Fluconazole 200mg/100ml infusion bags

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Fluconazole

Disponibbli minn:

Bowmed Ibisqus Ltd

Kodiċi ATC:

J02AC01

INN (Isem Internazzjonali):

Fluconazole

Dożaġġ:

2mg/1ml

Għamla farmaċewtika:

Infusion

Rotta amministrattiva:

Intravenous

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 05020100; GTIN: 5060130139402 5060130131468

Fuljett ta 'informazzjoni

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
This medicine has been prescribed for you. Do NOT pass it on to
others. It may harm them even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.
Your medicine is called FLUCONAZOLE 2MG/ML SOLUTION FOR INFUSION
(referred to as FLUCONAZOLE INFUSION in this leaflet.
IN THIS LEAFLET:
1. What Fluconazole is and what it is used for
2. Before you are given Fluconazole Infusion
3. How Fluconazole Infusion is given
4. Possible side effects
5. How to store Fluconazole Infusion
6. Further information
1. WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR
Fluconazole infusion is one of a group of medicines called antifungal
agents.
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 infections. 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 - infections 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 thrush 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 medicine by your doctor to treat the following
types of
fungal infections:
• Mucosal thrush - infections af

Karatteristiċi tal-prodott

OBJECT 1
FLUCONAZOLE 200MG/100ML INFUSION BAGS (2MG/ML
IN 200ML INFUSION BAGS)
Summary of Product Characteristics Updated 21-Dec-2017 | Bowmed
Ibisqus Limited
1. Name of the medicinal product
Fluconazole 2mg/ml Solution for Infusion
2. Qualitative and quantitative composition
Each ml of solution for infusion contains 2mg fluconazole.
Each 50 ml infusion bag contains 100mg fluconazole.
Each 100 ml infusion bag contains 200mg fluconazole.
Each 200 ml infusion bag contains 400mg fluconazole
Excipients
Also contains 15 mmol sodium per 100 ml dose.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Infusion
Infusion bag containing a clear, colourless 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 topical treatments are
insufficient
Fluconazole is indicated in adults for the prophylaxis of: 0
• Relapse of crytopcoccal 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
• 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 imm