Patient leaflet - Netvax
. -
D. STATEMENT OF THE MRLs .
Pharmacologically active substance(s)
Animal species
Other provisions j
Thiomersal
All food producing species
Annex II of Council Regulation (E EC) No. 2377/90
EDTA
All food producing species
Annex II of Council^RegU|qtion (EEC) No. 2377/90
Formaldehyde
All food producing species
Annex II of Council Regulation (EEC) No. 2377/90
Mineral oil
All food producing species
Annex II of Council Regulation (EEC) No. 2377/90 W
Benzyl alcohol
All food producing species
Annex II of Council Regulation (EEC) No. 2377/90
Triethanolamine (at doses up to 0.25 mg/kg bw) is considered not within the scope of Council Regulation (EEC) No. 2377/90.
Carton
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
* International units per ml of rabbit serum determined by haemolysis i
3. PHARMACEUTICAL FORM
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Netvax
Emulsion for injection for chickens
4. PACKAGE SIZE
7. METH
5. TARGET SPECIES
1 × 500ml
6 × 500ml
ROUTE(S) OF ADMINISTRATION
THDRAWAL PERIOD
Intramuscular use.
Shake well before use. Read the package leaflet before use
Per dose of 0.5ml:
Clostridium perfringens Type A alpha toxoid: > 6.8 IU*
Light mineral oil: 0.31 ml
Thiomersal: 0.035–0.05 mg
Chickens
6. INDICATIONS
Vaccine against necro
awal period: Zero days
9. SPECIAL WARNING(S), IF NECESSARY
Accidental injection is dangerous – read package leaflet before use.
10. EXPIRY DATE
EXP month/year
Once opened, use within 8 hours
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2°C- 8°C). Do not freeze Protect from light
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF WASTE MATERIALS, IF ANY
Disposal: read package leaflet
13. THE WORDS “FOR ANIMAL TREATM
RESTRICTIONS REGARDING SUPPLY
For animal treatment only.
To be supplied only on veterinary prescription.
15. NAME AND ADDR
Intervet International B Wim de Korverstraat 5831AN Boxmeer The Netherlands
Keep out of the reach and sight
14. THE WORDS “KEEP OUT
16. MA
EU/2/09 EU/2/
PRODUCTS OR
ONLY” AND CONDITIONS OR
) USE, if applicable
REACH AND SIGHT OF CHILDREN
THE MARKETING AUTHORISATION HOLDER
G AUTHORISATION NUMBER(S)
Label
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
* International units per ml of rabbit serum determined by haemolysi
3. PHARMACEUTICAL FORM
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Netvax
Emulsion for injection for chickens
4. PACKAGE SIZE
7. METH
1 × 500ml
6 × 500ml
ROUTE(S) OF ADMINISTRATION
Intramuscular use.
Shake wore use. Read the package leaflet before use
Per dose of 0.5ml:
Clostridium perfringens Type A alpha toxoid: > 6.8 IU*
Light mineral oil: 0.31 ml
Thiomersal: 0.035–0.05 mg
5. TARGET SPECIES
Chickens
6. INDICATION(S)
Vaccine against necr
HDRAWAL PERIOD
awal period: Zero days
9. SPECIAL WARNING(S), IF NECESSARY
Accidental injection is dangerous – read package leaflet before use.
10. EXPIRY DATE
EXP month/year
Once opened, use within 8 hours
-
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2°C- 8°C). Do not freeze
Protect from light
PRODUCTS OR
-
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL WASTE MATERIALS, IF ANY
-
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
To be supplied only on veterinary prescri
-
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
-
15. NAME AND ADD R ESS OF THE MARKETING AUTHORISATION HOLDER
Intervet International B.V
Wim de Korverstraat 35 5831AN Boxmeer The Netherlands
16.
NG AUTHORISATION NUMBER(S)
EU/2/
PACKAGE LEAFLET FOR
RODUCT
ANCE(S) AND OTHER INGREDIENT(S)
OF
CH
Netvax emulsion for injection for chickens
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDE THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE F RELEASE, IF DIFFERENT
Marketing authorisation holder :
Intervet International B.V.
Wim de Körverstraat 35 5831AN Boxmeer The Netherlands
Manufacturer for the batch release:
S-P Veterinary Ltd Breakspear Road South Harefield
Uxbridge
Middlesex, UB9 6LS United Kingdom
2. NAME OF THE VETERINARY MEDIC
Netvax emulsion for injection for chickens
3. STATEMENT OF THE ACTIV
One dose (0.5ml) contains:
Active substance: Clostridium perfringens Ty
Adjuvant
Light Mineral Oil Excipients Thiomersal
ha toxoid Not less than 6.8 IU
0.31 ml
0.035–0.05 mg
International units per ml of rabbit serum determined by haemolysis inhibition assay
For the act their prog
4. INDIC
nization of chickens to provide passive immunisation against necrotic enteritis to ing the laying period.
