MIZART Tablet (2022)

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

1. Name of the medicinal product

MIZART Telmisartan tablet.

2. Qualitative and quantitative composition

Each MIZART tablet contains 40 mg or 80 mg of telmisartan as the active ingredient. Excipients with known effect: sulfites. For the full list of excipients, see Section 6.1 List of excipients. ...

3. Pharmaceutical form

40 mg Tablet: MIZART tablets are white to off-white color, oval-shaped, biconvex uncoated tablets debossed with L203 on one side and plain on the other side. 80 mg Tablet: MIZART tablets ...

4.1. Therapeutic indications

MIZART is indicated for: Treatment of hypertension in adults Prevention of cardiovascular morbidity and mortality in adult 55 years or older with coronary artery disease, peripheral artery disease, previous ...

4.2. Posology and method of administration

MIZART is available as tablets for oral administration. Treatment of Hypertension Adults: The recommended dose is 40 mg once daily. In cases where the target blood pressure is not achieved, telmisartan ...

4.3. Contraindications

Hypersensitivity to any of the components of the product Pregnancy Lactation Biliary obstructive disorders Severe hepatic impairment The concomitant use of telmisartan with aliskiren is contraindicated ...

4.4. Special warnings and precautions for use

Diabetes Mellitus Exploratory post-hoc analyses of two placebo-controlled telmisartan trials suggested an increased risk of fatal myocardial infarction and unexpected cardiovascular death (death occurring ...

4.5. Interaction with other medicinal products and other forms of interaction

Other interactions of clinical significance have not been identified. Co-administration of telmisartan did not result in a clinically significant interaction with digoxin, warfarin, hydrochlorothiazide, ...

4.6. Fertility, pregnancy and lactation

Effects on Fertility No studies on fertility in humans have been performed. Fertility of male and female rats was unaffected at oral telmisartan doses up to 100 mg/kg/day. Use in Pregnancy Pregnancy Category ...

4.7. Effects on ability to drive and use machines

There are no data to suggest that telmisartan affects the ability to drive and use machines. However, when driving or operating machinery it should be taken into account that with antihypertensive therapy, ...

4.8. Undesirable effects

Adverse reactions have usually been mild and transient in nature and have only infrequently required discontinuation of therapy. The incidence of adverse reactions was not dose related and showed no correlation ...

4.9. Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia). Limited information is available with regard to overdose in humans. Symptoms The most prominent ...

5.1. Pharmacodynamic properties

Mechanism of Action Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II. Telmisartan ...

5.2. Pharmacokinetic properties

Absorption Following oral administration of telmisartan, absorption is rapid (tmax ranges from 0.5 to 2 hours) although the amount absorbed varies. Absolute bioavailability of telmisartan was shown to ...

5.3. Preclinical safety data

Genotoxicity Telmisartan was not genotoxic in a battery of tests for gene mutations and clastogenicity. Carcinogenicity Two-year studies in mice and rats did not show any increases in tumour incidences ...

6.1. List of excipients

Tablet core: povidone, meglumine, sodium hydroxide, mannitol, sodium stearylfumarate and magnesium stearate.

6.2. Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 30°C. Protect from light and moisture. MIZART tablets should not be removed from their foil pack until required for administration.

6.5. Nature and contents of container

Blister Pack (Alu silver/Alu HSL) of 28 tablets. Australian Register of Therapeutic Goods (ARTG) AUST R 230974 MIZART telmisartan 40mg tablets blister pack AUST R 230975 MIZART telmisartan 80mg tablet ...

6.6. Special precautions for disposal and other handling

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Alphapharm Pty Ltd trading as Viatris, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.viatris.com.au, Phone: 1800 274 276

9. Date of first authorization / renewal of the authorization

04 August 2015

10. Date of revision of the text

05 October 2022

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf