ALKINDI Granule in capsule (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Alkindi 0.5 mg granules in capsules for opening. Alkindi 1 mg granules in capsules for opening. Alkindi 2 mg granules in capsules for opening. Alkindi 5 mg granules in capsules for opening.

2. Qualitative and quantitative composition

Alkindi 0.5 mg granules in capsules for opening: Each capsule contains 0.5 mg hydrocortisone. Alkindi 1 mg granules in capsules for opening: Each capsule contains 1 mg hydrocortisone. ...

3. Pharmaceutical form

Granules in capsules for opening. The granules are white to off-white and contained in a transparent colourless (size 00el) hard capsule. Alkindi 0.5 mg granules in capsules for opening: The capsule ...

4.1. Therapeutic indications

Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to <18 years old).

4.2. Posology and method of administration

Posology Dosage must be individualised according to the response of the individual patient. The lowest possible dosage should be used. Monitoring of the clinical response is necessary and patients should ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with dysphagia or premature infants where oral feeding has not been established.

4.4. Special warnings and precautions for use

Adrenal crisis Where a child is vomiting or acutely unwell parenteral hydrocortisone should be started without delay, carers should be trained in adminstering this in an emergency. Sudden discontinuation ...

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

Hydrocortisone is metabolised by cytochrome P450 3A4 (CYP3A4). Concomitant administration of medicinal products that are inhibitors or inducers of CYP3A4 may therefore lead to unwanted alterations in serum ...

4.6. Fertility, pregnancy and lactation

Pregnancy Hydrocortisone for replacement therapy can be used during pregnancy The ability of corticosteroids to cross the placenta varies between the different types of corticosteroids, however, hydrocortisone ...

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

Summary of safety profile A total of 30 healthy (but dexamethasone-suppressed) adult male subjects in two phase 1 studies and 24 paediatric patients with adrenal insufficiency in two phase 3 studies have ...

4.9. Overdose

Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare. No antidote is available. Treatment is probably not indicated for reactions due to chronic poisoning unless the patient ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids for systemic use; Glucocorticoids ATC code: H02AB09 Mechanism of action Hydrocortisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, ...

5.2. Pharmacokinetic properties

Absorption Following oral administration, hydrocortisone is rapidly absorbed from the gastro-intestinal tract and the oral Alkindi 4x5 mg was approximately 87% bioavailable when compared to intravenous ...

5.3. Preclinical safety data

Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate, intrauterine growth retardation and effects on brain growth and development. ...

6.1. List of excipients

Granules: Microcrystalline cellulose Hypromellose Magnesium stearate Ethyl cellulose Capsule Hypromellose Printing ink: All inks contain Shellac, Propylene glycol, Concentrated ammonia solution ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years. After first opening: 60 days.

6.4. Special precautions for storage

Do not store above 30°C. Store in the original bottle in order to protect from light.

6.5. Nature and contents of container

Hard capsule for opening, containing a single dose of granules. The capsules are provided in high-density polyethylene bottles with polypropylene closure with integrated desiccant. Pack sizes: 1 ...

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

Diurnal Europe B.V., Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, The Netherlands, Tel. +31 (0)20 6615 072, info@diurnal.co.uk

8. Marketing authorization number(s)

Alkindi 0.5 mg granules in capsules for opening: EU/1/17/1260/001 Alkindi 1 mg granules in capsules for opening: EU/1/17/1260/002 Alkindi 2 mg granules in capsules for opening: EU/1/17/1260/003 Alkindi ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 09 February 2018

10. Date of revision of the text

8/05/2021

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