PROCTOLOG SUPPOSITORY
국가: 싱가포르
언어: 영어
출처: HSA (Health Sciences Authority)
환자 정보 전단 유효 성분:
RUSCOGENINS; TRIMEBUTINE
제공처:
PFIZER PRIVATE LIMITED
ATC 코드:
C05AX03
복용량:
10 mg
약제 형태:
SUPPOSITORY
구성:
RUSCOGENINS 10 mg; TRIMEBUTINE 120 mg
관리 경로:
RECTAL
처방전 유형:
Prescription Only
Manufactured by:
FARMEA
승인 상태:
ACTIVE
승인 날짜:
1989-06-03
환자 정보 전단
Page 1 of 4
PROCTOLOG
1.
NAME OF THE MEDICINAL PRODUCT
PROCTOLOG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rectal
cream
Suppository
Trimebutine
5.8 g
120 mg
Ruscogenins
0.50 g
10 mg
in 100 g
in 1 suppository
3.
PHARMACEUTICAL FORM
Rectal
cream
and suppositories
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC
INDICATIONS
Haemorrhoidal itching.
Anal fissures – fissure syndromes.
Anal inflammation related to fissures.
Rectal bleeding from fissures and haemorrhoids.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
One to two applications of rectal cream per day.
One to two suppositories per day.
4.3 CONTRAINDICATIONS
Hypersensitivity to one of the ingredients in the
rectal cream (in particular propylene
glycol) or the suppositories.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The administration of this product does not dispense with the
need for the specific
treatment of other anal diseases. Treatment
must
be short-term. If the symptoms are not
relieved rapidly, a
proctological examination must be carried out and the
treatment
reviewed.
Page 2 of 4
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER
FORMS OF INTERACTION
None actually recorded
4.6
PREGNANCY AND LACTATION
_Pregnancy:_
There are no adequate and
well controlled studies of proctolog in pregnant
women. There was no evidence of teratogenicity or other adverse developmental effects
when Trimebutine was administered to pregnant rats and rabbits.
Similar studies on
ruscogenin are not available. Therefore, Proctolog should be used during pregnancy only
if the potential benefit
to the patient outweighs the risk to the patient and fetus.
No sufficiently relevant data are currently
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제품 특성 요약
PROCTOLOG
1.
NAME OF THE MEDICINAL PRODUCT
PROCTOLOG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 120 mg trimebutine and 10 mg ruscogenins.
3.
PHARMACEUTICAL FORM
Suppositories
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Haemorrhoidal itching.
Anal fissures – fissure syndromes.
Anal inflammation related to fissures.
Rectal bleeding from fissures and haemorrhoids.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
One to two suppositories per day.
4.3
CONTRAINDICATIONS
Hypersensitivity to one of the ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The administration of these products does not dispense with the need
for the specific
treatment of other anal diseases. Treatment must be short-term. If the
symptoms are not
relieved rapidly, a proctological examination must be carried out and
the treatment reviewed.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None actually recorded.
4.6
PREGNANCY AND LACTATION
_Pregnancy:_
There are no adequate and well controlled studies of proctolog in
pregnant
women. There was no evidence of teratogenicity or other adverse
developmental effects when
Trimebutine was administered to pregnant rats and rabbits. Similar
studies on ruscogenins are
not available. As a precautionary measure, it is preferable not to use
trimebutine during the
first trimester of pregnancy. In the absence of any expected harmful
effect for either mother
or child, the use of trimebutine during the 2nd and 3rd trimesters of
pregnancy should only be
considered if it is necessary.
Proctolog should be used during pregnancy only if the potential
benefit to the patient
outweighs the risk to the patient and fetus.
_ _
_Lactation_
: Safety for use in lactation has not been established.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
The effect of trimebutine on the ability to drive or use machinery has
not been systematically
evaluated.
4.8
UNDESIRABLE EFFECTS
The following Adverse Drug Reactions (ADRs) have been reported in
patients receiving
trimebut
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