Actria powder for solution for injection or infusion

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

cefotaxime (cefotaxime sodium)

Mevcut itibaren:

PharmaTech CJSC

ATC kodu:

J01DD01

INN (International Adı):

cefotaxime (cefotaxime sodium)

Doz:

1000mg

Farmasötik formu:

powder for solution for injection or infusion

Paketteki üniteler:

(1) and (50) glass vial 10ml

Reçete türü:

Prescription

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2019-09-09

Bilgilendirme broşürü

1
Package leaflet: information for the Patient
Actria
®
cefotaxime powder for solution for injection or infusion 1.0 g
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. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
What is in this leaflet?
1.
What Actria
®
is and what it is used for
2.
What you need to know before you are given Actria
®
3.
How Actria
®
is given
4.
Possible side effects
5.
How to store Actria
®
6.
Contents of the pack and other information
1.
What Actria
®
is and what it is used for
Actria
®
is
a
semisynthetic
broad-spectrum
cephalosporin,
belonging
to the
third
generation, with bacterial activity.
Actria
®
is used to treat severe infections caused by microorganisms sensitive
to
Cefotaxime:
Osteomyelitis;
Septicaemia;
Bacterial endocarditis;
Meningitis, except that caused by Listeria monocytogenes;
Peritonitis;
Other
severe
bacterial
infections
requiring
parenteral
antibiotics
therapy
(pneumonia,
urinary
tract
infections,
skin
and
soft
tissue
infections,
endocervical and urethral gonococcal infections).
Cefotaxime
may
be administered
before surgery to prevent
infections in
patients
undergoing
contaminated
or
potentially
contaminated
surgical
procedures.
2
_2._
_ _
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ACTRIA
® _ _
_YOU MUST NOT BE GIVEN ACTRIA_
_®_
_: _
-If you are allergic (hypersensitive) to cefotaxime or other
cephalosporins.
When
reconstituted
with
Lidocaine:
it
will
be
administered
strictly
intramuscularly, and only after exclusion of Lidocaine
contraindications. (eg.
Prophyria, heart block non-manifest, severe heart failure, cardiogenic
shock,
therapeutically
un

Ürün özellikleri

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Actria
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefotaxime Sodium (equivalent to Cefotaxime 1.0 g)
3. PHARMACEUTICAL FORM
Powder for solution for injection or infusion
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Actria
®
is a semisynthetic broad-spectrum cephalosporin, belonging to the
third generation, with
bacterial activity.
Actria
®
is used to treat severe infections caused by microorganisms sensitive
to Cefotaxime:
Osteomyelitis;
Septicaemia; Bacterial endocarditis;
Meningitis, except that caused by Listeria monocytogenes; Peritonitis;
Other
severe
bacterial
infections
requiring
parenteral
antibiotics
therapy
(pneumonia,
urinary tract infections, skin and soft tissue infections,
endocervical and urethral gonococcal
infections).
Cefotaxime may be administered before surgery to prevent infections in
patients undergoing
contaminated or potentially contaminated surgical procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous infusion: Use sterile water for injection. Add 10 mL to
the 500 mg vial and 10 mL to
the 1.0 g vial. Withdraw the entire content and add to an intravenous
solution of physiological
saline (or 5% Dextrose in water).
Direct
Intravenous
injection:
Reconstitute
as
directed
above:
resulting
solution
should
be
administered over a 3 to 5 minute period with care.
Intramuscular injection: Add 2 mL to the 500mg vial and 4 mL to the
1.0 g vial. Withdraw the
entire content.
The total daily dose, route and frequency of administrations should be
determined according to
severity of infection, the sensitivity of the microorganism that
caused the infection and the status of
the patient.
Duration of treatment depends on the response to therapy. As with all
antibiotics, the administration
of Cefotaxime should continue for at least 48 to 72 hours after the
patient becomes a febrile or there
is evidence of bacterial eradication.
2
_Adults and adolescents:_
The usual dose is 1 g every 12 hours. In more severe cases, th