Neocell

Spasmium comp. 500 mg/ml + 4 mg/ml
solution for injection

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:

Active substances:
Metamizole sodium monohydrate    500.0 mg
(equivalent to 443 mg metamizole)

Hyoscine butylbromide    4.0 mg
(equivalent to 2.76 mg hyoscine)

Excipient:
Phenol (as preservative)    5.0 mg

Clear, yellowish solution.


INDICATION(S)
Horses, cattle, pigs, dogs: For treatment of spasms or sustained increased tonus of smooth muscles of the gastro-intestinal tract or of the urine and bile excretory organs associated with pain.

Additional specific indication in horses: Spastic colics

Additional specific indication in cattle, pigs, dogs: As supportive therapy of acute diarrhoea

CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances or to any of the excipients.

Do not use in cases of:
-    gastro-intestinal ulceration
-    chronic gastro-intestinal disorders
-    mechanic stenoses in the gastro-intestinal system
-    paralytic ileus in horses
-    disorders of the haematopoietic system
-    blood clotting disorders
-    renal insufficiency
-    tachyarrhythmia
-    glaucoma
-    prostate adenoma.

ADVERSE REACTIONS
In horses and cattle, a slight increase in heart rate may be observed occasionally due to the inhibitory effect of hyoscine butylbromide on the parasympathetic system.
In dogs painful reactions at the injection site can occur immediately after injection, which abate rapidly and have no negative impact on the expected therapeutic benefit.
In very rare cases, anaphylactic reactions may occur and should be treated symptomatically.    

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

TARGET SPECIES
Horses, cattle, pigs, dogs

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Horse, cattle:    intravenous use
Pig:            intramuscular use
Dog:            intravenous or intramuscular use

Dosage instruction:

Horse:        25 mg metamizole sodium monohydrate/kg body weight and
            0.2 mg hyoscine butylbromide/kg body weight (i.e. 2.5 ml per 50 kg)

Cattle:        40 mg metamizole sodium monohydrate/kg body weight and
            0.32 mg hyoscine butylbromide/kg body weight (i.e. 4 ml per 50 kg)

Calf:            50 mg metamizole sodium monohydrate/kg body weight and
            0.4 mg hyoscine butylbromide/kg body weight (i.e. 1 ml per 10 kg)

Pig:            50 mg metamizole sodium monohydrate/kg body weight and
            0.4 mg hyoscine butylbromide/kg body weight (i.e. 1 ml per 10 kg)

Dog:            50 mg metamizole sodium monohydrate/kg body weight and
            0.4 mg hyoscine butylbromide/kg body weight (i.e. 0.1 ml per kg)

Treatment frequency:
Cattle and calves: up to twice daily for three days.
Horses and pigs: single injection.
Dogs: single injection. Treatment can be repeated after 24 hours if necessary.

The stopper must not be punctured more than 25 times.

ADVICE ON CORRECT ADMINISTRATION
See section 12. “Special warnings” in the package leaflet.

WITHDRAWAL PERIOD
Meat and offal:
Horse, cattle (IV)    12 days
Pig (IM)    15 days

Milk:
Cattle (IV)    4 days

Do not use in mares whose milk is intended for human consumption.

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 vial and carton label after “EXP”. The expiry date refers to the last day of that month.  
Shelf life after first opening the container: 28 days
After first opening do not store above 25°C.
When the container is broached for the first time write in the space provided on the label the date on which any product remaining in the container is to be discarded.

SPECIAL WARNING(S)
Special warnings for each target species
None.

Special precautions for use in animals
Due to the risk of anaphylactic shock metamizole-containing solutions should be administered slowly when given intravenously.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Take care to avoid self-injection. In a very small number of people, metamizole can cause reversible, but potentially serious agranulocytosis and other reactions such as skin allergy.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
People with known hypersensitivity to metamizole or hyoscine butylbromide should avoid contact with the veterinary medicinal product. Avoid use of the product if you are known to be sensitive to pyrazolones, or are sensitive to acetylsalicylic acid.
Wash splashes from skin and eyes immediately.

Use during pregnancy and lactation:
Studies in laboratory animals (rabbit, rat) have not produced any evidence of a toxic effect on reproduction. No information on use during pregnancy in the target species is available. An effect upon the smooth muscles of the birth canal can occur. Metabolites of metamizole cross the placental barrier and penetrate into milk. Therefore this product should be used only according to the benefit-risk assessment by the responsible veterinarian.

Interaction with other medicinal products and other forms of interaction:
The effects of metamizole and/or hyoscine butylbromide may be potentiated by concurrent use of other anticholinergic or analgesic substances.
Concomitant use of inducers of hepatic microsomal enzymes (e.g. barbiturates, phenylbutazone) reduces the half-life period and hence the duration of action of metamizole. Simultaneous administration of neuroleptics, especially phenothiazines derivatives, may lead to severe hypothermia. Furthermore the risk of gastro-intestinal bleeding is increased upon concurrent use of glucocorticoids. The diuretic effect of furosemide is attenuated.
Co-administration of other weak analgesics increases the effects and side-effects of metamizole.

The anticholinergic action of chinidin and antihistaminics as well as the tachycardic effects of β sympathomimetics may be enhanced by this veterinary medicinal product.

Overdose (symptoms, emergency procedures, antidotes):
The acute toxicity of both active substances is very low. In studies with rats the symptoms were non specific and included: ataxia, dilation of pupils, increased heart rate, exhaustion, convulsions, unconsciousness and respiratory signs.
In case of overdosage treatment should be discontinued. Physostigmin is recommended as an antidote to hyoscine butylbromide. A specific antidote for metamizole sodium is not available. Therefore symptomatic treatment should be initiated in case of overdosage.

Due to the inhibitory effect of hyoscine butylbromide on the parasympathetic system a slight increase in the heart rate was observed in some cases in horses and cattle following administration of the double therapeutic dose.

Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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.

OTHER INFORMATION
Pack sizes: 100 ml, 5 x 100 ml
Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

M.A. numbers  22725 / 9-3-2016