need to know before you take Minaxen
3.
How to take Minaxen
4.
Possible side effects
5.
How to store Minaxen
6.
Contents of the pack and other information
1.
WHAT MINAXEN IS AND WHAT IT IS USED FOR
Minaxen is indicated for the treatment of:
A
–
the following infections caused by the mentioned microorganisms that
are sensitive to minocycline:
Rickettsioses including ehrlichiosis, Q fever, spotted fever, trench
fever and typhus.
Respiratory tract infections caused by
_Mycoplasma pneumoniae_
.
Venereal lymphogranuloma caused by
_Chlamydia trachomatis_
.
Psittacosis caused by
_Chlamydia psittaci_
.
Trachoma and conjunctivitis caused by
_Chlamydia trachomatis_
.
Non-gonococcal urethritis, trachilitis, or proctitis caused by
_Chlamydia trachomatis_
or
_Ureaplasma _
_urealyticum_
.
Infections of the upper and lower respiratory caused by
_Chlamydophila pneumoniae_
.
Relapsing fever caused by
_Borrelia recurrentis_
.
Early stages of Lyme disease caused by
_Borrelia burgdorferi_
.
Chancroid caused by
_Haemophilus ducreyi_
.
Plaque caused by
_Yersinia pestis_
, in combination with streptomycin.
Tularemia caused by
_Francisella tularensis._
Cholera caused by
_Vibrio cholerae_
.
Infections caused by
_Campylobacter fetus_
.
Brucellosis in combination with streptomycin or rifampicin.
Bartonellosis

Karakteristik produk

Page 1 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Minaxen 50 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg of minocycline as minocycline
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules
Light orange, hard gelatin capsule size 3, containing light yellow
powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Minaxen is indicated for the treatment of:
Α- the following infections that are caused by the mentioned
microorganisms that are
sensitive to minocycline:
Rickettsioses including ehrlichiosis, Q fever, of spotted fever,
trench fever and typhus.
Respiratory tract infections caused by Mycoplasma pneumoniae.
Venereal lymphogranuloma caused by Chlamydia trachomatis.
Psittacosis caused by Chlamydia psittaci.
Trachoma and conjunctivitis caused by Chlamydia trachomatis.
Non-gonococcal urethritis, trachilitis, or proctitis caused by
Chlamydia trachomatis or
ureaplasma urealyticum.
Infections of the upper and lower respiratory caused by Chlamydophila
pneumoniae.
Relapsing fever caused by Borrelia recurentis.
Early stages of Lyme disease caused by Borrelia burgdorferi.
Chancroid caused by Haemophilus ducreyi.
Plaque caused by Yersinia pestis, in combination with streptomycin.
Tularemia caused by Francisella tularensis.
Cholera caused by Vibrio cholerae.
Infections caused by campylobacter fetus.
Brucellosis in combination with streptomycin or rifampicin.
Bartonellosis caused by Bartonella bacilliformis.
Lymphogranuloma inguinale caused by Callymmatobacterium granulomatis.
Inflammatory diseases of the pelvis (pyelitis) in women.
B- Infections caused by the following gram-negative microorganisms
when culture testing
indicates sensitivity to minocycline:
Escherichia coli.
Enterobacter aerogenes.
Shigella species.
Page 2 of 11
Acinetobacter species.
Respiratory tract infections caused by
_Haemophilus influenzae_
.
Respiratory tract and urinary tract infections caused by
_Klebsiella species_
.
C-
Infections caused by
gram- positive microorga