Fluconazole 2 mg/ml solution for infusion

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Fluconazole

可用日期:

Claris Lifesciences (UK) Limited

ATC代码:

J02AC; J02AC01

INN（国际名称）:

Fluconazole

剂量:

2 milligram(s)/millilitre

药物剂型:

Solution for infusion

处方类型:

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

治疗领域:

Triazole derivatives; fluconazole

授权状态:

Not marketed

授权日期:

2008-07-04

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 2 MG/ML SOLUTION FOR INFUSION
Fluconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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, 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fluconazole is and what it is used for
2.
What you need to know before you are given Fluconazole
3.
How Fluconazole is given
4.
Possible side effects
5.
How to store Fluconazole
6.
Contents of the pack and other information
1.
WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR
Fluconazole is one of a group of medicines called “antifungals”.
The active substance is
fluconazole.
Fluconazole is used to treat infections caused by fungi and may also
be used to stop you from
getting candidal infection. The most common cause of fungal infections
is a yeast called
_Candida_.
ADULTS
You might be given this medicine by your doctor to treat the following
types of fungal
infections:

cryptococcal meningitis – a fungal infection in the brain;

coccidioidomycosis – a disease of the bronchopulmonary system;

infections caused by_ Candida_ and found in the blood stream, body
organs (e.g. heart,
lungs) or urinary tract;

mucosal thrush - infection affecting the lining of the mouth, throat
and denture sore
mouth.
You might also be given Fluconazole to:

stop cryptococcal meningitis from coming back;

stop mucosal trush from coming back;

stop you from getting an infection caused by _Candida _(if your immune
system is weak
and not working properly).
CHILDREN AND ADOLESCENTS (0 TO 17 YEARS OLD)
You might be given this medicin

产品特点

Health Products Regulatory Authority
11 January 2019
CRN008HF9
Page 1 of 25
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluconazole 2 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2 mg of fluconazole.
Each 100 ml solution for infusion contains 200 mg fluconazole.
Excipient with known effect
Each 100 ml solution for infusion contains 15.4 mmol sodium (see
section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear and colorless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluconazole is indicated in the following fungal infections (see
section 5.1).
Fluconazole is indicated in adults for the treatment of:

cryptococcal meningitis (see section 4.4);

coccidioidomycosis (see section 4.4);

invasive candidiasis;

mucosal candidiasis including oropharyngeal, oesophageal candidiasis,
candiduria and chronic mucocutaneous candidiasis;

chronic oral atrophic candidiasis (denture sore mouth) if dental
hygiene or
topical treatment are insufficient.
Fluconazole is indicated in adults for the prophylaxis of:

relapse of cryptococcal meningitis in patients with high risk of
recurrence;

relapse of oropharyngeal or oesophageal candidiasis in patients
infected
with HIV who are at high risk of experiencing relapse;
Health Products Regulatory Authority
11 January 2019
CRN008HF9
Page 2 of 25

prophylaxis of candidal infections in patients with prolonged
neutropenia
(such as patients with haematological malignancies receiving
chemotherapy or patients receiving Hematopoietic Stem Cell
Transplantation (see section 5.1)).
Fluconazole is indicated in term newborn infants, infants, toddlers,
children and
adolescents aged from 0 to 17 years old:

Fluconazole is used for the treatment of mucosal candidiasis
(oropharyngeal, oesophageal), invasive candidiasis, cryptococcal
meningitis
and the prophylaxis of candidal infections in immunocompromised
patients. Fluconazole can be used a