Страна: Израел
Език: английски
Източник: Ministry of Health
PAPAVERINE HYDROCHLORIDE
TEVA ISRAEL LTD
A03AD01
SOLUTION FOR INJECTION
PAPAVERINE HYDROCHLORIDE 40 MG / 2 ML
I.M, I.V
Required
TEVA ISRAEL LTD, ISRAEL
PAPAVERINE
PAPAVERINE
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.
2012-12-31
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 Прочетете целия документ
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 Прочетете целия документ