DIFICID fidaxomicin 200 mg tablets in bottles

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

fidaxomicin, Quantity: 200 mg

Prieinama:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (Tarptautinis Pavadinimas):

Fidaxomicin

Vaisto forma:

Tablet, film coated

Sudėtis:

Excipient Ingredients: microcrystalline cellulose; hyprolose; butylated hydroxytoluene; sodium starch glycollate; magnesium stearate; pregelatinised maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; lecithin

Vartojimo būdas:

Oral

Vienetai pakuotėje:

20 tablets, 60 tablets

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

DIFICID (fidaxomicin) is indicated for the treatment of confirmed Clostridium difficile infection (CDI) in adults.

Produkto santrauka:

Visual Identification: Tablets are white to off-white, film coated, capsule-shaped tablets debossed with "FDX" on one side and "200" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorizacija statusas:

Licence status A

Leidimo data:

2013-04-23

Pakuotės lapelis

DIFICID
®
_fidaxomicin tablets_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about fidaxomicin tablets.
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 taking DIFICID
against the benefits they expect it
will 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 DIFICID IS USED
FOR
This medicine is used to treat
infections of the lining of the colon
(large intestine) with certain bacteria
called Clostridium difficile. This
serious illness can result in painful,
severe diarrhoea.
DIFICID contains the active
ingredient fidaxomicin.
Fidaxomicin is an antibiotic that
belongs to a new group of medicines
called macrocyclic antibiotics.
It works by killing the bacteria which
cause Clostridium difficile infections.
DIFICID will not work against viral
infections such as colds or flu or
against infections with other types of
bacteria.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
THIS MEDICINE IS ONLY AVAILABLE
WITH A DOCTOR’S PRESCRIPTION.
There is no evidence that this
medicine is addictive.
BEFORE YOU TAKE
DIFICID
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
Fidaxomicin
•
Any of the other ingredients of
DIFICID 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 THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for d

Prekės savybės

1
AUSTRALIAN PI – DIFICID (FIDAXOMICIN) TABLETS
1
NAME OF THE MEDICINE
fidaxomicin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fidaxomicin is the active ingredient in DIFICID.
Each film-coated tablet contains 200 mg of fidaxomicin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
DIFICID tablets are white to off-white film-coated, oblong tablets;
each tablet is debossed with
“FDX” on one side and “200” on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
DIFICID (fidaxomicin) is indicated for the treatment of confirmed
_Clostridium difficile_ infection
(CDI) in adults.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dose is 200 mg (one tablet) administered twice daily
(once every 12 hours)
for 10 days.
DIFICID can be taken before, during or after meals.
_Adults and elderly (≥65 years of age)_:
No dose adjustment is recommended for elderly patients.
_Patients with renal impairment_:
No dose adjustment is recommended for patients with renal impairment.
Due to the limited
clinical data in this population, DIFICID should be used with caution
in patients with severe
renal impairment (see section 5.2).
_Patients with hepatic impairment_:
No dose adjustment is recommended for patients with hepatic
impairment. Due to the limited
clinical data in this population, DIFICID should be used with caution
in patients with moderate
to severe hepatic impairment (see Section 5.2).
_Patients undergoing dialysis_:
No dose adjustment is recommended for patients undergoing dialysis.
2
_Patients with concomitant disease_:
No dose adjustment is recommended for patients with concomitant
disease.
_Children_:
Safety and efficacy of DIFICID in patients under the age of 18 has not
been established.
Therefore, DIFICID is not recommended for use in children.
4.3
C
ONTRAINDICATIONS
Patients who are hypersensitive to this drug or to any ingredient in
the formulation or
component of the container.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
General
_Not for Systemic In