ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
RHINISENG Suspension for injection for pigs.
2.
Each dose of 2 ml contains:
Active substances:
Inactivated
Bordetella bronchiseptica,
strain 833CER:.........................................9.8 BbCC(*)
Recombinant Type D
Pasteurella multocida
toxin (PMTr): .............................≥
1 MED
63
(**)
(*)
Bordetella bronchiseptica
Cell Count in log
10
.
(**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a 5-fold diluted vaccine by
subcutaneous route induces seroconversion in at least 63% of the animals.
Adjuvants:
Aluminium hydroxide gel .......................................................................... 6.4 mg (aluminium)
DEAE-Dextran
Ginseng
Excipient:
Formaldehyde.................................................................................................................. 0.8 mg
For a full list of excipients, see section 6.1.
3.
Suspension for injection.
4.
4.1
Sows and gilts.
4.2
For the passive protection of piglets via colostrum after active immunisation of sows and gilts to
reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as
to reduce weight loss associated with
Bordetella bronchiseptica
and
Pasteurella multocida
infections during the fattening period.
Challenge studies have demonstrated that passive immunity lasts until piglets are 6 weeks of age
while in clinical field trials, the beneficial effects of vaccination (reduction in nasal lesion score and
weight loss) are observed until slaughter.
4.3
Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the
excipients.
2
4.4
None.
4.5
Vaccinate only healthy animals
Special precautions to be taken by the person administering the veterinary medicinal product
to animals
In case of accidental self-injection only a minor injection site reaction is expected.
Transient local reactions may occur after the administration of one dose of vaccine. A transient
slight swelling of less than 2 to 3 cm in diameter is common at the injection site which may last up
to five days and occasionally up to two weeks.
A transient increase in body temperature of about 0.7°C is common during the first 6 hours after
injection. An increase of rectal temperature up to 1.5ºC may occur. This rectal temperature increase
is spontaneously resolved within 24 hours without treatment.
Can be used during pregnancy.
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.
4.9
Intramuscular use.
Allow the vaccine to reach room temperature (15-25˚C) before administration.
Shake well before use.
Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the
following schedule:
Basic vaccination:
sows and gilts which have not been previously vaccinated with the product
should be given two injections with an interval of 3-4 weeks. The first injection should be
administered 6-8 weeks before the expected date of farrowing.
Revaccination:
a single injection should be given 3-4 weeks prior to each subsequent farrowing.
No adverse reactions other than already mentioned under point 4.6 can be expected, except for an
increase of rectal temperature up to 2ºC. This rectal temperature increase is spontaneously resolved
within 24 hours without treatment.
3
Discoloration of muscular fibres of the inoculation site (0.5 cm wide x 2 cm long) may be observed
at necropsy in 10% of animals. This discoloration is attributable to aluminium hydroxide and may
be observed up to seven weeks after the injection of a double dose of vaccine.
4.11 Withdrawalperiod
Zero days.
5.
Pharmacotherapeutic group: Inactivated bacterial vaccines (Bordetella and Pasteurella) for pigs
ATCvet code: QI09AB04.
To stimulate active immunity in order to provide passive immunity to the progeny against atrophic
rhinitis associated with
Bordetella bronchiseptica
and
Pasteurella multocida
infections.
6.
6.1 List of excipients
Aluminium hydroxide
DEAE-dextran
Ginseng
Formaldehyde
Simethicone
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Sodium chloride
Potassium chloride
Water for injections
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 10 hours stored at room temperature.
6.4. Special precautions for storage
Store and transport refrigerated (2 C to 8 C)
Protect from light.
Do not freeze.
6.5 Nature and composition of immediate packaging
Type I colourless glass vials of 20 ml
Type II colourless glass vials of 50 ml and 100 ml
The vials are closed with a rubber stopper and aluminium cap.
20 ml, 50 ml, 100 ml and 250 ml Polyethylene (PET) bottles closed with a rubber stopper and
aluminium cap.
4
Pack sizes:
- Cardboard box with 1 or 10 glass vials of 10 doses.
- Cardboard box with 1 glass vial of 25 doses.
- Cardboard box with 1 glass vial of 50 doses.
- Cardboard box with 1 or 10 PET bottles of 10 doses.
