UNASYN ORAL

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

SULTAMICILLIN TOSYLATE

Dostupné z:

PFIZER (MALAYSIA) SDN. BHD.

INN (Medzinárodný Name):

SULTAMICILLIN TOSYLATE

Počet v balení:

30ml mL; 100ml mL

Výrobca:

Haupt Pharma Latina S.r.l.

Príbalový leták

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
UNASYN
®
POWDER FOR ORAL SUSPENSION
Sultamicillin (250 mg/5 ml)
1
WHAT IS IN THIS LEAFLET
1.
What UNASYN is used for
2.
How UNASYN works
3.
Before you use UNASYN
4.
How to use UNASYN
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of UNASYN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT UNASYN IS USED FOR
UNASYN is indicated for infections
caused by susceptible micro-organisms
which include:
-
upper respiratory tract infections
including sinus infection, middle ear
infection and tonsils inflammation
-
infections of the lower respiratory tract
including inflammation of the lungs
and inflammation of the bronchial
tubes
-
kidneys and urinary tract infections
-
skin and soft tissues infections
-
gonococcal infections (a sexually
transmitted disease)
UNASYN may also be used in patients
who have been treated with injections
and who have to further continue
treatment with the same medicine orally.
HOW UNASYN WORKS
UNASYN contains the active substance
sultamicillin. Inside the body,
sultamicillin is split into two substances,
sulbactam and ampicillin. Together,
these two substances are able to kill
various types of bacteria.
BEFORE YOU USE UNASYN
-
_When you must not use it_
Do not use UNASYN
-
If you are allergic to sultamicillin or
any penicillin, or any of the other
ingredients of this medicine
_Pregnancy and lactation_
UNASYN crosses the placenta and
reaches the foetus. If necessary, your
doctor will assess the benefits of
treatment with this medicine compared to
the possible risks.
Do not take UNASYN if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start to use it_
Tell your doctor if you have:
-
allergic reactions to penicillins,
cephalosporins, carbapenems, beta
lactams and other allergens
-
any kidney or liver problems or if
you develop any signs and
symptoms of liver disease
-
hereditary problems of fructose
intolera

Súhrn charakteristických

Pfiz\b 
\bntial
1
UNAS\b
L
Sultamicillin
1. NAME OF THE MEDICINAL PRODUCT
UNASYN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sultamicillin is a doubl\b \b\br in which ampicillin and th\b b\ba -lactamas\b inhibitor sulbactam
ar\b link\b via a m\b,\bn\b group. Ch\b7 sultamicillin is th\b oxym\b,1\bnicillinat\b
sulfon\b\bst\b 1
,\bcular w\b-,0%3).
3. PH ARMACEUTICAL FORM
Sultamicillin is availabl\b as film -coat\b tabl\b containing th\b tosylat\b salt \bC!\bnt to 375
mg sultamicillin ,which is a mutual prodrug of sulbactam and ampicillin ,yi\b
- th\b
\bC!\bnt of 147 mg sulbactam and 220 mg ampicillin.
Sultamicillin is also availabl\b as a powd\b for oral susp\b containing sultamicillin bas\b that ,
aft\b  \bconstitution with wat\br ,provid\b#0-1\br 5 ml.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Sultamicillin is indicat\b for inf\b caus\b by susc\b1"\b micro -organisms. Typical
indications ar\b11\br r\b1   \bctions including sinusitis, otitis m\b

*
low\b r\b1   tract inf\b including bact\b  pn\b and bronchitis; urinary tract
inf\b
1\blon\b1, *A
\b inf\b
-\bctions.
Sultamicillin may also b\b indicat\b in pati\b r\bC - sulbactam/ampicillin th\b 1
following initial tr\b\bnt with sulbactam/ampicillin IM/IV.
4.2 Posology and Method of Administration
Th\b r\b\bnd\b dos\b of sultamicillin in adults (including \b
\brly pati\b is 375 -750 mg
orally twic\b
.
In both adults and childr\bn ,tr\b\bnt is usually continu\b until 48 hours aft\b pyr\bB and oth\b
abnormal signs hav\b r\b!\bd. Tr\b\bnt is normally giv\b for 5 -14 days, but th\b tr\b\bnt
p\b 
"\b \bB\bnd\b
\bc\b .
In th\b tr\b\bnt of uncomplicat\b
- ,\ba, sultamicill in can b\b-!\bn as a singl\b oral dos\b
2.25 g (six 375 mg tabl\b) Concomitant prob\b\bcid 1.0 g should b\b administ\b \bd in ord\b