VOCINTI Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Vocinti (Tablet) 10 mg. Vocinti (Tablet) 20 mg.
2. Qualitative and quantitative composition
<u>Vocinti (Tablet) 10 mg:</u> Each film-coated tablet contains 10 mg of vonoprazan (as 13.36 mg vonoprazan fumarate). <u>Vocinti (Tablet) 20 mg:</u> Each film-coated tablet contains 20 mg of vonoprazan ...
3. Pharmaceutical form
Available<br>Pharmaceutical<br>Forms Stengths Color Shape Markings<br>(upperside) Film-coated Tablet 10 mg Pale yellow Oval tablet B217 20 mg Pale red Oval scored tablet B218
4.1. Therapeutic indications
Treatment of gastric ulcer (GU) Treatment of duodenal ulcer (DU) Treatment of reflux esophagitis (RE) (erosive esophagitis EE) Prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose ...
4.2. Posology and method of administration
Dosage Adults Gastric ulcer The usual dose is 20 mg of vonoprazan once a day. Administration should be limited to 8 weeks. Duodenal ulcer The usual dose is 20 mg of vonoprazan once a day. Administration ...
4.3. Contraindications
Hypersensitivity to the active ingredients or to any of the excipients.
4.4. Special warnings and precautions for use
Hepatotoxicity Hepatic function abnormalities including liver injury have been reported in clinical studies (see Section 4.8). Post marketing reports have also been received in patients treated with vonoprazan, ...
4.5. Interaction with other medicinal products and other forms of interaction
Administration of vonoprazan results in elevation of intragastric pH, suggesting that it may interfere with the absorption of drugs where gastric pH is an important determinant of oral bioavailability. ...
4.6. Pregnancy and lactation
Pregnancy No clinical studies have been conducted to date to evaluate vonoprazan in subjects who are pregnant. In a rat toxicology study, embryo-foetal toxicity was observed following exposure of more ...
4.7. Effects on ability to drive and use machines
The influence of vonoprazan on the ability to drive or use machines is unknown.
4.8. Undesirable effects
Clinical Trials Clinical trial data for expected adverse events is based on pooled safety analysis from the following studies: EE healing (CCT-001 and CCT-002), EE maintenance therapy (CCT-003 and OCT-001), ...
4.9. Overdose
There is no experience of overdose with vonoprazan. Vonoprazan is not removed from the circulation by hemodialysis. If overdose occurs, treatment should be symptomatic and supportive. Drug Abuse and Dependence ...
5.1. Pharmacodynamic properties
Mechanism of Action Vonoprazan is a potassium competitive acid blocker (PCAB) and inhibits H+, K+-ATPase in a reversible and potassium-competitive manner. It does not require activation by acid. Vonoprazan ...
5.2. Pharmacokinetic properties
Following 7 day repeat once daily doses of vonoprazan at doses of 10-40 mg, in healthy adult male subjects, AUC<sub>τ,ss</sub> and C<sub>max</sub> increase in a slightly greater than dose proportional ...
5.3. Preclinical safety data
Carcinogenesis Vonoprazan was non-carcinogenic in a long term carcinogenicity study in mice when administered the drug daily via oral gavage for up to 2 years at 0.6, 20, 60, and 200 mg/kg/day. Treatment-related ...
6.1. List of excipients
D-Mannitol Microcrystalline cellulose Hydroxypropylcellulose Fumaric acid Croscarmellose sodium Magnesium stearate Hypromellose Macrogol 6000* Titanium oxide Red ferric oxide (20 mg tablet only) Yellow ...
6.2. Incompatibilities
Not applicable.
6.4. Special precautions for storage
Store below 30°C.
6.5. Nature and contents of container
Polyvinyl chloride (PVC) film/Aluminum foil blister, one blister contains 10 tablets.
7. Marketing authorization holder
Manufactured by TAKEDA PHARMACEUTICAL COMPANY LIMITED, Hikari Plant, Yamaguchi, Japan. Repacked by KOKANDO CO. LTD, Toyama, Japan Imported by Takeda (Thailand) Ltd., Bangkok, Thailand
8. Marketing authorization number(s)
Vocinti 10 mg: Reg.No.1C 15049/61(NC) Vocinti 20 mg: Reg.No.1C 15050/61(NC)
9. Date of first authorization / renewal of the authorization
6 July 2018
10. Date of revision of the text
April 2019
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