ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
STARTVAC
Emulsion for injection for cattle
2.
One dose (2 ml) contains:
Active substances:
Escherichia coli
J5 inactivated............................................................................ > 50 RED
60
*
Staphylococcus aureus
(CP8) strain SP 140 inactivated, expressing Slime Associated
Antigenic Complex (SAAC) ..........…………………………………………… > 50 RED
80
**
* RED
60
: Rabbit effective dose in 60 % of the animals (serology).
** RED
80
: Rabbit effective dose in 80 % of the animals (serology).
Adjuvant:
Liquid paraffin.............................................................................. 18.2 mg
Excipient:
Benzyl alcohol…………….......................................................... 21 mg
For a full list of excipients, see section 6.1.
3.
Emulsion for injection.
4.
4.1
Cattle (cows and heifers).
4.2
For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis
problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the
clinical signs of clinical mastitis caused by
Staphylococcus aureus
, coliforms and coagulase-negative
staphylococci.
The full immunisation scheme induces immunity from approximately day 13 after the first injection
until approximately day 78 after the third injection (equivalent to 130 days post-parturition).
4.3
None.
2
4.4
The whole herd should be immunised.
Immunisation has to be considered as one component in a complex mastitis control program that
addresses all important udder health factors (e.g. milking technique, dry-off and breeding
management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality, health
monitoring) and other management practices.
4.5
Only healthy animals should be immunised.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
To the user:
This product contains mineral oil. Accidental injection/self injection may result in severe pain and
swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the
affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt medical advice even if only a very
small amount is injected and take the package leaflet with you.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
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.
4.6
Slight to moderate transient local reactions may occur after the administration of one dose of vaccine.
They would mainly be: swelling (up to 5 cm
2
on average), which disappears within 1 or 2 weeks at
most. In some cases, there may also be pain at the inoculation site that spontaneously subsides in a
maximum of 4 days.
A mean transient increase in body temperature of about 1°C, in some cows up to 2°C, may occur in
the first 24 hours after injection.
4.7 Use during pregnancy or lactation
Can be used during pregnancy and lactation.
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.
3
4.9
Intramuscular use. The injections should be preferably administered on the alternate sides of the neck.
Allow the vaccine to reach a temperature of +15 to + 25
°
C before administration. Shake before use.
Administer one dose (2 ml) by deep intramuscular injection in the neck muscles and according to the
following schedule:
-
First injection at 45 days before the expected parturition date.
-
Second injection 35 days thereafter (corresponding to 10 days before the expected parturition
date).
-
Third injection 62 days after the second injection (equivalent to 52 days post-parturition).
The full immunisation program should be repeated with each gestation.
No adverse reactions other than those mentioned in section 4.6. were observed after the administration
of a double dose of vaccine.
Zero days.
5.
To stimulate active immunity against
Staphylococcus aureus
, coliforms and coagulase-negative
staphylococci.
ATCvet code: QI02 AB (Inactivated bacterial vaccines for bovidae).
6.
6.1
List of excipients
Benzyl alcohol
Liquid paraffin
Sorbitan monooleate
Polysorbate 80
Sodium alginate
Calcium chloride, dihydrate
Simeticone
Water for injections
6.2 Incompatibilities
Do not mix with any other vaccine or immunological product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Shelf life after first opening the immediate packaging: 10 hours stored at +15 to +25 ºC.
4
6.4. Specialprecautionsforstorage
Store and transport refrigerated (2 to 8
°
C) and protected from light.
Do not freeze.
6.5 Nature and composition of immediate packaging
3 ml, 10 ml and 50 ml Type I colourless glass vials, closed with rubber stoppers and aluminium caps.
Pack sizes
:
- Cardboard box with 1, 10 and 20 vials of 1 dose.
- Cardboard box with 1 and 10 vials of 5 doses.
- Cardboard box with 1 and 10 vials of 25 doses
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
LABORATORIOS HIPRA, S.A.
Avda. La Selva, 135
17170- AMER (Girona)
SPAIN
Tel. +34 972 430660
Fax. +34 972 430661
E-mail: hipra@hipra.com
8.
9.
DD/MM/YYYY
10.
MM/YYYY
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMA)
http://www.ema.europa.eu
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
5
ANNEX II
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCEs AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
BATCH RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
WITH REGARD TO SAFE AND EFFECTIVE USE
D. STATEMENT OF THE MRLs
6
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substances
Laboratorios Hipra, S.A.
Avda. La Selva, 135
17170 Amer (Girona)
Spain
Name and address of the manufacturer responsible for batch release
Laboratorios Hipra S.A.
