Vakunis powder for solution for injection/infusion

Ország: Örményország

Nyelv: angol

Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktív összetevők:

cefuroxime (cefuroxime sodium)

Beszerezhető a:

Anfarm Hellas S.A.

ATC-kód:

J01DC02

INN (nemzetközi neve):

cefuroxime (cefuroxime sodium)

Adagolás:

750mg

Gyógyszerészeti forma:

powder for solution for injection/infusion

db csomag:

(1) glass vial 10ml

Recept típusa:

Prescription

Engedélyezési státusz:

Registered

Engedély dátuma:

2018-09-12

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VAKUNIS 1.5 G, 750 MG
CEFUROXIME
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 nurse.
- If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1 What Vakunis is and what it is used for
2 What you need to know before you are given Vakunis
3 How Vakunis is given
4 Possible side effects
5 How to store Vakunis
6 Contents of the pack and other information
1 WHAT VAKUNIS IS AND WHAT IT IS USED FOR
Vakunis is an antibiotic used in adults and children. It works by
killing bacteria that cause
infections. It belongs to a group of medicines called _cephalosporins.
_
VAKUNIS IS USED TO TREAT INFECTIONS OF:

the lungs or chest

the urinary tract

the skin and soft tissue

the abdomen
Vakunis is also used:

to prevent infections during surgery.
Your doctor may test the type of bacteria causing your infection and
monitor whether the
bacteria are sensitive to Vakunis during your treatment.
2 WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VAKUNIS
YOU MUST NOT BE GIVEN VAKUNIS :

IF YOU ARE ALLERGIC to ANY CEPHALOSPORIN ANTIBIOTICS or any of the
other ingredients of
Vakunis (listed in section 6).

if you have ever had a severe allergic (_hypersensitive_) reaction to
any other type of
betalactam antibiotic (penicillins, monobactams and carbapenems).

TELL YOUR DOCTOR BEFORE you start on Vakunis if you think that this
applies to you. You
must not be given Vakunis.
TAKE SPECIAL CARE WITH VAKUNIS
You
must
look
out
for
certain
symptoms
such
as
allergic
reactions,
skin
rashes,
gastrointestinal disorders such as diarrhoea or fungal infections
while you are being given
Vakunis. This will reduce the risk of possible problems. See
(‘_Conditions you need to look out _
_for_’) in sec

Termékjellemzők

SUMMARY OF PRODUCTS CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Vakunis
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Vials contain either 750mg or 1.5g cefuroxime (as sodium).
The total quantity of sodium per vial is as follows:
Vakunis strength
Amount of sodium per vial
750 mg
42 mg
1.5 g
83 mg
3. PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
Cefuroxime is a white to cream powder to which appropriate amounts of
water are added to prepare an
off-white suspension for intramuscular use or a yellowish solution for
intravenous administration.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vakunis is indicated for the treatment of the infections listed below
in adults and children, including
neonates (from birth) (see sections 4.4 and 5.1).
• Community acquired pneumonia
• Acute exacerbations of chronic bronchitis
• Complicated urinary tract infections, including pyelonephritis
• Soft-tissue infections: cellulitis, erysipelas and wound
infections
• Intra-abdominal infections (see section 4.4)
• Prophylaxis against infection in gastrointestinal (including
oesophageal), orthopaedic, cardiovascular,
and gynaecological surgery (including caesarean section)
In the treatment and prevention of infections in which it is very
likely that anaerobic organisms will be
encountered, cefuroxime should be administered with additional
appropriate antibacterial agents.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Table 1. Adults and children ≥ 40 kg_
INDICATION
DOSAGE
Community acquired pneumonia and acute exacerbations 750 mg every 8
hours
of chronic bronchitis
(intravenously or intramuscularly)
Soft-tissue
infections:
cellulitis,
erysipelas
and
wound
infections.
Intra-abdominalinfections
Complicated
urinary
tract
infections,
including
pyelonephritis
1.5 g every 8 hours
(intravenously or intramuscularly)
Severeinfections
750 mg every 6 hours (intravenously)
1.5 g every 8 hours (intraveno