Mohamed Abd El Aziz
$20/hr
Translation Dutch Arabic - Swedish Arabic-English Arabic
- Reply rate:
- -
- Availability:
- Hourly ($/hour)
- Age:
- 49 years old
- Location:
- Dirmawas, Al Minya, Egypt
- Experience:
- 8 years
The Ministry of Economic Affairs
BD/2014/REG NL 3703/case 413028
The State Secretary for Economic Affairs
In accordance with
The minister of Health, Welfare and Sports,
Having regard to a request by Alfasan International BV Holland , situated in Woerden dated 6 April 1987 for the registration of the veterinary medicinal product ERYTHROMYCIN 20% PRO INJ.;
Taking into consideration article 2.19 of the Animals Act (Law on Animals ).
Hearing by the registration of the veterinary medicinal product commission
DECISION :
(1)The registration of the veterinary medicinal product ERYTHROMYCIN 20% PRO INJ.; registered under number REG NL 3703 has been modified on 6 April 1987 as requested .
(2) The revised summary of product characteristics relating to the veterinary medicinal product ERYTHROMYCIN 20% PRO INJ.; registered under number REG NL 3703 can be found as annex A accompanying this decision .
(3) The modified label and , Where appropriate , the modified leaflet relating to the veterinary medicinal product ERYTHROMYCINE 20% PRO INJ.; registered under number REG NL 3703 can be found as annex B accompanying this decision .
(4) The manufacturer must deliver the existing stock (with unmodified product information ) within the six months after being provided of the modified decision .
(5) This Decision shall enter into force today .
BD/2014/REG NL 3703/case 413028
The State Secretary for Economic Affairs
for this :
Utrecht , 15 July 2014
Signature ) )
Mr F. Verheijen MSc
Head of Veterinary Medicines Office
BD/2014/REG NL 3703/case 413028
ANNEX A
SUMMARY OF PRODUCT CHARACTERISTICS
BD/2014/REG NL 3703/case 413028
(1) THE NAME OF THE VETERINARY MEDICINE ,
ERYTHROMYCIN 20% PRO INJ, 200 mg/ml , Solution for injection for dogs and cats .
(2) QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml:
Active substance
Erythromycin 200 mg
Excipients :
Sodium metabisulphite (E223) 1 mg
Benzyl alcohol (E1519) 40 mg
Propylene glycol (E1520) 500 mg
For the full list of excipients, see section 6.1.
(3) PHARMACEUTICAL FORM
Solution for injection.
(4) CLINICAL PARTICULARS
(4.1) TARGET SPECIES
Dog , Cat
(4.2 ) INDICATION FOR USE, SPECIFYING THE TARGET SPECIES.
For the treatment of :
Respiratory infections caused by Streptococcus spp., en Staphylococcus spp.
Skin infections caused by Streptococcus spp., en Staphylococcus spp.
(4.3 ) CONTRAINDICATIONS
None
(4.4) SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
( 4.5 ) SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based upon local ( regional )
epidemiological information about susceptibility of the relevant bacteria.
BD/2014/REG NL 3703/case 413028
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In connection with possible sensitization and hypersensitivity reactions when we use product , direct contact with the veterinary medicinal product should be avoided. Always wear single use disposable gloves when applying the veterinary medicinal product to animals.
(4.6) Adverse reactions (frequency and seriousness)
None known.
(4.7) Use during pregnancy, lactation or lay
The safety of the product has not been proven during pregnancy and lactation.
(4.8) Interaction with other medicinal products and other forms of interaction.
An in vitro antagonism exists between erythromycin and beta-lactam antibiotics . Erythromycin antagonises the action of clindamycin, lincomycin and chloramphenicol. The same applies for streptomycin, tetracyclines and colistin.
4.9 ) Amounts to be administered and administration route)
For Intramuscular or subcutaneous administration
5 mg to 10 mg of erythromycin per kg bodyweight (corresponding to 0,025-0,05 ml veterinary medicinal product per kg bodyweight ) , 2-3 times daily, minimal 3-5 days.
( 4.10) Overdose (symptoms, emergency procedures, antidotes)
There is no information available.
(4.11) Withdrawal Period(s)
Not applicable.
(5) Pharmacological properties
Pharmacotherapeutic group : Macrolides
ATCvet-code: QJ01FA01
(5.1) Pharmacodynamic properties
Erythromycin is a macrolide antibiotic that acts as bacteriostatic, but what is the bactericidal effect against susceptible bacteria in high concentrations. Macrolides are working by binding to the large 50S subunit of the sensitive bacterial ribosome.
Erythromycin is especially active against gram positive cocci such as Staphylococcus spp. and Streptococcus spp. such as Staphylococcus spp. and Streptococcus spp. and several Gram-positive bacilli . It is also active against some Gram-negative bacteria including Haemophilus , Pasteurella and Brucella .
