ATTENT 5 MG

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Beli sekarang

Download Risalah maklumat (PIL)
28-01-2018
Download Ciri produk (SPC)
28-01-2018
Download Laporan Penilaian Awam (PAR)
20-03-2017

Bahan aktif:

AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Boleh didapati daripada:

ABIC MARKETING LTD, ISRAEL

Borang farmaseutikal:

TABLETS

Komposisi:

AMPHETAMINE SULFATE 1.250 MG; DEXTROAMPHETAMINE SULFATE 1.250 MG; AMPHETAMINE ASPARTATE MONOHYDRATE 1.250 MG; DEXTROAMPHETAMINE SACCHARATE 1.250 MG

Laluan pentadbiran:

PER OS

Jenis preskripsi:

Required

Dikeluarkan oleh:

BARR LABORATORIES INC.,

Tanda-tanda terapeutik:

Treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

Tarikh kebenaran:

2015-07-12

Risalah maklumat

                                PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
ATTENT 5 MG TABLETS
ATTENT 10 MG TABLETS
ATTENT 20 MG TABLETS
ATTENT 30 MG TABLETS
COMPOSITION
EACH ATTENT 5 MG TABLET CONTAINS
1.25 mg of each of the following ingredients:
Dextroamphetamine Saccharate
Amphetamine Aspartate Monohydrate
Dextroamphetamine Sulfate
Amphetamine Sulfate
The total equivalent amount of amphetamine
is 3.13 mg
EACH ATTENT 10 MG TABLET CONTAINS
2.5 mg of each of the following ingredients:
Dextroamphetamine Saccharate
Amphetamine Aspartate Monohydrate
Dextroamphetamine Sulfate
Amphetamine Sulfate
The total equivalent amount of amphetamine
is 6.3 mg
EACH ATTENT 20 MG TABLET CONTAINS
5 mg of each of the following ingredients:
Dextroamphetamine Saccharate
Amphetamine Aspartate Monohydrate
Dextroamphetamine Sulfate
Amphetamine Sulfate
The total equivalent amount of amphetamine
is 12.6 mg
EACH ATTENT 30 MG TABLET CONTAINS
7.5 mg of each of the following ingredients:
Dextroamphetamine Saccharate
Amphetamine Aspartate Monohydrate
Dextroamphetamine Sulfate
Amphetamine Sulfate
The total equivalent amount of amphetamine
is 18.8 mg
For the list of inactive ingredients in the
preparation, see section 6 – “Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains concise information about the
medicine. If you have further questions, refer
to the doctor or pharmacist.
THIS MEDICINE HAS BEEN PRESCRIBED FOR THE
TREATMENT OF YOUR AILMENT. DO NOT PASS IT
ON TO OTHERS. IT MAY HARM THEM EVEN IF IT
SEEMS TO YOU THAT THEIR MEDICAL CONDITION
IS SIMILAR.
THE MEDICINE CAN BE TAKEN BY ADULTS
AND ALSO BY CHILDREN AND THEREFORE, THE
INFORMATION IN THIS LEAFLET IS ALSO INTENDED
FOR CHILDREN TAKING THIS MEDICINE.
THE MEDICINE CONTAINS AMPHETAMINES,
WHICH HAVE POTENTIAL TO BE MISUSED. TAKING
FOR A LONG TIME MAY LEAD TO DEPENDENCE.
1.
WHAT IS THE MEDICINE INTENDED
FOR?
The medicine contains a mix of amphet
                                
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Ciri produk

                                Attent tablets 03-2017 FW
This leaflet format has been determined by the Ministry of Health and
the content
thereof has been checked and approved on March 2017
PHYSICIANS’ PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
ATTENT
5 mg, 10 mg, 20 mg, 30 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
A single entity amphetamine product combining the neutral sulfate
salts of
dextroamphetamine and amphetamine, with the dextro isomer of
amphetamine saccharate and
d, l-amphetamine aspartate.
EACH TABLET
CONTAINS
5 MG
10 MG
20 MG
30 MG
Dextroamphetamine
Saccharate
1.25 mg
2.5 mg
5 mg
7.5 mg
Amphetamine Aspartate
Monohydrate
1.25 mg
2.5 mg
5 mg
7.5 mg
Dextroamphetamine Sulfate
1.25 mg
2.5 mg
5 mg
7.5 mg
Amphetamine Sulfate
1.25 mg
2.5 mg
5 mg
7.5 mg
Total amphetamine base
equivalence
3.13 mg
6.3 mg
12.6 mg
18.8 mg
For a full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
ATTENT 5 MG
:
Blue oval tablet, debossed with "b" over "971" between two horizontal
lines on one side. On
the other side, debossed with "5" above two lines perpendicular to
each another.
ATTENT 10 MG
:
Blue oval tablet, debossed with "b" over "972" between two horizontal
lines on one side. On
the other side, debossed with "1" and "0" on both sides of a bisect
line [1│0] and between two
horizontal lines.
ATTENT 20 MG
:
Peach oval tablet, debossed with "b" over "973" between two horizontal
lines on one side. On
the other side, debossed with "2" and "0" on both sides of a bisect
line [2 │ 0] and
betweentwo horizontal lines.
ATTENT 30 MG
Peach oval tablet, debossed with "b" over "974" between two horizontal
lines on one side. On
the other side, debossed with "3" and "0" on both sides of a bisect
line [3 │ 0] and between
two horizontal lines.
Attent tablets 03-2017 FW
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of Attention Deficit Hyperactivity Disorder (ADHD) and
Narcolepsy.
ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD;
Diagnostic and Statistical
Manual 
                                
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