Zinacef

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

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Download Tờ rơi thông tin (PIL)
07-10-2013

Thành phần hoạt chất:

Cefuroxime sodium 789mg equivalent to 750 mg cefuroxime;  ;  

Sẵn có từ:

GlaxoSmithKline NZ Limited

INN (Tên quốc tế):

Cefuroxime sodium 789 mg (= 750 mg cefuroxime)

Liều dùng:

750 mg

Dạng dược phẩm:

Powder for injection

Thành phần:

Active: Cefuroxime sodium 789mg equivalent to 750 mg cefuroxime    

Các đơn vị trong gói:

Vial, glass, 750mg, 5 dose units

Lớp học:

Prescription

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

ACS Dobfar SpA

Chỉ dẫn điều trị:

Cefuroxime is a bactericidal cephalosporin antibiotic which is resistant to most ?-lactamases and is active against a wide range of Gram-positive and Gram-negative organisms. It is indicated for the treatment of infections before the infecting organism has been identified or when caused by sensitive bacteria. Susceptibility to cefuroxime sodium will vary with geography and time and local susceptibility data should be consulted where available. Indications include - Respiratory tract infections for example, acute exacerbation of chronic bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess and post-operative chest infections. - Ear, nose and throat infections for example, sinusitis, tonsillitis, pharyngitis and otitis media. - Urinary tract infections for example, acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria. - Soft-tissue infections for example, cellulitis, erysipelas and wound infections. - Bone and joint infections for example, osteomyelitis and septic arthritis. - Obstetric and gynaecological infections, pelvic inflammatory diseases. - Gonorrhoea particularly when penicillin is unsuitable. - Other infections including septicaemia, meningitis and peritonitis. - Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal and vascular surgery where there is increased risk from infection.

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Vial, glass, 750mg - 5 dose units - 24 months from date of manufacture stored at or below 25°C 5 hours reconstituted (not refrigerated) stored at or below 25°C. for suspension and solution for injection after reconstitution and dilution under aseptic conditions 72 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). for suspension and solution for injection after reconstitution and dilution under aseptic conditions 3 hours reconstituted (not refrigerated) stored at or below 25°C. for solution for infusion after reconstitution and dilution under aseptic conditions 72 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). for solution for infusion after reconstitution and dilution under aseptic conditions 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). if reconstitution and dilution has not taken place in controlled and validated aseptic conditions 0 hours reconstituted (not refrigerated), use immediately. if reconstitution and dilution has not taken place in controlled and validated aseptic conditions

Ngày ủy quyền:

1979-05-24

Tờ rơi thông tin

                                1
ZINACEF INJECTION
_Cefuroxime sodium injection 750mg and 1.5g _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully.
This leaflet answers some common
questions about Zinacef injection. It
does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you being administered Zinacef
Injection against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ZINACEF IS USED
FOR
Zinacef Injection contains an
antibiotic called cefuroxime, which
treats infections caused by bacteria,
in different parts of the body and can
be used during surgery. It can be
given to adults and children.
Zinacef injection belongs to a group
of antibiotics called cephalosporins.
These antibiotics work by either
killing the bacteria that cause the
infections or stopping their growth.
Zinacef will not work against
infection caused by viruses such as
colds or the flu (influenza).
ZINACEF IS USED IN ADULTS AND
CHILDREN TO TREAT INFECTIONS OF THE:
•
LUNGS OR CHEST
•
EARS, NOSE AND THROAT
•
URINARY TRACT
•
SKIN
•
BONES AND JOINTS
•
FEMALE REPRODUCTIVE ORGANS
•
BRAIN (_MENINGITIS_)
•
ABDOMEN (_PERITONITIS_)
•
BLOOD (_SEPTICAEMIA_).
ZINACEF IS ALSO USED TO:
•
TREAT A SEXUALLY TRANSMITTED
INFECTION CALLED_ GONORRHOEA_
•
PREVENT INFECTIONS DURING
SURGERY.
Ask your doctor if you have any
questions or if you aren’t sure why
Zinacef injection has been prescribed
for you.
Zinacef is only available with a
doctor’s prescription.
Zinacef is not addictive
.
BEFORE YOU ARE GIVEN
ZINACEF
_ _
_WHEN YOU MUST NOT BE GIVEN _
_IT _
Do not use Zinacef if you have ever
had an allergic reaction to Zinacef or
other cephalosporins.
Do not use Zinacef if you have ever
had an allergic reaction to penicillins
or antibiotics known as 
                                
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Đặc tính sản phẩm

                                1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ZINACEF Cefuroxime sodium 750 mg powder for injection or infusion
ZINACEF Cefuroxime sodium 1.5 g powder for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZINACEF injection contains either 750 mg, or 1.5 g of cefuroxime. Each
750
mg vial contains 42 mg sodium (1.8 mEq).
For full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Powder for injection/infusion.
Cefuroxime is a white to faintly yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS _ _
Cefuroxime is a bactericidal cephalosporin antibiotic which is
resistant to most
β
-lactamases and is active against a wide range of Gram-positive and
Gram-
negative organisms.
It is indicated for the treatment of infections before the infecting
organism has
been identified or when caused by sensitive bacteria. Susceptibility
to
cefuroxime sodium will vary with geography and time and local
susceptibility
data should be consulted where available (see Section 5.1
Pharmacodynamic
properties).
INDICATIONS INCLUDE
-
Respiratory tract infections for example, acute exacerbation of
chronic
bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess
and post-operative chest infections.
-
Ear, nose and throat infections for example, sinusitis, tonsillitis,
pharyngitis and otitis media.
-
Urinary tract infections for example, acute and chronic
pyelonephritis,
cystitis and asymptomatic bacteriuria.
-
Soft-tissue infections for example, cellulitis, erysipelas and wound
infections.
-
Bone and joint infections for example, osteomyelitis and septic
arthritis.
-
Obstetric and gynaecological infections, pelvic inflammatory diseases.
-
Gonorrhoea particularly when penicillin is unsuitable.
-
Other infections including septicaemia, meningitis and peritonitis.
-
Prophylaxis against infection in abdominal, pelvic, orthopaedic,
cardiac,
pulmonary, oesophageal and vascular surgery where there is
increased risk from infection.
2
Usually ZINACEF will be effective alone, but when app
                                
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