ATROPINE TEVA 20 MG10 ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ATROPINE SULFATE

Available from:

TEVA ISRAEL LTD

ATC code:

A03BA01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ATROPINE SULFATE 20 MG / 10 ML

Administration route:

I.V, I.M

Prescription type:

Required

Manufactured by:

TEVA ISRAEL LTD, ISRAEL

Therapeutic group:

ATROPINE

Therapeutic area:

ATROPINE

Therapeutic indications:

Preanesthetic medication to decrease excessive salivation and secretions of the respiratory tract. Treatment of sinus bradycardia, particularly if complicated by hypotension. Antidote in poisoning by organophosphorus.

Authorization date:

2021-08-31

Patient Information leaflet

מ"עב תויטבצמרפ תוישעת עבט
הנאתה 'חר
1
.ד.ת ן"מח הישעת קראפ ,
975
םהוש ,
6085001
:לט |
972-3-6864000
|
www.tevapharm.com לירפא
2019 ה/דבכ ת/חקור ,ה/אפור
,
ט תרבח העידומ עב
לש אפורל ןולעב םיאבה םיוכדעה לע
רישכתה
:
ATROPINE TEVA 20MG/10ML
SOLUTION FOR I.M. OR I.V. INJECTION עבט ןיפורטא
20
/ג"מ
10
ל"מ
דירווה ךותל וא רירשה ךותל הקרזהל הסימת
Atropine sulfate 20mg
לש הלופמא לכ
1
:הליכמ ל"מ :םושירה תדועתב הרשואש יפכ היוותה
Preanesthetic medication to decrease excessive salivation and
secretions of the respiratory tract.
Treatment of sinus bradycardia, particularly if complicated by
hypotension.
Antidote in poisoning by organophosphorus.
:בוהצב תומוסמ עדימ תופסות .דבלב
םיירקיעה םיוכדעה םילולכ ןלהלש
טוריפב .ןכדוע אפורל ןולעה
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
medication to decrease excessive salivation and secretions of the
respiratory tract.
Preanesthetic
.
Treatment of sinus bradycardia, particularly if complicated by
hypotension
.
Antidote in poisoning by organophosphorus
4.2 Posology and method of administration
C MEDICATION
PREANESTHETI
0.6 mg by intravenous injection immediately before the
-
The recommended dose is 0.3
_Adults:_
60 minutes before the
-
injection 30
by subcutaneous or intramuscular
anesthesia induction or
.
induction
.
The recommended dose is 0.02 mg/kg (maximum dose 0.6 mg)
_Children:_
TREATMENT OF SINUS BRADYCARDIA
.
The recommended dose is between 0.3 and 1.0 mg intravenously
מ"עב תויטבצמרפ תוישעת עבט
הנאתה 'חר
1
.ד.ת ן"מח הישעת קראפ ,
975
םהוש ,
6085001
:לט |
972-3-6864000
|
www.tevapharm.com
in poisoning by organophosphorus
ANTIDOTE
intravenously, taking into account the
: The recommended dose is 2 mg (intramuscularly or
_Adults_
10 minutes, until the

Summary of Product characteristics

Atropine Teva 20mg/10ml HS 05/2019 Notification CLEAN
ATROPINE TEVA 20 MG/10 ML
SOLUTION FOR I.V. OR I.M. INJECTION
1. NAME OF THE MEDICINAL PRODUCT
Atropine Teva 20 mg/10 ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampule of 10 ml of solution contains:
Active ingredient:
Atropine sulfate 20 mg.
For the full list of the excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colorless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Preanesthetic medication to decrease excessive salivation and
secretions of the respiratory
tract. Treatment of sinus bradycardia, particularly if complicated by
hypotension.
Antidote in poisoning by organophosphorus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
PREANESTHETIC MEDICATION
_Adults:_ The recommended dose is 0.3-0.6 mg by intravenous injection
immediately before the
anesthesia induction or by intramuscular injection 30-60 minutes
before the induction.
_Children:_ The recommended dose is 0.02 mg/kg (maximum dose 0.6 mg).
TREATMENT OF SINUS BRADYCARDIA
The recommended dose is between 0.3 and 1.0 mg intravenously.
ANTIDOTE in poisoning by organophosphorus
_Adults_: The recommended dose is 2 mg (intramuscularly or
intravenously, taking into account
the severity of the poisoning) every 5-10 minutes, until the skin
becomes red and dry, the pupils
dilate and tachycardia appears._ _
_Children_: The recommended dose is 0.02 mg/kg.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients.
Angle-closure glaucoma,
esophageal reflux, pyloric stenosis, gastrointestinal obstruction,
ulcerative colitis, prostatic
hypertrophy, paralytic ileus, intestinal atony.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR ADMINISTRATION
The solution should be clear, colorless and free of visible particles.
The ampoule is for a single, uninterrupted administration and any
unused residual solution
should be discarded.
Precautions must be taken in geriatric patients for whom you may need
a dose adjustment for
a possible occurrence of