Recommended label information



In addition to the information required by law, it is recommended that the following information also be provided on the prescription label.

- number of dosage units or volume of product dispensed;

- number of refills allowed.

Presented below is an example of a proper label. This is the fоrmat whiсh you should fо1low when writing labels in English.

 

UNC School of Pharmacy Chapel Hill, NC 27511 962-0057 Rx # 123456                                                                            Pat Annsir Dr. Upendown                                                                         9/1/98 Take one tablet every four to six hours as needed for pain. Acetaminophen 325 mg, Codeine sulfate 15 mg/tablet (#30) 3 refills; expires 9/31/98 Dispensed by Y.Ourname R.Ph

 

§ Other labeling guidelines indicate the dosage form to be administered, e.g. "Take one tablet every day" instead of "Take one every day."

§ Use words instead of numbers, e.g. "Take one tablet every day" instead of "Take 1 tablet every day."

§ Express quantities to be administered in units which are familiar to the patient, and for which they are likely to have suitable measuring devices, e.g. “Take two teaspoonfuls every six hours.” instead of “Take 10 ml…”. In some instances it may be critical that an exact volume, such as 2.0 ml, be administered. In such a case, the pharmacist should provide a properly calibrated measuring device along with the medication.

§ Specify the route of administration if the medication is not intended for oral use, e.g. insert one suppository vaginally every night at bedtime.

§ Do not use abbreviations, e.g. “Take two capsules twice a day” not “Take two caps twice a day”.

§ Specify all active ingredients in a compounded prescription. Inert bases or vehicles may, but need not, be labeled.

§ In general, the amount of active ingredient per dosage unit should be specified, e.g. Inderal 2 mg/chart, Amoxicillin 250 mg/5ml., Phenergan 25 mg/suppository.

II.9. Найдите в правой колонке синонимы для слов и выражений из левой колонки.

directions inert
strength to allow
to check again guidelines
the first potency
rules to re-check
to forbid regulations
to permit the mode of administration
the route of administration to prohibit
inactive initial

 

II.10. Составьте пары антонимов из этих слов.

Active, to prohibit, dangerous, proper, inert, safe, initial, to permit, improper, final.

II.11. Ознакомьтесь со словами к тексту С.

an employee [¸emplO΄i:] служащий, сотрудник
an entity [΄entItI] (зд.) юридическое лицо
providing [pr@΄vaIdiÎ] при условии, что; если
to handle smth [΄h{ndl] торговать
to conduct an inventory [k@n΄dökt] [In΄vent@rI] проводить инвентаризацию
on hand в наличии
biennial [bI΄enI@l] 1 раз в два года
a finished form готовая (лекарственная) форма
exact [I΄gz{kt] точное
estimated [΄estImeItId] count приблизительное количество

 

the Federal Pharmacy Law Федеральное фармацевтическое законодательство
a registrant [΄redZIstr@nt] зарегистрированное лицо
a receipt [rI΄si:t] квитанция
an invoice [΄InvOIs] счет-фактура
a packing slip [΄p{kIÎ΄ slIp] накладная
to suffice [s@΄faIs] быть достаточным
the practitioner [pr@k΄tIS@n@] практикующий врач
at retail [rI΄teIl] в розницу
an ounce [΄auns] унция (28,35 г)
a purchaser [΄p@:tS@s@] покупатель

II.12. Прочтите текст С и озаглавьте его. Сколько подтем в нем можно выделить? Назовите каждую из них. Переведите текст.

Text C

Certain drugs have a potential for abuse that leads to physical or psychological dependence. Therefore, these drugs have been placed into schedules (schedules I, II, III, IV, V) and they are referred to as controlled substances.

Schedule I drugs may not be kept in a pharmacy nor dispensed pursuant to prescription. The drug is placed in schedule I (marked as C1 or C–1) if:

a) the drug has a high potential for abuse;

b) there is a lack of accepted safety for its use under medical supervision;

c) the drug or other substance has no currently accepted medical use in the country.

All controlled substances in schedules II-V are the substances with a lower potential for abuse.

All pharmacies and hospitals must conduct an initial inventory of all controlled substances in schedules II, III, IV and V. Initial inventory must be taken on the date the pharmacy starts business and begins dispensing controlled substances. If the pharmacy has no controlled substances on hand this fact must be recorded at its initial inventory.

Then, biennial inventory must be taken at least every 2 years from the date of the initial inventory.

Because all records for schedule II controlled substances must be maintained separately from other records, schedule II inventories must be maintained separately from other controlled inventories.

All inventory records must contain the date the inventory is taken, the name of each finished form of the substances (dosage form and strength), and the number of units or volume of each finished form in each commercial container (e. g. 100 tablet bottle). For opened commercial containers inventory must be taken as follows. For schedule II controlled substances, an exact count or measure must be taken. For schedules III, IV and V controlled substances, an estimated count or measure may be taken.

Schedule II controlled substances must be obtained from a supplier (wholesaler or manufacturer) by using DEA Form 222. The federal Pharmacy Law does not require the use of any special form to obtain substances in schedules III-IV. Each registrant must, however, maintain a complete and accurate receipt for each such substance. The record must be maintained at either the registered location of the pharmacy or hospital, or at a central location. For central records, an invoice or packing slip will suffice as a record of receipt.

Schedule II controlled substance prescription must be written with ink or indelible pencil or typewritten except in cases of oral emergency schedule II prescriptions. Schedule III-V controlled substance prescriptions may be orally ordered by the practitioner.

Controlled substances that are not prescription (or legend) drugs may be dispensed to a patient at retail without a prescription. These drugs do not have on the manufacturer’s label the federal statement: “Caution. Federal law prohibits dispensing without a prescription”. The dispensing must be made only by a licensed pharmacist. Not more than 8 ounces of any substance containing opium, 4 ounces of any other controlled substance, 48 dosage units of any substance containing opium, or 24 dosage units of any other controlled substance may be dispensed to the same purchaser in any 48-hour period, and the purchaser must be at least 18 years old.

 


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