AZEPTIL Capsule, hard (2023)
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Περιεχόμενα
1. Name of the medicinal product
Azeptil 500 mg capsules.
2. Qualitative and quantitative composition
Each capsule contains 500mg tranexamic acid. <u>Excipient(s) with known effect:</u> Carmoisine (E122). For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard. Maroon-white hard gelatin capsules filled with a white powder.
4.1. Therapeutic indications
Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis may occur in the following conditions: Prostatectomy and bladder surgery Menorrhagia ...
4.2. Posology and method of administration
Posology Local fibrinolysis The recommended standard dosage is 15-25mg/kg bodyweight (2-3 tablets) 2-3 times daily. For the indications listed below the following doses may be used: <em>Adults</em> <u> ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe renal impairment because of risk of accumulation. Subarachnoid haemorrhage. The limited clinical experience ...
4.4. Special warnings and precautions for use
In patients with renal insufficiency a reduction in dosage is recommended (see section 4.2) because of the risk of accumulation. Tranexamic acid should be used with caution in massive haematuria from the ...
4.5. Interaction with other medicinal products and other forms of interaction
Tranexamic acid will counteract the thrombolytic effect of fibrinolytic preparations.
4.6. Pregnancy and lactation
Pregnancy There is no evidence from animal studies of a teratogenic effect. Clinical use in pregnant women is limited and as tranexamic acid passes the placenta it should not be used during pregnancy unless ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), ...
4.9. Overdose
No cases of overdosage have been reported. Signs and symptoms may include dizziness, headache, hypotension and convulsions. It has been shown that convulsions tend to occur at higher frequency with increasing ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antihemorrhagics, Antifibrinolytics, Aminoacids <b>ATC code:</b> B02AA02 Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the ...
5.2. Pharmacokinetic properties
Absorption Peak plasma tranexamic acid concentration is obtained immediately after intravenous administration (500 mg). Then concentration decreases until the 6<sup>th</sup> hour. Elimination half-life ...
5.3. Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
6.1. List of excipients
Povidone Croscarmellose sodium Talc Magnesium stearate <u>Capsule shell is gelatin with colorants:</u> Erythrosine (E127) Brilliant blue (E133) Titanium dioxide (E171) Carmoisine (E122)
6.2. Incompatibilities
None known.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C in the original package, in order to protect from light.
6.5. Nature and contents of container
Azeptil is packaged in combination blisters of polyvinylchloride film and aluminum foil. Blisters and leaflet are found in an outer carton. Azeptil is available in packs of 20, or 50 capsules as well as ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
13426
9. Date of first authorization / renewal of the authorization
Date of first authorization: 25.06.1991 Date of latest renewal: 30.07.2013
10. Date of revision of the text
06/02/2023
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