Exercise 15. Put the sentences into the correct order to explain the term “package insert”:
__ All licensed medicines need to carry such a leaflet.
__ The first thing listed is usually the brand name and generic name of the product.
__ Patient information leaflets are written by the manufacturing pharmaceutical company.
__ The main sections of package insert are clinical pharmacology, indications and usage, contraindications, warnings, precautions, adverse reactions, drug abuse, overdosage, dosage and administration, physical properties.
__ Package Inserts or Patient information leaflets (drug leaflet) are leaflets containing specific information about medicines.
Завдання для самостійної роботи студентів (СРС)
І. Перекладіть наступні словосполучення:
Анотації до лікарських засобів
побічні дії
фармацевтична компанія виробник
непатентована назва лікарського засобу
зареєстрована патентована назва лікарського засобу
поглинати та видаляти
результати різних клінічних дослідів
взаємодія ліків
визивати фізичну залежність
інформація щодо зберігання
II. Дайте відповіді на наступні питання:
What is a package insert?
What are the main sections of an information leaflet?
What does the section Clinical Pharmacology contain?
What does the section Indications and Contraindications contain?
What does the section Overdosage give?
III. Розкрийте поняття: Анотація до лікарських засобів
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Test
1. …are leaflets containing specific information about medical conditions, doses, side effects that packed with medicines to give the user information about the product.
a) prescriptions b) recommendations c) instructions d) package inserts e) administrations
2. Patient information leaflets are written by …
a) the physician b) the manufacturing pharmaceutical company c) the chemist d) the nurse e) the district doctor
3. The first thing listed in a package insert is usually … of the product.
a) the dosage b) the contraindications c) the brand name and generic name d) the side effects e) indications
4. …tells how the medicine works in the body, how it is absorbed and eliminated, and what its effects are likely to be at various concentrations.
a) Section Warnings b) Section Clinical Pharmacology
c) Section Overdosage d) Section Physical properties
e) Section Contraindication
5. Section Indication and Usage includes…
a) possible side effects of the drug
b) situations in which the medication should not be used
c) uses (indications) for which the drug has been approved
d) information regarding whether prolonged use of the medication can cause physical dependence
e) explanation how to use the medication safely including physical impairments and drug interactions
6. Section Contraindications lists…
a) possible side effects of the drug
b) situations in which the medication should not be used
c) uses (indications) for which the drug has been approved
d) information regarding whether prolonged use of the medication can cause physical dependence
e) explanation how to use the medication safely including physical impairments and drug interactions
7. Section Dosage and administration includes…
a) uses (indications) for which the drug has been approved
b) situations in which the medication should not be used
c) information regarding whether prolonged use of the medication can cause physical dependence
d) recommended dosage(s)
e) explanation how to use the medication safely including physical impairments and drug interactions
8. Section Precautions explains…
a) the physical characteristics of the medication including color, shape, markings, etc., and storage information
b) how to use the medication safely including physical impairments and drug interactions
c) what should be done in case of overdosage
d) what side effects may occur
e) recommended dosage(s)
9. Section Physical properties explains …
a) what side effects may occur
b) the physical characteristics of the medication including color, shape, markings, etc., and storage information
c) what should be done in case of overdosage
d) what side effects may occur
e) what recommended dosage(s)
10. Section Overdosage gives …
a) the physical characteristics of the medication including color, shape, markings, etc., and storage information
b) recommended dosage(s)
c) situations in which the medication should not be used
d) the results of an overdose and provides recommended action in such cases
e) explanation how to use the medication safely including physical impairments and drug interactions
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