- Cardboard box with 1 PET bottle of 25 doses.
- Cardboard box with 1 PET bottle of 50 doses.
- Cardboard box with 1 PET bottle of 125 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.
EU/2/10/109/001-009
9.
16/09/2010
10
16/09/2010
Detailed information on this veterinary medicinal product is available on the website of the
European Medicines Agency
http://www.ema.europa.eu
/
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
The import, sale, supply and/or use of Rhiniseng is or may be prohibited in certain Member States
on the whole or part of their territory pursuant to national animal health policy. Any person
intending to import, sell, supply and/or use Rhiniseng must consult the relevant Member State’s
competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
5
ANNEX II
A.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
MANUFACTURING AUTHORISATION HOLDER 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 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 leaflet 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 THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D.
STATEMENT OF THE MRLs
The active substances being principles of biological origin intended to produce active immunity are
not in the scope of Regulation (EC) 470/2009.
The following constituent of RHINISENG Suspension for injection for pigs are included in Table
1 of the Annex to Commission Regulation (EU) No 37/2010 as follows:
Pharmacologi
-
cally active
substance
Marker
residue
Animal
species
MRL
Target
tissues
Other provisions
Therapeutic
classification
Aluminium
hydroxide
N/a
All food
producing
species
No MRL
required.
Not
applica
ble
No entry
No entry
Ginseng
(standardised
extracts and
preparations
thereof)
N/a
All food
producing
species
No MRL
required.
Not
applica
ble
No entry
No entry
Formaldehyde
N/a
No MRL
required.
Not
applica
ble
No entry
No entry
7
Simethicone
(dimethicone)
N/a
All food
producing
species
No MRL
required.
Not
applica
ble
No entry
No entry
Disodium
phosphate
dodecahydrate
covered by
entry for food
additives with
an E number
(E339)
N/a
All food
producing
species
No MRL
required
N/a
Only substances approved
as additives in foodstuffs
for human consumption,
with the exception of
preservatives listed in part
C of Annex III to European
Parliament and Council
Directive 95/2/EC
No entry
Potassium
dihydrogen
phosphate -
covered by entry
for food
additives with
an E number
(E340i)
N/a
All food
producing
species
No MRL
required
N/a
Only substances approved
as additives in foodstuffs
for human consumption,
with the exception of
preservatives listed in part
C of Annex III to European
Parliament and Council
Directive 95/2/EC
No entry
All food
producing
species
Sodium chloride
N/a
No MRL
required.
N/a
No entry
No entry
Potassium
chloride -
covered by
entry for food
additives with
an E number
(E508)
N/a
All food
producing
species
No MRL
required
N/a
Only substances approved
as additives in foodstuffs
for human consumption,
with the exception of
preservatives listed in part
C of Annex III to European
Parliament and Council
Directive 95/2/EC
No entry
In addition to the above constituents the product contains the following excipients: DEAE-dextran
and water for injection. These excipients are considered as not falling within the scope of
Regulation (EC) No 470/2009.
8
ANNEX III
LABELLING AND PACKAGE LEAFLET
9
A. LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
{CARDBOARD BOX }
1.
RHINISENG Suspension for injection for pigs.
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Per dose of 2 ml:
Inactivated
Bordetella bronchiseptica,
strain 833CER:.........................................9.8 BbCC(*)
Recombinant Type D
Pasteurella multocida
toxin (PMTr): .............................≥
1 MED
63
(**)
(*)
Bordetella bronchiseptica
Cell Count in log
10
.
(**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a 5-fold diluted vaccine by
subcutaneous route induces seroconversion in at least 63 % of the animals.
Aluminium hydroxide gel .......................................................................... 6.4 mg (aluminium)
DEAE-Dextran
Ginseng
Formaldehyde.................................................................................................................. 0.8 mg
3.
Suspension for injection.
4.
PACKAGE SIZE
1 vial of 10 doses (20 ml)
10 vials of 10 doses (20 ml)
1 vial of 25 doses (50 ml)
1 vial of 50 doses (100 ml)
1 bottle of 125 doses (250 ml)
1 bottle of 10 doses (20ml)
10 bottles of 10 doses (20 ml)
1 bottle of 25 doses (50 ml)
1 bottle of 50 doses (100 ml)
5.
