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Patient's leaflet
Livestock / Animal Husbandry
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Blue Board entries made by this user
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English to Bulgarian: business General field: Other Detailed field: Business/Commerce (general)
Source text - English ΠΠ΅ Π·Π½Π°Π΅ΡΠ΅ ΠΏΠΎ ΠΊΠΎΠΉ ΠΏΡΡ
Π΄Π° ΠΏΠΎΠ΅ΠΌΠ΅ΡΠ΅?
ΠΠΊΠΎ ΠΈΠΌΠ°ΡΠ΅ Π²ΡΠΏΡΠΎΡΠΈ ΠΎΡΠ½ΠΎΡΠ½ΠΎ ΠΏΡΠ°Π²ΠΈΠ»Π½ΠΎΡΠΎ
ΡΠ΅ΡΠ΅Π½ΠΈΠ΅ ΠΈΠ»ΠΈ ΠΏΡΠΈΡΠ΅ΡΠ½Π΅Π½ΠΈΡ ΠΎΡΠ½ΠΎΡΠ½ΠΎ Π½Π΅ΡΠΎ
Π½Π΅ΡΠ΅Π΄Π½ΠΎ, Π½ΠΈΠ΅ Π±ΠΈΡ ΠΌΠ΅ ΠΈΡΠΊΠ°Π»ΠΈ Π΄Π° Π²ΠΈ ΠΏΠΎΠΌΠΎΠ³Π½Π΅ΠΌ.
Π’Π΅Π»Π΅ΡΠΎΠ½Π½Π° ΠΈ ΡΠ΅Π± Π»ΠΈΠ½ΠΈΡ Π·Π° ΠΊΠΎΡΠΏΠΎΡΠ°ΡΠΈΠ²Π½Π°
ΠΎΡΠ³ΠΎΠ²ΠΎΡΠ½ΠΎΡΡ Π½Π° Kraft Foods
β’ ΠΡ Π²ΡΠ½ΡΠ½Π° Π»ΠΈΠ½ΠΈΡ ΠΈΠ·Π±Π΅ΡΠ΅ΡΠ΅ Π΄ΠΈΡΠ΅ΠΊΡΠ½ΠΈΡ Π½ΠΎΠΌΠ΅Ρ Π·Π° Π΄ΠΎΡΡΡΠΏ Π·Π° Π²Π°ΡΠ΅ΡΠΎ ΠΌΠ΅ΡΡΠΎΠ½Π°Ρ ΠΎΠΆΠ΄Π΅Π½ΠΈΠ΅:
ΠΡΠ»Π³Π°ΡΠΈΡ: 00-800-0010
β’ ΠΡΠΈ ΠΏΠΎΠΈΡΠΊΠ²Π°Π½Π΅ Π½Π°Π±Π΅ΡΠ΅ΡΠ΅ 800-381-6402
http://www.KraftFoodsEthics.com
ASKING QUESTIONS, RAISING CONCERNS
βWhen we follow the rules, ask questions
if weβre not sure, and report problems, we
are helping our company succeed. We are
living our values and building trust. Thatβs
good for the bottom line. And itβs our way
of doing business.β
-- Kraft Foods Code of Conduct
No matter where you work, and no matter
what your job is, if you learn of wrongdoing,
the company wants to hear from you. By
raising concerns, you help to protect yourself,
your co-workers, and Kraft Foods.
ASK BEFORE ACTING:
β’ Is it legal?
β’ Does it follow Kraft Foods policy?
β’ Is it right?
β’ How would it look to those outside of Kraft
Foods? For example, how would it look to our
customers, the people in the communities
where we work, and the general public?
WHOM SHOULD I CONTACT?
Your supervisor is a good place to start, but
you also can report issues and get help or
advice from:
β’ your supervisorβs supervisor,
β’ your department head,
β’ your Regional Compliance Offi cer,
β’ your Kraft Foods Lawyer,
β’ Kraft Foods Chief Compliance Offi cer, or
β’ The Compliance & Integrity Group.
Face-to-face discussions are often best, but
there may be times when you do not feel
comfortable talking to someone in person.
