Fomicyt 40mg/ml Powder for solution for infusion

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

FOSFOMYCIN SODIUM

Dostupno od:

InfectoPharm Arzneimittel und Consilium GmbH

ATC koda:

J01XX; J01XX01

INN (International ime):

FOSFOMYCIN SODIUM

Doziranje:

40 milligram(s)/millilitre

Farmaceutski oblik:

Powder for solution for infusion

Tip recepta:

Product subject to prescription which may not be renewed (A)

Područje terapije:

Other antibacterials; fosfomycin

Status autorizacije:

Marketed

Datum autorizacije:

2015-07-31

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fomicyt 40 mg/ml Powder for solution for infusion
Fosfomycin
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, or pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Fomicyt is and what it is used for
2.
What you need to know before you use Fomicyt
3.
How to use Fomicyt
4.
Possible side effects
5.
How to store Fomicyt
6.
Contents of the pack and other information
1.
WHAT FOMICYT IS AND WHAT IT IS USED FOR
Fomicyt contains the active substance fosfomycin. It belongs to a
group of medicines called
antibiotics. It works by killing certain types of germs (bacteria)
that cause serious infectious diseases.
Your doctor has decided to treat you with Fomicyt to help your body
fight an infection. It is important
that you receive effective treatment for this condition.
Fomicyt is used in adults, adolescents and children to treat bacterial
infections of:

the urinary tract

the heart - sometimes called ‘endocarditis’

the bones and joints

the lungs called "pneumonia"

the skin and tissues below the skin

the central nervous system

the abdomen

the blood, when caused by any of the conditions listed above
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FOMICYT
DO NOT USE FOMICYT:

if you are allergic to fosfomycin or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS:
2
Talk to your doctor, pharmacist or nurse before using Fomicyt if you
suffer from one of the following
disorders:

heart problems (cardiac insufficiency)

Svojstava lijeka

Health Products Regulatory Authority
20 April 2021
CRN00C5T9
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fomicyt 40mg/ml Powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution for infusion 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 solution 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 solution 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 solution 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
Fomicyt is indicated in all age groups for the treatment of the
following infections when it is considered inappropriate to use
antibacterial agents that are commonly recommended for their initial
treatment (see sections 4.2, 4.4 and 5.1):
- complicated urinary tract infections
- infective endocarditis
- bone and joint infections
- hospital-acquired pneumonia, including ventilator-associated
pneumonia
- complicated skin and soft tissue infection
- bacterial meningitis
- complicated intra-abdominal infections
- bacteraemia that occurs in association with, or is suspected to be
associated with, any of the infections listed above
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 function. In children, it is
also determined by age and body weight.
_Adults and adolescents (≥ 12 years of age) (≥ 40 kg):_
The general dosage guidelin