ADRENALIN LEVEL
COMPOSITION PER 1 ml: Epinephrine (I.C.D.) 1 mg. Excipients: hydrochloric acid, chloretone, sodium bisulphite, sodium chloride, water for injection.
INDICATIONS: Shock or collapse. Copious hemorrhages. Asthma. Anaphylactic phenomena.
DOSAGE: In case of shock or collapse, 0.5 to 1 ml injected intramuscularly. For copious hemorrhages, 2 to 3 ml, by subcutaneous injection or even intravenously incorporated in 400 ml of physiological saline solution. For asthma, 1/2 ml, eventually associated with other medicines. In anaphylactic reactions, one to three tenths of a ml several times a day.
GUIDELINES FOR CORRECT USE: Separate the protective cover from the syringe cone by rotating. Insert needle in the syringe. Expel air and the syringe is ready for use. Inject intramuscularly or subcutaneously or even intravenously, incorporated in 400 ml of physiological saline solution. Warning: this syringe must be used once and then must be destroyed. Shared use constitutes a risk of infection.
CONTRAINDICATIONS: Arterial hypertension, pancreatic diabetes, hyperthyroidism.
INCOMPATIBILITIES: With those medicines which oppose its biological actions, such as acetylcholine, insulin, betaadrenergic blockers.
INTERACTIONS: Do not use with digitalis nor mercurial diuretics nor other sympathomimetic agents. The effects of epinephrine can be strengthened by tricyclic anti-depressants, Lthyroxine sodium and certain antihistamines, such as diphenhydramine, tripelennamine and Dchlorpheniramine. The epinephrine solution is incompatible with alkalis and oxidizing agents, such as oxygen, bromine, iodine, permanganate, chromates, nitrates and easily reducible metal salts, especially iron salts.
WARNING: If the solution is a brown color, or contains precipitate, it should not be used.
SIDE EFFECTS: Palpitations, cold sweat, hypertension. You must inform your doctor or your pharmacist of any adverse reaction not described in this prospectus.
INTOXICATION AND TREATMENT: An overdose of epinephrine may lead to severe toxic reactions, which in some cases may cause cerebrovascular hemorrhages, as a result of the increase in blood pressure, as well as pulmonary edemas, due to peripheral vasoconstriction and the cardiac stimulation produced. Dilators will be immediately taken, such as nitrites or alpha-blocking agents which counteract the pressure effects of the epinephrine. Cardiac arrhythmias may be palliated with the fast intake of anti-arrhythmic agents or beta blockers. In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone number: +34 91 562 04 20.
FORMATS AND PRICES
Single box with 1 syringe pre-filled with 1 ml of 1/1000.
National Code: 686444. Published price: 401 Ptas. Published price+VAT: 417 Ptas.
Clinical box of 50 syringes pre-filled with 1 ml of 1/1000.
National Code: 641670. Laboratory price: 10,395 Ptas. Published price: 12,158 Ptas. Published price+VAT: 12,644 Ptas.
Medicine must kept out of the reach of children.
BY PRESCRIPTION
ERN Laboratories Corp.
Pedro IV, 499 08020 Barcelona
Tel. +34 93 314 8011 Fax +34 93 314 4096
AFTA-JUVENTUS GARGLE
Local treatment of aphthas
and ulcerations in the buccal mucous membrane
COMPOSITION:
Hydrocortisone hemisuccinate (ICD)...... 60 mg
Benzalkonium chloride (ICD)...... 3 mg
Excipient: glycerine, q.s...... 30 mg
INDICATIONS:
Aphthas
Infectious stomatitis (mouth rot)
Catarrhal stomatitis
Muguet
DOSAGE: 2 or 3 applications a day on the affected area, making use of the stick-spatula (always according to the practitioner's prescription).
GUIDELINES FOR ITS CORRECT USE: After every use and before putting the stick-spatula into the bottle to get more liquid, it is advisable to clean the stick with cotton soaked in alcohol.
CONTRAINDICATIONS AND PRECAUTIONS: Treatment should not be prolonged for long periods nor for herpes-type diseases.
INCOMPATIBILITIES: It has no incompatibilities.
INTERACTIONS: Interactions have not been described in the topical use of this formula.
SIDE EFFECTS: Its prolonged application for weeks may cause symptoms of hypercorticism, which disappear when use is suspended.
