Zinacef 250mg powder for solution for injection vials

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Cefuroxime sodium

Sẵn có từ:

Sandoz Ltd

Mã ATC:

J01DC02

INN (Tên quốc tế):

Cefuroxime sodium

Liều dùng:

250mg

Dạng dược phẩm:

Powder for solution for injection

Tuyến hành chính:

Intramuscular; Intravenous

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 05010201; GTIN: 5000123310821

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZINACEF® 1.5 G, 750 MG AND 250 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 Zinacef is and what it is used for
2
What you need to know before you are given Zinacef
3
How Zinacef is given
4
Possible side effects
5
How to store Zinacef
6
Contents of the pack and other information
1 WHAT ZINACEF IS AND WHAT IT IS USED FOR
Zinacef 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. _
_ _
ZINACEF IS USED TO TREAT INFECTIONS OF:

the lungs or chest

the urinary tract

the skin and soft tissue

the abdomen
Zinacef 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 Zinacef during your treatment.
2 WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZINACEF
YOU MUST NOT BE GIVEN ZINACEF :

IF YOU ARE ALLERGIC to ANY CEPHALOSPORIN ANTIBIOTICS or any of the
other
ingredients of Zinacef (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 Zinacef if you think that this
applies to you. You must not be given Zinacef.
TAKE SPECIAL CARE WITH ZINACEF
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 Zinacef. This will reduce the risk of possible
problems.
See (‘_Conditions you need to look out f

Đặc tính sản phẩm

OBJECT 1
ZINACEF
Summary of Product Characteristics Updated 05-Aug-2015 |
GlaxoSmithKline UK
1. Name of the medicinal product
Zinacef® for Injection or Infusion.
2. Qualitative and quantitative composition
Vials contain either 250 mg, 750mg or 1.5g cefuroxime (as sodium).
The total quantity of sodium per vial is as follows:
Zinacef strength
Amount of sodium per vial
250 mg
14 mg
750 mg
42 mg
1.5 g
83 mg
3. Pharmaceutical form
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
Zinacef 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 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 m