البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
PROGESTERONE
ZOETIS ISRAEL HOLDING B.V., ISRAEL
VAGINAL INSERT
PROGESTERONE 0.35 G
INTRAVAGINAL
Required
DEC INTERNATIONAL (NZ) LTD
Estrus control in sheeps.
2020-09-30
Component Pharma Code GTIN CR Number Description Artwork Code Supplier Market Perigord Nº Colours TEXT SIZE The BODY text on this A/W is at: Dimensions SKU N o Drawing Number Date: Time: Proof Nº Tel: +353 (0)1 440 3222 Web: www.perigord-as.com E-mail: PerigordZoetis@perigord-as.com GLOBAL EXTERNAL SUPPLY 39020464-04/22 DEC NZ Israel 662556 Leaflet N/A N/A 200012258 N/A 210 x 297 mm 7.5 pt N/A 04 09 : 52 Black LEAFLET CIDR G IUD 0.33 GMX20BGX1 HE_IL 02 JUN 2022 VETERINARY MEDICINE PACKAGE LEAFLET This medicine is dispensed with a veterinarian’s prescription only For use in animals only 1. NAME, FORM AND STRENGTH OF THE VETERINARY MEDICINE Eazi Breed CIDR G Veterinary, intravaginal insert 2. ACTIVE INGREDIENT Progesterone 0.35 g List of the inactive ingredients in section 13. 3. WHAT IS THIS MEDICINE INTENDED FOR? Estrus control in sheep Induction of oestrus in sheep (ewes) during seasonal anoestrus; this is the period in which the sheep (ewes) do not have regular oestrus cycles outside the natural breeding season. Eazi Breed CIDR G Veterinary intravaginal insert has not been tested in oestrous cycling ewes. Therapeutic group: Genito-urinary system and sex hormones. ATCVet code: QG03DA04 4. CONTRAINDICATIONS Do not use in pregnant ewes. Do not use in ewes with abnormal or immature or infected genital tracts. 5. SIDE EFFECTS Local irritation and discharge of cloudy/yellow mucus are common and discharge of dark red, brown or bloody mucus is uncommon. However, these signs resolve on their own within 2 days of removal of the insert without the need for treatment. You can report side effects to the Ministry of Health by following the link ‘Reporting Side Effects of Drug Treatment’ on the Ministry of Health home page (www.health.gov.il) which links to an online form for reporting side effects. You can also use this link: https://sideeffects.health.gov.il. 6. TARGET ANIMALS Sheep (ewes) 7. ROUTE OF ADMINISTRATION AND DOSE For induction of oestrus in ewes (sheep) during seasonal anoestrus: Administer the Eazi Bree اقرأ الوثيقة كاملة
EAZI BREED CIDR G LPD .2021 14.12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT EAZI BREED CIDR G VETERINARY 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES(S): Each device contains: Progesterone 0.35 g For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Vaginal delivery system. A “T” shape device consisting of progesterone impregnated silicone rubber elastomer skin moulded over an inert nylon spine. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep (ewes). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Estrus control in sheep. 4.3 CONTRAINDICATIONS Do not use in pregnant ewes. Do not use in ewes: - with abnormal or immature genital tracts. - with genital infections. 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS The efficacy and safety of the veterinary medicinal product has not been evaluated in ewes which are unwell, which have a BCS < 2 or ≥ 4, which have had complications during previous pregnancies or lambings, or which have lambed within the last 45 days. Use only according to the benefit/risk assessment by the responsible veterinarian. Animals in poor condition, whether from illness, inadequate nutrition, or other factors, may respond poorly to treatment. EAZI BREED CIDR G LPD .2021 14.12 II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Progesterone is a potent steroid hormone and may cause adverse effects on the reproductive system in cases of high or prolonged exposure. Adverse effects on unborn children cannot be ruled out. The product may cause skin and eye irritation, as well as allergic skin rashes. Those administering the product should avoid contact with the silicone section; pregnant women should avoid using the product completely. Wear gloves when administering and disposing of the product; insert the device using the applicator. Wash hands and exposed skin with soap and water after use. Do not smoke, eat اقرأ الوثيقة كاملة