SUMMARY OF PRODUa CHARAaERISTICS :
1. PRODUCT NAME
Maxilase 200 U.CEIP / ml Syrup
2. OUALlTATlVE AND OUANTITATIVE COMPOSITION
Each milliliter of syrup contains 200 U.CEIP alpha-amylase.
It contains excipients:
Sucrose: 640 mg / ml
For Methyl-hydroxybenzoate sodium: 0.094 mg / ml
For propyl-hydroxybenzoate sodium: 0.3 mg / ml
Glycerol 9 mg / ml
Sunset yellow (Ell0): 0.015 mg/ ml
Sodium 0.047 mg / ml (as sodium methyl parahydroxybenzoate and
Sodium propyl parahydroxybenzoate)
Full list of excipients-see section 6.1.
3. PHARMACEUTICAL FORM
4.1 Therapeutic Indications :
Therapy and prophylaxis of edema in various situations. An adjunct to antibiotic therapy, in the following indications:
– Rhinoplasty, tonsillectomy;
– Various Interventions (sinusitis, laryngectomy, nasal polipectomia, nasal septum resection)
– Tonsillitis pharyngitis, sinusitis, laryngitis, Rhino trachea bronchitis
– Bronchitis, acute and chronic lung disease;
– Respiratory complications of infectious diseases, etc.
– Maxillo-facial surgery
– Extractions of impacted teeth;
– Multiple or simple extractions;
– Various interventions; apical resection, bone grafts, excision of the submaxillary glands
Periodontitis (complementary treatment).
Orthopedics and traumatology
– Edema post – traumatic and post-surgical;
– Simple Injuries (face , .. )
– Reduced fractures or orthopedic surgery;
– Intra-articular interventions (Meniscectomy, foreign bodies);
– Reconstructive surgery (tendons);
– Plastic surgery; skin grafts, rhinoplasty;
– Facial trauma; wounds of the face with or without fractures;
– Interventions in soft tissues.
4.2 Dosage and method of administration
Method of administration: Oral.
The power of enzyme alpha-amylase is expressed in U. IEPe. (Enzyme weight hydrolyses 1 mg of soluble starch in 10 seconds at 37°C). Infants and children up to 3 years of age (15 kg): 1 teaspoon (5 ml) 3 times a day (5 ml of syrup contain U. IEPC 1000)
Children over 3 years of age (> 15 kg): 1 tablespoon (10 ml) 3 times per day (10 ml syrup contain U.CEIP 2000)
Adults: 1 tablespoon (15 ml) 3 times a day. (15 ml syrup contain 3.000 U.CEIP).
4.3 Contra – indications
Hypersensitivity to alpha-amylase or any of the excipients.
4.4 Special warnings and precautions for use
Due to the presence of sucrose, patients with rare hereditary problems of intolerance the fructose, glucose-galactose malabsorption or sucrase- isomaltase insufficiency, should not take this medicine. Diabetics should take into account that a teaspoon (5 ml) contains 3.2 g of sucrose and a tablespoon (15 ml) contains 9.6 g sucrose. Maxilase syrup contains sunset yellow (Ell0) which may cause allergic reactions. Maxilase syrup contains sodium parahydroxybenzoate and methyl parahydroxybenzoate sodium propyl which may cause allergic reactions (possibly delayed).
Special precautions for use:
In the case of persistence or appearance of new symptoms (severe sore throat.headaches. nausea, vomiting) or in case of associated fever, must be reevaluated to therapeutic strategy.
This medicine should not be used for long periods of time without the physician advice
4.5 Drug interactions and other forms of interaction
There are no known interactions of accounts between alpha amylase and otlu medicines.
4.6 Pregnancy and lactation
As regards alpha-amylase, no clinical data is available on the pregnancy Animal studies revealed no harmful effects direct or indirect on pregnancy, embryo-fetal development and delivery. This medecine should only be prescribed to pregnant women with extreme caution
It is not known if the alpha amylase passes into human breast milk. This medicine should be avoided the for use during breastfeeding.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
Adverse reactions were positioned according to the organ system classification
– Class and frequency using the following convention: very common (~ 1/10);
Common (~ 1/100, <1/10); uncommon (~ 1/1000, <1/100); rare (~ 1/10000 < 1/1000); very rare «1/10000).
Skin and subcutaneous tissue disorders:
– Very rare: urticaria type of eruptions.
No case of overdose of this medicine.
In case of accidental ingestion, should start appropriate treatment.
5. Pharmacological Properties
5.1 Pharmacodynamic properties:
pharmacotherapeutic group: 9.5 locomotor apparatus. anti-inflammatory enzymes.
Enzymatic Preparation of anti-edematous and anti-inflammatory activity. The mode of action of alpha-amylase in inflammatory edema is characterized by:
– Hydrolysis with polysaccharides inflammatory exudate, making it more fluid
– Inhibition of abnormal capillary permeability (which is increased during the first stage of inflammation) by decreasing the output of liquids from vessels allowing easier edema resorption.
5.2 Pharmacokinetic properties
Alpha-amylase is an endoamylase that catalyzes the starch molecules on the links of glucosides so there are no pharmacokinetic data.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies for safety, pharmacology, repeated dose, toxicity; genetic or, reproductive, potential carcinogenicity and.
6. PHARMACEUTICAL :
6.1 List of excipients
sucrose;Para-hydroxybenzoate sodium methyl;Para hydroxybenzoate sodium propyl;glycerol;soluble tangerine essence (S 164); Sunset Yellow (E110);
Citric acid monohydrate (q.s. pH 6.5-7.0);
Pu rified water.
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25 0 C.
6.5 Nature and contents of container
amber glass bottle with tamper evident seal Type III in white opaque polyethylene
average density and capacity of 100 ml.
Pack of 1 bottle with 100 ml of syrup.
6.6 Special precautions for disposal
No special requirements.
7. MARKETlN(j AUTHORIZATION HOLDER MARKETlNG :
SANOFI-AVENTIS – Pharmaceuticals, SA
Manufactured by Sanofi-Egypt