NAFPENZAL DC VETERINARY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DIHYDROSTREPTOMYCIN SULFATE; NAFCILLIN AS NAFCILLIN SODIUM; PROCAINE BENZYLPENICILLIN

Available from:

INTERVET ( ISRAEL) LTD

Pharmaceutical form:

OINTMENT

Composition:

PROCAINE BENZYLPENICILLIN 300 MG / 3 G; DIHYDROSTREPTOMYCIN SULFATE 100 MG / 3 G; NAFCILLIN AS NAFCILLIN SODIUM 100 MG / 3 G

Administration route:

INTRAMAMMARY

Prescription type:

Required

Manufactured by:

INTERVET INTERNATIONAL B.V., NETHERLANDS

Therapeutic indications:

Treatment of mastitis in cows during the dry peirod caused by penicillin nafcillin and streptomycin sensitive microorganisms.

Authorization date:

2018-07-09

Patient Information leaflet

CONSUMER PACKAGE INSERT FOR VETERINARY MEDICINAL
PRODUCT
THE MEDICINE IS DISPENSED WITH A VETERINARIAN’S PRESCRIPTION ONLY
FOR USE IN ANIMALS ONLY
1.
NAME OF THE MEDICINE:
Nafpenzal DC Veterinary
Intramammary Ointment
2.
COMPOSITION:
Each 3 g syringe contains the following active ingredients:
Procaine benzylpenicillin 300 mg (300,000 I.U.)
Dihydrostreptomycin (as sulphate) 100 mg
Nafcillin (as sodium) 100 mg
A list of the inactive ingredients is detailed in section 13 –
“Further
information”.
3.
WHAT THE MEDICINE IS INTENDED FOR:
For treatment of cows during the dry period, for mastitis caused by
bacteria susceptible to penicillin, streptomycin or nafcillin.
Therapeutic
group:
A
combination
of
antibacterial
agents
for
intramammary use; combinations of procaine benzylpenicillin with other
antibacterial agents.
4.
CONTRAINDICATIONS:
Do
not
use
in
cases
of
hypersensitivity
to
penicillin,
nafcillin
or
dihydrostreptomycin, or to the inactive ingredients.
Do not use in lactating cows.
5.
SIDE EFFECTS:
In very rare cases (less than one animal in 10,000 animals, including
isolated
reports),
hypersensitivity
(allergic)
reactions
have
been
observed.
If you have noticed any serious effects or other effects not mentioned
in
this consumer leaflet, please inform your veterinarian.
Side effects can be reported to the Ministry of Health by clicking on
the
link “Reporting Side Effects due to Drug Treatment” found on the
Ministry
of Health homepage (www.health.gov.il), that directs you to the online
form
for
reporting
side
effects,
or
by
entering
the
link:
HTTP://SIDEEFFECTS.HEALTH.GOV.IL
6.
TARGET ANIMALS:
Cows during the dry period
7.
METHOD OF ADMINISTRATION AND DOSAGE:
An ointment for intramammary administration.
The content of one syringe is infused into each quarter of an udder
via
the teat canal when the cow is dried off at the end of the lactation
period.
8.
HOW TO USE THE MEDICINAL PRODUCT:
Before administration, milk the udder completely dry and thoroughly
clean the end of the teat. Break off the tip of the c

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nafpenzal DC Veterinary
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 g syringe contains:
ACTIVE SUBSTANCES:
Procaine benzylpenicillin 300 mg
Dihydrostreptomycin (as the sulfate) 100 mg
Nafcillin (as the sodium salt) 100 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Intramammary ointment.
White, to off-white ointment.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dry cows
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of mastitis in cows during the dry period caused by
penicillin, nafcillin and
streptomycin sensitive microorganisms.
_ _
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to penicillin, nafcillin or
dihydro-streptomycin, or to any of the
excipients listed in section 6.1.
Do not use in lactating animals.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not transfer the syringe from one teat to another.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Penicillin and cephalosporins may cause hypersensitivity (allergy)
following injection, inhalation, ingestion
or skin contact. Hypersensitivity to penicillin may lead to cross
reactions to cephalosporins and
_vice versa_
.
Allergic reactions to these substances are occasionally serious.
1.
Do not handle this product if you know you are sensitised or if you
have been advised not to work with
such preparations.
2.
Handle this product with great care to avoid exposure, taking all
recommended precautions.
3.
If you develop symptoms following exposure, such as a skin rash, you
should seek medical advice and
show the doctor this warning. Swelling of the face, lips or eyes or
difficulty with breathing are more
serious symptoms and require urgent medical attention.
4.
It is recommended to avoid contact with the active ingredient and to
use gloves.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
All