CEFTRIAXONE ALVOGEN POWDER FOR SOLUTION FOR INJECTION INFUSION 1GVIAL

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Ceftriaxone Sodium 1.079g eqv to Ceftriaxone

Tersedia dari:

LOTUS INTERNATIONAL PTE. LTD.

Kode ATC:

J01DD04

Dosis:

1.0 g

Bentuk farmasi:

INJECTION, POWDER, FOR SOLUTION

Komposisi:

Ceftriaxone Sodium 1.079g eqv to Ceftriaxone 1.0 g

Rute administrasi :

INTRAVENOUS, INTRAMUSCULAR

Jenis Resep:

Prescription Only

Diproduksi oleh:

Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

2014-11-20

Karakteristik produk

1
Package Insert
_ _
1.
NAME OF THE MEDICINAL PRODUCT
CEFTRIAXONE ALVOGEN POWDER FOR SOLUTION FOR INJECTION/ INFUSION
1G/VIAL
CEFTRIAXONE ALVOGEN POWDER FOR SOLUTION FOR INJECTION/ INFUSION
2G/VIAL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 g ceftriaxone (as ceftriaxone sodium).
Each vial contains 2 g ceftriaxone (as ceftriaxone sodium).
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
Almost white or yellowish, slightly hygroscopic, crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftriaxone is indicated for the treatment of the following infections
when known or likely to be due
to one or more susceptible micro-organisms (see section 5.1) and when
parenteral therapy is required:
-
Pneumonia.
-
Sepsis.
-
Meningitis.
-
Bone, skin and soft tissue infections.
-
Infections in neutropenic patients.
-
Gonorrhoea.
-
Peri-operative prophylaxis of infections.
Treatment may be started before the results of susceptibility tests
are known.
Consideration should be given to official guidance on the appropriate
use of antibacterials.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CEFTRIAXONE ALVOGEN may be administered by intramuscular injection,
intravenous injection,
or as intravenous infusion, after reconstitution of the solution
according to the directions given below.
Do not use diluents containing calcium, such as Ringer’s solution or
Hartmann’s solution, to
reconstitute ceftriaxone vials or to further dilute a reconstituted
vial for IV administration because a
precipitate can form. Precipitation of ceftriaxone-calcium can also
occur when ceftriaxone is mixed
with calcium-containing solutions in the same IV administration line.
Ceftriaxone must not be
administered simultaneously with calcium-containing IV solutions,
including continuous calcium-
containing infusions such as parenteral nutrition via a Y-site.
However, in patients other than
neonates, ceftriaxone and calcium-containing solutions may be
administered sequentially of one
another if the in