VETPEN CANINSULIN CARTRIDGES 230 2.7ML 10 UNITS

VETPEN CANINSULIN, 40 IU/ml Injectable Suspension

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Insulin ……………………………………………………………………………. 40,00 IU
(Insulin of porcine origin that is presented as a mixture of 65% insulin-zinc in crystalline form and 35% in
amorphous)
Excipients:
Methyl parahydroxybenzoate………………………………………………..1,00 mg
Water for injections, qs ………………………………………………….. 1,00 ml
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Injectable suspension.
4. CLINICAL DATA
4.1 Target species
Dogs and cats
4.2 Indications for use, specifying the target species
Indicated in cases of diabetes mellitus (absolute or relative insulin deficiency) in
dogs and cats, to reduce hyperglycemia and associated clinical symptoms
by individual adjustment of the dose of Caninsulin.
4.3 Contraindications
The drug should not be administered intravenously.
The medicinal product contains an insulin of porcine origin with a medium duration of action
and is not indicated for the initial treatment of animals with acute diabetes mellitus.
presenting in a ketoacidotic state.
Do not administer to animals with a history of hypersensitivity to products of origin
porcine or any of the components of the drug.
4.4 Special warnings for each target species

Due to day-to-day variation in blood glucose response and variations in
insulin responsiveness that is seen over time, the owners of the
Animals should be instructed to recognize the symptoms of hypo- or hyperglycemia and
Inform, where appropriate, your veterinarian about any possible unusual effect detected,
including those related to the efficacy of the drug.
4.5 Special precautions for use
Special precautions for use in animals
Avoid stress and excessive and irregular exercise. Also, the use of corticosteroids should
be done with caution.
The use of progestogens (estrous inhibitors) should be avoided in patients suffering from
Mellitus diabetes. In entire bitches, ovariohysterectomy should be considered as
option.
It is important to establish a strict feeding scheme that includes the minimum
possible fluctuations and changes.
After establishing the maintenance dose, they should be checked periodically
glucose levels in blood and urine.
Before administering Caninsulin, owners should be advised to keep a
box of glucose powder Clinical symptoms of hunger, increased anxiety,
unsteady walking, muscle twitching, stumbling or flexing of the hindquarters and
disorientation of the animal, indicate hypoglycemia and require the immediate administration of
glucose solution and/or food to restore normal glucose concentrations
blood.
The drug must be administered with specific single-use sterile syringes.
40 IU (vial) or with VetPen (cartridge).
Special precautions to be taken by the person administering the medicinal product
to the animals
Accidental self-injection may cause clinical symptoms of hypoglycemia that should be
be treated with oral administration of glucose.
Accidental self-injection may cause hypersensitivity (allergy) reactions.
In the case of insulin-dependent diabetics, take extreme precautions when
administer the medication.
In case of accidental self-injection, see a doctor immediately and show him the
leaflet or label.
4.6 Adverse reactions (frequency and seriousness)
On rare occasions (more than 1 but less than 10 animals in 10.000) there have been
observed alterations in blood glucose levels, having manifested in
systemic signs such as polyuria-polydipsia, lethargy, weakness, and anorexia; disorders

neurological such as muscle tremor, seizures and ataxia, and disturbances of
behavior. Local hypersensitivity reactions have also been observed, in the
injection site and general and gastrointestinal disturbances such as vomiting and
diarrhea. In case these symptoms appear, it is recommended to follow the precautions
established for its use and, if necessary, institute a symptomatic treatment.
4.7 Use during pregnancy, lactation or lay
Caninsulin does not present risks of use during the periods of pregnancy and lactation,
but requires close veterinary supervision to detect changes in the
metabolic requirements during them.
4.8 Interaction with other medicinal products and other forms of interaction
The administration of substances that impair glucose tolerance, such as
corticosteroids, thiazide diuretics, progestogens, and alpha-2 agonists such as
medetomidine, dexamedetomidine, xylacine and amitraz, may lead to changes in the
insulin needs. Monitoring of the concentrations of
blood glucose to adjust the dose accordingly. The use of
progestin in animals suffering from diabetes mellitus and consideration should be given to the
ovarian hysterectomy.
Similarly, changes in diet or exercise can alter energy requirements.
insulin
4.9 Amounts to be administered and administration route
Caninsulin should be administered once or twice daily, as appropriate, via
subcutaneous injection. Alternate the injection site daily. shake the vial
vigorously until a homogeneous suspension with a milky appearance is obtained. Has to
surface foam formed during agitation be allowed to disperse before
before using the product and, if necessary, the product should be mixed gently to
Keep the suspension homogeneous, with a uniform milky appearance before use.
Agglomerates may form in insulin suspensions: do not use the product if
after vigorous shaking, visible agglomerates persist.
For the vial, the drug must be administered with specific sterile syringes from a
I only use 40 IU.
The cartridge is designed to be used with the VetPen dispensing device. VetPen
It is accompanied by a leaflet with detailed instructions that must be followed for its
utilization.
One injection a day is sufficient to lower the blood glucose concentration in the
most diabetic dogs. However, the duration of action may vary.
necessitating twice-daily dosing of insulin in some dogs
diabetics
In diabetic cats it is necessary to administer Caninsulin twice a day.

