DIPYRONE KALCEKS 500 MGML

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

METAMIZOLE SODIUM MONOHYDRATE

Disponibil de la:

A.L. MEDI-MARKET LTD.

Codul ATC:

N02BB02

Forma farmaceutică:

SOLUTION FOR INJECTION

Compoziție:

METAMIZOLE SODIUM MONOHYDRATE 500 MG / 1 ML

Calea de administrare:

I.M, I.V

Tip de prescriptie medicala:

Required

Produs de:

HBM PHARMA S.R.O., SLOVAKIA

Zonă Terapeutică:

METAMIZOLE SODIUM

Indicații terapeutice:

As an analgesic: Dypirone Kalceks, 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: Dypirone Kalceks 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

Data de autorizare:

2020-02-03

Caracteristicilor produsului

1.
NAME OF THE MEDICINAL PRODUCT
Dipyrone Kalceks 500 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains 500 mg metamizole sodium
monohydrate
(dipyrone).
One ampoule (2 ml) contains 1000 mg (1 gr) metamizole sodium
monohydrate
(dipyrone).
One ampoule (5 ml) contains 2500 mg (2.5 gr) metamizole sodium
monohydrate
(dipyrone).
Excipient with known effect: Sodium
1 ml of solution for injection contains 32.71 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, almost colourless to brownish-yellow coloured solution,
practically free from
particles
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ AS AN ANALGESIC _
Dipyrone Kalceks 500 mg/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 _
Dipyrone Kalceks 500 mg/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 _
_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 for relief of pain is not
recomm