ILOMEDIN Solution for infusion (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
ILOMEDIN 50 microgram/0.5 mL Solution for infusion.
2. Qualitative and quantitative composition
ILOMEDIN 0.5 mL aqueous solution contains iloprost trometamol 67 micrograms (equivalent to iloprost 50 micrograms).
3. Pharmaceutical form
Clear, colourless, sterile pyrogen-free solution for infusion.
4.1. Therapeutic indications
Treatment of patients with severe peripheral arterial occlusive disease (PAOD), particularly those at risk of amputation and in whom surgery or angioplasty is not possible. Treatment of advanced thromboangiitis ...
4.2. Posology and method of administration
ILOMEDIN should be used only under strict monitoring in hospitals or out-patient clinics with adequate facilities. Pregnancy must be excluded before the start of treatment in women. ILOMEDIN is administered ...
4.3. Contraindications
Hypersensitivity to iloprost or to any of the excipients. Pregnancy, lactation. Conditions where the effects of ILOMEDIN on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, ...
4.4. Special warnings and precautions for use
Surgery should not be delayed in patients requiring urgent amputation (e.g. in infected gangrene). Patients should be strongly advised to stop smoking. Iloprost elimination is reduced in patients with ...
4.5. Interaction with other medicinal products and other forms of interaction
Iloprost may increase the antihypertensive activity of β-receptor blockers, calcium antagonists, vasodilators and ACE inhibitors. Should significant hypotension occur this can be corrected by dose reduction ...
4.6. Fertility, pregnancy and lactation
ILOMEDIN must not be administered to pregnant or lactating women. Use in pregnancy There are no adequate data from the use of iloprost in pregnant women. Preclinical studies have shown evidence of foetotoxicity ...
4.7. Effects on ability to drive and use machines
It is unlikely that ILOMEDIN will have any deleterious effects (e.g. sedation), but care should be exercised during initiation of therapy until any effects on the individual have been determined. In patients ...
4.8. Undesirable effects
The most frequently observed adverse drug reactions (≥10%) in patient receiving iloprost in clinical trials are headache, flushing, nausea, vomiting and hyperhidrosis. These are likely to occur while the ...
4.9. Overdose
Symptoms of Overdose Hypotensive reaction might be anticipated as well as headache, flushing, nausea, vomiting and diarrhoea. An increase of blood pressure, bradycardia or tachycardia and limb or back ...
5.1. Pharmacodynamic properties
Iloprost is a synthetic prostacyclin analogue. The following pharmacological effects have been observed: Inhibition of aggregation, platelet adhesion and release reaction; Dilatation of arterioles and ...
5.2. Pharmacokinetic properties
Distribution Steady-state plasma levels are achieved as early as 10-20 minutes after the start of an intravenous infusion. The steady-state plasma levels are linearly related to the infusion rate. Plasma ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential. Preclinical effects were observed ...
6.1. List of excipients
Trometamol; Ethanol, 96 % (v/v); Sodium chloride; Hydrochloric acid, 1N; Water for injections
6.2. Incompatibilities
No data available for other than those medicinal products described under 6.6 Special precautions for disposal and other handling.
6.3. Shelf life
48 months.
6.4. Special precautions for storage
Store all medicines properly and keep them out of reach of children. Store below 30°C.
6.5. Nature and contents of container
Pack of 5 ampoules each containing 0.5 mL concentrate for solution for infusion.
6.6. Special precautions for disposal and other handling
Any unused medicine or waste material should be disposed of in accordance with local requirements. ILOMEDIN should be used only after dilution. Because of the possibility of interactions, no other medicine ...
7. Marketing authorization holder
Bayer New Zealand Limited, 3 Argus Place, Hillcrest, North Shore, Auckland 0627, Free Phone 0800 229 376, www.bayer.co.nz
9. Date of first authorization / renewal of the authorization
19<sup>th</sup> March 2012
10. Date of revision of the text
5 December 2019
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