The dose depends on the degree of deficiency in the production of insulin by the animal itself.
and is, therefore, different in each case.
Stabilization phase
- Dog: Insulin therapy is started with a starting dose of 0,5 – 1 IU/kg of body weight once
once a day rounding down to the lowest whole number of units.
In order to reduce the risk of hypoglycemia, it is recommended to administer the dose
lowest within the starting dose range.
Subsequently, the adjustment must be made to establish the maintenance dose.
increasing or decreasing the daily dose by approximately 10% according to the evolution
of the clinical signs of diabetes and the results of serial determinations of
Blood glucose. Dose modifications should not normally be made with
a frequency greater than between 3 and 7 days.
In some dogs the duration of insulin action may require treatment
is administered twice a day. In such cases, the dose per injection should be reduced by a
25% so that the total daily dose is less than double. For example, for a dog
10 kg receiving 5 IU once a day, the new dose (rounded down to the unit
lower integer) would be 3 IU per injection initially. The two daily doses should be
administered with an interval of 12 hours. Subsequent dose adjustments should
be done progressively as indicated above.
To achieve a balance between glucose generation and drug effect, the
feeding must be synchronized with the treatment and the daily ration must be divided into two
same meals. The composition and quantity of the daily feed intake should be
constants. In dogs treated once a day, the second meal is usually
at the time of peak insulin effect (approximately 7,5 hours later). In
dogs treated twice daily, food coincides with Caninsulin administration.
Each meal should be done every day at the same time.
- Cat: The starting dose is 1 or 2 IU per injection depending on the baseline of the
blood glucose concentration, as presented in the following table. The cats
They require two administrations per day.

The starting dose should not be more than 2 IU per injection.
Subsequently, the adjustment must be made to establish the maintenance dose.
increasing or decreasing the daily dose according to the evolution of the results of the
Serial blood glucose determinations. Dose modifications
they should not normally be done more often than once a week. HE
recommend increases of 1 IU per injection. Ideally, they should not be administered more
2 IU per injection in the first 3 weeks of treatment. Due to day variation
to day of blood glucose response and insulin receptivity variations

that is being seen over time, larger or larger dose increases are not recommended.
more frequent.
The composition and amount of the daily feed intake should be constant.
Maintenance phase in dogs and cats
Once the maintenance dose has been reached and the animal is stabilized, it is
It is necessary to establish a long-term treatment program. The goal should be to treat
to the animal in a way that minimizes variations in its insulin requirements.
This includes clinical monitoring to detect under- or overdoses of insulin and
adjust the dose if necessary. Stabilization and meticulous monitoring
help limit chronic problems associated with diabetes, including cataracts
(dogs), fatty liver (dogs and cats), etc.
Follow-up exams by the veterinarian should be performed every 2-4 months (or more at
often if there are problems) to monitor the health of the animal, the annotations of the
owners and biochemical parameters (such as blood glucose and/or concentration of
fructosamine). Adjustments in insulin dosage should be made by the veterinarian at
based on the interpretation of clinical signs supported by laboratory results.
The Somogyi effect, also called rebound hyperglycemia, is a response to a
enough insulin overdose to cause potentially fatal hypoglycemia. TO
As hypoglycemia begins to develop, a response is triggered.
hormone that results in the release of glucose from glycogen stores
hepatic. This produces a rebound hyperglycemia that can also manifest
as glycosuria during a part of the 24-hour cycle. There is a danger that the effect
Somogyi is interpreted as a need to increase the insulin dose instead of
decrease it. This can be avoided by basing the decision on serial determinations of
blood glucose instead of single point determinations.
The owners ability to recognize the symptoms of hypo- or hyperglycemia and
responding properly is very important
4.10 Overdose (symptoms, emergency procedures, antidotes), if
necesario
Insulin overdose results in the symptoms of hypoglycemia. The signs
Symptoms may include hunger, restlessness, tremors, ataxia, disorientation,
seizures and coma; some animals just stay very still and stop eating. The
Immediate oral administration of a glucose source (1 g/kg body weight) may relieve
these signs. After emergency glucose administration should be provided
small amounts of food repeatedly at 1-2 hour intervals.
Owners and veterinarians should be aware of the possible development of an effect
Somogyi, since it is dangerous to interpret it as a need to increase the dose of
insulin instead of decreasing it. This situation can lead to an overdose
severe enough to produce clinical hypoglycemia that can lead to
death of the animal

