NEXGARD 68 MG VETERINARY
Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
Taarifa za kipeperushi
(PIL)
31-12-2023
Tabia za bidhaa
(SPC)
31-12-2023
Viambatanisho vya kazi:
AFOXOLANER
Inapatikana kutoka:
BEIT-EREZ HAVAT MILATIN LTD
Dawa fomu:
CHEWABLE TABLETS
Tungo:
AFOXOLANER 68 MG
Njia ya uendeshaji:
PER OS
Dawa ya aina:
Required
Viwandani na:
BOEHRINGER INGELHEIM VETMEDICA GMBH, GERMANY
Matibabu dalili:
Treatment of flea infestation in dogs (Ctenocephalides felis and C. canis) for at least 5 weeks. The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus). One treatment kills ticks for up to one month.Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.Treatment of demodicosis (caused by Demodex canis).Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
Idhini ya tarehe:
2022-04-30
Taarifa za kipeperushi
ҎҋҖҊҋ҅ҋҎҔҜҐҚ҄Ғ҆ Қ҇Ҕ҃ҙҋҊҖ҇ҙҚғҎқҜ҇Ҕҋ҄Ғ҃Ҏ҇ҖҋҊ
Ⴠ
ҎҔҚ҇҈҉Ҏқҋ
6DUFRSWHVVFDELHLYDUFDQLV
Ҝҋ҅Қҙ҄҇ғҐ
҆ҋ҆ҋ҇ґҍҜҋҋҏҋҖ҇ҘҚҏҋқ҅҇҉ҋҒқҌқҐҎ֟։֍ԵՒ֚֓֘Ҏ҇ҖҋҊ҆
҃Ҏҍ҆Ҏқ҅҇Қҋ҄҆҃ҘҐҎҏ҂Ҝ҆҃҆Җ҇ҚҜ҆ґҜҐҌқҐ҆҃ҌҚ҇Ҙ
ҚҒҋҚҊ҇҆҂Җ҇Қ҆ҋ҅ҋҎҔ҃ҘҐ҆ҜҍҚҔ҆Ҏ҇
ҌҒ҆қҏҔҖҎҍ҃҆ҒҐ҆҇Ҝҋ҇҇Ҝ҆ҙ҇҅҃Ҍқ҇҉҃҆Җ҇ҚҜ҆Ҝ҂ҜҜҎґҋ҂
ҏ҂ҏ҆Ҏҙ҇ҙ҈ҌҒ҆ҏ҂ҏҋҋҖҙқҐ҃ҍҚ҆҃ҎҍҎ҆Җ҇ҚҜ҆Ҝ҂ґҜ҇Ғ
҂Җ҇Қ҃җҔ҇҇ҋ҆҆Җ҇ҚҜ҃қ҇ҐҋқҎҔ҄҇Ғ҃Ҝ҇Җғ҇ҒҜ҇Ҏ҂қҌҎқҋ
҉ҙ҇Қ҃҇҂ҚҒҋҚҊ҇҆
֊֚֞֠ԵՒ֟֔֏֟֊֚֕Ֆ
ҏҋ҃Ҏҍ҆҃҇ҚҎҜ҇ҐҋҔҊ҇Ҝ҇ғҋҔҎҜ҇ҋҎ҃Ҋ҆
Ⴠ
ґҜ҇҂ҜҜҎґҜҋҒҜ҇ҋҎ҃Ҋ҆Ҝ҂ғ҇ҔҎҎґҍ҇Ґ҇Ғҋ҂҃Ҏҍ҆҇҆҅ҋҐ҃
Ⴠ
ґ҇҈ҐҏҔ҅҉ҋ҃
Ҝ҇ғҋҔҎ҆Ҝ҇ҋҎ҃Ҋ҆Ҝ҂Ҝ҇Ҙ҉Ҏґҋ҂
Ⴠ
֊֖֠֔֊֕֔
ҏҋ҃ҎҍҎҜ҅Ҕ҇ҋҐ҆Җ҇ҚҜ҆ҋҊҒ҃ҎҚ҂Ҏ ֊֎֏֍֟֏֖֚֒֊֖֠֔֊֏֖֔
҅҃Ҏ҃
֠֞֊Ֆ
҆Җ҇ҚҜ҆
֊֞֎֔֊֠֏֏֍ԵՒ֟֔֏֟֒֠֘ֈ֖֊֠։֍֏֔֠֞֊Ֆ
Ⴠ
҆Қ҇Ҙ҃ҏҋҎҍ҇҂҇ҏҋ҂ҘҐҒҜ҇ҋҘҚҙ҆҇ҏҋқ҇ҔҚҖ҆Ққ҂ҍҜҎҔ҇Җ
҂ҎҜ҇ҋҘҚҙ҆҇ҏҋқ҇ҔҚҖ҆҅҇ҔҎҍґҍҎ҃Ҏҍ҆Ҝ҇҇ҚҖҎҔ҆ҎҋҔҖ
҆Җ҇ҚҜ҆Ҝ҂Ҏ҃ҋҙ҆ҜҔ҆҈қ҃Ҏҍ҆қґҍҜҋҋ҆ҎҋҔҖ҆Қ҇Ҙ҃҇Ҏҍ҂
Ҝ҇ҋҘҚҙ҃҇ҏҋқ҇ҔҚҖ҃ҏҋҚ҉҂ҏҋ҃Ҏҍҙҋ҃҅҆Ҏҋ҇қҔґҋҋ҅Ҕ
֏֒֘ԵՒԵՒ֊֚֞֠ԵՒ֟֔֏֟֊֠֍֏֎ԵՒ֒֠֘ֈ֖֊֠։֍֏֔֠֞֊Ֆ
Ⴠ
ҏҋҚ҇҄҃Ҏ҇ҖҋҊ҆҆ҜҔҜҔҎҙҖғҐҔ҅ҋҐҚ҅Ҕ҆Ҝ҇҃ҙҔ҃ ֓֏֏֍
҄ҡҙҐҜ҇҉ҖҏҋҎҙ҇қ҆ҏҋ҃Ҏҍ҃҇҂҇Ҝ҇Ҕ҇҃қҐҜ҇҉ҖҋҒ҃
ҜҐ҇ҔҎґ҇ҍҋғ҆Ҝ҂Ҏ҇ҙқҋҎҖҊҐ҆ҚҒҋҚҊ҇҆҂Җ
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VETERINARY PHYSICIAN’S PRESCRIBING INFORMATION
NEXGARD VETERINARY
1. TRADE NAME OF MEDICINAL PRODUCT