Avda. La Selva, 135
17170 Amer (Girona)
Spain
The printed package insert of the medicinal product must state the name and address of the
manufacturer responsible for the release of the concerned batch.
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
The holder of this marketing authorisation must inform the European Commission about the marketing
plans for the medicinal product authorised by this decision.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO SAFE AND EFFECTIVE USE
Not applicable
D. STATEMENT OF THE MRLs
which are be accepted in accordance with Council Regulation (EEC) No 2377/90 and in accordance
with Article 31 (3b) of Council Regulation (EEC) No 2309/93 of 22 July 1993, as amended.
Pharmacologically active
substances
Animal Species
Other provisions
Benzyl alcohol
Annex II for all food
producing species
Council Regulation (EEC) No 1442/95. For
use as excipient.
Liquid paraffin
Annex II for all food
producing species
Mineral hydrocarbons, low to high viscosity
including microcrystalline waxes,
approximately C10-C60; aliphatic, branched
aliphatic and alicyclic compounds. CR No
2804/95.
7
Sorbitan monooleate
Annex II for all food
producing species
Approved food additive (E494). CR No
2034/96
Polysorbate 80
Annex II for all food
producing species
CR No. 2796/95
Sodium alginate
Annex II for all food
producing species
Approved food additive (E401). CR No
2034/96
Calcium chloride,
dihydrate
A
nnex II for all food
producing species
Council Regulation (EEC) No 1102/95
Simeticone
(dimethicone)
Annex II for all food
producing species
Council Regulation (EEC) No 2796/95
8
ANNEX III
LABELLING AND PACKAGE LEAFLET
9
A. LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
{CARDBOARD BOXES}
1.
STARTVAC
Emulsion for injection for cattle
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
One dose (2 ml) contains:
E. coli
J5 inactivated > 50 RED
60
(Rabbit effective dose in 60 % of the animals (serology)).
S. aureus
(CP8) strain SP140 inactivated, expressing Slime Associated Antigenic Complex (SAAC) >
50 RED
80
(In 80 % of the animals).
Liquid paraffin: 18.2 mg
Benzyl alcohol: 21 mg
3.
Emulsion for injection.
4.
PACKAGE SIZE
1 vial of 1 dose (2ml)
10 vials of 1 dose (2 ml)
20 vials of 1 dose (2 ml)
1 vial of 5 doses (10 ml)
10 vials of 5 doses (10 ml)
1 vial of 25 doses (50 ml)
10 vials of 25 doses (50 ml)
5.
Cattle (cows and heifers).
6.
For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis
problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the
clinical signs of clinical mastitis caused by
Staphylococcus aureus
,
coliforms
and coagulase-negative
staphylococci.
The full immunisation scheme induces immunity from approximately day 13 after the first injection
until approximately day 78 after the third injection (equivalent to 130 days post-parturition).
11
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular use.
Read the package leaflet before use.
8.
Withdrawal period: Zero days.
9.
SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP {month/yyyy}
Once opened, use within a 10-hour period, stored at +15 to + 25 ºC.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (+2 to +8
°
C) and protected from light.
Do not freeze.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
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 prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
LABORATORIOS HIPRA, S.A.
Avda. La Selva, 135
17170- AMER (Girona)
SPAIN
12
EU/0/00/000/000
17. MANUFACTURER’S BATCH NUMBER
Batch{number}
13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{LABEL OF 1 DOSE VIAL}
1.
STARTVAC
Emulsion for injection.
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
One dose contains:
E.coli
J5 inactivated;
S.aureus
CP8 strain SP140 inactivated; Liquid paraffin; Benzyl alcohol.
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
1 dose (2 ml)
4.
ROUTE(S) OF ADMINISTRATION
Intramuscular use.
5.
Withdrawal period: Zero days.
6.
BATCH NUMBER
Batch {number}
7.
EXPIRY DATE
EXP {month/yyyy}
Once opened, use within a 10-hour period, stored at +15 to + 25 ºC.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
14
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{LABEL OF 5 DOSES VIAL}
1.
STARTVAC
Emulsion for injection.
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
One dose (2 ml) contains:
E.coli
J5 inactivated > 50 RED
60
S. aureus
CP8 strain SP140 inactivated > 50 RED
80
Liquid paraffin: 18.2 mg
Benzyl alcohol: 21 mg
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
5 doses (10 ml)
4.
ROUTE(S) OF ADMINISTRATION
Intramuscular use.
5.
Withdrawal period: Zero days.
