Ceftriaxone-AFT

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ceftriaxone sodium 2.385 g (Present as 2.385g ceftriaxone Sodium*3.5H2O. Eq 2.1586g of ceft. sodium anh or 2g ceftriaxone anh)

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Ceftriaxone sodium 2.1586 g (equivalent to ceftriaxone 2 g)

Dosage:

2 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Ceftriaxone sodium 2.385 g (Present as 2.385g ceftriaxone Sodium*3.5H2O. Eq 2.1586g of ceft. sodium anh or 2g ceftriaxone anh)

Units in package:

Vial, glass, Type 1 with rubber stopper (qilu), 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Qilu Antibiotics Pharmaceutical Co Ltd

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 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.

Product summary:

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

Authorization date:

2010-09-14

Summary of Product characteristics

Page 1 of 18
NEW ZEALAND DATA SHEET
1.
CEFTRIAXONE-AFT POWDER FOR INJECTION
Ceftriaxone-AFT 500 mg powder for injection.
Ceftriaxone-AFT 1 g powder for injection.
Ceftriaxone-AFT 2 g powder for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ceftriaxone-AFT 500 mg: each vial contains 500 mg ceftriaxone (as
sodium).
Ceftriaxone-AFT 1 g: each vial contains 1 g ceftriaxone (as sodium).
Ceftriaxone-AFT 2 g: each vial contains 2 g ceftriaxone (as sodium).
Excipients with known effect:
Each gram of ceftriaxone contains approximately 83 mg (3.6 mmol) of
sodium.
3.
PHARMACEUTICAL FORM
Powder for injection.
White to pale yellow 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 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Considerations should be given to local guidelines on appropriate use
of antibacterial agents.
Dose
_Adults and children over twelve years _
The usual dosage is 1-2 g of ceftriaxone administered once daily
(every 24 hours). In severe cases or in
infections caused by moderately sensitive organisms, the dosage may be
raised to 4 g, administered once
daily. Twice daily (12 hourly) administration may be considered where
doses greater than 2g daily are
administered.
Specific dosage schedules
Page 2 of 18
_Gonorrhoea _
For the treatment of gonorrhoea (penicillinase-producing and
non-penicillinase-producing strains), a
single IM dose of 250 mg ceftriaxone is recommended.
_Perioperative prophylaxis _
To
prevent
postoperative
infections
in
contaminated
or
potentially
conta