NEXGARD 11 MG VETERINARY – chewable tablets for dogs 2–4 kg
NEXGARD 28 MG VETERINARY – chewable tablets for dogs >4-10 kg
NEXGARD 68 MG VETERINARY – chewable tablets for dogs >10-25 kg
NEXGARD 136 MG VETERINARY – chewable tablets for dogs >25–50 kg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
ACTIVE SUBSTANCES:
NEXGARD VETERINARY
AFOXOLANER (MG)
chewable tablets for dogs 2–4 kg
11.3 mg
chewable tablets for dogs >4–10 kg
28.3 mg
chewable tablets for dogs >10–25 kg
68 mg
chewable tablets for dogs >25–50 kg
136 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Chewable tablets
Mottled red to reddish brown, circular shaped (tablets for dogs 2–4
kg) or rectangular shaped
(tablets for dogs >4–10 kg, tablets for dogs >10–25 kg and tablets
for dogs >25–50 kg).
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES: Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
-
Treatment of flea infestation in dogs (_Ctenocephalides felis _and _C.
canis_) for at least 5 weeks.
The product can be used as part of a treatment strategy for the
control of flea allergy dermatitis
(FAD).
-
Treatment of tick infestation in dogs (_Dermacentor reticulatus,
Ixodes ricinus, Rhipicephalus _
_sanguineus). _One treatment kills ticks for up to one month.
-
Fleas and ticks must attach to the host and commence feeding in order
to be exposed to the
active substance.
-
Treatment of demodicosis (caused by _Demodex canis_).
-
Treatment of sarcoptic mange (caused by _Sarcoptes scabiei _var.
_canis_).
4.3 CONTRAINDICATIONS: Do not use in cases of hypersensitivity to the
active substance or to any of
the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES: Parasites need to start
feeding on the host to become
exposed to afoxolaner; therefore the risk of the transmission of
parasite borne diseases cannot be
excluded.
4.5 SPECIAL PRECAUTIONS FOR USE:
Special p
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