Axetine 750mg Powder for Solution for Injection or infusion

국가: 몰타

언어: 영어

출처: Malta Medicines Authority

유효 성분:

CEFUROXIME

제공처:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC 코드:

J01DC02

INN (국제 이름):

CEFUROXIME 750 mg

약제 형태:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

구성:

CEFUROXIME 750 mg

처방전 유형:

POM

치료 영역:

ANTIBACTERIALS FOR SYSTEMIC USE

승인 상태:

Authorised

승인 날짜:

2006-11-16

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AXETINE 750 MG, POWDER FOR SOLUTION FOR INJECTION OR INFUSION CEFUROXIME
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 nurse.

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 nurse. 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.
2
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 (_hypersensitivity_)
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
Talk to your doctor or nurse before taking Axetine.
You must look out for certain symptoms such as allergic reactions and
gastrointestinal disorders such
as diarrhoea while you are being given Axetine. This

제품 특성 요약

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Axetine 750mg, powder for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 750mg cefuroxime as cefuroxime sodium.
Axetine strength
Amount of sodium per vial
750 mg
40.65mg (1.77mmol)
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).
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.
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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 intramuscularly)
Severe infections
750 mg every 6 hours (intravenously)
1.5 g every 8 hours (intravenously)
Surgical
prophylaxis
for
gastrointestinal,
gynaecological
surgery (including caesarean section)
and orthopaedic operat