ATOVAQUOPRO LUPIN 62.5/25 atovaquone/proguanil hydrochloride 62.5/25 mg film-coated tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

atovaquone, Quantity: 62.5 mg; proguanil hydrochloride, Quantity: 25 mg

제공처:

Generic Health Pty Ltd

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: colloidal anhydrous silica; sodium starch glycollate type A; microcrystalline cellulose; poloxamer; magnesium stearate; hyprolose; purified water; povidone; titanium dioxide; macrogol 8000; hypromellose; iron oxide red; macrogol 400

관리 경로:

Oral

패키지 단위:

12 tablets, 24 tablets, 60 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

AtovaquoPro Lupin is indicated for:,? Prophylaxis of Plasmodium falciparum malaria in adults and children greater than or equal to 11 kg.,? Treatment of Plasmodium falciparum malaria in adults and children aged 3 years or older.

제품 요약:

Visual Identification: Pink, round, biconvex, film-coated tablets, debossed with 'I' on one side and '11' on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

2022-08-16

환자 정보 전단

AtovaquoPro Lupin
250/100 and AtovaquoPro Lupin 62.5/25 V1
1
ATOVAQUOPRO LUPIN 250/100 AND ATOVAQUOPRO
LUPIN 62.5/25
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 ATOVAQUOPRO LUPIN 250/100 AND ATOVAQUOPRO LUPIN
62.5/25?
This product contains the active ingredients atovaquone and proguanil
hydrochloride, which are used to prevent or treat the
type of malaria infection known as _Plasmodium falciparum_ malaria.
For more information, see Section 1. Why am I using AtovaquoPro Lupin
250/100 and AtovaquoPro Lupin 62.5/25? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ATOVAQUOPRO LUPIN 250/100 AND
ATOVAQUOPRO LUPIN
62.5/25?
Do not use if you have ever had an allergic reaction to atovaquone and
proguanil 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
AtovaquoPro Lupin 250/100 and AtovaquoPro Lupin
62.5/25? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AtovaquoPro Lupin 250/100 and
AtovaquoPro Lupin 62.5/25 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 ATOVAQUOPRO LUPIN 250/100 AND ATOVAQUOPRO LUPIN 62.5/25?
Take this medicine as directed by your doctor or pharmacist.
More instructions can be found in Section 4. How do I use AtovaquoPro
Lupin 250/100 and AtovaquoPro Lupin 62.5/25? in the
full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ATOVAQUOPRO LUPIN 250/100 AND
ATOVAQUOPRO LUPIN
62.5/25?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
AtovaquoPro Lupin 250/100 and
AtovaquoPro Lupin 62.5/25 or if you are about to be started on any new
medicine.
•
Tell your doctor if

제품 특성 요약

AUSTRALIAN PRODUCT INFORMATION – ATOVAQUOPRO LUPIN 250/100
AND ATOVAQUOPRO LUPIN 62.5/25
(ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Atovaquone and proguanil hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AtovaquoPro Lupin 250/100 and AtovaquoPro Lupin 62.5/25 are fixed
combination products containing
atovaquone and proguanil hydrochloride.
Each
AtovaquoPro
Lupin
250/100
tablet
contains
250 mg
atovaquone
and
100 mg
proguanil
hydrochloride.
Each
AtovaquoPro
Lupin
62.5/25
tablet
contains
62.5 mg
atovaquone
and
25 mg
proguanil hydrochloride.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
AtovaquoPro Lupin 250/100: Pink, round, biconvex, film-coated tablets,
debossed with 'H' on one side
and '175' on the other side.
AtovaquoPro Lupin 62.5/25: Pink, round, biconvex, film-coated tablets,
debossed with 'I' on one side
and '11' on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AtovaquoPro Lupin is indicated for:
•
Prophylaxis of _Plasmodium falciparum _malaria in adults and children
≥11 kg.
•
Treatment of _Plasmodium falciparum_ malaria in adults and children
aged 3 years or older.
4.2 DOSE AND METHOD OF ADMINISTRATION
The daily dose should be taken with food or a milky drink at the same
time each day.
In the event of vomiting within 1 hour of dosing, a repeat dose should
be taken.
AtovaquoPro Lupin 250/100 or AtovaquoPro Lupin 62.5/25 tablets should
preferably be swallowed
whole. If difficulties are encountered when dosing young children, the
tablet(s) may be crushed and
added to a small amount of milk, all of which should be consumed
immediately.
AtovaquoPro Lupin 250/100 and AtovaquoPro Lupin 62.5/25 v1
Page 2 of 18
(atovaquone and proguanil hydrochloride) film-coated tablets
PROPHYLAXIS
Prophylaxis should start 1 to 2 days before entering a malaria-endemic
area and be continued daily until
seven days after leaving the area.
If patients are unable to tolerate food, AtovaquoPro Lupin tablets
should