GINKGO BILOBA Film coated tablet (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Ginkgo-Biloba Pharma Nord film-coated tablets.

2. Qualitative and quantitative composition

Each tablet contains 100 mg of extract (as dry extract, refined) from Ginkgo biloba L., folium (Ginkgo leaf) (35-67:1), corresponding to: 22.0-27.0 mg of flavonoids expressed as flavone glycosides ...

3. Pharmaceutical form

Film coated tablet (tablet). White, round (12 mm diameter), biconvex film coated tablet.

4.1. Therapeutic indications

A traditional herbal medicinal product used to alleviate the symptoms of poor blood flow in conditions such as cold hands and feet. This is exclusively based on long-standing use. Prior to use, other serious ...

4.2. Posology and method of administration

Posology Adults One tablet to be taken twice daily, after food. Tablets should be swallowed whole with a glass of water. Elderly No adjustment of dose is required for the treatment of elderly patients. ...

4.3. Contraindications

Hypersensitivity to Ginkgo preparations or to any of the excipients listed in section 6.1 Pregnancy and Lactation (see section 4.6 Fertility, pregnancy and lactation).

4.4. Special warnings and precautions for use

The use in children and adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought. There are rare cases of spontaneous bleeding in association ...

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

Appropriate studies have not been conducted to determine whether drug interactions occur with Ginkgo-Biloba Pharma Nord and its active constituents. Products containing Ginkgo biloba have been observed ...

4.6. Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of Ginkgo biloba in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Ginkgo-Biloba ...

4.7. Effects on ability to drive and use machines

Specific studies to determine the potential effect of Ginkgo biloba extract on the ability to drive or operate machinery have not been carried out.

4.8. Undesirable effects

The follow adverse reactions have been reported rarely in association with the use of products containing Ginkgo biloba extract. Immune system disorders: Allergy Nervous system disorders: ...

4.9. Overdose

There have been no reports of overdose with Ginkgo biloba extract.

5.1. Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC, as amended.

5.2. Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC, as amended.

5.3. Preclinical safety data

Adequate tests on reproductive toxicity and tests on genotoxicity and carcinogenicity have not been performed.

6.1. List of excipients

Tablet core: Microcrystalline cellulose Colloidal anhydrous silica Talc Magnesium stearate Film coating: Hypromellose Talc Titanium Dioxide

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25ºC. Store in the original package to protect from moisture.

6.5. Nature and contents of container

PVC/PVDC blisters with aluminium foil backing in a cardboard carton. Each pack contains 60 or 150 tablets in 30 tablet blister trays. Not all packs sizes may be marketed.

7. Marketing authorization holder

Pharma Nord ApS, Tinglykke 4-6, DK-6500 Vojens, Denmark

8. Marketing authorization number(s)

TR1242/001/001

9. Date of first authorization / renewal of the authorization

Date of First Registration: 16th March 2018 Date of last renewal: 15th March 2023

10. Date of revision of the text

September 2022

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