Fomicyt 2g powder for solution for infusion vials

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Fosfomycin sodium

Saadav alates:

Kent Pharma (UK) Ltd

ATC kood:

J01XX01

INN (Rahvusvaheline Nimetus):

Fosfomycin sodium

Annus:

2gram

Ravimvorm:

Powder for solution for infusion

Manustamisviis:

Intravenous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 05010700; GTIN: 5060103660018

Toote omadused

OBJECT 1
FOMICYT 40MG/ML POWDER FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 11-Dec-2017 | Nordic Pharma
Limited
1. Name of the medicinal product
Fomicyt 40 mg/ml powder for solution for infusion
2. Qualitative and quantitative composition
One ml of reconstituted solution contains 40 mg fosfomycin.
Each bottle with 2.69 g of powder contains 2.64 g disodium fosfomycin,
corresponding to 2 g fosfomycin
and 0.64 g sodium, for reconstitution in 50 ml of solvent.
Each bottle with 5.38 g of powder contains 5.28 g disodium fosfomycin,
corresponding to 4 g fosfomycin
and 1.28 g sodium, for reconstitution in 100 ml of solvent.
Each bottle with 10.76 g of powder contains 10.56 g disodium
fosfomycin, corresponding to 8 g
fosfomycin and 2.56 g sodium, for reconstitution in 200 ml of solvent.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for infusion.
White to cream-coloured powder.
4. Clinical particulars
4.1 Therapeutic indications
Fosfomycin is indicated for the treatment of the following infections
in adults and children including
neonates (see section 5.1):
- Osteomyelitis
- Complicated urinary tract infections
- Nosocomial lower respiratory tract infections
- Bacterial meningitis
- Bacteraemia that occurs in association with, or is suspected to be
associated with, any of the infections
listed above
Fosfomycin should be used only when it is considered inappropriate to
use antibacterial agents that are
commonly recommended for the initial treatment of the infections
listed above, or when these alternative
antibacterial agents have failed to demonstrate efficacy.
For information regarding the combination with other antibiotics see
section 4.4 and 4.5.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
The daily dose of fosfomycin is determined based on the indication,
severity and site of the infection,
susceptibility of the pathogen(s) to fosfomycin and the renal
fun