Special Warning : אזהרת שימוש

4.4       Special warnings and precautions for use
V-DALGIN CONCENTRATED SYRUP FOR ADULTS contains the pyrazolone derivative Dipyrone and bears the rare, but life-threatening risks of shock and agranulocytosis (see section 4.8).
Patients showing anaphylactoid reactions to this medical product are particularly at risk to react similarly to other non-narcotic analgesics.
Patients showing an anaphylactic or another immunologically mediated reaction to this medical product (e.g. agranulocytosis), are particularly at risk to react similarly to other pyrazolones and pyrazolidines medical products.
Patients showing an anaphylactic or other immunologically mediated reaction to other pyrazolones, pyrazolidines or other non-narcotic analgesics medical products, are also at high risk to react correspondingly to this medical product.
Agranulocytosis
Already in the event of neutropenia (<1,500 neutrophils/mm3), treatment must be stopped immediately, and the full blood count be monitored until it has normalized.
Patients must be informed that the use of this medicinal product must be stopped immediately and a physician must be seen if the following signs and symptoms occur: unexpected deterioration of the general condition (such as fever, chills, sore throat, swallowing problems), non-ceasing or new occurrence of fever and painful changes of the mucosa, in particular in the region of the mouth, nose and throat or in the genital or anal region. Use of this medicinal product must be stopped immediately and the blood count (including differential blood count) must be checked. Discontinuation of treatment must not be deferred until the results of the laboratory tests are available (see section 4.8).
Thrombocytopenia
If signs of thrombocytopenia, such as increased tendency to bleeding and petechiae on the skin and mucosal membranes, occur (see section 4.8), the use of this medical product must be stopped and the blood count (including differential blood count) must be checked immediately. Discontinuation of treatment must not be deferred until the results of the laboratory tests are available.
Pancytopenia
In the event of pancytopenia, treatment must be discontinued immediately, and the full blood count must be monitored until it has normalized (see section 4.8). All patients should be informed that they should immediately see a physician if signs of disease and symptoms occur during treatment, which indicate blood dyscrasia (e.g. general malaise, infection, persistent fever, effusions, bleeding, paleness).
Anaphylactic/anaphylactoid reactions
When selecting the method of application, please consider that the parenteral administration of this medical product is associated with a higher risk for anaphylactic or anaphylactoid reactions.
The risk of potentially severe anaphylactoid reactions to this medical product is obviously increased in patients with:
-   Analgesic asthma syndrome or analgesic intolerance of the urticaria-angioedema type (see section 4.3).
-   Bronchial asthma, in particular with simultaneously existing rhinosinusitis and nasal polyps, -   chronic urticaria.
-   Alcohol intolerance. Such patients react already to small quantities of alcoholic beverages with symptoms such as sneezing, watering eyes and severe facial reddening. Such an alcohol intolerance might be an indication of an analgesic asthma syndrome not yet diagnosed to date (see section 4.3).
An anaphylactic shock may predominantly occur in sensitive patients. Therefore, particular caution should be taken for the use in patients with asthma or atopy.
The patient must be asked accordingly before the administration of this medical product. In patients with an increased risk for anaphylactoid reactions, this medical product must only be used following careful weighing of possible risk against the expected benefits (see also section 4.3). If this medical product is administered in such cases, the patient must be monitored at close intervals by a physician and readiness for cases of emergency must be ensured.
Severe cutaneous reactions
Severe cutaneous skin reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which might be life-threatening or fatal, were reported in connection with Dipyrone treatment.
The patients must be informed about the signs and symptoms and be monitored closely for skin reactions.
If signs and symptoms occur that indicate these reactions, Dipyrone should be discontinued immediately and treatment with Dipyrone must at no point be resumed (see section 4.3).
Drug-induced liver damage
Cases of hepatitis, which had a predominantly a hepatocellular pattern and which occurred within a few days up to a few months after the start of treatment, were reported in patients who were treated with Dipyrone. Signs and symptoms included increased liver enzyme values in serum with or without jaundice, often in connection with other drug hypersensitivity reactions (e.g. rash, changes in the blood count, fever and eosinophilia) or accompanied by features of autoimmune hepatitis. Most patients recovered after discontinuation of Dipyrone treatment. In individual cases, however, a progression to acute liver failure with need for liver transplantation was reported.
The mechanism of Dipyrone-induced liver damage is not clearly understood. The data, however, reveal indications of an immune-allergic mechanism.
Patients should be asked to contact their doctor if symptoms occur which indicate liver damage. In these patients, treatment with Dipyrone should be discontinued and the liver function should be checked.
Dipyrone should not be used again in a liver damage, for which no other cause could be found, occurred previously with Dipyrone treatment.
Isolated hypotensive reactions
This medical product might trigger hypotensive reactions (see also section 4.8). These reactions might depend on the dose. This is more likely with parenteral than with enteral administration.
The risk of such reactions is also increased in:
-   Patients with, for example, previous hypotension, volume deficiency or dehydration, unstable circulation or incipient circulation failure (such as in patients with myocardial infarction or polytrauma).
-   Patients with high fever.
Careful verification of the indication and monitoring at close intervals are therefore necessary in these patients. Preventative measures (such as stabilization of circulation) might be required to reduce the risk of hypotensive reactions.
This medical product must only be used with careful monitoring of the hemodynamic parameters in patients in whom a lowering of the blood pressure must be avoided under all circumstances, such as patients with severe coronary heart disease or relevant stenoses of the vessels supplying the brain.
This medical product should only be used following strict risk-benefit assessment and respective precautionary measures in elderly patients and patients with impaired kidney and liver function.
Children and adolescents:
This medical product is not intended for children under 15 years of age.
Monitoring and Laboratory Tests:
In the event of longer-term treatment with V-DALGIN CONCENTRATED SYRUP FOR ADULTS, regular monitoring of blood count is required, including differential blood count.
Excipients:

•   Sodium:
This medicinal product contains 41.38 mg sodium per unit dose of 2 ml, equivalent to 2% of the maximum daily dietary sodium intake of 2 g, recommended by the World Health Organization (WHO) for an adult.
•   Sucrose:
This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Additionally, teeth damage (caries) may occor only when the medical product is intended for chronic use, e.g. for two weeks or more.


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