PAPAVERINE TEVA INJECTION

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

PAPAVERINE HYDROCHLORIDE

Fáanlegur frá:

TEVA ISRAEL LTD

ATC númer:

A03AD01

Lyfjaform:

SOLUTION FOR INJECTION

Samsetning:

PAPAVERINE HYDROCHLORIDE 40 MG / 2 ML

Stjórnsýsluleið:

I.M, I.V

Gerð lyfseðils:

Required

Framleitt af:

TEVA ISRAEL LTD, ISRAEL

Meðferðarhópur:

PAPAVERINE

Lækningarsvæði:

PAPAVERINE

Ábendingar:

Antispasmodic in visceral spasm, e.g. gastrointestinal colic, biliary and urinary tract spasms. Peripheral vascular disease with vasospastic element. Vascular spasm associated with acute myocardial infarcion, angina pectoris, peripheral and pulmonary embolism.

Leyfisdagur:

2012-12-31

Upplýsingar fylgiseðill

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor's
prescription only
PAPAVERINE TEVA
INJECTION 40 MG / 2 ML
Solution for I.M. or I.V. Injection
COMPOSITION
Each 2 ml ampule contains:
Papaverine hydrochloride 40 mg
For information regarding inactive ingredients and
allergens, see section 2 - “Important information
about some ingredients of the medicine” and section
6 - “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. This leaflet contains concise information
about the medicine. If you have additional questions,
refer to the doctor or the pharmacist.
This medicine has been prescribed for your
treatment. Do not pass it on to others. It may harm
them even if it seems to you that their medical
condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Muscle relaxation in the following situations:
•
Visceral spasmotic cramps, e.g. gastrointestinal,
biliary and urinary tract spasms.
•
Peripheral vascular disease with vasospastic
element.
•
Vascular spasms associated with acute
myocardial infarction, angina pectoris, peripheral
and pulmonary embolism.
THERAPEUTIC CLASS: antispasmodics, smooth muscle
relaxants.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE:
•
If you are sensitive (allergic) to papaverine or
to any of the other ingredients this medicine
contains (see section 6 – “Additional
information”).
•
As an intravenous injection if you have
experienced complete heart block (complete
atrioventricular block).
•
In case of severe heart failure.
•
In case of recent myocardial infarction.
•
In case of recent heart attack.
•
In case of abnormal heart rhythm (abnormally
low heart rate).
•
In case of increased intracranial pressure.
•
In case of liver disease.
SPECIAL WARNINGS REGARDING THE USE OF THE
MEDICINE
Consult a doctor before using Papaverine Teva
Injection.
•
A too rapid intravenous injection may lead to heart
rhythm disorders (arrhythmias) and fatal a

Vara einkenni

Papaverine Teva Injection FW 01/2022 Minor updates
SUMMARY OF PRODUCT CHARACTERISTICS
PAPAVERINE TEVA INJECTION 40 MG/2 ML
SOLUTION FOR I.V. OR I.M. INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
Papaverine Teva Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampule of 2 ml solution for injection contains 40 mg of
papaverine hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an antispasmodic in the following conditions:

Visceral spasm, e.g., gastrointestinal colic, biliary and urinary
tract spasms.

Peripheral vascular disease in which there is a vasospastic element.

Vascular spasm associated with acute myocardial infarction, angina
pectoris, peripheral and
pulmonary embolism.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Intramuscular or intravenous route.
Posology
Papaverine should be administered by or under the immediate
supervision of a physician.
Papaverine administration should be discontinued if any sign or
symptom of liver tenderness occurs
in the treated patient.
ECG monitoring should be performed before and during parenteral
treatment.
_Adults:_
From 30 to 120 mg.
Administration should be slow (1-2 minutes).
Intravenous use should be reserved for cases where an immediate effect
is desired.
Papaverine Teva Injection FW 01/2022 Minor updates
4.3
CONTRAINDICATIONS
-
Hypersensitivity to papaverine or any of the other ingredients
mentioned in section 6.1.
-
Intravenous injection: contraindicated in patients with complete
atrioventricular block.
-
Severe heart failure.
-
Recent myocardial infarction.
-
Recent heart attack.
-
Heart rhythm disorders (bradycardia).
-
In case of intracranial hypertension.
-
Hepatic disease.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
-
A too rapid intravenous injection may lead to arrhythmias and fatal
apnea.
-
Due to the risk of heart rhythm disorders, caution should be exercised
in cases of cardiac