AZALIA Film-coated tablet (2021)

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

Azalia 75 microgram film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains 75 microgram desogestrel. Excipient with known effect: 52.34 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet. White or almost white, round, biconvex film-coated tablets of about 5,5 mm in diameter, with a sign D on one side and 75 on the other side.

4.1. Therapeutic indications

Contraception

4.2. Posology and method of administration

Posology To achieve contraceptive effectiveness, Azalia must be used as directed (see How to take Azalia and How to start Azalia). Special populations Renal impairment No clinical studies have been performed ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active venous thromboembolic disorder. Presence or history of severe hepatic disease as long as liver function ...

4.4. Special warnings and precautions for use

If any of the conditions/risk factors mentioned below is present, the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before ...

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

Interactions Note: The prescribing information of concomitant medications should be consulted to identify potential interactions. Effect of other medicinal products on Azalia Interactions can occur ...

4.6. Fertility, pregnancy and lactation

Pregnancy Azalia is not indicated during pregnancy. If pregnancy occurs during treatment with Azalia, further intake should be stopped. Animal studies have shown that very high doses of progestogenic substances ...

4.7. Effects on ability to drive and use machines

Azalia has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using desogestrel 75 microgram ...

4.9. Overdose

There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Hormonal contraceptives for systemic use, Progestogens ATC code: G03AC09 Mechanism of action Azalia is a progestogen-only pill, which contains the progestogen desogestrel. ...

5.2. Pharmacokinetic properties

Absorption After oral dosing of Azalia desogestrel is rapidly absorbed and converted into etonogestrel. Under steady-state conditions, peak serum levels are reached 1.8 hours after tablet-intake and the ...

5.3. Preclinical safety data

Toxicological studies did not reveal any effects other than those, which can be explained from the hormonal properties of desogestrel. Environmental Risk Assessment (ERA) The active substance etonogestrel ...

6.1. List of excipients

Tablet core: Lactose monohydrate Potato starch Povidone K-30 Silica, colloidal anhydrous Stearic acid all-rac-α-Tocopherol Tablet coat: Poly[vinyl alcohol] Titanium dioxide, E171 Macrogol ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

24 months.

6.4. Special precautions for storage

Store in the original package in order to protect from light and moisture. This medicinal product does not require any special temperature storage conditions.

6.5. Nature and contents of container

Azalia film-coated tablets are packaged in a blister made of transparent, hard PVC/PVDC-Aluminium foil. Each blister is placed in a laminated aluminium sachet. The blisters in the sachets are packed into ...

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

Gedeon Richter Plc, Gyömroi út 19-21, H-1103, Budapest, Hungary

8. Marketing authorization number(s)

PA1330/010/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 8th October 2010 Date of last renewal: 26th October 2014

10. Date of revision of the text

September 2021

Πηγαίο έγγραφο

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

application/pdf