That is why the Kraft Foods Integrity HelpLine
and WebLine, both operated by a third-party
for the company, are available to allow you
to report your concerns anywhere, anytime,
anonymously if you wish.
WHAT HAPPENS WHEN I RAISE A
CONCERN OR MAKE A REPORT?
We take all reports seriously. We do not
assume a person is βguiltyβ based on a report
without a fair and impartial investigation of the
matter. We investigate the facts to determine
objectively what happened and decide what
to do based on those facts.
WHAT IF I REPORT SOMETHING AND
IβM TOLD TO βKEEP QUIETβ ABOUT IT?
If you think that youβre being discouraged
from reporting a potential violation of the law
or company policy, you should report both the
original concern and the fact that youβve been
told to βkeep quiet.β
WHAT IF I BELIEVE THAT I MAY
HAVE BEEN INVOLVED IN CONDUCT
THAT VIOLATES THE LAW OR
COMPANY POLICY?
In the event that you feel you may have violated
a law or policy, it is always better to self-report
than have the company independently learn of
the issue. Kraft Foods will consider the situation
fully when deciding what action to take.
KRAFT FOODS DOES NOT
TOLERATE RETALIATION.
When you speak up and raise concerns or
report wrongdoing in good faith, you are doing
the right thing and Kraft Foods will not tolerate
any retaliation against you. If you think
someone has retaliated against you or any
other employee for raising a concern, tell your
Regional Compliance Offi cer, Kraft Foods Chief
Compliance Offi cer, or contact the Compliance
& Integrity Group or the Integrity HelpLine
or WebLine. On the other hand, concerns
or allegations made in bad faith will not be
tolerated and employees who make them are
subject to discipline, including termination
of employment. For more information about
βspeaking upβ refer to the Speaking Up Policy.
REPORTING CONCERNS FOR EMPLOYEES
IN THE EUROPEAN UNION.
Due to data privacy rules in the European
Union (EU), HelpLine or WebLine contacts
from EU countries are limited to fi nancial,
accounting or auditing practices of the
company, fraud or bribery allegations. If your
concern pertains to other issues, you should
report them to local management or through
other established reporting channels referred
to throughout this brochure.
HOW CAN I LEARN MORE?
If you have have any questions, please contact
your Regional Compliance Offi cer or visit the
Compliance & Integrity Group intranet site to
learn more about our compliance programs
and reporting mechanisms such as the
Integrity HelpLine and WebLine.
If you see improper conduct, speak up.
If you suspect improper conduct, speak up.
If you are unsure, or need advice, speak up.
Translation - Bulgarian SUDACHIM LTD
10A Yordan Stubel Str.
1700 Sofia
tel/fax: 860 1571
Π΅-mail: [email protected]
Record
for a registration of the veterinary product
solution
Volume 1
CONTENT OF DOCUMENTATION
page
Part 1. Administrative data - 3.
Part Π. A. Administrative data - 4.
Part Π. B. Short characteristic of the Veterinary Medicinal Product - 6.
Part Π. C. Project label, project package and project leaflet -17.
Part Π.D. Expert reports (volume ΠΠ) -20.
1.Physicochemical, pharmaceutical and biological documentation
2.Documentation for safety and remaining quantity
3.Preclinical and clinical documentation
Part ΠΠ. Analytical documentation for the veterinary medicinal product (physicochemical, pharmaceutical, microbiological and biological tests) -21.
Part ΠΠ.Π. Data for the quantity and quality of the components -22.
Part ΠΠ.B. Description of the production method -29.
Part ΠΠ.C. Control of the initial raw material -36.
Part ΠΠ.D. Specific measures for protection against transmissive spongiform encephalophaties in animals -45.
Part ΠΠ.E. Control tests made during medial stages of the production process- -46.
Part ΠΠ.F. End product Testing -47.
Part ΠΠ.G. Stability of the product. Expiry dare. Storage conditions -51.
Part ΠΠΠ. Testing for safety and remaining substances -54.
Part ΠΠΠ.Π. Tests for safety -55.
Part ΠΠΠ.B. Tests for definition of remaining substances -67.
Part ΠV. Preclinical and clinical tests -81.