INTOXICATION AND ITS TREATMENT: The ingestion of one container does not cause toxic effects, although the age and state of the patient must be considered in each case.
FORMAT AND PRICE:
Bottle with applicator, containing 30 ml.
Published price+VAT: 509 Ptas.
By prescription. Excluded from financing by the National Health System.
ERN Laboratories Corp.
Pedro IV, 49908020 Barcelona
APRIETAL COMPROMIDOS 160mg
COMPOSITION:
By tablet:
Paracetamol (D.C.I)……………….160mg
Excipìents: Sodium Saccharin, povidone, manitol, sodium carboxymethyl (type A), potato starch, talc, raspberry essence and azorubine (E-122)
ACTION: Analgesic, antipyretic.
POSOLOGY
Children:
From 0 to 3 months: ¼ of a tablet (40 mg)
From 4 to 11 months: ½ of a tablet (80 mg)
From 1 to 2 years: ¾ of a table (120 mg)
From 2 to 3 years: 1 tablet (160 mg)
From 4 to 5 years: 1 ½ tablet (240 mg)
From 6 to 8 years: 2 tablets (320 mg)
From 9 to 10 years: 2 ½ tablets (400 mg)
This dose can be repeated 4 or 5 times a day without exceeding a total of 5 doses in 24 hours. A dosage scheme of 10 mg/kg can also be applied.
The administration of the product is recommended at the onset of symptoms of pain or fever. When these symptoms disappear, treatment should be discontinued.
INSTRUCTIONS FOR CORRECT ADMINISTRATION: The tablets may be chewed, before a drink of water or other liquid. They may also be administered broken into a little water, milk or fruit juice.
COUNTERINDICATIONS: Disorders of the liver.
PRECAUTIONS: In patients with hepatic and/or renal insufficiency, anaemia, cardiac or pulmonary disorders, long treatments should be avoided.
Do not exceed the stated dose.
It is advisable to consult a doctor before using this product in under-threes or in treatments exceeding 10 days.
WARNING: “important for women”: IF you are pregnant, or believe that you may be so, consult your doctor before taking this medicine. The consumption of medication during pregnancy can be dangerous for the embryo or foetus, and must be monitored by your doctor.Warning regarding excipients: This medicine contains azorubine as an excipient. It can cause allergic reactions, including asthma, especially in patients allergic to acetylsalicylic acid.
SECONDARY EFFECTS: Hepatoxicity with high doses or prolonged treatments.
Occasionally cutaneous eruptions and haematological alterations, such as leucopenia and neutropenia, may occur.
INTERACTIONS: It can increase the toxicity of chloramphenicol.
In the case of treatment with oral anticoagulants it may be administered occasionally as analgesic of choice.
INTOXICATION AND ITS TREATMENT: The symptomology of overdose includes sickness, vomiting, loss of appetite, jaundice and abdominal pain. In case of an overdose the affected person must go to a Medical Centre immediately, even if no symptoms have yet appeared. Even though the symptoms of overdose are very severe, they do not usually appear until the third day after it occurs.
In adults, an overdose of paracetamol is considered to be a single dose of more than 6g, and in children a dose of more than 100mg/kg of weight. Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to an overdose of paracetamol.
The treatment consists of aspiration and gastric lavage, activated charcoal orally, intravenous administration of an adequate dose of N-acetylcysteine, and if necessary haemodialysis.
The period in which the treatment offers most guarantee of success is during the 12 hours after the ingestion of the overdose.
In the event of overdose or accidental ingestion consult El Servicio de Información Toxocológica. Tel (91) 562 04 20.
PRESENTATION AND PRICE
Packet with 20 x 160mg paracetamol tablets.
P.V.P IVA 225 ptas. (1.36 EUR) C. N. 947457
Available without prescription. Can be financed by S.N.S. S.N.S subsidy at normal rate.
APIRETAL SUPOSITORIOS NIÑOS
Read the whole of this prospectus in detail, because it contains information that will be important to you.
This medication can be obtained without a prescription for the treatment of minor afflictions without the intervention of a doctor. However, you must use APRIETAL SUPOSITORIOS NINOS with care to obtain the best results.
-Keep this prospectus, you may need to read it again.
-If you have any doubts, consult your doctor or pharmacists.
This medicine has been prescribed to you and must not be given to others. It may harm them, even when their symptoms are the same as yours.
