PACKAGE INSERTS
PACKAGE INSERTS
Exercise 1. Learn the active vocabulary:
| Package insert (patient information leaflet; drug leaflet) – анотація до лікарського засобу medical condition – медична умова side effect (adverse reaction) – побічна дія manufacturing pharmaceutical company [ˌmænjʊˈfæktʃərɪŋ ˌfɑːməˈsjuːtɪkəl ] - фармацевтична компанія виробник generic name – непатентована назва лікарського засобу | brand name – зареєстрована патентована назва лікарського засобу indications [ˌɪndɪˈkeɪʃənz] – показання contraindications – протипоказання warning [ˈwɔːnɪŋ] - попередження precautions [prɪˈkɔːʃənz] – застереження drug abuse – зловживання ліками dependence – залежність |
Exercise 2. Translate the following word combinations into Ukrainian:
Licensed medicines; follow a standard format; clinical pharmacology; absorb and eliminate; results of various clinical trials; medication's effect on various populations; physical impairments and drug interactions; cause physical dependence; results of an overdose; storage information.
Exercise 3. Read and translate the following text:
PACKAGE INSERTS
Package Inserts orPatient information leaflets (drug leaflet) are leaflets containing specific information about medical conditions, doses, side effects that packed with medicines to give the user information about the product. Patient information leaflets are written by the manufacturing pharmaceutical company. All licensed medicines need to carry such a leaflet.
Package inserts follow a standard format for every medication and include the same types of information. The first thing listed is usually the brand name and generic name of the product. The other sections are as follows:
· Clinical pharmacology - 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. It may also contain results of various clinical trials (studies) and/or explanations of the medication's effect on various populations (e.g. children, women, etc.).
· Indications and usage - uses (indications) for which the drug has been approved (e.g. migraines, seizures, high blood pressure).
· Contraindications - lists situations in which the medication should not be used, for example in patients with other medical conditions such as kidney problems or allergies
· Warnings - covers possible serious side effects that may occur
· Precautions - explains how to use the medication safely including physical impairments and drug interactions
· Adverse reactions - lists all side effects observed in all studies of the drug (as opposed to just the dangerous side effects which are separately listed in "Warnings" section)
· Drug abuse and dependence - provides information regarding whether prolonged use of the medication can cause physical dependence (only included if applicable)
· Overdosage - gives the results of an overdose and provides recommended action in such cases
· Dosage and administration - gives recommended dosage(s); may list more than one for different conditions or different patients (e.g., lower dosages for children)
· Physical properties - explains in detail the physical characteristics of the medication including color, shape, markings, etc., and storage information (e.g., "Do not store above 95°")
Exercise 4. Answer the following questions:
1) What is a package insert?
2) Who are patient information leaflets written by?
3) What are the main sections of an information leaflet?
4) What does the section Clinical Pharmacology contain?
5) What does the section Indications and Usage contain?
6) What does the section Contraindications list?
7) What does the section Warnings cover?
8) What does the section Precautions explain?
9) What does the section Overdosage give?
10) Which section explains in detail the physical characteristics of the medication including color, shape, markings, etc., and storage information?
Exercise 5. Translate the following word combinations into English:
Анотації до лікарських засобів; медичні умови; побічні дії; фармацевтична компанія виробник; непатентована назва лікарського засобу; зареєстрована патентована назва лікарського засобу; поглинати та видаляти; результати різних клінічних дослідів; схвалені ліки; взаємодія ліків; визивати фізичну залежність; інформація щодо зберігання.
Exercise 6. Here are some sentences taken from different package inserts, read them translate and decide which sections ( indications, contraindications, physical properties, side effects, etc.) they refer to:
1. Zaditen is an antiasthmatic drug with marked antianaphylactic properties and a specific antihistaminic effect.
2.Following oral administration, Fosiopril is absorbed slowly.
3.Daflon treats venous insufficiently and oedema of venous origin by reinforcing the walls of veins.
4.Atrovent is indicated as a bronchodilator for maintenance treatment of bronchospasm.
5.Eye drops may be used for the prevention of ocular infection after removal of a corneal or conjuctival foreign body.
6.Phenergan is indicated in many allergic disorders and anaphylactic reactions including hay fever, urticaria and sensitization reactions of various drugs.
7.Dosage should be adjusted according to blood pressure response.
8.If immediate action is required, the capsule could be chewed and held in mouth.
9. Take half of the tablet twice daily or 1 capsule in the evening only for children under 3.
10. The use of Unasyn is contraindicated in individuals with a history of hypersensitivity to any of the penicillins.
Exercise 7. Put questions to the underlined words:
1. Tablets Noroxin should be stored in a tightly closed container.
2. The expiration date is nfentioned on the package.
3. Renal function should be closely monitored, as it may be further impaired by the use of antihypertensive drugs.
4. Prolonged use of antibiotics may give rise to overgrowth of nonsusceptible microorganisms and fungi.
5. Pantrisin ophthalmic solution and ointment are incompatible with other preparations.
6.Kesalamine produces an acute intolerance syndrome characterized by acute abdominal pain and bloody diarrhea.
7.Tachycardia and blood pressure generally subside after a few days.
8. Zocar may cause fatal harm when administered to a pregnant woman.
Exercise 8. Open the brackets using the verbs in the appropriate form, translate the sentences into Ukrainian:
1. Isocard (to contraindicate) in patients sensitive to the drug.
2. Hypersensitivity to atropine or its derivatives (to report).
3.Mesalanine is 5-amino-2-hydroxybensoic acid, and it (to classify) as an anti-inflammatory drug.
4.Benazepril hydrochloride (to be) soluble in water, in methanol.
5. Zocor is a cholesterol lowering agent that (to derive) synthetically from a fermentation product of Aspergillus terreus.
6. Cetax (to indicate) for the treatment of patient with genitourinary infections caused by susceptible strains of microorganisms.
7.Suppositories (to indicate) for the treatment of active ulcerative proctitis.
8.Weight gain occasionally (to report).
Exercise 9. Read the following package insert and answer the questions: