ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

Transcription

1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1

2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Aqupharm 1 (9 mg/ml) solution for injection/infusion (UK/IE) Natriumklorid Animalcare 9 mg/ml solution for injection/infusion (IS, DK, FI, SE) Aqupharm Sodium Chloride 9 mg/ml solution for injection/infusion (FR, AT, BE, HU, NL, PL) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Sodium Chloride 9 mg The solution provides Sodium: 150 mmol/litre Chloride: 150 mmol/litre For the full list of excipients, see section PHARMACEUTICAL FORM Solution for injection/infusion Clear, colourless particle free solution 4. CLINICAL PARTICULARS 4.1 Target species Cattle, horses, sheep, goats, pigs, dogs, cats and rabbits. 4.2 Indications for use, specifying the target species Correction of water: sodium imbalances. Treatment of metabolic alkalosis. Rehydration in disease conditions which result in excessive loss of water and sodium chloride, and during and after surgery. A vehicle solution for the administration of other compatible drugs. 4.3 Contraindications Do not use in animals with: - sodium and water retention including heart failure, - hypernatraemia, - hyperchloraemia, - hyperhydration 4.4 Special warnings for each target species None 2

3 4.5 Special precautions for use Special precautions for use in animals Use with caution in animals with cardiac or renal impairment as sodium overload may occur. It should be noted that sodium excretion may be impaired post-surgery/trauma. Use with caution in animals with hypokalaemia. Serum electrolyte levels, water and acid-base balance and the clinical condition of the animal should be closely monitored during the treatment in order to prevent overdose, particularly in cases of renal or metabolic changes. A risk of thrombosis with intravenous infusion should be considered. This product should not be used for longer than is necessary to correct and sustain circulating volume. Inappropriate/excessive use may worsen or create a metabolic acidosis. Maintain aseptic precautions. This product does not contain an antimicrobial preservative. The solution should be warmed to approximately 37 C prior to the administration of large volumes, or if the administration rate is high, in order to avoid hypothermia. The volume and infusion rate must be adapted to the clinical status of each animal. Ensure that the solution is clear and contains no visible particles and the unit is perfectly intact. Otherwise, do not use the solution. Discard any unused portion. Do not exceed maximum dose rate of 90ml/kg/hour. This solution does not contain the appropriate electrolyte balance for longer term maintenance fluid administration Special precautions to be taken by the person administering the veterinary medicinal product to animals None 4.6 Adverse reactions (frequency and seriousness) Not known under normal conditions of use. Where the product is used as a drug carrier, this can lead to other adverse effects. 4.7 Use during pregnancy, lactation or lay The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction It is recommended to take appropriate precautions in animals receiving corticosteroids or corticotrophins to prevent high blood pressure and excessive fluid retention during administration of large volumes. Concomitant administration of colloids requires a dose reduction. 4.9 Amounts to be administered and administration route 3

4 Slow intravenous injection or infusion, or subcutaneous injection. When given subcutaneously, reduced doses are recommended. The amount of fluid and electrolytes to be administered should be calculated by adding the existing deficits to the ongoing maintenance requirements and any ongoing fluid losses (e.g. from vomiting, diarrhoea etc) estimated from the history of the animal, clinical examination and laboratory findings. To calculate the existing fluid deficit, the following equation should be used; Fluid deficit (mls) = Percentage dehydration x Bodyweight (kg) x 10 (e.g. for a 10 kg dog with 5% dehydration the fluid deficit would be 5 x 10 x 10 = 500ml) To calculate the ongoing crystalloid maintenance requirement, the following equation should be used; Maintenance per day for Cattle, Horses, Sheep, Goats, Pigs, Dogs and Cats (mls) = 50ml x Bodyweight (kg) Maintenance per day for Rabbits (mls) = ml x Bodyweight (kg) (e.g. for a 10 kg dog, the daily maintenance fluid requirement is 10 x 50 = 500ml) The administration rate should be adjusted to each animal. The objective is to correct the deficit over hours Overdose (symptoms, emergency procedures, antidotes), if necessary It is recommended to maintain a serum sodium less than or equal to 130 meq / l. In the presence of volume overload signs, treatment should involve administering diuretics and stopping the infusion. Overdose may lead to hypernatraemia, hyperchloraemia, hypokalaemia, cardiac decompensation, hyperhydration and metabolic acidosis. Clinical signs of excessive overdose include restlessness, hypersalivation, shivering, tachycardia, serous nasal discharge, tachypnoea, moist lung sounds, coughing, protrusion of the eye from the orbit, widespread oedema, vomiting and diarrhoea. Long-term infusion may cause electrolyte imbalance. Saline solution is not balanced and it may cause acidaemia because it will increase renal elimination of bicarbonate. Prolonged use may cause hypokalaemia 4.11 Withdrawal period(s) Meat and offal: zero days. Milk: zero hours. 5. PHARMACOLOGICAL IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Solutions affecting the electrolyte balance ATC vet code: QB05BB01 4

