APO-ITRACONAZOLE itraconazole 100 mg capsule blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

itraconazole, Quantity: 100 mg

זמין מ:

Arrotex Pharmaceuticals Pty Ltd

INN (שם בינלאומי):

Itraconazole

טופס פרצבטיות:

Capsule

הרכב:

Excipient Ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; Gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

28 capsules, 15 capsules, 60 capsules, 6 capsules, 4 capsules

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

APO-ITRACONAZOLE indicated for use in adults for the treatment of: ? Superficial dermatomycoses not responding to topical treatment. ? Fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. ? Pityriasis versicolor not responding to any other treatment. ? Vulvovaginal candidiasis not responding to topical treatment. ? Oral candidiasis in immunocompromised patients. ? Onychomycosis caused by dermatophytes. ? Systemic mycoses: - Systemic aspergillosis, histoplasmosis, sporotrichosis. - Treatment and maintenance therapy in AIDS patients with disseminated or chronic pulmonary histoplasmosis infection. - Treatment of oropharyngeal and/or oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. - Treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.

leaflet_short:

Visual Identification: Size 0el hard gelatin white opaque capsules filled with off-white to cream colored pellets and imprinting with ITR on cap and 100 on body; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

מצב אישור:

Licence status A

תאריך אישור:

2016-08-09

עלון מידע

APO-ITRACONAZOLE
1
APO-ITRACONAZOLE
_Itraconazole _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about itraconazole. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using itraconazole
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Itraconazole is used to treat certain
fungal infections, such as:
•
infections of the nails, skin,
hands, feet or groin
•
persistent candida (yeast) vaginal
infections
•
eye infections which have not
responded to other treatment or
which may be affecting vision
•
candida (yeast) infections of the
mouth or throat in patients with a
weakened immune system
•
generalised infections
Itraconazole works by killing or
stopping the growth of the fungus
that causes the infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
itraconazole for another reason.
This medicine is not addictive.
This medicine is only available with
a doctor’s prescription._ _
Itraconazole is not recommended for
use in children and in the elderly.
BEFORE YOU USE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ITRACONAZOLE IF YOU
HAVE AN ALLERGY TO:
•
itraconazole
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE ITRACONAZOLE IF YOU ARE
ALSO TAKING ANY OF THE FOLLOWING
MEDICINES:
•
terfenadine, astemizole or
mizolastine, used for allergies
•

מאפייני מוצר

1
AUSTRALIAN PRODUCT INFORMATION
APO-ITRACONAZOLE (ITRACONAZOLE) CAPSULES
1
NAME OF THE MEDICINE
Itraconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-Itraconazole capsules contain itraconazole 100 mg.
EXCIPIENTS WITH KNOWN EFFECT
Sucrose, gelatin.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-Itraconazole is available as white opaque capsules printed with
ITR on the cap and 100
on the body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
APO-Itraconazole is indicated for use in adults for the treatment of:
•
Superficial dermatomycoses not responding to topical treatment.
•
Fungal keratitis which has failed to respond to topical treatment or
where the disease
is either progressing rapidly or is immediately sight threatening.
•
Pityriasis versicolor not responding to any other treatment.
•
Vulvovaginal candidiasis not responding to topical treatment.
•
Oral candidiasis in immunocompromised patients.
•
Onychomycosis caused by dermatophytes.
•
Systemic mycoses, only in the following fungal infections:
-
Systemic
aspergillosis,
histoplasmosis,
lymphocutaneous/cutaneous
sporotrichosis.
-
Treatment and maintenance therapy in AIDS patients with disseminated
or
chronic pulmonary histoplasmosis infection.
-
Treatment of oropharyngeal and/or oesophageal candidiasis when first
line
systemic antifungal therapy is inappropriate or has proven
ineffective.
-
Treatment of non-invasive candidiasis in non-neutropenic patients when
first-
line systemic antifungal therapy is inappropriate or has proven
ineffective. This
may be due to underlying pathology, insensitivity of the pathogen or
drug
toxicity.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Itraconazole capsules are intended for oral administration.
DOSAGE
It is essential that APO-Itraconazole capsules are taken immediately
after a meal for maximal
absorption. The capsules must be swallowed whole. Treatment schedules
are as follows:
_SUPERFICIAL DERMATOMYCOSES: _
•
Tinea corporis, tinea cruris: 1 capsule (