To reduce mortality and the incidence and severity of lesions caused by Clostridium perfringens Type A induced necrotic enteritis. Efficacy was demonstrated by challenge of chicks approximately three er hatching.
The onset of passive transfer of immunity: 6 weeks following completion of the vaccination procedu
The duration of passive transfer of immunity: 51 weeks following completion of the vaccination procedure
5. CONTRAINDICATIONS
None
6. ADVERSE REACTIONS
No systemic reactions to vaccination were seen following intramuscular vaccination. Vaccination may result in moderate swelling of the breast tissue which will resolve within 30 days. Following the second vaccination swelling may persist for at least 35 days. Swellingry common. After administration of a double dose, local reactions may increase sli
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
7. TARGET SPECIES
Chickens
8. DOSAGE FOR EACH SPECIES,
Vaccinate chickens by the intramuscular route in
One dose of 0.5 ml should be
D METHOD OF ADMINISTRATION
e breast.
given at 10 to 14 weeks of age.
A second dose of 0.5 ml should be administered 4 to 10 weeks after the first vaccination. The second dose should be administered no later than 6 weeks before the onset of lay.
9. ADVICE ON CORREC
ISTRATION
Shake well before use.
Syringes and needles must
e before use. Follow usual aseptic procedures.
10. WITHDRAWAL PERIOD
Zero days
11. SPE
ORAGE PRECAUTIONS
Keep oureach and sight of children.
Store ansport refrigerated (2°C- 8°C). Do not freeze.
Protect from light.
Do not use after the expiry date stated on the carton.
Shelf-life after first opening the immediate packaging: 8 hours
-
12. SPECIAL WARNING(S)
Special precautions to be taken by the person administering the veterinary medicinal prod animals
To the user:
This product contains mineral oil. Accidental injection/self injection may result in se swelling, particularly if injected into a joint or finger, and in rare cases could result affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt medical advice ev small amount is injected and take the package leaflet with you.
in and of the
nly a very
If pain persists for more than 12 hours after medical examination, seek medical
gain.
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
-
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
14. DATE ON WHICH THE PAC
15. OTHER INFORMATI
AFLET WAS LAST APPROVED
Any unused veterinary medicinal product or wa products should be disposed of in accordance
als derived from such veterinary medicinal ional requirements.
-
D. STATEMENT OF THE MRLs .
Pharmacologically active substance(s)
Animal species
Other provisions j
Thiomersal
All food producing species
Annex II of Council Regulation (E EC) No. 2377/90
EDTA
All food producing species
Annex II of Council^RegU|qtion (EEC) No. 2377/90
Formaldehyde
All food producing species
Annex II of Council Regulation (EEC) No. 2377/90
Mineral oil
All food producing species
Annex II of Council Regulation (EEC) No. 2377/90 W
Benzyl alcohol
All food producing species
Annex II of Council Regulation (EEC) No. 2377/90
Triethanolamine (at doses up to 0.25 mg/kg bw) is considered not within the scope of Council Regulation (EEC) No. 2377/90.
Carton
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
* International units per ml of rabbit serum determined by haemolysis i
3. PHARMACEUTICAL FORM
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Netvax
Emulsion for injection for chickens
4. PACKAGE SIZE
7. METH
5. TARGET SPECIES
1 × 500ml
6 × 500ml
ROUTE(S) OF ADMINISTRATION
THDRAWAL PERIOD
Intramuscular use.
Shake well before use. Read the package leaflet before use
Per dose of 0.5ml:
Clostridium perfringens Type A alpha toxoid: > 6.8 IU*
Light mineral oil: 0.31 ml
Thiomersal: 0.035–0.05 mg
Chickens
6. INDICATIONS
Vaccine against necro
awal period: Zero days
9. SPECIAL WARNING(S), IF NECESSARY
Accidental injection is dangerous – read package leaflet before use.
10. EXPIRY DATE
EXP month/year
Once opened, use within 8 hours
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2°C- 8°C). Do not freeze Protect from light
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF WASTE MATERIALS, IF ANY
Disposal: read package leaflet
13. THE WORDS “FOR ANIMAL TREATM
RESTRICTIONS REGARDING SUPPLY
For animal treatment only.
To be supplied only on veterinary prescription.
15. NAME AND ADDR
Intervet International B Wim de Korverstraat 5831AN Boxmeer The Netherlands
Keep out of the reach and sight
14. THE WORDS “KEEP OUT
16. MA
EU/2/09 EU/2/
PRODUCTS OR
ONLY” AND CONDITIONS OR
) USE, if applicable
REACH AND SIGHT OF CHILDREN
THE MARKETING AUTHORISATION HOLDER
G AUTHORISATION NUMBER(S)
Label
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
* International units per ml of rabbit serum determined by haemolysi
3. PHARMACEUTICAL FORM
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Netvax
Emulsion for injection for chickens
4. PACKAGE SIZE
7. METH
1 × 500ml
6 × 500ml
ROUTE(S) OF ADMINISTRATION
Intramuscular use.
