ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS . 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Diazedor 5 mg/ml solution for injection for dogs and cats (AT DE ES FR IE IT NL PT UK) Diazedor vet. 5 mg/ml solution for injection for dogs and cats (DK FI NO SE)
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. 2 1. NAME OF THE MEDICINAL PRODUCT Bridion 100mg/mLsolution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1mLcontains sugammadex sodium equivalent to 100mg sugammadex. Each vial of 2mLcontains sugammadex sodium equivalent to 200mg sugammadex.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. 2 1. NAME OF THE MEDICINAL PRODUCT. Fexinidazole Winthrop 600 mg tablets . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION. Each tablet contains 600 mg fexinidazole. Excipient with known effect Each tablet contains 115.5 mg of lactose (as monohydrate).
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
annex i summary of product characteristics 1. name of the medicinal product vitamin a provepharm 100 000 iu /2 ml solution for injection (i.m.) 2. qualitative and quantitative composition
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I . SUMMARY OF PRODUCT CHARACTERISTICS NOTE tThe following are those items of information required by Article 14 of Directive 2001/82/EC as amended the Guideline on Summary of the Product Characteristics SPCPharmaceuticals and the Guideline on Summary of the Product Characteristics SPC -
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS . January 2020 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Eprinex Multi 5 mg/ml pour-on for beef and dairy cattle sheep and goats. Eprinex vet. 5 mg/ml pour-on for beef and dairy cattle sheep and goats (for DK FI NO SE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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ANNEX I . SUMMARY OF PRODUCT CHARACTERISTICS . 2 . 1. NAME OF THE MEDICINAL PRODUCT . AMMONAPS 500 mg tablets. This medicinal product contains 62 mg sodium per tablet equivalent to 3 of the WHO recommended No studies on the effects on the ability to drive and use machines have been performed.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Jun 10 2014 · ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS . 2 1. NAME OF THE MEDICINAL PRODUCT Infanrix hexa Powder and suspension for suspension for injection. Diphtheria (D) tetanus (T) pertussis (acellular component) (Pa) hepatitis B (rDNA) (HBV) No data are available. Method of administration
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. 4.9 Amounts to be administered and administration route Subcutaneous use.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS . 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new No dosage adjustment is required in
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS . 2 . This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS . Page 2 of 18 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Optomease Vet 200mg/ml concentrate for solution for fish treatment (UK NO DK IE) Optomease 200mg/ml concentrate for solution for fish treatment (ES EL) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS . 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I . SUMMARY OF PRODUCT CHARACTERISTICS . 2 . 1. NAME OF THE MEDICINAL PRODUCT . Remsima 100 mg powder for concentrate for solution for infusion . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION . One vial contains 100 mg of infliximab . After reconstitution each mL contains 10 mg of infliximab.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I . SUMMARY OF PRODUCT CHARACTERISTICS . 2 . 1. NAME OF THE MEDICINAL PRODUCT . Remsima 100 mg powder for concentrate for solution for infusion . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION . One vial contains 100 mg of infliximab . After reconstitution each mL contains 10 mg of infliximab.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. 2 1. NAME OF THE MEDICINAL PRODUCT. Fexinidazole Winthrop 600 mg tablets . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION. Each tablet contains 600 mg fexinidazole. Excipient with known effect Each tablet contains 115.5 mg of lactose (as monohydrate).
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I . SUMMARY OF PRODUCT CHARACTERISTICS . 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. 4.9 Amounts to be administered and administration route Subcutaneous use.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I . SUMMARY OF PRODUCT CHARACTERISTICS . 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS . Page 2 of 18 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Optomease Vet 200mg/ml concentrate for solution for fish treatment (UK NO DK IE) Optomease 200mg/ml concentrate for solution for fish treatment (ES EL) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
medicinal product are applicable. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin therefore extreme care must be taken to avoid pregnancy in patients and in partners of male patients (see the Summary of Product Characteristics for ribavirin).
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
medicinal product are applicable. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin therefore extreme care must be taken to avoid pregnancy in patients and in partners of male patients (see the Summary of Product Characteristics for ribavirin).
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I. SUMMARY OF PRODUCT CHARACTERISTICS 1 . This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS . 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new No dosage adjustment is required in
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS . 2 1. NAME OF THE MEDICINAL PRODUCT ABILIFY 5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of aripiprazole. described in section 5.1 but no
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
intramuscularly on Days 1 15 29 and once monthly thereafter. Please refer to the Summary of Product Characteristics of fulvestrant. Prior to the start of treatment with the combination of palbociclib plus fulvestrant and throughout its duration pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
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No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
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