OSELTAMIVIR STR oseltamivir (as phosphate) 45 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oseltamivir phosphate, Quantity: 59.1 mg

Available from:

Strides Pharma Science Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: purified water; Gelatin; iron oxide black; sodium stearylfumarate; croscarmellose sodium; pregelatinised maize starch; titanium dioxide; purified talc; povidone; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; potassium hydroxide

Administration route:

Oral

Units in package:

10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Oseltamivir STR 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 STR 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.

Product summary:

Visual Identification: White to off white powder filled in size "3" hard gelatin capsule with grey opaque cap/body printed 45 on cap and OP on body in black; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-03-04

Patient Information leaflet

Oseltamivir STR®
OSELTAMIVIR STR
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING OSELTAMIVIR STR?
Oseltamivir STR is an antiviral medicine containing the active
ingredient oseltamivir. Oseltamivir STR 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.
For more information, see Section 1. Why am I using Oseltamivir STR?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OSELTAMIVIR STR?
Do not use if you have ever had an allergic reaction to oseltamivir or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Oseltamivir STR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Oseltamivir STR and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE OSELTAMIVIR STR?
•
Take Oseltamivir STR exactly as your doctor has prescribed.
•
Start taking Oseltamivir STR as soon as possible within the first two
days of the onset of the first symptoms of
influenza or exposure to someone with influenza.
More instructions can be found in Section 4. How do I use Oseltamivir
STR? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OSELTAMIVIR STR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Oseltamivir STR.
•
Tell your doctor if you have kidney failure or impairment or any other
problems with your kidneys.
•
Tell your doctor if you become pregnant while taking Oseltamivir STR.
THINGS YOU
SHOULD NOT DO
•
Do not give
Oseltamivir STR
to children under 1 year of age for the pr

Summary of Product characteristics

Oseltamivir STR
1
AUSTRALIAN PRODUCT
INFORMATION
OSELTAMIVIR STR
(OSELTAMIVIR PHOSPHATE)
CAPSULES
1.
NAME OF THE MEDICINE
Oseltamivir (as phosphate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oseltamivir STR75 mg capsule contains of 98.5 mg of oseltamivir
phosphate equivalent
to 75 mg oseltamivir.
Oseltamivir STR 45 mg capsule contains 59.1 mg oseltamivir phosphate,
equivalent to
45 mg of oseltamivir.
Oseltamivir STR 30 mg capsule contains 39.4 mg of oseltamivir
phosphate,
equivalent to 30 mg of oseltamivir.
Excipients with known effect
Contains gelatin, which may contain sulfites as residue.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Hard capsules
Oseltamivir STR 75 mg capsules has a white to off white powder filled
in size “2” hard
gelatin capsule with cream cap and brown body printed “OP” on cap
and “75” on body in
black.
Oseltamivir STR 45 mg capsules has a white to off white powder filled
in size “3” hard
gelatin capsule with grey opaque cap/body printed “45” on cap and
“OP” on body in
black.
Oseltamivir STR 30 mg capsules has a white to off white powder filled
in size “4” hard
gelatin capsule with light yellow opaque cap/body printed “30” on
cap and “OP” on body in
black
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oseltamivir STR 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 STR 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
Oseltamivir STR
2
infection with influenza virus.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
_Oseltamivir oral suspension is unavailable in this brand but it is
available in other brands. _
_Where correct dosing requires oseltamivir oral suspension, or if a
patient