NEBACETIN

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Unduh Karakteristik produk (SPC)
06-12-2021

Bahan aktif:

NEOMYCIN SULFATE, BACITRACIN

Tersedia dari:

PRIMA MEDIKA LABORATORIES - Indonesia

INN (Nama Internasional):

NEOMYCIN SULFATE, BACITRACIN

Dosis:

5 MG /4,107 MG

Bentuk farmasi:

SERBUK OBAT LUAR

Unit dalam paket:

DUS, 1 BOTOL @ 5 G

Diproduksi oleh:

PHAROS INDONESIA - Indonesia

Tanggal Otorisasi:

2021-12-06

Karakteristik produk

                                LFT. NEBACETIN OINT & POWDER (PML)
Ukuran : 100 x 240 mm (1/1)
Black
_Keterangan:_
·
As with other antibacterial preparations, prolonged use may
result in overgrowth by non- suspectible organism including
fungi.
·
Concurrent administration of other amynoglycosides is not
recommended.
CONTRAINDICATIONS
·
In patients who have demonstrated allergic hypersensitivity to
the product or any of its constituents, or to cross-sensitising
substances such as framycetin, kanamycin, gentamycin and
other related antibiotics.
·
Patients with any degree of nerve deafness in circumstances
in which significant systemic absorption could occur.
ADVERSE EFFECTS
·
The incidence of allergic hypersensitivity to neomycin sulphate
in the general population is low. However, there is an increased
incidence of sensitivity to neomycin in certain selected groups
of patients in dermatological practice particularly those with
venous stasis eczema and ulceration.
·
Allergic hypersensitivity to neomycin following topical
application may manifest it self as a reddening and scaling
of the effected skin, as an eczematous exacerbation of the
lesion, or as a failure of the lesion to heal.
·
Allergic hypersensitivity following application of bacitracin has
been reported but is rare.
·
Anaphylactic reactions following the topical administration
of bacitracin have been reported but are rare.
DRUG INTERACTIONS
Following significant systemic absorption, neomycin sulphate can
intensify and prolong the respiratory depressant effect of
neuromuscular blocking agent.
PRESENTATION
®
NEBACETIN
Ointment
Tube of 5 g
Reg. No. ....
®
NEBACETIN Powder
Bottle of 5 g
Reg. No. ....
ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER
®
NEBACETIN
Powder
Store below 30
°
C
Manufactured by :
PT. Pharos Indonesia
Jakarta - Indonesia
For :
®
NEBACETIN
Ointment
Store below
25°
C
Manufactured by :
000000 - 2 A 1
COMPOSITION
®
Each gram of NEBACETIN contains :
·
5 mg of neomycin sulphate (equivalent to 2.244 IU of neomycin
base).
·
250 IU of bacitracin.
PHARMACO
                                
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