5 5.1 Pharmacodynamic properties Sodium chloride and water are normal constituents of the plasma of animals. Sodium is the major cation of the extracellular space and regulates the size of this space together with other anions. The sodium content and the fluid homeostasis of the body are closely related. Each deviation of the plasma sodium concentration from the physiological one simultaneously affects the fluid status of the body. An increase in the sodium content of the body also means reduction of the body's free water content independent of the serum osmolarity. A 0.9 per cent sodium chloride solution has the same osmolarity as plasma. Administration of this solution primarily leads to a replenishment of the interstitial space which is about 2/3 of the entire extracellular space. Only 1/3 of the administered volume remains in the intravascular space. 5.2 Pharmacokinetic particulars Sodium chloride administered by the intravenous route quickly joins the normal distribution and metabolism of sodium chloride and water, in the intracellular and extracellular spaces. Sodium and chloride are normal components of the body and their balance is maintained by the kidneys. The sodium level of the veterinary medicinal product is similar to the physiological level in the serum. The kidneys are the major regulator of the sodium and water balance. In cooperation with the hormonal control mechanisms (renin-angiotensin-aldosterone system, antidiuretic hormone), the kidneys are primarily responsible for the maintenance of a constant volume of the extracellular space and regulation of its fluid composition. Chloride is exchanged for hydrogen carbonate in the tubule system. Thus, it is involved in the regulation of the acid-base balance. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sodium hydroxide (for ph adjustment) Hydrochloric acid (for ph adjustment) Water for injection 6.2 Incompatibilities The compatibility of an added drug with the product must be estimated by monitoring for a color change or appearance of a precipitate of insoluble complexes or crystals. Reference should be made to the SPC of the drug being co-administered for incompatibilities information. Before adding a drug, verify it is soluble and stable in water at the ph of the product. 6.3 Shelf life Shelf life of the veterinary medicinal product as packaged for sale : 100 ml: 2 years 250 m l, 500 ml, 1000 ml, 3000 ml, 5000 ml : 3 years After first opening, use immediately and dispose of any unused product, 6.4. Special precautions for storage 5

6 250 ml, 500 ml, 1000 ml, 3000 ml and 5000 ml bags do not require any special storage conditions. 100ml bags: Store below 25 ºC 6.5 Nature and composition of immediate packaging Polyvinyl chloride (PVC) bag with polyisoprene/polycarbonate ports, overwrapped with polypropylene. Pack sizes Cardboard box containing 50 bags of 100 ml 30 bags of 250 ml 20 bags of 500 ml 10 bags of 1000 ml 4 bags of 3000 ml 2 bags of 5000 ml Not all pack sizes may be marketed. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER Animalcare Limited 10 Great North Way York YO26 6RB UK 8. MARKETING AUTHORISATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10 DATE OF REVISION OF THE TEXT PROHIBITION OF SALE, SUPPLY AND/OR USE 6

7 ANNEX III LABELLING AND PACKAGE LEAFLET 7

8 A. LABELLING 8

9 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Aqupharm 1 (9 mg/ml) solution for injection/infusion (UK/IE) NatriumKlorid Animalcare solution for injection/infusion (IS, DK, FI, SE) Aqupharm Sodium Chloride (9 mg/ml) solution for injection/infusion (FR, AT, BE, HU, NL, PL) 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each ml contains: Sodium Chloride 9mg 3. PHARMACEUTICAL FORM Solution for injection/infusion 4. PACKAGE SIZE 50 x 100ml 30 x 250ml 20 x 500ml 10 x 1000ml 4 x 3000ml 2 x 5000ml 5. TARGET SPECIES Cattle, horses, sheep, goats, pigs, dogs, cats and rabbits. 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Slow intravenous injection or infusion or subcutaneous injection. Read the package leaflet before use. 8. WITHDRAWAL PERIOD Withdrawal period: Meat and offal: zero days 9

