ZYNQUISTA Film-coated tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Zynquista 200 mg film-coated tablets.
2. Qualitative and quantitative composition
Each tablet contains 200 mg sotagliflozin. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet). Oval, blue, film-coated tablet printed with 2456 on one side in black ink (tablet length: 14.2 mm, tablet width: 8.7 mm).
4.1. Therapeutic indications
Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥27 kg/m², who have failed to achieve adequate ...
4.2. Posology and method of administration
Therapy with Zynquista should be initiated and supervised by a physician experienced in the management of type 1 diabetes mellitus. Posology The recommended dose is 200 mg sotagliflozin once daily before ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Diabetic ketoacidosis Sodium-glucose co-transporter 2 (SGLT2) inhibitors should be used with caution in patients with increased risk of DKA. In the clinical trials (pool of two 52-week placebo-controlled ...
4.5. Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on sotagliflozin The coadministration of a multiple dosing regimen of rifampicin, an inducer of various UGT and CYP metabolizing enzymes, with a single dose of 400 mg ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no data from the use of sotagliflozin in pregnant women. Animal studies have shown that sotagliflozin crosses the placenta. Animal studies do not indicate direct or indirect harmful ...
4.7. Effects on ability to drive and use machines
Sotagliflozin has no or negligible influence on the ability to drive and use machines. However, patients should be alerted to the risk of hypoglycaemia as sotagliflozin is used in combination with insulin. ...
4.8. Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions were genital mycotic infections, diabetic ketoacidosis and diarrhoea. Tabulated list of adverse reactions The following adverse ...
4.9. Overdose
Multiple doses of 800 mg once daily were administrated in healthy volunteers and these doses were well tolerated. In the event of an overdose, appropriate supportive treatment should be initiated as dictated ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Drugs used in diabetes, sodium-glucose co-transporter 2 (SGLT2) inhibitors ATC code: A10BK06 Mechanism of action Sotagliflozin is a dual inhibitor of sodium glucose cotransporter ...
5.2. Pharmacokinetic properties
The pharmacokinetics (PK) of sotagliflozin has been characterized in healthy subjects and in diabetic patients. No clinically relevant differences were noted between the two populations. Absorption The ...
5.3. Preclinical safety data
In a rat carcinogenicity study, a statistically significant increase in thyroid follicular cell carcinoma was observed in males at 75 mg/kg/day, approx. 14 times the MRHD, the highest dose evaluated. In ...
6.1. List of excipients
<u>Tablet core:</u> Microcrystalline cellulose (E460i) Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Talc <u>Film-coating:</u> Poly(vinyl alcohol) Macrogol Titanium dioxide (E171) ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
30 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
PVC/PCTFE/Aluminium opaque blisters. Pack sizes of 10, 20, 30, 60, 90, 100, 180 film-coated tablets, and a multipack of 200 film-coated tablets (2 packs of 100 film-coated tablets). Not all pack sizes ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Guidehouse Germany GmbH, Albrechtstr. 10c, 10117 Berlin, Germany
8. Marketing authorization number(s)
Zynquista 200 mg film coated tablets: EU/1/19/1363/001 10 film coated tablets EU/1/19/1363/002 20 film coated tablets EU/1/19/1363/003 30 film coated tablets EU/1/19/1363/004 60 film coated tablets EU/1/19/1363/005 ...
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 26 April 2019
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