Get the free Summary of Product Characteristics - HPRA

1. Name of the Medicinal Product1.1Name of the Medicinal ProductAPREDIN INJECTION (Hydrazine Hydrochloride Injection USP) 1.2. Strength 20 mg/ml 1.3. Pharmaceutical Dosage Form Liquid Injection 2.

How to fill out summary of product characteristics

How to fill out summary of product characteristics

1. To fill out the summary of product characteristics, follow these steps:
2. Start by providing the basic information about the product, such as its name, manufacturer, and active ingredients.
3. Include a brief description of the product, its indications, and the intended population.
4. Provide detailed information on the product's composition, including the quantitative and qualitative composition of the active substances.
5. Include information on the pharmaceutical form, route of administration, and dosage.
6. Mention the therapeutic indications and contraindications, as well as any special warnings and precautions.
7. Include information on the use during pregnancy and lactation, as well as in specific patient populations (e.g., geriatric or pediatric patients).
8. Provide details on the posology and method of administration, as well as information on any known interactions with other medicinal products.
9. Discuss any undesirable effects and adverse reactions associated with the product, and provide recommendations for their management.
10. Include information on the product's shelf life, storage conditions, and packaging.
11. Finally, provide the date of the last revision of the summary of product characteristics.
12. Remember to adhere to regulatory guidelines and ensure that all information provided is accurate and up-to-date.

Who needs summary of product characteristics?

1. The summary of product characteristics is needed by various stakeholders in the pharmaceutical industry, including:
2. - Healthcare professionals (doctors, pharmacists) who prescribe and dispense the product
3. - Regulatory authorities who evaluate and approve the product for market authorization
4. - Pharmaceutical companies who develop and manufacture the product
5. - Medical and scientific researchers who study the product
6. - Patients and consumers who seek information about the product's safety and efficacy
7. - Pharmacovigilance professionals who monitor and report adverse reactions
8. Having a comprehensive and accurate summary of product characteristics is essential for ensuring the safe and effective use of the product.

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What is summary of product characteristics?

Summary of product characteristics is a document that provides detailed information about a medicinal product.

Who is required to file summary of product characteristics?

Marketing authorization holders are required to file summary of product characteristics.

How to fill out summary of product characteristics?

Summary of product characteristics is filled out by providing detailed information about the medicinal product, including its composition, indications, contraindications, and dosage.

What is the purpose of summary of product characteristics?

The purpose of summary of product characteristics is to provide healthcare professionals and patients with essential information about a medicinal product.

What information must be reported on summary of product characteristics?

Summary of product characteristics must include information on the composition, indications, contraindications, dosage, and adverse reactions of the medicinal product.