OPTALGIN TEVA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DIPYRONE

Available from:

TEVA ISRAEL LTD

ATC code:

N02BB02

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

DIPYRONE 1 G / 2 ML

Administration route:

I.V, I.M

Prescription type:

Required

Manufactured by:

TEVA ISRAEL LTD, ISRAEL

Therapeutic area:

METAMIZOLE SODIUM

Therapeutic indications:

As an analgesic: Optalgin Teva injection, by intravenous administration, is indicated for the relief of severe and acute pain when oral treatment is not feasible or suitable, as in post-traumatic or post-surgical pain, biliary or renal colic, and pain associated with malignant diseases. As an antipyretic: Optalgin injection by intramuscular administration is indicated to lower temperature in life-threatening situations, when this cannot be achieved by other means. Hyperthermic patients in critical condition may also be treated in non-hospital environment, under close medical supervision.

Authorization date:

2023-02-28

Patient Information leaflet

עב תויטבצמרפ תוישעת עבט
"
מ
הנאתה 'חר
1
.ד.ת ן"מח הישעת קראפ ,
975
םהוש ,
6085001
|
www.tevapharm.com
_ _
_ _
ה/דבכ ת/חקור ,ה/ אפור
, עבט תרבח םיאבה םיוכדעה לע העידומ
ל ןולעב
אפור :רישכתה לש
OPTALGIN TEVA
SOLUTION FOR I.V. OR I.M. INJECTION
א
ןיגלטפו
עבט
הקרזהל הסימת ךותל
ה ךותל וא דירוה רירש
_ לש הלופמא לכ_
_2_
_ _
_הליכמ ל"מ_
_ :_
_Dipyrone 1g_
_ _
_ _
אפורל ןולעב ןוכדע
---------------------------------------------------------------------------------------------------------------------
יוותה
ה :םושירה תדועתב הרשואש יפכ
As an analgesic:
Optalgin Teva solution for injection, by intravenous administration,
is indicated for the relief of severe
and acute pain when oral treatment is not feasible or suitable, as in
post-traumatic or post-surgical
pain, biliary or renal colic, and pain associated with malignant
diseases.
As an antipyretic:
Optalgin Teva solution for injection, by intramuscular administration,
is indicated to lower temperature
in life-threatening situations, when this cannot be achieved by other
means.
Hyperthermic patients in critical condition may also be treated in
non-hospital environment, under
close medical supervision.
תונמוסמ תופסות) דבלב םיירקיעה
םינוכדעה םילולכ ןלהלש טוריפב .ןכדוע
אפורל ןולעהש עידוהל וננוצרב
:(קוחמ טסקטכ עדימ תורסהו םודאב
…..
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Optalgin
®
Teva 1 g/2 ml solution for injection contains the pyrazolone
derivative metamizole and
carries the rare but life-threatening risks of shock and
agranulocytosis (see section 4.8).
עב תויטבצמרפ תוישעת עבט
"
מ
הנאתה 'חר
1
.ד.ת ן"מח הישעת קראפ ,
975
םהוש ,
6085001
|
www.tevapharm.com
Patients who display anaphylactoid reactions to dipyrone are at

Summary of Product characteristics

1
Optalgin Teva 1g/2ml FW 06-2022 Notification
Summary of Product Characteristics
OPTALGIN
® TEVA 1 G/2 ML
SOLUTION FOR I.V. OR I.M. INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
Optalgin
®
Teva 1 g/2 ml
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains 500 mg dipyrone (metamizole
sodium ).
Each ampoule of 2 ml solution for injection contains 1g dipyrone.
Excipient with known effect:
Each ampoule of 2 ml solution for injection contains 65 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_AS AN ANALGESIC _
Optalgin
®
Teva 1 g/2 ml solution for injection, by intravenous administration,
is indicated for the
relief of severe and acute pain when oral treatment is not feasible or
suitable, as in post-traumatic or
post-surgical pain, biliary or renal colic, and pain associated with
malignant diseases.
_AS AN ANTIPYRETIC _
Optalgin
®
Teva 1 g/2 ml solution for injection, by intramuscular administration,
is indicated to lower
temperature in life-threatening situations, when this cannot be
achieved by other means.
Hyperthermic patients in critical condition may also be treated in a
non-hospital environment, under
close medical supervision.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Parenteral drug products should be inspected visually for particulate
matter and discoloration prior _
_to administration, whenever solution and container permit_
.
_ADULTS AND ADOLESCENTS OVER 14 YEARS OF AGE _
2
Optalgin Teva 1g/2ml FW 06-2022 Notification
_ _
_INTRAVENOUS ADMINISTRATION AS AN ANALGESIC _
1 g (2 ml), administered by slow injection, up to 4 times daily. In
severe pain, 2.5 g (5 ml) may be
administered twice daily (the maximum daily dosage is 5 g).
Intravenous administration of dipyrone should be carried out slowly
over a period of at least 5
minutes, followed by reasonable clinical observation.
Intramuscular administration of dipyrone fo