Aqupharm 11 (Hartmann'S) Solution For Infusion
Issued: September 2016
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Aqupharm 11 (Hartmann’s) Solution for Infusion (UK/IE)
Ringer- Lactat Animalcare solution for infusion (IS, DK, FI, SE)
Aqupharm Ringer Lactate Solution for Infusion (FR, AT, BE, HU, NL, PL)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
chloride 6.00 mg
Potassium chloride 0.40 mg
Calcium chloride 0.204 mg
Corresponding to calcium chloride dihydrate 0.27 mg
Sodium S-lactate 3.20 mg
lactate (50% w/v)
Sodium 131 mmol/litre
Potassium 5 mmol/litre
Calcium 2 mmol/litre
(as lactate) 29 mmol/litre
Chloride 111 mmol/litre
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for 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
Treatment of dehydration of extracellular predominance.
Treatment and prevention of perioperative hypovolaemia and haemorrhagic shock.
Treatment of mild metabolic acidosis.
Do not use in
- congestive heart failure,
- metabolic alkalosis,
- severe metabolic or lactic acidosis,
- hepatic insufficiency,
- Addison's disease.
4.4 Special warnings for each target species
4.5 Special precautions for use
Special precautions for use in animals
Do not use unless the solution is clear, free from visible particles, and the container is undamaged. A risk of thrombosis with intravenous infusion should be considered. Maintain aseptic precautions. This product does not contain an antimicrobial preservative. It is intended for single use only and any unused contents should be discarded.
The solution should be warmed to approximately to 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.
Use of this solution requires monitoring of the clinical and physiological status of the animal especially in cases of:
- severe renal impairment,
- sodium retention with oedema,
- treatments with corticosteroids and their derivatives.
Monitor serum potassium and serum calcium in treated animals, particularly potassium levels in cases at risk of hyperkalaemia, such as during chronic renal failure.
In animals with hepatic impairment, the product may not produce its alkalising action since lactate metabolism may be altered.
Do not inject intramuscularly.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
4.6 Adverse reactions (frequency and seriousness)
The use of the product can cause metabolic alkalosis, in cases of excessive administration or impaired metabolism of lactate.
Not known under normal conditions of use.
product is used as a drug carrier, this can lead to other adverse
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 accordingly to the benefit/risk assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
linked to calcium.
In case of concomitant blood transfusion, the product should not be administered with the blood in the same infusion set due to the risk of clotting. This veterinary medicinal product contains calcium. Do not add drugs to this solution that may bind (chelate) to calcium.
4.9 Amounts to be administered and administration route
Administer by intravenous infusion.
Management of dehydration including patients with mild metabolic acidosis
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 ongoing
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 maintenance requirement, the following equation should be used;
Maintenance for Cattle, Horses, Sheep, Goats, Pigs, Dogs and Cats (mls) = 50ml x Bodyweight (kg) per day
Maintenance of Rabbits (mls) = 75-100ml x Bodyweight (kg) per day
(e.g. for a 10 kg dog, the daily maintenance fluid requirement is 10 x 50 = 500ml)
administration rate should be adjusted to each animal. The
objective is to correct the deficit over 12 – 24 hours.
Prevention of peri-operative hypovolaemia
Administer at a rate of 5 – 10ml/kg/hr during anaesthesia
Treatment of hypovolaemic and haemorrhagic shock
Cattle, Horses, Sheep, Goats, Pigs, Dogs Rabbits; up to 90ml/kg/hr
Cats; up to 60ml/kg/hr
High infusion rates should not be continued for longer than 1 hour.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In the presence of volume overload signs (e.g. restlessness, moist lung sounds, tachycardia, tachypnoea or coughing), treatment should involve administering diuretics and stopping the infusion.
An excessive infusion of product may cause metabolic alkalosis due to the presence of lactate ions.
4.11 Withdrawal period(s)
offal: zero days.
Milk: zero hours
5. PHARMACOLOGICAL IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Solutions affecting the
ATC vet code:
5.1 Pharmacodynamic properties
crystalloid solutions are for vascular filling and electrolyte
replacement. They have an ionic composition very close to the
Sodium is the major cation of extracellular fluid. It is responsible for maintaining the volume of liquid and extracellular osmolarity.
Potassium is mainly an intracellular cation.
99% of calcium is present in the skeleton.
Chloride is essentially an extracellular anion.
Lactate produces bicarbonate salts (hence its alkalising effect).
5.2 Pharmacokinetic particulars
diffuses into the extracellular space whose volume is increased
The lactate ion is rapidly metabolised by the liver where it is converted to pyruvate used in the Krebs cycle with production of bicarbonates.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections
with other medications should be checked prior to mixing in order
to avoid precipitate formation, turbidity, or a problem with the
Reference should be made to the SPC of the drug being co-administered for incompatibilities information.
This veterinary medicinal product is incompatible with chlortetracycline, amphotericin B, oxytetracycline, methylprednisolone, and sodium lactate or sodium bicarbonate intravenous infusions. Mixtures with additives and other drugs (e.g. oxalate-, phosphate- and carbonate-/hydrogen carbonate-containing ones) may cause incompatibilities.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale 3 years
After first opening, use immediately and dispose of any unused product.
6.4 Special precautions for storage
This veterinary medicinal does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Polyvinyl chloride (PVC) bag with polyisoprene/polycarbonate ports, overwrapped with polypropylene
Cardboard box containing
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.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
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
10 Great North Way
York Business Park
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
22 September 2016
10. DATE OF REVISION OF THE TEXT
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