(5.2) Pharmacokinetic properties
Erythromycin will be distributed on the most tissues after intramuscular or subcutaneous administration . The mirrors in the cerebrospinal fluid are low . The plasma-protein binding is high . Erythromycin can cross the placenta and is excreted through the milk as well. Excretion takes place mainly unchanged via the bile , a part will be metabolised to inactive metabolites in the liver .
BD/2014/REG NL 3703/case 413028
About 2-5% of the dose is excreted unchanged through the kidneys . Half-life of erythromycin in dogs is 60-90 minutes .
6) PHARMACEUTICAL PARTICULARS)
(6.1) List of excipients
Sodium metabisulphite (E223)
Benzyl alcohol (E1519)
Propylene glycol (E1520)
Edetate disodium
Sodium hydroxide
water for injections.
(6.2) Incompatibilities
In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary
medicinal products.
(6.3) Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
The product should be used immediately after piercing the vial , do not store .
(6.4) Special precautions for storage
Protect from light.
Do not store above 25 °C.
Do not freeze.
(6.5) Nature and composition of immediate packaging
Glass vial ( Type II ) with butyl rubber stopper and aluminium cap .
12 vials of 100 ml packed in polystyrene box .
(6.6) Special precautions for the disposal of unused veterinary medicinal products or the resulting waste materials .
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
(7) NAME OF MARKETING AUTHORISATION HOLDER
Alfasan Holland BV
Kuipersroad 9
3449 JA Woerden
Tel.: 0031-348416945
Fax.: 0031-348423577
E-mail: [email protected]
BD/2014/REG NL 3703/case 413028
(8) MARKETING AUTHORISATION NUMBER(S)
REG NL 3703
(9) DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Date of first authorization : 22 January 1992
Date of last renewal : 22 January 2002
(10) DATE OF REVISION OF THE TEXT
15 July 2014
Channeling UDD
BD/2014/REG NL 3703/case 413028
Annex B
LABELLING AND PACKAGE LEAFLET
BD/2014/REG NL 3703/case 413028
LABELLING . I
BD/2014/REG NL 3703/case 413028
The following particulars shall be given on the outer packaging
polystyrene box
1. Designation of the veterinary medicinal product
ERYTHROMYCIN 20% PRO INJ, 200 mg/ml , Solution for injection for dogs and cats .
ERYTHROMYCIN
2. Content of active and further component(s)
Per ml:
Erythromycin 200 mg
3. pharmaceutical form
Solution for injection
4. Packaging size
12 vials of 100 ml
5. Animal species for which the veterinary medicinal product is intended .
Dog and cat
6. Indication(s)
For the treatment of :
Respiratory infections caused by Streptococcus spp., en Staphylococcus spp.
Skin infections caused by Streptococcus spp., en Staphylococcus spp.
7. METHOD AND ROUTE(S) OF ADMINISTRATION
For Intramuscular or subcutaneous administration
5 mg to 10 mg of erythromycin per kg bodyweight (corresponding to 0,025-0,05 ml veterinary medicinal product per kg bodyweight ) , 2-3 times daily, minimal 3-5 days.
Read the package leaflet before use.
8. Waiting period
Not applicable
9. Special warning(s)
Read the package leaflet before use.
BD/2014/REG NL 3703/case 413028
10. The expiry date
EXP:
Shelf-life after piercing the vial , product should be used immediately, do not store .
11. Special precautions for storage
Protect from light.
Do not store above 25 °C.
Do not freeze.
12. Special precautions for the disposal of unused veterinary medicinal products or the resulting waste materials .
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
13. Indication " Used exclusively for animal treatment " and conditions or limitations in respect of deliveries and the use , if applicable.
Used exclusively for animal treatment UDD
14. Indication "Keep this medicine out of the sight and reach of children" .
Keep this medicine out of the sight and reach of children
15. NAME AND ADDRESS OF MARKETING AUTHORISATION HOLDER
Alfasan Holland BV
Kuipersroad 9
3449 JA Woerden
Tel.: 0031-348416945
Fax.: 0031-348423577
E-mail: [email protected]
16. MARKETING AUTHORISATION NUMBER(S)
REG NL 3703
17. The batch number of manufacturer .
{number}
BD/2014/REG NL 3703/case 413028
Particulars shall be given on immediate packaging.
Glass vial
1. Designation of the veterinary medicinal product
ERYTHROMYCIN 20% PRO INJ, 200 mg/ml , Solution for injection for dogs and cats .
ERYTHROMYCIN
2. Content of active and further component(s)
Per ml:
Erythromycin 200 mg
3. pharmaceutical form
Solution for injection
4. Packaging size
100 ml
5. Animal species for which the veterinary medicinal product is intended .
Dog and cat
6. Indication(s)
For the treatment of :
Respiratory infections caused by Streptococcus spp., en Staphylococcus spp.
