Ceftriaxone (Devatis)

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Ceftriaxone sodium 0.596 g equivalent to Ceftriaxone 0.5g

Inapatikana kutoka:

Devatis Limited

INN (Jina la Kimataifa):

Ceftriaxone sodium 0.596 g (equivalent to Ceftriaxone 0.5 g)

Kipimo:

0.5 g

Dawa fomu:

Powder for injection

Tungo:

Active: Ceftriaxone sodium 0.596 g equivalent to Ceftriaxone 0.5g

Dawa ya aina:

Prescription

Viwandani na:

Hanmi Fine Chemical Company Ltd

Matibabu dalili:

Infections caused by pathogens sensitive to ceftriaxone, e.g.: - sepsis - meningitis - abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts) - infections of the bones, joints, soft tissue, skin and of wounds; - infections in patients with impaired defence mechanisms - renal and urinary tract infections - respiratory tract infections, particularly pneumonia, and ear, nose and throat infections - genital infections, including gonorrhoea - Perioperative prophylaxis of infections.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Vial, glass, Type III, with rubber stopper sealed with aluminium cap - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at or below 25°C 3 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type III, with rubber stopper sealed with aluminium cap - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at or below 25°C 3 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type III, with rubber stopper sealed with aluminium cap - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at or below 25°C 3 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Idhini ya tarehe:

2013-04-02

Taarifa za kipeperushi

Version NZ-V01
Page 1
CEFTRIAXONE 0.5 G & 1 G POWDER FOR INJECTION,
CEFTRIAXONE 2 G POWDER FOR INFUSION
DEVA
_Ceftriaxone sodium _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about CEFTRIAXONE Powder
for Injection
/Infusion. It does not contain all 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 given
CEFTRIAXONE Powder for Injection/Infusion against the benefits they
expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, TALK TO YOUR
DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CEFTRIAXONE POWDER FOR INJECTION/INFUSION IS USED FOR
CEFTRIAXONE Powder for Injection/Infusion contains ceftriaxone (as
ceftriaxone sodium)
as the active ingredient.
CEFTRIAXONE Powder for Injection/Infusion is an antibiotic used to
treat infections in
different parts of the body caused by bacteria. It is also used to
prevent infections before,
during and after surgery.
CEFTRIAXONE Powder for Injection/Infusion belongs to a group of
antibiotics called
cephalosporins. These antibiotics work by killing the bacteria that
are causing your infection
or by stopping bacteria from growing.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor’s prescription.
There is no evidence that it is addictive.
Version NZ-V01
Page 2
BEFORE YOU ARE GIVEN IT
_ _
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN CEFTRIAXONE POWDER FOR INJECTION/INFUSION IF YOU
HAVE HAD
AN ALLERGIC REACTION TO:
•
any medicine containing ceftriaxone
•
any other cephalosporin antibiotic.
YOU MUST NOT BE GIVEN CEFTRIAXONE POWDER FOR INJECTION/INFUSION IF YOU
HAVE HAD A
SERIOUS ALLERGIC REACTION TO PENICILLIN.
Signs of an allergic reaction may include shortness

Tabia za bidhaa

CEFTRIAXONE 0.5 G & 1 G POWDER FOR INJECTION,
CEFTRIAXONE 2 G POWDER FOR INFUSION
MODULE 1.3.1 NEW ZEALAND DATA SHEET
DEVATIS LIMITED Property-Strictly confidential
Page 1/15
Version: NZ-V10 / October 2023
NEW ZEALAND DATA SHEET
1.
NAME OF THE MEDICINAL PRODUCT
CEFTRIAXONE 0.5 g & 1 g Powder For Injection & CEFTRIAXONE 2 g Powder
For Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Each 0.5 g vial contains Ceftriaxone sodium equivalent to 0.5 g of
Ceftriaxone.
Each 1 g vial contains Ceftriaxone sodium equivalent to 1 g of
Ceftriaxone.
Each 2 g vial contains Ceftriaxone sodium equivalent to 2 g of
Ceftriaxone.
EXCIPIENTS:
For full list of excipients see 6.1.
3.
PHARMACEUTICAL FORM
Powder for Injection/Infusion
Sterile, non-pyrogenic, almost white or yellowish, crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infections caused by pathogens sensitive to ceftriaxone, e.g.:

Sepsis

Meningitis

Abdominal infections (peritonitis, infections of the biliary and
gastrointestinal tracts)

Infections of the bones, joints, soft tissue, skin and of wounds

Infections in patients with impaired defense mechanisms

Renal and urinary tract infections

Respiratory tract infections, particularly pneumonia, and ear, nose
and throat infections

Genital infections, including gonorrhea

Perioperative prophylaxis of infections
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Considerations should be given to local guidelines on appropriate use
of antibacterial agents.
POSOLOGY
_ADULTS AND CHILDREN OVER 12 YEARS _
The usual dosage is 1 to 2 g Ceftriaxone Injection once daily (every
24 hours). In severe cases or in infections
caused by moderately sensitive organisms, the dosage may be raised to
4 g, once daily. Twice daily (12 hourly)
administration may be considered
where doses greater than 2g daily are administered.
Specific dosage schedules
_Gonorrhoea_
For penicillinase-producing and non-penicillinase-producing strains,
give a single intramuscular
dose of 250
mg.
_ _
_Per