CRED SMPC 2024

23/09/2024

SmPC: Pharmaceutical information 2. Qualitative and quantitative composition 3. Pharmaceutical form

– Description of dosage form (film coated tablet, oral solution, solution for injection

– Organoleptic properties (colour, shape, size, pH) of the dosage form .

Excipients and its compositions found in the product.

(Full list of excipients in the product detailed under “Section 6.1 List of excipients”)

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Clinical information

4.1 Therapeutic indications

● Detail on the treatment is for symptomatic, curative or preventive purposes

● Any restrictions that may apply to certain patient populations, such as patients with renal failure

4.2 Posology and method of administration

● Based on indication, age, and comorbidities, the maximum recommended single, daily or total dose, and the normal duration of use with any restrictions on duration is described

4.3 Contraindications

● Situations where the medicinal product must not be given for safety reasons

4.4 Special warnings and precautions for use

● Risks requiring a precaution for use prior or during treatment

● Special patient groups that are at increased risk

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Fertility, pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

4.9 Overdose

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