Quốc gia: Armenia
Ngôn ngữ: Tiếng Anh
Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
morphine (morphine hydrochloride)
Kalceks JSC
N02AA01
morphine (morphine hydrochloride)
10mg/ml
solution for injection
(10/2x5/) ampoules 1ml in plastic liner
Prescription
Registered
2019-12-27
AGREED BY SAM 27-08-2020 PACKAGE LEAFLET: INFORMATION FOR THE USER MORFĪNA HIDROHLORĪDS-KALCEKS 10 MG/ML SOLUTION FOR INJECTION _Morphini hydrochloridum _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. – Keep this leaflet! You may need to read it again. – If you have any further questions, ask your doctor, pharmacist or nurse. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Morfīna hidrohlorīds-Kalceks is and what it is used for 2. What you need to know before you use Morfīna hidrohlorīds-Kalceks 3. How to use Morfīna hidrohlorīds-Kalceks 4. Possible side effects 5 How to store Morfīna hidrohlorīds-Kalceks 6. Contents of the pack and other information 1. WHAT MORFĪNA HIDROHLORĪDS-KALCEKS IS AND WHAT IT IS USED FOR The medicine Morfīna hidrohlorīds-Kalceks contains morphine hydrochloride (hereafter – morphine). It belongs to a group of medicines called narcotics or opioid analgesics. Morphine is a naturally occurring substance with very potent analgesic effect. It is used in following cases: - to relieve severe, acute pain after severe injuries, fractures of bones, burns, surgery; - to prevent acute and chronic pain in the case of myocardial infarction, as well as in the case of acute pancreatitis; - to relieve severe chronic pain in the case of malignant tumour and to relieve colic pain arising from movements of renal and gall stones; - as cough suppressant in the case of chest injury and pulmonary bleeding, when cough attacks become life-threatening, and at end-stage of lung cancer if it is difficult to stop cough; - breathing disorders associated with left ventricular damage and pulmonary oedema; - for premedication (medical p Đọc toàn bộ tài liệu
AGREED BY SAM 27-08-2020 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Morfīna hidrohlorīds-Kalceks 10 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule (1 ml) contains 10 mg of morphine hydrochloride (_Morphini _ _hydrochloridum_). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear colourless or yellowish solution without visible particles. pH of solution 3.0-5.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Morphine hydrochloride is prescribed: - to reverse severe, acute pain after severe injuries, fractures of bones, burns, surgery; - to prevent acute and chronic pain in the case of myocardial infarction, as well as in the case of acute pancreatitis; - to relieve severe chronic pain in the case of malignant tumour and to relive colicky pain arising from movements of renal and gall stones; - as cough suppressant in the case of chest injury and pulmonary bleeding, when cough attacks become life-threatening and at end-stage of lung cancer if it is difficult to stop cough; - in the case of dyspnoea associated with left ventricular damage and pulmonary oedema; - for premedication before anaesthesia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _For intravenous, subcutaneous or intramuscular administration _ When administered as slow intravenous injection, ¼ - ½ from the corresponding intramuscular dose is used. For dilution 0.9 % sodium chloride or 5 % glucose solution is used. _ _ AGREED BY SAM 27-08-2020 _ADULTS _ _In _ _the _ _case _ _of _ _acute _ _pain_,_ _ subcutaneously or intramuscularly: 10 mg of morphine hydrochloride is usually given. The injection can be repeated after 4-6 hours if necessary. _To reverse postoperative pain_, subcutaneously or intramuscularly:_ _ 10 mg of morphine hydrochloride is given every 2-4 hours (as necessary). _ _ _In the case of chronic pain_, subcutaneously or intramuscularly: 5-20 mg is injected every 4 hours. _In the case of myocardial infarction _ Đọc toàn bộ tài liệu