SIMPARICA 10 MG VETERINARY

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Kúpte ho teraz

Príbalový leták Príbalový leták (PIL)
11-04-2019

Aktívna zložka:

SAROLANER

Dostupné z:

ZOETIS ISRAEL HOLDING B.V., ISRAEL

Forma lieku:

CHEWABLE TABLETS

Zloženie:

SAROLANER 10 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

ZOETIS LLC (SUBSIDIARY OF ZOETIS INC.)

Terapeutické indikácie:

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.

Dátum Autorizácia:

2018-12-10

Príbalový leták

                                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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Súhrn charakteristických

                                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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