Part ΠV.Π. Preclinical documentation -82.
Chapter ΠΠ. Clinical test of the Veterinary Medicinal Product Urzopronil - -91.
Clinical report after testing the product in ovine and bovine animals -97.
A P P E N D I X E S
PART I.
ADMINISTRATIVE DATA
Part Π.Π. ADMINISTRATIVE DATA
1. Name of the veterinary medicinal product and its active components
1.1. Name of the veterinary medicinal product
Π£Π ΠΠΠΠ ΠΠΠΠ
URZOPRONIL
1.2. International name of the active components
Sodium Propionate.
2. Pharmaceutical form and concentration/activity of the veterinary medicinal product, method and mode of administration, package and animals to be used for:
Pharmaceutical form:
water solution
Concentration of 1 ml product :
Active component: Natrii propionas 0,40 g.
Subsidiary substances: Ferri sulfas 0,89 mg; Cupri sulfas 0,59 mg;
Mangani sulfas 1,18 mg; Cobalti sulfas 0,04 mg ; aqua destillata up to 1,0 ml.
Mode of administration:
Orally β diluted with water;
Type of package:
Plastic phials of 200 ml
Animals to be used for:
Cattle, sheep, goat
3. Name and address of the notifier.
SUDACHIM LTD
10A Yordan Stubel Str.
1700 Sofia
3.1. Name and address of the permit holder for use
SUDACHIM LTD
10A Yordan Stubel Str.
1700 Sofia
3.2. Name and address of the manufacturer
VETPROM AD
26 Otetz Paisii Str.
2400 Radomir
4. Name, description and copy of the record volumes for the license of the veterinary medicinal product
The current documentation is presented in volume 2:
Volume Π. β Registration record and appendixes;
Volume ΠΠ. β Expert reports
5. Samples and description of the end commercial look of the product
Three samples of the product (200ml) are presented.
6. Production permit for the veterinary medicinal product
β 009 since 18/03/2004
7. A list of the countries in which the veterinary medicinal product is licensed for use
- Republic of Bulgaria
- Republic of Macedonia
4
PART I. B.
SHORT CHARACTERISTIC OF THE VETERINARY MEDICINAL PRODUCT
1.Name of the veterinary medicinal product and concentration /activity
Π£Π ΠΠΠΠ ΠΠΠΠ
URZOPRONIL
2. General or chemical name of the active substance(s) and excipient(s) and their quality and quantity composition
2.1. General or chemical name of the active substance
Sodium Propionate; Natrii propionas.
Quality and quantity composition of the product in 100 ml:
_________________________________________________________________
Mangani sulfas 0,118 carrier of Mn2
MnSO4
Cobalti sulfas 0,004 carrier of
CoSO4 Co2
Acidum hydrochloricum 2,200 Correction of ΡΠ
HCL 35-38%
2.Pharmaceutical Form
Water solution
4. Clinical data:
4.1. Animals for which the veterinary medicinal product should be used for
Cattle, sheep, goat
4.2 Directions for use
Urzopronil is used in the disease of acetonaemia (ketosis) in cattle, sheep and goat. It is also used in primary and secondary indigestions caused by unilateral feeding, a sudden change in the feeding regime, overfeeding with concentrated fogares and forage poisoning; in indigestion after tympania, reticuloperitonitis and omasus obstipation, operation, etc. Urzopronil is also used as a stimulating drug for the rumen microflora in the treatment with antibiotics, sulfanilamides, antiseptics and nitrofuran products.
4.2.Contraindications
No contraindications.
4.4. Special protective measures for the animals it is used for:
There are no special protective measures.
4.5. Special protective measures for use, including special protective measures that have to be taken by the person who uses the drug to treat animals.
There are no special protective measures.
Direct contact of the product with the skin and mucosa must be avoided.
When you finish using the product you have to wash your hands thoroughly with water and a cleaning agent. If the product affects the skin of the person who uses the product, he has to wash the affected area thoroughly under running water.
The dirty working clothes should be changed with clean ones.
4.6. Unfavorable reactions (frequency of appearance and seriousness)
No unfavorable reactions have been observed.