Sows and gilts.
6.
INDICATIONS
For the passive protection of piglets via colostrum after active immunisation of sows and gilts to
reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as
to reduce weight loss associated with
Bordetella bronchiseptica
and
Pasteurella multocida
infections during the fattening period.
Challenge studies have demonstrated that passive immunity lasts until piglets are 6 weeks of age
while in clinical field trials, the beneficial effects of vaccination (reduction in nasal lesion score and
weight loss) are observed until slaughter.
11
7.
METHOD AND ROUTE OF ADMINISTRATION
Intramuscular use.
Read the package leaflet before use.
8.
Withdrawal period:
Zero days.
9.
SPECIAL WARNINGS, IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Once opened, use within a 10 hours stored at 15ºC to 25ºC.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated
Protect 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.
12
LABORATORIOS HIPRA, S.A.
Avda. la Selva, 135
17170 Amer (Girona)
SPAIN
EU/2/10/109/001-009
17. MANUFACTURER’S BATCH NUMBER
Batch {number}
13
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
{BOTTLE AND VIAL LABEL}
1.
RHINISENG Suspension for injection for pigs.
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
One dose of 2 ml contains:
Inactivated
Bordetella bronchiseptica,
strain 833CER:.........................................9.8 BbCC(*)
Recombinant Type D
Pasteurella multocida
toxin (PMTr): .............................≥
1 MED
63
(**)
(*)
Bordetella bronchiseptica
Cell Count in log
10
.
(**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a 5-fold diluted vaccine by
subcutaneous route induces seroconversion in at least 63% of the animals.
Aluminium hydroxide gel .......................................................................... 6.4 mg (aluminium)
DEAE-Dextran
Ginseng
Formaldehyde.................................................................................................................. 0.8 mg
3.
Suspension for injection.
4.
PACKAGE SIZE
50 doses (100 ml)
50 doses (100 ml) (bottle)
125 doses (250 ml) (bottle)
5.
Sows and gilts.
6.
INDICATIONS
For the passive protection of piglets via colostrum after active immunisation of sows and gilts to
reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as
to reduce weight loss associated with
Bordetella bronchiseptica
and
Pasteurella multocida
infections during the fattening period.
Challenge studies have demonstrated that passive immunity lasts until piglets are 6 weeks of age
while in clinical field trials, the beneficial effects of vaccination (reduction in nasal lesion score and
weight loss) are observed until slaughter.
14
7.
METHOD AND ROUTE OF ADMINISTRATION
Intramuscular use.
Read the package leaflet before use.
8.
Withdrawal period:
Zero days.
9.
SPECIAL WARNINGS, IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/yyyy}
Once opened, use within a 10-hour period, stored at 15 ºC to 25 ºC.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated
Protect from light.
Do not freeze.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
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 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
15
EU/2/10/109/004
EU/2/10/109/008
EU/2/10/109/009
17. MANUFACTURER’S BATCH NUMBER
Batch{number}
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{LABEL}
1.
RHINISENG Suspension for injection for pigs.
2.
QUANTITY OF THE ACTIVE SUBSTANCES
One dose contains:
Inactivated
Bordetella bronchiseptica,
strain 833CER: ............................................. 9.8 BbCC
Recombinant Type D
Pasteurella multocida
toxin (PMTr): ................................... ≥
1 MED
63
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 doses (20 ml)
25 doses (50 ml)
4.
ROUTE 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 ºC to 25 ºC.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET FOR
RHINISENG Suspension for injection for pigs
1.
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.
RHINISENG Suspension for injection for pigs.
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Each dose of 2 ml contains:
Inactivated
Bordetella bronchiseptica,
strain 833CER: .........................................9.8 BbCC(*)
Recombinant Type D
Pasteurella multocida
toxin (PMTr): .............................≥
1 MED
63
(**)
(*)
Bordetella bronchiseptica
Cell Count in log
10
.
(**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a 5-fold diluted vaccine by
subcutaneous route induces seroconversion in at least 63 % of the animals.
Aluminium hydroxide gel .......................................................................... 6.4 mg (aluminium)
DEAE-Dextran
Ginseng
Formaldehyde.................................................................................................................. 0.8 mg
4.