6.
BATCH NUMBER
Batch {number}
7.
EXPIRY DATE
EXP {month/yyyy}
Once opened, use within a 10-hour period, stored at +15 to + 25 ºC.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
15
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{LABEL OF 25 DOSES VIAL}
1.
STARTVAC
Emulsion for injection.
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
One dose (2 ml) contains:
E.coli
J5 inactivated > 50 RED
60
*
S. aureus
CP8 strain SP140 inactivated, expressing SAAC > 50 RED
80
*
* RED: Rabbit effective dose in 60 % or in 80 % of the animals (serology).
Liquid paraffin: 18.2 mg
Benzyl alcohol: 21 mg
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
25 doses (50 ml)
4.
ROUTE(S) OF ADMINISTRATION
Intramuscular use.
5.
Withdrawal period: Zero days.
6.
BATCH NUMBER
Batch {number}
7.
EXPIRY DATE
EXP {month/yyyy}
Once opened, use within a 10-hour period, stored at +15 to + 25 ºC.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET
STARTVAC
Emulsion for injection for cows and heifers
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer:
LABORATORIOS HIPRA, S.A.
Avda. La Selva, 135
17170- AMER (Girona)
SPAIN
2.
STARTVAC
emulsion for injection for cattle
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Escherichia coli
(J5) inactivated ......................................................................... > 50 RED
60
*
Staphylococcus aureus
(CP8) strain SP 140 inactivated, expressing Slime Associated Antigenic
Complex (SAAC) ............................................................................................... > 50 RED
80
**
* RED
60
: Rabbit effective dose in 60 % of the animals (serology).
** RED
80
: Rabbit effective dose in 80 % of the animals (serology).
Liquid paraffin: 18.2 mg
Benzyl alcohol: 21 mg
STARTVAC is an ivory-coloured homogeneous emulsion for injection.
4.
For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis
problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the
clinical signs of clinical mastitis caused by
Staphylococcus aureus
, coliforms and coagulase-negative
staphylococci.
The full immunisation scheme induces immunity from approximately day 13 after the first injection
until approximately day 78 after the third injection (equivalent to 130 days post-parturition).
5.
None.
18/20
6.
Slight to moderate transient local reactions may occur after the administration of one dose of vaccine.
They would mainly be: swelling (up to 5 cm
2
on average), which disappears within 1 or 2 weeks at
most. In some cases, there may also be pain at the inoculation site that spontaneously subsides in a
maximum of 4 days.
A mean transient increase in body temperature of about 1°C, in some cows up to 2°C, may occur in
the first 24 hours after injection.
Animals immunised with an overdose did not show adverse reactions other than those observed after
the administration of one dose of vaccine.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Cattle (cows and heifers).
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Intramuscular use. The injections should be preferably administered on the alternate sides of the neck.
Administer one dose (2 ml) be deep intramuscular injection in the neck muscles and according to the
following schedule:
-
First injection at 45 days before the expected parturition date.
-
Second injection 35 days thereafter (corresponding to 10 days before the expected
parturition date).
-
Third injection 62 days after the second injection (equivalent to 52 days post-parturition).
The full immunisation program should be repeated with each gestation.
9.
ADVICE ON CORRECT ADMINISTRATION
Allow the vaccine to reach a temperature of +15 to + 25
°
C before administration. Shake before use.
10. WITHDRAWAL PERIOD
Zero days.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store and transport refrigerated (+2 to +8
°
C) and protected from light.
Do not freeze.
Do not use after the expiry date stated on the label.
Shelf life after first opening the immediate packaging: 10 hours stored +15 to +25 ºC.
19/20
12.
SPECIAL WARNING(S)
The whole herd should be immunised.
Immunisation has to be considered as one component in a complex mastitis control program that
addresses all important udder health factors (e.g. milking technique, dry-off and breeding
management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality, health
monitoring) and other management practices.
Only healthy animals should be immunised.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
To the user:
This product contains mineral oil. Accidental injection/self injection may result in severe pain and
swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the
affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt medical advice even if only a very
small amount is injected and take the package leaflet with you.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
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.
Can be used during pregnancy and lactation.
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.
Do not mix with any other vaccine or immunological product.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
15. OTHER INFORMATION
Pack sizes:
- Cardboard box with 1, 10 and 20 vials of 1 dose.
- Cardboard box with 1 and 10 vials of 5 doses.
- Cardboard box with 1 and 10 vials of 25 doses.
Not all pack sizes may be marketed.
20/20
Source: European Medicines Agency
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