4.7. Use during pregnancy, lactation or lay.
No restrictions.
4.8. Interaction with other veterinary medicinal products and/or other forms of interaction.
In an acid medium and at temperature under 10 Β°C, Sodium Propionate crystallizes in needle-like crystals. After neutralization of the medium and warming up to 20 β 25 Β°C, the crystals dissolve.
In an acid medium and in the presence of sulfides (Hydrogen sulph; ammon sulfide, etc.) the microelements precipitate in the form of sulfides.
In an alkaline medium (with alkaline base) the microelements precipitate as hydroxides. The precipitation is convertible. In neutralization of the medium, hydroxides dissolve.
4.9. Dose and mode of administration
For cattle, 200 β 250 ml of the product should be dissolved in 1 β 3 litres of water and given once up to three times a day, for 3 to 5 days.
For sheep and goat, 70 β 80 ml of the product should be dissolved in 0.5 β 1 litre of water and given once up to three times a day, for 3 to 5 days.
Orally, dissolved with water
4.10. Overdose β symptoms, action procedures in emergencies and antidotes in case of necessity.
Overdose of the product is slightly possible.
4.11. Withdrawal period
No withdrawal period.
5. Pharmacological properties.
Pharmacological group:
QA16QA Drugs for treatment of acetonemia.
QA16QA52 Sodium propionate, combinations.
Sodium Propionate resorbs from the proventriculus of the ruminant animals and turns into glucose. It increases the blood sugar levels and liver glycogen content. Sodium Propionate contributes indirectly for the improvement and normalization of the carbohydrate exchange and liver detoxification function. It cooperates for the neutralization of the acid products in the proventriculus and provides optimum conditions for micro flora development in the rumen. It activates the ruminal motor function in hypo and atonic conditions, increases the secretion of the abomasus and causes increase of serum proteins, esp. of globulins.
Cobalt is needed for the synthesis of cyanocobalamin (vitamin B12) from the microorganisms in the proventriculus. It stimulates the protein synthesis, growth, eritropoesis and limits the fatty liver dystrophy.
The microelements /Copper, Iron and Manganese/ activate eritropoesis and also some enzyme systems that take part in metabolism. These microelements have favourable influence over indigestions of the ruminant animals.
Urzopronil has an anti-inflammatory function and contributes to the faster healing of inflammatory processes in the proventriculus and intestines with no need for the animal to be kept hungry or on any special diet.
5.1Pharmacological properties
Propionic Acid is met in the composition of different natural products (Swiss cheeses contain up to 1 % of Propionic Acid). During the fermentation of starch and sugars in the rumen of ruminant animals, Propionic Acid is produced by the bacteria called Propionibacterium acidipropionici (Carrondo et al.,1988; Blanc&Gomaq 1989). It falls to the physiological products from the metabolism in mammals and during the oxidation processes, it is easily absorbed by the body and turns into glucose. For instance, the lactating cow with live weight of about 550 kg, produces through the microflora of the rumen, about 1.5 l Propionic Acid per day which is an important energy source for the animal.
Besides that, Propionic Acid has a strong antimicrobial activity. This effect is bactericidal and bacteriostatic as well as fungicidal and micostatic.
Sugars and starch ferment quickly in the proventriculus of the ruminant animals and that's why they are called easily fermenting carbohydrates. They are resorbed and used mainly as volatile fatty acids. The main part of the necessary energy for the animals is provided through easily fermeting carbohydrates. They are also needed for the normal functioning of the processes in the proventriculus. Their deficiency reduces the microbiological processes, worsens the microbial protein synthesis, and alters unfavourably the proportion between the Acetic Acid and Propionic Acid which worsens the use of energy. Their surplus has also bad circumstances: it worsens the consumption and digestibility of the rough forages and reduces the Acetic Acid at the expense of the Propionic Acid which lowers the content of fatty substances in the milk of the lactating animals (N. Todorov, B. Marinov, Al. Alexandrov, 1995).
