Land: Zweden
Taal: Zweeds
Bron: Läkemedelsverket (Medical Products Agency)
atropinsulfat (monohydrat)
Abboxia AB
A03BA01
atropine sulfate (monohydrate)
0,5 mg/ml
Injektionsvätska, lösning
atropinsulfat (monohydrat) 0,5 mg Aktiv substans
Receptbelagt
Förpacknings: Ampull, 5 x 1 ml; Ampull, 10 x 1 ml; Ampull, 20 x 1 ml; Ampull, 50 x 1 ml; Ampull, 100 x 1 ml
Godkänd
2022-02-04
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ATROPIN ABBOXIA 0,5 MG/ML SOLUTION FOR INJECTION ATROPIN ABBOXIA 1 MG/ML SOLUTION FOR INJECTION atropine sulphate 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Atropin Abboxia is and what it is used for 2. What you need to know before you use Atropin Abboxia 3. How to use Atropin Abboxia 4. Possible side effects 5. How to store Atropin Abboxia 6. Contents of the pack and other information 1. WHAT ATROPIN ABBOXIA IS AND WHAT IT IS USED FOR Atropin Abboxia belongs to a group of medicines which are called anticholinergics. Atropine sulphate, the active substance in Atropin Abboxia, temporarily blocks some nerve endings. This decreases glands secreting, makes some muscles (such as in the gut) relax and speeds up the heart. Atropin Abboxia is used for: - relaxation of muscles in the gastro-intestinal tract during cramps - to reduce saliva, fluid in the lungs and/or gastric juice - to treat a slow heartbeat - as medication during surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ATROPIN ABBOXIA DO NOT USE ATROPIN ABBOXIA - if you are allergic to atropine sulphate or any of the other ingredients of this medicine (listed in section 6) - if you have troubles passing urine (i.e. if you are a man and have an enlarged prostate) - if you have increased pressure in the eye (glaucoma) - if you have blockage in the intestines or paralysis of the bowel - if you suffer from severe inflammation of the colon (ulcerative colitis) or complication of colonic inflammation These contraindications do not apply in the event of life-threatening situations. WARNINGS AND PRECAUTIONS Talk to your doctor before your are given Atropin Abboxia Lees het volledige document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Atropin Abboxia 0,5 mg/ml solution for injection Atropin Abboxia 1 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains 0,5 mg atropine sulphate. 1 ampoule á 1 ml contains 0,5 mg atropine sulphate. 1 ml solution for injection contains 1 mg atropine sulphate. 1 ampoule á 1 ml contains 1 mg atropine sulphate. Excipient with known effect 1 ml solution for injection contains 3,5 mg sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atropin Abboxia is indicated in children and adults for: • Spastic contractions in the gastrointestinal tract • Hypersecretion of saliva, bronchial fluid and/or gastric acid. • Bradycardia. • Per operative medication. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Spastic contractions in the gastrointestinal tract, hypersecretion: Administered in optimal effective dose which is titrated individually and with moderate mouth dryness as a sign of achievement of an optimal dose. Bradycardia: 0,5–1 mg intravenously. Per operative medication in adults: 0,5 mg subcutaneously. _Pediatric population_ Per operative medication to children: 3–10 kg 0,10–0,15 mg 10–12 kg 0,15 mg 12–15 kg 0,20 mg 2 15–17 kg 0,25 mg 17–20 kg 0,30 mg 20–30 kg 0,35 mg 30–50 kg 0,40–0,50 mg Subcutaneous injection should be given 1 hour before surgery. In case of narrow timelines, an emergency dose 0,75 of the recommended subcutaneous dose may be injected intravenously 10-15 minutes before initiation of anesthesia. The effect though becomes worse. Elderly Dose reduction may be necessary in elderly. Method of administration Atropin Abboxia 0,5 mg/ml is used for both intravenous and subcutaneous administration. Atropin Abboxia 1 mg/ml is used for intravenous administration. 4.3 CONTRAINDICATIONS • Hypersensitivity to atropine sul Lees het volledige document