SIMPARICA 20 MG VETERINARY

国家: 以色列

语言: 英文

来源: Ministry of Health

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资料单张 资料单张 (PIL)
11-04-2019
产品特点 产品特点 (SPC)
04-09-2022

有效成分:

SAROLANER

可用日期:

ZOETIS ISRAEL HOLDING B.V., ISRAEL

药物剂型:

CHEWABLE TABLETS

组成:

SAROLANER 20 MG

给药途径:

PER OS

处方类型:

Required

厂商:

ZOETIS LLC (SUBSIDIARY OF ZOETIS INC.)

疗效迹象:

Indicated for dogs.For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus). The veterinary medicinal product has immediate and persistent tick killing activity for at least 5 weeks. For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for at least 5 weeks. The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).For the treatment of sarcoptic mange (Sarcoptes scabiei). For the treatment of ear mite infestations (Otodectes cynotis). For the treatment of demodicosis (Demodex canis). Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.

授权日期:

2018-12-10

资料单张

                                لامعتسلاا ةقيرط .8
.اهباحصأ لب
ِ
ق نم اهل ىطع
ُ
ت امدنع ةبغرب اهلوانتت بلاكلا نإف
كلذلو ،ذيذل معط تاذو غضملل ةلباق يرطيب
اكيرپميس صارقأ
.مفلا لخاد ىلإ ةرشابم وأ ،ماعط عم هايإ
هؤاطعإ نكمي ،صرقلا بلكلا لكأي مل اذإ راظتنلاا ةدم .9
.ةلص دجوت لا تاريذحت .10
ةفدهتسملا تاناويحلا ىدل لامعتسلااب
قلعتت ةصاخ تاريذحت
نكمي لا يلاتلابو ،همد صاصتماو
ناويحلاب قاصتللاا اهيلع بجي ،sarolaner ةلا
ّ
عفلا ةداملل تا
ّ
يليفطلا ضرعتت نأ لجأ نم
.يليفطلا اهلقني ضارمأب ةباصلإا
داعبتسا
تاناويحلا ىدل ءاودلا لامعتسا ةملاسب
قلعتت ةصاخ تاريذحت
ىصوأ اذإ لاإ ،مارغوليك 2.5 نم لقأ نزت
يتلا وأ/و ،عيباسأ 8 نم لقأ اهرمع غلبي
يتلا بلاكلل رضحتسملا لامعتسا عنم
ُ
ي
.جلاعلا اذهب يرطيبلا بيبطلا
رضحتسملاب جلاع
ُ
ملا صخشلا ةملاسب قلعتت ةصاخ تاريذحت
.رضحتسملا ةسملام دعب نيديلا لسغ بجي
.أطخلا قيرط نع رضحتسملا علب
ّ
مت اذإ ثدحت نأ نكمم ،يبصع ج
ّ
يهت نم ةرباع ضارعأ لثم ة
ّ
يبناج ضارعأ
ةداعإ بجي .ةجاحلا بسحب ،ة
ّ
رم لك يف طيرشلا نم دحاو صرق جارخإ بجي
،رضحتسملا ىلإ لافطلأا لوصو ةيناكمإ
عنمل
علب
ّ
مت اذإ .لافطلأا ةيؤر لاجمو يديأ لوانتم
نع ا
ً
ديعب نوتركلا ة
ّ
وبع ظفحو ،لامعتسلاا نم ءاهتنلاا روف
نوتركلا ة
ّ
وبع ىلإ طيرشلا
.بيبطلا ىلع رضحتسملا ة
ّ
وبع وأ ةرشنلا ضرعو ،ة
ّ
يبط ةدعاسم ىلع 
                                
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产品特点

                                Simparica LPD 07.08.22 CC
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Simparica 5 mg Veterinary chewable tablets
Simparica 10 mg Veterinary chewable tablets
Simparica 20 mg Veterinary chewable tablets
Simparica 40 mg Veterinary chewable tablets
Simparica 80 mg Veterinary chewable tablets
Simparica 120 mg Veterinary chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Simparica chewable tablets
sarolaner (mg)
for dogs 1.3–2.5 kg
5
for dogs >2.5–5 kg
10
for dogs >5–10 kg
20
for dogs >10–20 kg
40
for dogs >20–40 kg
80
for dogs >40–60 kg
120
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablets.
Mottled brown coloured, square shaped chewable tablets with rounded
edges.
The number embossed on one side refers to the strength (mg) of the
tablets:
“5”, “10”,”20”, “40”, “80” or “120”.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of tick infestations (_Dermacentor reticulatus,
Ixodes hexagonus, _
_Ixodes ricinus _and _ Rhipicephalus sanguineus_). The veterinary
medicinal product
has immediate and persistent tick killing activity for at least 5
weeks.
For the treatment of flea infestations (_Ctenocephalides felis _and
_Ctenocephalides _
_canis_). The veterinary medicinal product has immediate and
persistent flea killing
Simparica LPD 07.08.22 CC
activity against new infestations for at least 5 weeks. The veterinary
medicinal
product can be used as part of a treatment strategy for the control of
Flea Allergy
Dermatitis (FAD).
For the treatment of sarcoptic mange (_Sarcoptes scabiei_).
For the treatment of ear mite infestations (_Otodectes_ _cynotis_).
For the treatment of demodicosis (_Demodex canis_).
Fleas and ticks must attach to the host and commence feeding in order
to be
exposed to the active substance.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active sub
                                
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其他语言的文件

资料单张 资料单张 阿拉伯文 11-04-2019
资料单张 资料单张 希伯来文 04-09-2022

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