Biltricide

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Praziquantel 600mg

Boleh didapati daripada:

Bayer New Zealand Limited

INN (Nama Antarabangsa):

Praziquantel 600 mg

Dos:

600 mg

Borang farmaseutikal:

Film coated tablet

Komposisi:

Active: Praziquantel 600mg Excipient: Hypromellose Macrogol 4000 Magnesium stearate Maize starch Microcrystalline cellulose Povidone Purified water   Sodium laurilsulfate Titanium dioxide

Unit dalam pakej:

Bottle, glass, Type II with PE cap, 8 tablets

Kelas:

Prescription

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Merck KGaA

Tanda-tanda terapeutik:

Treatment of schistosoma infections due to various types of blood fluke (e.g. Schistosoma haematobium, S. japonicum, S. mekongi or S mansoni).

Ringkasan produk:

Package - Contents - Shelf Life: Bottle, glass, - brown, Type II with PE cap - 8 tablets - 48 months from date of manufacture stored at or below 25°C

Tarikh kebenaran:

2011-06-08

Risalah maklumat

BILTRICIDE® CMI VX2.0
1
BILTRICIDE®
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 BILTRICIDE?
BILTRICIDE contains the active ingredient praziquantel. BILTRICIDE is
used for the treatment of schistosomiasis or bilharziasis,
which is a chronic parasitic infestation in humans caused by blood
flukes (worms).
For more information, see Section 1. Why am I using BILTRICIDE?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BILTRICIDE?
Do not use if you have ever had an allergic reaction to BILTRICIDE 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
BILTRICIDE?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BILTRICIDE 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 BILTRICIDE?
•
You must take all the BILTRICIDE tablets prescribed by your doctor or
pharmacist to kill the type of blood fluke you have.
Your doctor will prescribe a dose specifically for you. It is
important to take all the tablets your doctor prescribed.
•
Swallow the tablets with a full glass of water.
More instructions can be found in Section 4. How do I use BILTRICIDE?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BILTRICIDE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
BILTRICIDE.
•
If you are on corticosteroid therapy or if you are about to start
taking any new medicine, especially
medicines used to treat tuberculosis, leprosy, epilepsy, malaria,
stomach acidity, reflux or ulcers, tell
your doctor or pharmacist that you are taking BILTRICIDE.
THINGS YOU
SHOULD NOT DO
•
Do not stop using t

Ciri produk

BILTRICIDE DS VX2.0, CCDS 08
Page 1 of 8
DATA SHEET
1.
BILTRICIDE
® (600 MG FILM COATED TABLET)
Biltricide, 600 mg film coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg praziquantel.
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
The film-coated tablets are white to pale yellow lacquer-coated oblong
shaped tablets with
three scores with “Bayer” on one side and "LG" on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of schistosoma infections due to various types of blood
fluke (eg _Schistosoma _
_haematobium, S.japonicum, S.mekongi, S.mansoni_).
4.2
DOSE AND METHOD OF ADMINISTRATION
The doctor must prescribe individual doses for individual cases,
according to the diagnosis.
_Schistosoma haematobium_
20 mg/kg body weight
_Schistosoma mansoni_
three times a day
_Schistosoma japonicum_
at four hourly intervals
Schistosoma mekongi
for one day.
The tablet has 3 score marks, each fragment contains 150 mg active
substance, thus
allowing a precise dose to be given, corresponding to the patient’s
body weight.
If 1/4 of a tablet is required, it is convenient to begin by breaking
the tablet at one of the outer
grooves.
The simplest way to break the tablet is to place the thumbnail in the
groove.
BILTRICIDE DS VX2.0, CCDS 08
Page 2 of 8
TABLE 1: CONVERSION TABLE
BODY WEIGHT IN KG
20-25
26-33
34-41
42-48
49-56
57-63
64-70
71-78
79-86
No. of tablets
corresponding to
1 x 20 mg/kg
¾
1
1¼
1½
1¾
2
2¼
2½
2¾
Biltricide should be swallowed whole with a little liquid, preferably
after meals.
4.2.1
PAEDIATRIC POPULATION
See Section 4.4.
4.2.2
HEPATIC IMPAIRMENT
See Section 4.4.
4.2.3
RENAL IMPAIRMENT
See Section 4.4.
4.3
CONTRAINDICATIONS
Known hypersensitivity to praziquantel or any of the excipients.
Ocular cysticercosis - parasite destruction within the eye may cause
irreparable damage.
The concomitant administration of strong inducers of Cytochrome P 450
such as rifampicin
must be avoided as therapeutically effective pla