ProZinc

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

Insulin human

Saadav alates:

Boehringer Ingelheim Vetmedica GmbH

ATC kood:

QA10AC01

INN (Rahvusvaheline Nimetus):

insulin human

Terapeutiline rühm:

Cats; Dogs

Terapeutiline ala:

Insulins and analogues for injection, intermediate-acting

Näidustused:

For the treatment of diabetes mellitus in cats and dogs to achieve reduction of hyperglycaemia and improvement of associated clinical signs.

Toote kokkuvõte:

Revision: 9

Volitamisolek:

Authorised

Loa andmise kuupäev:

2013-07-12

Infovoldik

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET:
PROZINC 40 IU/ML SUSPENSION FOR INJECTION FOR CATS AND DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE,
IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch
release:
Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 173
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
KVP Pharma + Veterinär Produkte GmbH
Projensdorfer Str. 324
24106 Kiel
GERMANY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ProZinc 40 IU/ml suspension for injection for cats and dogs
insulin human
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each ml contains:
ACTIVE SUBSTANCE:
Insulin human*
40 IU as protamine zinc insulin.
One IU (International Unit) corresponds to 0.0347 mg of insulin human.
*produced by recombinant DNA technology
EXCIPIENTS:
Protamine sulfate
0.466 mg
Zinc oxide
0.088 mg
Phenol
2.5 mg
Cloudy, white, aqueous suspension.
4.
INDICATION(S)
For the treatment of diabetes mellitus in cats and dogs to achieve
reduction of hyperglycaemia and
improvement of associated clinical signs.
5.
CONTRAINDICATIONS
Do not use for the acute management of diabetic ketoacidosis.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
26
6.
ADVERSE REACTIONS
Hypoglycaemic reactions were very commonly reported in clinical
studies: 13% (23 of 176) of treated cats
and 26.5% (44 of 166) of treated dogs. These reactions were generally
mild in nature. Clinical signs may
include hunger, anxiety, unstable locomotion, muscle twitching,
stumbling or sinking in the rear legs and
disorientation.
In this case immediate administration of a glucose containing solution
or gel and/or food is required.
Insulin administration should be temporarily stopped and the next dose
of insulin adjusted appropriately.
Local injection site reactions were very rarely reported and resolved
without cessation of therapy.
The frequency of adverse rea

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ProZinc 40 IU/ml suspension for injection for cats and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Insulin human*
40 IU as protamine zinc insulin.
One IU (International Unit) corresponds to 0.0347 mg of insulin human.
*produced by recombinant DNA technology
EXCIPIENTS:
Protamine sulfate
0.466 mg
Zinc oxide
0.088 mg
Phenol
2.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Cloudy, white, aqueous suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats and dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of diabetes mellitus in cats and dogs to achieve
reduction of hyperglycaemia and
improvement of associated clinical signs.
4.3
CONTRAINDICATIONS
Do not use for the acute management of diabetic ketoacidosis.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Very stressful events, inappetance, concomitant treatment with
gestagens and corticosteroids or other
concomitant diseases (e.g. gastro-intestinal, infectious or
inflammatory or endocrine diseases), might
influence insulin effectiveness and therefore the insulin dose may
need to be adjusted.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The insulin dose may need to be adjusted or discontinued in case of
remission of the diabetic state in cats or
3
after resolution of transient diabetic stages in dogs (e.g.
dioestrus-induced diabetes mellitus, diabetes mellitus
secondary to hyperadrenocorticism).
After the daily insulin dose is established, monitoring for diabetic
control is recommended.
Treatment with insulin can cause hypoglycaemia, for clinical signs and
appropriate treatment, see section
4.10.
Special precautions for use in dogs
In cases where hypoglycaemia is suspected, blood glucose measurements
should be taken at the time of
occurr