10 Milk: zero hours 9. SPECIAL WARNING(S), IF NECESSARY 10. EXPIRY DATE EXP: DD/MM/YY After first opening, use immediately and dispose of any unused product. 11. SPECIAL STORAGE CONDITIONS 100ml bags: Store below 25 ºC 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Disposal: Read package leaflet 13. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only. To be supplied only on veterinary prescription 14. THE WORDS KEEP OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Animalcare Limited 10 Great North Way York YO26 6RB UK 16. MARKETING AUTHORISATION NUMBER(S) 17. MANUFACTURER S BATCH NUMBER Lot {number} 10

11 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Labels 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Aqupharm 1 (9 mg/ml) solution for injection/infusion (UK/IE) Natriumklorid Animalcare solution for injection/infusion (IS, DK, FI, SE) Aqupharm Sodium Chloride (9 mg/ml) solution for injection/infusion (FR, AT, BE, HU, NL, PL) 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each ml contains: Sodium Chloride 9mg 3. PHARMACEUTICAL FORM Solution for injection/infusion 4. PACKAGE SIZE 100ml 250ml 500ml 1000ml 3000ml 5000ml 5. TARGET SPECIES Cattle, horses, sheep, goats, pigs, dogs, cats and rabbits. 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION IV, SC Read the package leaflet before use. 8. WITHDRAWAL PERIOD Withdrawal period: 11

12 Meat and offal: zero days Milk: zero hours 9. SPECIAL WARNING(S), IF NECESSARY 10. EXPIRY DATE EXP: DD/MM/YY 11. SPECIAL STORAGE CONDITIONS 100ml bags Store below 25 ºC 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY 13. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only. To be supplied only on veterinary prescription. 14. THE WORDS KEEP OUT OF THE SIGHT AND REACH OF CHILDREN 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Animalcare Limited 10 Great North Way York YO26 6RB UK 16. MARKETING AUTHORISATION NUMBER(S) 17. MANUFACTURER S BATCH NUMBER Lot {number} 12

13 B. PACKAGE LEAFLET 13

14 PACKAGE LEAFLET FOR: Aqupharm 1 (9 mg/ml) solution for injection/infusion (UK/IE) Natriumklorid Animalcare solution for injection/infusion (IS, DK, FI, SE) Aqupharm Sodium Chloride (9 mg/ml) solution for injection/infusion (FR, AT, BE, HU, NL, PL) NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder Animalcare Ltd 10 Great North Way York YO26 6RB UK Manufacturer responsible for batch release: Infomed Fluids SRL, 50 Theodor Pallady blvd., District 3, Bucharest, Romania 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Aqupharm 1 (9mg/ml) solution for injection/infusion (UK/IE) Natriumklorid Animalcare solution for injection/infusion (IS, DK, FI, SE) Aqupharm Sodium Chloride (9mg/ml) solution for injection/infusion (FR, AT, BE, HU, NL, PL) 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains: Sodium Chloride 9mg Solution for injection/infusion. Clear, colourless particle free solution. 4. INDICATION(S) Correction of water: sodium imbalances. Treatment of metabolic alkalosis. Rehydration in disease conditions which result in excessive loss of water and sodium chloride, and during and after surgery. A vehicle solution for the administration of other compatible drugs. 14