Skin infections caused by Streptococcus spp., en Staphylococcus spp.
7. METHOD AND ROUTE(S) OF ADMINISTRATION
For Intramuscular or subcutaneous administration
5 mg to 10 mg of erythromycin per kg bodyweight (corresponding to 0,025-0,05 ml veterinary medicinal product per kg bodyweight ) , 2-3 times daily, minimal 3-5 days.
Read the package leaflet before use.
8. Waiting period
Not applicable
9. Special warning(s)
Read the package leaflet before use.
BD/2014/REG NL 3703/case 413028
10. The expiry date
EXP:
Shelf-life after piercing the vial , product should be used immediately, do not store .
11. Special precautions for storage
Protect from light.
Do not store above 25 °C.
Do not freeze.
12. Special precautions for the disposal of unused veterinary medicinal products or the resulting waste materials .
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
13. Indication " Used exclusively for animal treatment " and conditions or limitations in respect of deliveries and the use , if applicable.
Used exclusively for animal treatment UDD
14. Indication "Keep this medicine out of the sight and reach of children" .
Keep this product out of the sight and reach of children
15. NAME AND ADDRESS OF MARKETING AUTHORISATION HOLDER
Alfasan Holland BV
Kuipersroad 9
3449 JA Woerden
Tel.: 0031-348416945
Fax.: 0031-348423577
E-mail: [email protected]
16. MARKETING AUTHORISATION NUMBER(S)
REG NL 3703
17. The batch number of manufacturer .
{number}
BD/2014/REG NL 3703/case 413028
LEAFLET .I
BD/2014/REG NL 3703/case 413028
LEAFLET
Erythromycin 20% pro inj , 200 mg/ml , Solution for injection for dogs and cats .
1. NAME AND ADDRESS OF MARKETING AUTHORISATION HOLDER AND THE MANUFACTURER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT.
Alfasan Holland BV
Kuipersroad 9
3449 JA Woerden
Tel.: 0031-348416945
Fax.: 0031-348423577
E-mail: [email protected]
2. Designation of the veterinary medicinal product
ERYTHROMYCIN 20% PRO INJ, 200 mg/ml , Solution for injection for dogs and cats .
ERYTHROMYCIN
3. Content of active and further component(s)
Per ml:
Active component
Erythromycin 200 mg
Excipients
Sodium metabisulphite (E223)
Benzyl alcohol (E1519)
Propylene glycol (E1520)
4. Indications
For the treatment of :
Respiratory infections caused by Streptococcus spp., en Staphylococcus spp.
Skin infections caused by Streptococcus spp., en Staphylococcus spp.
5. Contra-indications
None
6. Side – effects
None known.
If any of the side effects get serious , or if you notice any side effects not listed in this leaflet , tell the veterinarian .
7. Animal species for which the veterinary medicinal product is intended .
Dog and cat
BD/2014/REG NL 3703/case 413028
8. DOSAGE FOR EACH TARGET ANIMAL SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION.
For Intramuscular or subcutaneous administration
5 mg to 10 mg of erythromycin per kg bodyweight (corresponding to 0,025-0,05 ml veterinary medicinal product per kg bodyweight ) ,
2-3 times daily, minimal 3-5 days.
9. ADVICE ON CORRECT ADMINISTRATION
Not applicable
10. WAITING PERIOD
Not applicable
11. SPECIAL PRECAUTIONS FOR STORAGE
Keep this product out of the sight and reach of children.
Protect from light.
Do not store above 25 °C.
Do not freeze.
Do not use after expiry date shown on product label after EXP:
Shelf-life after piercing the vial , product should be used immediately, do not store .
12. Special warnings
Special precautions for use in animals
Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based upon local ( regional )
epidemiological information about susceptibility of the relevant bacteria.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In connection with possible sensitization and hypersensitivity reactions when we use product , direct contact with the veterinary medicinal product should be avoided. Always wear single use disposable gloves when applying the veterinary medicinal product to animals.
Use during pregnancy, lactation or lay
The safety of the product has not been proven during pregnancy and lactation
Interaction with other medicinal products and other forms of interaction.
An in vitro antagonism exists between erythromycin and beta-lactam antibiotics . Erythromycin antagonises the action of clindamycin, lincomycin and chloramphenicol. The same applies for streptomycin, tetracyclines and colistin.
Incompatibilities
Given the lack of research into the compatibility , the veterinary medicinal product must not be mixed with other veterinary medicinal products .
BD/2014/REG NL 3703/case 413028
13. Special precautions for the disposal of unused veterinary medicinal products or the resulting waste materials .
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
14. The date on which the package leaflet was last revised.
15 July 2014
15. OTHER INFORMATION
Glass vial ( Type II ) with butyl rubber stopper and aluminium cap .
12 vials of 100 ml packed in polystyrene box .
REG NL 3703
Channeling UDD
