BUTRANS 20

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BUPRENORPHINE

متاح من:

RAFA LABORATORIES LTD

ATC رمز:

N02AE

الشكل الصيدلاني:

PATCHES MATRIX

تركيب:

BUPRENORPHINE 20 MG

طريقة التعاطي:

TRANSDERMAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

LTS LOHMANN THERAPIE SYSTEME AG, GERMANY

المجموعة العلاجية:

ORIPAVINE DERIVATIVES

الخصائص العلاجية:

Treatment of moderate to severe opioid responsive chronic pain conditions which are not adequately responding to non-opioid analgesics.

تاريخ الترخيص:

2021-12-31

نشرة المعلومات

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
BUTRANS 5, BUTRANS 10, BUTRANS 15, BUTRANS 20
MATRIX TYPE TRANSDERMAL PATCHES
ACTIVE INGREDIENT:
Each patch of Butrans 5 contains Buprenorphine 5 mg and releases 5
mcg/hr.
Each patch of Butrans 10 contains Buprenorphine 10 mg and releases 10
mcg/hr.
Each patch of Butrans 15 contains Buprenorphine 15 mg and releases 15
mcg/hr.
Each patch of Butrans 20 contains Buprenorphine 20 mg and releases 20
mcg/hr.
For the list of the additional ingredients, see section 6.
•
THE PATCHES CONTAIN A STRONG PAINKILLER (OPIOID).
•
ENSURE THAT THE OLD PATCH IS REMOVED BEFORE APPLYING A NEW PATCH.
•
DO NOT CUT THE PATCHES.
•
DO NOT EXPOSE THE PATCHES TO A HEAT SOURCE (SUCH AS HOT WATER
BOTTLES).
•
AVOID HOT BATHS AND/OR HOT SHOWERS WHILST WEARING THE PATCH.
•
IF YOU DEVELOP A FEVER INFORM YOUR DOCTOR IMMEDIATELY.
•
FOLLOW THE DOSAGE AND MANNER OF USAGE INSTRUCTIONS CAREFULLY AND
CHANGE YOUR PATCH
ON THE SAME DAY AND AT THE SAME TIME 7 DAYS LATER.
•
IF YOUR BREATHING BECOMES SHALLOW AND WEAK REMOVE THE PATCH AND SEEK
MEDICAL
ATTENTION.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. Keep
this leaflet in case you need to
read it again. If you have any further questions, please refer to your
doctor or pharmacist.
This medicine has been prescribed to treat your condition. Do not pass
it on to others. It may harm
them, even if you think their medical condition is similar to yours.
This medicine is intended for use in adults.
Medicines of the opioids group may cause addiction, especially with
prolonged use, and they
have a potential for misuse and overdose. A reaction to an overdose
may be manifested by slow
breathing and may even cause death.
Make sure you know the name of the medicine, the dosage that you take,
how often you take it,
the duration of treatment, potential side effects and risks.
Additional infor

خصائص المنتج

BuTrans-DL-30-April 2023- 07
1
DOCTOR LEAFLET
BUTRANS 5, 10, 15, 20
Transdermal patch
1.
NAME OF THE MEDICINAL PRODUCT
_BUTRANS 5_
transdermal patch
_BUTRANS 10_
transdermal patch
_BUTRANS 15_
transdermal patch
_BUTRANS 20_
transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
_BUTRANS 5_
transdermal patch contains 5 mg buprenorphine.
Area containing active substance: 6.25 cm
2
.
Nominal release rate: 5 micrograms of buprenorphine per hour (over a
period of 7 days).
Each
_BUTRANS 10_
transdermal patch contains 10 mg buprenorphine.
Area containing active substance: 12.5 cm
2
.
Nominal release rate: 10 micrograms of buprenorphine per hour (over a
period of 7 days).
Each
_BUTRANS 15_
transdermal patch contains 15 mg buprenorphine.
Area containing active substance: 18.75 cm
2
.
Nominal release rate: 15 micrograms of buprenorphine per hour (over a
period of 7 days).
Each
_BUTRANS 20_
transdermal patch contains 20 mg buprenorphine.
Area containing active substance: 25 cm
2
.
Nominal release rate: 20 micrograms of buprenorphine per hour (over a
period of 7 days).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch.
Beige coloured patch with rounded corners.
_BUTRANS 5_
: Square patch marked:
_BUTRANS 5_
μg/h,
_BUTRANS 10_
: Rectangular patch marked:
_BUTRANS 10_
μg/h.
_BUTRANS 15_
: Rectangular patch marked:
_BUTRANS 15_
μg/h.
_BUTRANS 20_
: Square patch marked:
_BUTRANS 20_
μg/h.
4.
CLINICAL PARTICULARS
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
•
Concomitant use of opioids with benzodiazepines or other central
nervous system (CNS) depressants, including
alcohol, may result in profound sedation, respiratory depression,
coma, and death [see section 4.4 & 4.5].
•
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative treatment options are
inadequate.
•
Limit dosages and durations to the minimum required.
•
Follow patients for signs and symptoms of respiratory depression and
sedation.
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4