Oseltamivir Lupin Oseltamivir (as phosphate) 75 mg capsule blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

oseltamivir phosphate, Quantity: 98.524 mg

متاح من:

Lupin Australia Pty Limited

الشكل الصيدلاني:

Capsule, hard

تركيب:

Excipient Ingredients: povidone; sodium stearylfumarate; pregelatinised maize starch; purified talc; croscarmellose sodium; ethanol absolute; titanium dioxide; purified water; iron oxide yellow; Gelatin; iron oxide black

طريقة التعاطي:

Oral

الوحدات في الحزمة:

10's

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

Oseltamivir is indicated for the treatment of infections due to influenza A and B viruses in adults and children including full-term neonates. Treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,Oseltamivir is indicated for the prevention of influenza in adults and children aged 1 year and older. Vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

ملخص المنتج:

Visual Identification: Size '2' Hard gelatin capsules with light yellow cap imprinted with '75 mg' in blue ink and grey opaque body imprinted with 'LU' in blue ink containing white to off white granular powder.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

الوضع إذن:

Registered

تاريخ الترخيص:

2020-12-03

نشرة المعلومات

CONSUMER MEDICINE INFORMATION
OSELTAMIVIR LUPIN
(OSELTAMIVIR) CAPSULES
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Oseltamivir Lupin capsules.
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
Oseltamivir Lupin 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 OSELTAMIVIR LUPIN
IS USED FOR
Oseltamivir Lupin is an antiviral
medicine containing the active
ingredient oseltamivir.
Oseltamivir Lupin is used for the
treatment and prevention of
influenza (an infection caused
by the influenza virus). It has no
effect on the common cold or
other respiratory virus infections.
Oseltamivir Lupin belongs to a
group of medicines called
neuraminidase inhibitors. These
medicines attack the influenza
virus and prevent it from
spreading inside your body.
Oseltamivir Lupin is absorbed to
the key sites of influenza
infection and treats the cause.
Taking Oseltamivir Lupin means
you feel better faster.
You will also be less likely to
develop complications of
influenza, such as bronchitis,
pneumonia and sinusitis.
Typical symptoms of influenza
include fever, headache, muscle
aches, sore throat, cough and
generally feeling unwell.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
OSELTAMIVIR LUPIN HAS BEEN
PRESCRIBED FOR YOU.
Oseltamivir Lupin is not
addictive.
This medicine is available only
with a doctor's prescription.
ASK YOUR DOCTOR ABOUT HAVING
THE INFLUENZA VACCINATION.
Vaccination every year is the
best way to prevent influenza.
BEFORE YOU TAKE
OSELTAMIVIR LUPIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE OSELTAMIVIR LUPIN
IF:
1. YOU HAVE HAD AN ALLERGIC
REACTION TO OSELTAMIVIR OR
ANY INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
Some of the symptoms of an
allergic reaction may include:
-

خصائص المنتج

AUSTRALIAN PRODUCT INFORMATION – OSELTAMIVIR LUPIN
(OSELTAMIVIR PHOSPHATE) CAPSULES
1
NAME OF THE MEDICINE
Oseltamivir phosphate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oseltamivir Lupin 75 mg capsules contain 98.5 mg of oseltamivir
phosphate equivalent to 75 mg of
oseltamivir.
Oseltamivir Lupin 45 mg capsules contain 59.1 mg oseltamivir
phosphate, equivalent to 45 mg of
oseltamivir.
Oseltamivir Lupin 30 mg capsules contain 39.4 mg of oseltamivir
phosphate, equivalent to 30 mg of
oseltamivir.
List of excipients with known effect: Contains sulfites (as gelatin).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
OSELTAMIVIR LUPIN CAPSULES
Oseltamivir Lupin 75 mg capsules: Size “2” hard gelatin capsule
with light yellow cap imprinted with
“75 mg” in blue ink and grey opaque body imprinted with “LU”
in blue ink containing white to off white
granular powder.
Oseltamivir Lupin 45 mg capsules: Size “4” hard gelatin capsule
with grey opaque cap imprinted with
“45 mg” in blue ink and grey opaque body imprinted with “LU”
in blue ink containing white to off white
granular powder.
Oseltamivir Lupin 30 mg capsules: Size “4” hard gelatin capsule
with light yellow cap imprinted with
“30 mg” in blue ink and light yellow body imprinted with “LU”
in blue ink containing white to off white
granular powder.
OSELTAMIVIR POWDER FOR ORAL SUSPENSION
Available in other brands.
Oseltamivir Lupin v3
(oseltamivir phosphate) capsules
Page 2 of 25
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oseltamivir Lupin is indicated for the treatment of infections due to
influenza A and B viruses in adults
and children including full-term neonates. Treatment should commence
as soon as possible, but no later
than 48 hours after the onset of the initial symptoms of infection.
Oseltamivir Lupin is indicated for the prevention of influenza in
adults and children aged 1 year and
older. Vaccination is the preferred method of routine prophylaxis
against infection with influ