ATROPINE TEVA 1 MGML

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

ATROPINE SULFATE

Disponible des:

TEVA ISRAEL LTD

Codi ATC:

A03BA01

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

ATROPINE SULFATE 1 MG/ML

Vía de administración:

I.M, I.V

tipo de receta:

Required

Fabricat per:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Grupo terapéutico:

ATROPINE

Área terapéutica:

ATROPINE

indicaciones terapéuticas:

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.

Data d'autorització:

2023-01-31

Informació per a l'usuari

מ"עב תויטבצמרפ תוישעת עבט
הנאתה 'חר
1
.ד.ת ן"מח הישעת קראפ ,
975
םהוש ,
6085001
:לט |
972-3-6864000
|
www.tevapharm.com
יאמ
2019
ה/דבכ ת/חקור ,ה/אפור
,
ט תרבח
מ עב
ןלהל טרופמה עדימ ןוכדע לע עידוהל תשקב
: עבט ןיפורטא
1
ל"מ/ג"מ
ATROPINE TEVA 1MG/ML דירווה ךותל וא רירשה ךותל הקרזהל
הסימת
SOLUTION FOR I.M. OR I.V. INJECTION
Atropine sulfate 1mg
לש הלופמא לכ
1
:הליכמ ל"מ
ןולע ןוכדעו םושיר יוכדע
תה :םושירה תדועתב הרשואש יפכ היוו
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.
:םיוכדעה רקיע

מ רישכתה לש ומשב יויש
-
Atropine Sulfate
ל
-
Atropine Teva 1mg/ml

ליעל טרופמכ היוותהל היוותהה ןוכדע

לש תוזירא םוקמב הזיראב תומכב יויש
5
ו
-
100
לש תוזיראל ,תולופמא
10
ולופמא
ת
:בוהצב תומוסמ עדימ תופסות .דבלב
םיירקיעה םיוכדעה םילולכ ןלהלש
טוריפב .ןכדוע אפורל ןולעה
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Preanesthetic medication to decrease excessive salivation and
secretions of the respiratory tract.
.
bradycardia, particularly if complicated by hypotension
Treatment of sinus
.
Antidote in poisoning by organophosphorus
4.2 Posology and method of administration
PREANESTHETIC MEDICATION
0.6 mg by intravenous injection immediately before the
-
The recommended dose is 0.3
_Adults:_
.
60 minutes before the induction
-
injection 30
by intramuscular
anesthesia induction or
.
The recommended dose is 0.02 mg/kg (maximum dose 0.6 mg)
_Children:_
מ"עב תויטבצמרפ תוישעת עבט
הנאתה 'חר
1
.ד.ת ן"מח הישעת קראפ

Fitxa tècnica

Atropine Teva 1mg/ml HS -01/2020 Notification
SUMMARY OF PRODUCT CHARACTERISTICS
ATROPINE TEVA 1 MG/ML
SOLUTION FOR I.V. OR I.M. INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
Atropine Teva 1 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains:
Active ingredient:
Atropine sulfate 1 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
PRE-ANESTHETIC 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 poisoning severity) every 5-10 minutes, until the skin
becomes red and
dry, 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
listed in section
6.1.
Angle-closure glaucoma, esophageal reflux, pyloric stenosis,
gastrointestinal
obstruction, ulcerative colitis, prostatic hypertrophy, paralytic
ileus, intestinal atony,
myasthenia gravis (unless co-administered with anticholinesterase).
However, all these contraindications are irrelevant in potentially
fatal emergency
Atropine Teva 1mg/ml HS -01/2020 Notification
situations (such as bradyarrhythmia, poisoning).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR ADMINISTRATION
The solution should be clear, colorless and