Axetine 1,5g powder for solution for injection or infusion

Երկիր: Հայաստան

Լեզու: անգլերեն

Աղբյուրը: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ակտիվ բաղադրիչ:

cefuroxime (cefuroxime sodium)

Հասանելի է:

Medochemie Ltd (Factory C)

ATC կոդը:

J01DC02

INN (Միջազգային անվանումը):

cefuroxime (cefuroxime sodium)

Դոզան:

1500mg

Դեղագործական ձեւ:

powder for solution for injection or infusion

Միավորները փաթեթում:

(10) glass vials

Ռեկվիզորի տեսակը:

Prescription

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2023-03-10

Տեղեկատվական թերթիկ

PILcefuinjall2.2-CY
PACKAGE LEAFLET: INFORMATION FOR THE USER
AXETINE 250 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION
AXETINE 750 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION
AXETINE 1.5 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
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 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 Axetine is and what it is used for
2.
What you need to know before you are given Axetine
3.
How Axetine is given
4.
Possible side effects
5.
How to store Axetine
6.
Contents of the pack and other information
1.
WHAT AXETINE IS AND WHAT IT IS USED FOR
Axetine 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._
_ _
_ _
AXETINE IS USED TO TREAT INFECTIONS
of:
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissue
•
the abdomen
Axetine is also used:
•
to prevent infections during surgery.
1
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2.
What you need to know before you are given Axetine
You must not be given Axetine:

if you are allergic (hypersensitive) to any cephalosporin antibiotics
or any of the other
ingredients of this medicine (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 Axetine if you think that this
applies to you. You must not be
given Axetine.
Warnings and precautions
You must look out for certain sympto

Ապրանքի հատկությունները

SPCcefuinjall2.2-CY
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Axetine 250 mg powder for solution for injection or infusion
Axetine 750 mg powder for solution for injection or infusion
Axetine 1.50 g powder for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250mg or 750mg or 1.5g cefuroxime as cefuroxime
sodium.
Axetine strength
Amount of sodium per vial
250 mg
13.55 mg (0.589 mmol)
750 mg
40.65 mg (1.77 mmol)
1.5 g
81.45 mg(3.54 mmol)
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
White or almost white to yellowish powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Axetine 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).
SPCcefuinjall2.2-CY
2
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 of chronic bronchitis
750 mg every 8 hours
(intravenously or intramuscularly)
Soft-tissue infections: cellulitis, erysipelas and
wound infections
Intra-abdominal infections
Complicated urinary tract infections, including
pyelonephritis
1.5 g every 8 hours
(intravenously or