INDICATIONS
For passive protection of piglets via colostrum after active immunisation of sows and gilts to reduce
the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as to reduce
weight loss associated with
Bordetella bronchiseptica
and
Pasteurella multocida
infections during the
fattening period.
Challenge studies have demonstrated that passive immunity lasts until piglets are 6 weeks of age while
in clinical field trials, the beneficial effects of vaccination (reduction in nasal lesion score and weight
loss) are observed until slaughter.
5.
Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the
excipients.
19
6.
Transient local reactions may occur after the administration of one dose of vaccine. A transient slight
swelling of less than 2 to 3 cm in diameter is common at the injection site which may last up to five
days and occasionally up to two weeks.
A transient increase in body temperature of about 0.7°C is common during the first 6 hours after
injection. An increase of rectal temperature up to 1.5ºC may occur. This rectal temperature increase is
spontaneously resolved within 24 hours without treatment.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform
your veterinary surgeon.
7.
Sows and gilts
8.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Intramuscular use.
Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following
schedule:
Basic vaccination:
sows and gilts which have not been previously vaccinated with the product should
be given two injections with an interval of 3-4 weeks. The first injection should be administered 6-8
weeks before the expected date of farrowing.
Revaccination:
a single injection should be given 3-4 weeks prior to each subsequent farrowing.
9.
ADVICE ON CORRECT ADMINISTRATION
Allow the vaccine to reach room temperature (15-25˚C) before administration.
Shake well 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 C to 8 C)
Protect 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 at 15 ºC to 25 ºC.
20
12. SPECIAL WARNING(S)
Only healthy animals should be vaccinated.
Can be used during pregnancy.
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.
No adverse reactions other than already mentioned under point 6 can be expected, except for an
increase of rectal temperature up to 2ºC. This rectal temperature increase is spontaneously resolved
within 24 hours without treatment.
Discoloration of muscular fibres of the inoculation site (0.5 cm wide x 2 cm long) may be observed at
necropsy in 10% of animals. This discoloration is attributable to aluminium hydroxide and may be
observed up to seven weeks after the injection of a double dose of vaccine.
Do not mix with any other veterinary medicinal product.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
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
16/09/2010
Detailed information on this product is available on the website of the European Medicines Agency
15. OTHER INFORMATION
Pack sizes:
- Cardboard box with 1 or 10 glass vials of 10 doses.
- Cardboard box with 1 glass vial of 25 doses.
- Cardboard box with 1 glass vial of 50 doses.
- Cardboard box with 1 or 10 PET bottles of 10 doses.
- Cardboard box with 1 PET bottle of 25 doses.
- Cardboard box with 1 PET bottle of 50 doses.
- Cardboard box with 1 PET bottle of 125 doses.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the
marketing authorisation holder.
21
Deutschland
HIPRA DEUTSCHLAND GmbH
Feldstrasse 21
D-40479 Düsseldorf - DEUTSCHLAND
e-mail: deutschland@hipra.com
Ελλάδα
HIPRA EΛΛAΣ A.E.
Ψuχάρη 3 / 184 53 Níκαια - ΕΛΛΑΣ
Tηλ: 210 4978660 - Fax: 210 4978661
e-mail:
greece@hipra.com
España
LABORATORIOS HIPRA, S.A.
Avda la Selva, 135
17170 Amer (Girona)
SPAIN
Polska
HIPRA POLSKA Sp.z.o.o.
Ul. Królowej Marysienki, 9 - 1
02-954 – WARSZAWA - POLSKA
e-mail:
polska@hipra.com
France
HIPRA FRANCE
1103 Avenue Jacques Cartier
44800 - SAINT HERBLAIN - FRANCE
Tél. - 02 51 80 77 91 Fax - 02 51 80 82 20
e-mail: france@hipra.com
Portugal
ARBUSET, Produtos Farmacêuticos e Sanitários
De Uso Animal, Lda
Portela de Mafra e Fontaínha - Abrunheira
2665 – 191 Malveira - PORTUGAL
e-mail:
portugal@hipra.com
United Kingdom
HIPRA UK, Ltd.
Innovation Center, Office 503
BioCity Nottingham
Pennyfoot Street
Nottingham
NG1 1GF - UNITED KINGDOM
e-mail: uk@hipra.com
22
Source: European Medicines Agency
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