Shake wore use. Read the package leaflet before use
Per dose of 0.5ml:
Clostridium perfringens Type A alpha toxoid: > 6.8 IU*
Light mineral oil: 0.31 ml
Thiomersal: 0.035–0.05 mg
5. TARGET SPECIES
Chickens
6. INDICATION(S)
Vaccine against necr
HDRAWAL PERIOD
awal period: Zero days
9. SPECIAL WARNING(S), IF NECESSARY
Accidental injection is dangerous – read package leaflet before use.
10. EXPIRY DATE
EXP month/year
Once opened, use within 8 hours
-
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2°C- 8°C). Do not freeze
Protect from light
PRODUCTS OR
-
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL WASTE MATERIALS, IF ANY
-
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
To be supplied only on veterinary prescri
-
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
-
15. NAME AND ADD R ESS OF THE MARKETING AUTHORISATION HOLDER
Intervet International B.V
Wim de Korverstraat 35 5831AN Boxmeer The Netherlands
16.
NG AUTHORISATION NUMBER(S)
EU/2/
PACKAGE LEAFLET FOR
RODUCT
ANCE(S) AND OTHER INGREDIENT(S)
OF
CH
Netvax emulsion for injection for chickens
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDE THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE F RELEASE, IF DIFFERENT
Marketing authorisation holder :
Intervet International B.V.
Wim de Körverstraat 35 5831AN Boxmeer The Netherlands
Manufacturer for the batch release:
S-P Veterinary Ltd Breakspear Road South Harefield
Uxbridge
Middlesex, UB9 6LS United Kingdom
2. NAME OF THE VETERINARY MEDIC
Netvax emulsion for injection for chickens
3. STATEMENT OF THE ACTIV
One dose (0.5ml) contains:
Active substance: Clostridium perfringens Ty
Adjuvant
Light Mineral Oil Excipients Thiomersal
ha toxoid Not less than 6.8 IU
0.31 ml
0.035–0.05 mg
International units per ml of rabbit serum determined by haemolysis inhibition assay
For the act their prog
4. INDIC
nization of chickens to provide passive immunisation against necrotic enteritis to ing the laying period.
To reduce mortality and the incidence and severity of lesions caused by Clostridium perfringens Type A induced necrotic enteritis. Efficacy was demonstrated by challenge of chicks approximately three er hatching.
The onset of passive transfer of immunity: 6 weeks following completion of the vaccination procedu
The duration of passive transfer of immunity: 51 weeks following completion of the vaccination procedure
5. CONTRAINDICATIONS
None
6. ADVERSE REACTIONS
No systemic reactions to vaccination were seen following intramuscular vaccination. Vaccination may result in moderate swelling of the breast tissue which will resolve within 30 days. Following the second vaccination swelling may persist for at least 35 days. Swellingry common. After administration of a double dose, local reactions may increase sli
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
7. TARGET SPECIES
Chickens
8. DOSAGE FOR EACH SPECIES,
Vaccinate chickens by the intramuscular route in
One dose of 0.5 ml should be
D METHOD OF ADMINISTRATION
e breast.
given at 10 to 14 weeks of age.
A second dose of 0.5 ml should be administered 4 to 10 weeks after the first vaccination. The second dose should be administered no later than 6 weeks before the onset of lay.
9. ADVICE ON CORREC
ISTRATION
Shake well before use.
Syringes and needles must
e before use. Follow usual aseptic procedures.
10. WITHDRAWAL PERIOD
Zero days
11. SPE
ORAGE PRECAUTIONS
Keep oureach and sight of children.
Store ansport refrigerated (2°C- 8°C). Do not freeze.
Protect from light.
Do not use after the expiry date stated on the carton.
Shelf-life after first opening the immediate packaging: 8 hours
-
12. SPECIAL WARNING(S)
Special precautions to be taken by the person administering the veterinary medicinal prod animals
To the user:
This product contains mineral oil. Accidental injection/self injection may result in se swelling, particularly if injected into a joint or finger, and in rare cases could result affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt medical advice ev small amount is injected and take the package leaflet with you.
in and of the
nly a very
If pain persists for more than 12 hours after medical examination, seek medical
gain.
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
-
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
14. DATE ON WHICH THE PAC
15. OTHER INFORMATI
AFLET WAS LAST APPROVED
Any unused veterinary medicinal product or wa products should be disposed of in accordance
als derived from such veterinary medicinal ional requirements.