4.11 Timeout
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for
intermediate acting injection. porcine insulin.
ATCvet code QA10AC03.
5.1 Pharmacodynamic properties
The active substance, highly purified porcine insulin, is a naturally occurring hormone produced
by the β cells of the islets of Langerhans in the pancreas. The overall effect of the
insulin is to promote the anabolic state.
Insulin facilitates the intake of glucose obtained from food or glycogenogenesis,
by cells and activates intracellular enzymes involved in the utilization and
storage of glucose, amino acids and fatty acids. Insulin also inhibits
catabolic processes such as proteolysis, gluconeogenesis and lipolysis.
Diabetes mellitus is characterized by absolute or relative deficiency of insulin that
leads to persistent hyperglycemia because the entry of glucose into the cells
it is inhibited.
Caninsulin contains an insulin whose action is of intermediate duration, being
composed of 35% amorphous fraction, which produces its effects around 3
hours after injection and for 6-8 hours and a 65% crystalline fraction, slower,
whose maximum effect occurs at 7 – 12 hours and lasts around 16 – 24 hours.
In diabetic dogs, the action of Caninsulin on plasma concentrations of
Glucose, after subcutaneous administration, reaches a maximum around 4-8 hours
after injection and is maintained for 14-24 hours. In diabetic cats, the
subcutaneous administration, it reaches its maximum around 4 – 6 hours and
maintains for 8-12 hours after injection.
5.2 Pharmacokinetic data
In diabetic dogs, the peak plasma insulin concentration occurs at 2-6
hours after subcutaneous administration and insulin remains above the
pre-injection levels for about 14 to 24 hours.
In diabetic cats, peak plasma concentrations occur around the
1,5 hours after subcutaneous administration and insulin remains at levels
higher than those prior to administration for 5-12 hours.
6. PHARMACEUTICAL DATA
6.1 List of excipients

Methyl parahydroxybenzoate
zinc chloride
sodium acetate trihydrate
Sodium chloride
Hydrochloric acid or sodium hydroxide (to adjust the pH))
Water for injections
6.2 Incompatibilities
In the absence of incompatibility studies, this medicinal product must not be mixed with
no other, particularly with any insulin-based preparation.
6.3 Validity period
Shelf life of the veterinary medicinal product packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 20 days.
6.4. Special storage precautions
Store upright and refrigerated (between 2ºC and 8ºC).
Protect from light.
Do not freeze.
After the first opening of the container, store at a temperature below 25 ºC.
6.5 Nature and composition of immediate packaging
Caninsulin is featured in:
– Glass vials (type I of the Farm. Eur.) closed with rubber stoppers
butylhalogenated and sealed with an aluminum capsule. The vials contain 2,5
ml of suspension.
– Glass cartridges (type I of the Farm. Eur.) closed with a two-layer rubber closure
(bromobutyl rubber/synthetic isoprene) sealed with an aluminum capsule and with
a bromobutyl rubber plunger on the opposite side.
Formats:
Box with 10 vials of 2,5 ml.
Box with 10 cartridges of 2,7 ml.
6.6 Special precautions for disposal of the veterinary medicinal product not
used or, where appropriate, the residues derived from its use
Any unused veterinary medicinal product or residues derived from it must be
disposed of in accordance with current regulations.
7. MARKETING AUTHORIZATION HOLDER
Merck Sharp & Dohme Animal Health, SL
El Montalvo I Industrial Estate
C/ Zeppelin, nº 6, plot 38
37008 Carbajosa de la Sagrada

Salamanca
8. MARKETING AUTHORIZATION NUMBER
869 ESP
9. DATE OF THE FIRST AUTHORIZATION OR RENEWAL OF THE
AUTHORIZATION
January 14, 1994
10. DATE OF REVISION OF THE TEXT
December 2013
PROHIBITION OF SALE, DISPENSATION AND/OR USE
Dispensing conditions: Medicine subject to a veterinary prescription
Administration conditions: Administration under the control or supervision of the
veterinarian.
Veterinary drug with a prescription that can be renewed

See technical sheet