Šalis: Armėnija
kalba: anglų
Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
trimeperidine (trimeperidine hydrochloride)
Kalceks JSC
N02AX
trimeperidine (trimeperidine hydrochloride)
20mg/ml
solution for injection
(10/2x5/) ampoules in plastic liner, (100/20x5/) ampoules in plastic liner
Prescription
Registered
2019-08-06
AGREED BY SAM 01-08-2019 PACKAGE LEAFLET: INFORMATION FOR THE USER PROMEDOLS 20 MG/ML SOLUTION FOR INJECTION _Trimeperidini 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 or pharmacist. – 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Promedols is and what it is used for 2. What you need to know before you receive Promedols 3. How to use Promedols 4. Possible side effects 5. How to store Promedols 6. Contents of the pack and other information 1. WHAT PROMEDOLS IS AND WHAT IT IS USED FOR Promedols (trimeperidine hydrochloride) is a narcotic analgesic. It is used: – to relieve severe pain in the case of injuries, fractures of bones, burns, heart attack, acute inflammation of pancreas (pancreatitis), kidney, liver and intestinal colic, in the case of malignant tumour, as well as after surgery; – to relieve labour pain and to accelerate labour in the case of cervical dysfunction, when epidural anaesthesia is impossible and childbirth is predictable not earlier than after two hours; – for medicated preparation before surgery (for premedication). 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE PROMEDOLS YOU SHOULD NOT RECEIVE PROMEDOLS IN FOLLOWING CASES: – if you are allergic to trimeperidine hydrochloride; – if you have breathing depression; – if you have obstructive airway diseases (with blockage), including bronchial asthma attacks; – if you have bowel obstruction (paralytic ileus) or the risk of its developing; – if you have abdominal pain of unknown origin; – if you have increased pressure in your skull or head injury; Perskaitykite visą dokumentą
APPROVED BY SAM 02-11-2017 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Promedols 20 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule (1 ml) contains 20 mg of trimeperidine hydrochloride (_Trimeperidini _ _hydrochloridum_). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear colourless or yellowish liquid. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS - To relieve severe pain in the case of injuries, fractures of bones, burns, miocardial infarction, acute pancreatitis, renal, biliary and intestinal colic, in the case of malignant tumour, as well as after surgery. - To relieve labour pain and to accelerate labour in the case of cervical dysfunction, when epidural anaesthesia is impossible and childbirth is predictable not earlier than after two hours. - For premedication before surgery. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The necessity of opioid use should be carefully considered before the initiation of therapy and during the therapy. Dose reduction, discontinuation of treatment or opportunity of opioid substitution should be regularly evaluated. In order to reduce opioid characteristic adverse reactions, it is recommended to avoid administration of other medicines, if possible. Posology _In _ _adults_ medium therapeutic dose is 10-40 mg of trimeperidine hydrochloride (corresponds to 0.5-2 ml of Promedols 20 mg/ml solution for injection). The dose can be repeated every 4 hours. The maximum adult dose is 40 mg, daily dose – 160 mg. _For premedication_ 20-30 mg of trimeperidine hydrochloride (corresponds to 1-1.5 ml of Promedols 20 mg/ml solution for injection) is administered subcutaneously or APPROVED BY SAM 02-11-2017 intramuscularly with 0.5 mg of atropine 30-45 minutes before surgery._ _In urgent cases the medicine can be injected into vein. _Postoperatively _ as_ _ analgesic and anti-shock agent, 20 mg of trimeperidine hydrochloride (corresponds to 1 ml of Promedols 20 mg/ml solution f Perskaitykite visą dokumentą