The Acetic Acid (Π‘H3βCOOH), Propionic Acid (Π‘2H5βCOOH) ΠΈ Fatty (Butyric) Acid (Π‘3H7βCOOH) form the group of the volatile fatty monocarboxylic acids. They are end products as a result of the microflora vital activity that takes place in the proventriculus of the ruminant animals. After their resorption they appear to be an important energy source for the ruminant animals.
The Acetic Acid consists of two carbon atoms in its molecule. It presents 55 β 70 % from the total quantity of volatile fatty acids produced by the rumen microflora and it is formed as a result of the absorption of crude plant fibres.
Propionates and Propionic Acid is a 3-carbon volatile fatty acid. It is a result from the absorption and processing of starch and sugar from the rumen microflora of the ruminant animals. In the liver, propionates turn into glucose. In Gluconeogenesis the glucose takes part in the synthesis of lactose and valuable amino acids. The content of the Propionic acid varies from 15 % up to 30 % from the whole quantity of volatile fatty acids, produced from the microflora of the rumen. Among the volatile fatty acids, the Propionic acid is the energy richest acid and it is of greatest importance for the prophylaxis, metaphylaxis and ketosis therapy in high productive cows and sheep.
The Butyric Acid consists of 4 carbon atoms in its molecule. Its content varies from 5 % up to 15 % from the whole quantity of volatile fatty acids produced by the rumen microflora. It is used as an energy source for the body and takes part in the synthesis of fatty substances in the milk of the lactating animals.
The proportion between the Acetic Acid and Propionic Acid in the total quantity of volatile fatty acids, influences the normal functioning of the processes in the proventriculus and the use of energy. Theoretically, this proportion is 60 % of the Acetic Acid and 25 % of the Propionic Acid (2,4:1). The optimum proportion is assumed to be above these values: 2,2:1. Values that exceed the optimum proportion could cause increase of the crude plant fibre absorption and suppression of the carbohydrate fermentation in ration. Higher values of the Propionic Acid could cause decrease of the absorption of crude fibres in ration.
The bacteria that absorb crude plant fibres grow with preference in pH medium from 6,0 up to 6,8 while the bacteria that absorb starch, grow in pH medium from 5,5 up to 6,0. That's why a pH level of about 6,0 has to be maintained in the rumen to provide optimum conditions for the growth of the two kinds of bacteria in the high productive ruminant animals.
The microelements Iron, Copper, Manganese and Cobalt are of small quantity in the product (altogether about 0,1 %) and their function is mainly to provide favourable conditions for the microorganisms in the rumen that take part in the carbohydrate fermentation.
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Master's degree - St.Cyril and St. Methodius University of Veliko Tarnovo, Bulgaria
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My name is Nataliya Nedkova. I am a professional English-Bulgarian, Bulgarian-English translator/interpreter. I possess excellent communication and written skills as I hold Bachelor degree in English Language and Literature and Master degree in Translations at St.Cyril and St. Methodius University of Veliko Tarnovo, Bulgaria. I am also a member of the Chartered Institute of Linguists, (IoL, UK), a member of the International Association of Professional Translators and Interpreters (IAPTI), a Proz Certified Pro member and a volunteer at Translators Without Borders.
I have 11 years of substantial experience as a translator and proofreader in Medicine: Pharmaceuticals for Human Medicine: Medical Trials β Protocol Synopsis, Patient Card, Site User Guide, Informed Consent, Patient Information, Adverse Events Forms, and other relevant documentation, Pharmaceutical QRD - Summary of Product Characteristics, Labeling, Patient leaflet, Marketing Authorization, etc., Medical Device Manuals; Medical and Dental Equipment and Supplies; Medical Reports; Miscellaneous patient documentation; Medical publications; Scientific articles; Various documents in Oncology, Cardiology, Psychology, Psychiatry, Nutrition, etc.
* Other areas: Veterinary Medicine - Pharmaceuticals; Health & Safety, General Politics, Business & Administration, Marketing and Advertising, General Law, Immigration, Education, Fashion, Tourism & Travelling, Psychology, general texts, etc.
I work with SDL Trados Studio 2009, MemoQ 5.0, XTM CAT tool, Agito Translate CAT tool, etc.; FineCount β counting words in various formats. I can translate a volume of about 2500-3000 words per day.
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