Itraconazole 10mg/ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Itraconazole

Available from:

Focus Pharmaceuticals Ltd

ATC code:

J02AC; J02AC02

INN (International Name):

Itraconazole

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Triazole derivatives; itraconazole

Authorization status:

Not marketed

Authorization date:

2013-10-18

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
ITRACONAZOLE 10MG/ML ORAL SOLUTION
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, 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 Itraconazole Oral Solution is and what it is used for
2. What you need to know before you take Itraconazole Oral Solution
3. How to take Itraconazole Oral Solution
4. Possible side effects
5. How to store Itraconazole Oral Solution
6. Contents of the pack and other information
1. WHAT ITRACONAZOLE ORAL SOLUTION IS AND WHAT IT IS USED FOR
Itraconazole 10mg/ml Oral Solution (called Itraconazole Oral Solution
throughout the
rest of this leaflet) belongs to a group of antifungal medicines
called triazole
derivatives. Your medicine works by stopping growth of the fungus.
This medicine is used:
•
to treat fungal infections which may occur in your mouth, throat or
gullet, in
patients who have HIV or a poorly functioning immune system.
•
to stop you from getting fungal infections, if your immune system is
not working
properly due to a reduced level of white blood cells (neutropenia), as
a result of a
blood disorder or a bone marrow transplant.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ITRACONAZOLE ORAL
SOLUTION
DO NOT TAKE ITRACONAZOLE ORAL SOLUTION
•
If you are allergic to itraconazole, or any of the other ingredients
of this
medicine (listed in section 6).
•
If you are pregnant, thinking of becoming pregnant or breastfeeding.
•
If you are taking any of the following medicines:

ASTEMIZOLE, MIZOLASTINE or TERFENADINE (antihistamines for
al

Summary of Product characteristics

Health Products Regulatory Authority
19 October 2018
CRN008L3J
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ranitidine 50mg/2ml Solution for Injection and Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each one ml of solution contains 25mg ranitidine as ranitidine
hydrochloride. Each
2ml ampoule contains 50mg ranitidine.
Excipient(s) with known effect:
Each ampoule contains 0.55mg (0.014mmol) of Potassium and 2.23mg
(0.097mmol)
of Sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection and Infusion
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Ranitidine Solution for Injection is indicated for the treatment of
duodenal ulcer,
benign gastric ulcer, post - operative ulcer, and of Zollinger -
Ellison Syndrome.
In the management of conditions where reduction of gastric secretion
and acid
output is desirable, such as reflux oesphagitis.
As prophylaxis against:

gastrointestinal haemorrhage from stress ulceration in seriously ill
patients

recurrent haemorrhage in patients with bleeding peptic ulcers

acid aspiration (Mendelson's Syndrome) before anaesthesia in patients
at
risk, particularly obstetric patients during labour.
Children (6 months to 18 years)

short term treatment of peptic ulcer
Health Products Regulatory Authority
19 October 2018
CRN008L3J
Page 2 of 10

treatment of gastro-oesophageal reflux, including reflux oesophagitis
and
symptomatic relief of gastro-oesophageal reflux disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
See section 5.2 Pharmacokinetic Properties – Special Patient
Populations
Posology
Adults (including elderly) and adolescents (12 years and older)
Ranitidine Solution for Injection may be given as:

a slow intravenous injection (over two minutes) up to a maximum of 50
mg,
after dilution to a volume of 20 ml per 50 mg dose. This dose may be
repeated every 6 to 8 hours or

as an intermittent intravenous infusion at a rate of 25 mg per hour
fo