15 5. CONTRAINDICATIONS Do not use in animals with: - sodium and water retention including heart failure, - hypernatraemia, - hyperchloraemia, - hyperhydration 6. ADVERSE REACTIONS Not known under normal conditions of use. Where the product is used as a drug carrier, this can lead to other adverse effects. 7. TARGET SPECIES Cattle, horses, sheep, goats, pigs, dogs, cats and rabbits. 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Slow intravenous injection or infusion, or subcutaneous injection The amount of fluid and electrolytes to be administered should be calculated by adding the existing deficits to the ongoing maintenance requirements and any ongoing fluid losses (e.g. from vomiting, diarrhoea etc) estimated from the history of the animal, clinical examination and laboratory findings. To calculate the existing fluid deficit, the following equation should be used; Fluid deficit (mls) = Percentage dehydration x Bodyweight (kg) x 10 (e.g. for a 10 kg dog with 5% dehydration the fluid deficit would be 5 x 10 x 10 = 500ml) To calculate the ongoing crystalloid maintenance requirement, the following equation should be used; Maintenance per day for Cattle, Horses, Sheep, Goats, Pigs, Dogs and Cats (mls) = 50ml x Bodyweight (kg) Maintenance per day for Rabbits (mls) = ml x Bodyweight (kg) (e.g. for a 10 kg dog, the daily maintenance fluid requirement is 10 x 50 = 500ml) The administration rate should be adjusted to each animal. The objective is to correct the deficit over hours. When given subcutaneously, reduced doses are recommended. For intravenous infusion, the administration rate should be adjusted to each animal. The objective is to correct the deficit over hours. 15

16 9. ADVICE ON CORRECT ADMINISTRATION 10. WITHDRAWAL PERIOD Meat and offal: zero days Milk: zero hours 11. SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. After first opening, use immediately and dispose of any unused product. 250 ml, 500 ml, 1000 ml, 3000 ml and 5000 ml bags do not require any special storage conditions. 100ml bags: Store below 25 ºC 12. SPECIAL WARNING(S) Special warnings for each target species: None Special precautions for use in animals: Use with caution in animals with cardiac or renal impairment as sodium overload may occur. It should be noted that sodium excretion may be impaired post-surgery/trauma. Use with caution in animals with hypokalaemia. Serum electrolyte levels, water and acid-base balance and the clinical condition of the animal should be closely monitored during the treatment in order to prevent overdose, particularly in cases or renal or metabolic changes. A risk of thrombosis with intravenous infusion should be considered. This product should not be used for longer than is necessary to correct and sustain circulating volume. Inappropriate/excessive use may worsen or create a metabolic acidosis. Maintain aseptic precautions. This product does not contain an antimicrobial preservative. The solution should be warmed to approximately 37 C prior to the administration of large volumes, or if the administration rate is high, in order to avoid hypothermia. The volume and infusion rate must be adapted to the clinical status of each animal. Ensure that the solution is clear and contains no visible particles and the unit is perfectly intact. Otherwise, do not use the solution. Discard any unused portion. Do not exceed maximum dose rate of 90ml/kg/hour. This solution does not contain the appropriate electrolyte balance for longer term maintenance fluid administration. Special precautions to be taken by the person administering the veterinary medicinal product to animals: 16

17 None Use during Pregnancy, Lactation or lay: The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian. Interaction with other medicinal products and other forms of interaction: It is recommended to take appropriate precautions in animals receiving corticosteroids or corticotrophins to prevent high blood pressure and excessive fluid retention during administration of large volumes. Concomitant administration of colloids requires a dose reduction. Overdose (symptoms, emergency procedures, antidotes): It is recommended to maintain a serum sodium less than or equal to 130 meq / l. In the presence of volume overload signs, treatment should involve administering diuretics and stopping the infusion. Overdose may lead to hupernatraemia, hyperchloraemia, hypokalaemia, cardiac decompensation, hyperhydration and metabolic acidosis. Clinical signs of excessive overdose include restlessness, hypersalivation, shivering, tachycardia, serous nasal discharge, tachypnoea, moist lung sounds, coughing, protrusion of the eye from the orbit, widespread oedema, vomiting and diarrhoea. Long-term infusion may cause electrolyte imbalance. Saline solution is not balanced and it may cause acidemia because it will increase renal elimination of bicarbonate. Prolonged use may cause hypokalaemia. Incompatibilities: The compatibility of an added drug with the product must be estimated by monitoring for a color change or appearance of a precipitate of insoluble complexes or crystals. Reference should be made to the SPC of the drug being co-administered for incompatibilities information. Before adding a drug, verify it is soluble and stable in water at the ph of the product. 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 15. OTHER INFORMATION> Polyvinyl chloride (PVC) bag with polyisoprene/polycarbonate ports, overwrapped with polypropylene. 17

18 Pack sizes Cardboard box containing 50 bags of 100 ml 30 bags of 250 ml 20 bags of 500 ml 10 bags of 1000 ml 4 bags of 3000ml 2 bags of 5000ml Not all pack sizes may be marketed. To be supplied only on a veterinary prescription 18