DOLESTINE

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

PETHIDINE HYDROCHLORIDE

MAH:

TEVA ISRAEL LTD

ATC_code:

N02AB02

pharmaceutical_form:

SOLUTION FOR INJECTION

composition:

PETHIDINE HYDROCHLORIDE 50 MG/ML

administration_route:

S.C, I.M, I.V

prescription_type:

Required

manufactured_by:

TEVA ISRAEL LTD, ISRAEL

therapeutic_group:

PETHIDINE

therapeutic_area:

PETHIDINE

therapeutic_indication:

Relief of severe pain pre-operative medication support of anesthesia obstetrical analgesia.

authorization_date:

2021-08-31

PIL

עבט
מ"עב תויטבצמרפ תוישעת
.
הנאתה בוחר
1
הישעת קראפ
ן"מח
,
.ד.ת
975
,
םהוש
60850
:לט
6864645
-
03
סקפ ,
6864944
-
03
www.tevapharm.com
_ _
ילוי
2018
ה/דבכנ ת/חקור ,ה/ אפור
,
עבט תרבח
:ןלהל טרופמכ עדימ ינוכדע לע עידוהל
תשקבמ
DOLESTINE
SOLUTION FOR I.M., I.V. OR S.C. INJECTION
ןיטסלוד
הקרזהל הסימת
רירשה ךותל
דירוה ךותל , וא
רועל תחתמ
_ לש הלופמא לכ_
_1_
_ _
_הליכמ ל"_
_מ_
_ :_
_Pethidine (meperidine) hydrochloride 50 mg_
_ _
_ לש הלופמא לכ_
_2_
_ _
_הליכמ ל"מ_
_ :_
_Pethidine (meperidine) hydrochloride 100 mg_
_ _
_ _ תפסוה
"BLACK BOX"
םייטאיפואה תצובקמ םירישכת ינולעב
---------------------------------------------------------------------------------------------------------------------
יוותה
ה :םושירה תדועתב הרשואש יפכ
Relief of severe pain, pre-operative medication, support of
anesthesia, obstetrical analgesia.
לעב תפסותה
:ןלהלכ איה ןו
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 Precautions and Drug Interactions).
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.
ןולעה
ל
אפור
םוסרפל
חלשנ
אה
רתאבש
תופורתה
רגאמב
י
תואירבה
דרשמ
לש
טנרטנ
HTTP://WWW.HEALTH.GOV.IL
לבקל ןתינו
ו
עבט תרבחל הינפ י"ע ספדומ .

SPC

COMPOSITION
_Active Ingredient_
Each ampoule of 1 ml contains:
Pethidine (meperidine) hydrochloride
50 mg
Each ampoule of 2 ml contains:
Pethidine (meperidine) hydrochloride
100 mg
_Other Ingredients_
Water for injections, sodium hydroxide (q.s.for pH
adjustment).
MECHANISM OF ACTION
Dolestine is a powerful narcotic analgesic.
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 Precautions and Drug Interactions).
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.
INDICATIONS
∙ Relief of severe pain.
∙ Pre-operative medication.
∙ Support of anesthesia.
∙ Obstetrical analgesia.
CONTRAINDICATIONS
Known hypersensitivity to the preparation.
Pethidine is contraindicated in patients who are receiving
monoamine oxidase inhibitors, or those who have recently
received such agents. Therapeutic doses of pethidine
have occasionally precipitated unpredictable, severe, and
occasionally fatal reactions in patients who have received
monoamine oxidase inhibitors within the last 14 days. The
mechanism of these reactions is unclear, but may be related
to a pre-existing hyperphenylalaninemia. Some have been
characterized by coma, severe respiratory depression, cyanosis
and hypotension, and have resembled the syndrome of
acute narcotic overdose. In other reactions, the predominant
manifestations have been hyperexcitability, convulsions,
tachycardia, hyperpyrexia, and hypertension.
Although it is not known that other narcotics are free of the
risk of such reactions, virtually all of the reported reactions
have occurred with pethidine. If a narcotic is needed in
such patients, a sensitivity test should be pe