IN THIS PROSPECTUS:
- WHAT ARE APIRETAL SUPOSITORIOS NINOS AND WHAT ARE THEY USED FOR?
- BEFORE USING APIRETAL SUPOSITORIOS NINOS
- HOW TO USE APIRETAL SUPOSITORIOS NINOS
- POSSIBLE ADVERSE EFFECTS
- STORAGE OF APIRETAL SUPOSITORIOS NINOS
APIRETAL SUPOSITORIOS NINOS 250mg
Paracetamol (D.C.I)
APIRETAL SUPOSITORIOS NINOS is presented in suppository form. Its active principle is paracetamol. Each suppository contains 250 mg of paracetamol (D.C.I)
The remaining components are solid semisynthetic glycerides.
COMMERCIALIZATION AND PRODUCTION
The owners of the commercialization and production rights for this product are
Laboratorios ERN SA
Pedro IV, 499-08020 Barcelona, España
WHAT ARE APIRETAL SUPOSITORIOS NINOS AND WHAT IS IT USED FOR?
APIRETAL SUPOSITORIOS NINOS is a medication which is presented in suppository form. It comes in a pouch containing 5 suppositories.
APIRETAL SUPOSITORIOS NINOS belongs to the Non-narcotic Analgesic and Antipyretic pharmacotherapeutic group.
APIRETAL SUPOSITORIOS NINOS is used in the treatment of:
- Pain of light and moderate intensity
- Fevers
BEFORE USING APRIETAL SUPOSITORIOS NINOS
Don’t use APRIETAL SUPOSITORIOS NINOS:
- If the patient suffers from any hepatic illness
- If the patient is hypersensitive to paracetamol
Take special care with APRIETAL SUPOSITORIOS NINOS: If the patient suffers from hepatic or renal weakness, anaemia, serious heart disease or chronic alcoholism. In these cases administration must be under the supervision of a doctor, and prolonged treatments must be avoided.
PREGNANCY: Consult your doctor or pharmacist before taking this medication.
There have been no problems described for pregnant women who have taken paracetamol.
BREASTFEEDING: Consult your doctor or pharmacist before taking this medication.
Paracetamol is excreted in small quantities through breast milk. Its use is accepted during breastfeeding.
DRIVING AND USE OF MACHINERY: No effects have been described on the capacity to drive and use machinery.
USE OF OTHER MEDICATION: Inform your doctor or pharmacist if the patient is taking or has recently taken any other medication- including those which do not require a prescription.
Remember that these instructions apply equally to medicines that might be taken before and those taken after this product.
It can increase the toxicity of chloramphenicol.
In the case of treatment with oral anticoagulants it may be administered occasionally as analgesic of choice.
Paracetamol can alter the value of the following analytical determinations: In blood: (biological) increase in transaminases (ALT and AST), alkaline phosphatase, ammonia, bilirrubine, creatine, dehydrogenase lactate (LDH) and urea: increase (analytical interference) of glucose, teophiline and uric acid.
The chronic use of barbiturates (except butalbital) or primidone diminishes the therapeutic effects of paracetamol. It must be taken into account that hepatic enzyme inducers may produce similar effects,
Prolonged simultaneous use of paracetamol and salicylates due to chronic administration of elevated doses of both analgesics significantly increases the risk of nephropathy, renal papillary necrosis, terminal kidney illnesses and bladder or kidney cancer caused by analgesics.
HOW TO USE APIRETAL SUPOSITORIOS NINOS
Follow these instructions unless your doctor has advised you otherwise.
Remember to take your medication.
If you believe APIRETAL SUPOSITORIOS NINOS is too weak or too strong, advise your pharmacist or doctor.
APIRETAL SUPOSITORIOS NINOS is administered rectally.
Do not exceed the recommended dose.
ADMINISTRATION:
The recommended dose for paracetamol in paediatrics is as follows:
From 0 to 3 months 40 mg
From 4 to 11 months 80 mg
From 1 to 2 years 120 mg
From 2 to 3 years 160 mg
From 4 to 5 years 240 mg
From 6 to 8 years 320 mg
From 9 to 10 years 400 mg
Above 10 years 480 mg
This dosage can be repeated 4 or 5 times a day without exceeding a total of 5 doses in 24 hours.
A dosage scheme of 10 mg/kg can also be applied. This dosage is equivalent to 1 APIRETAL SUPOSITORIOS NINOS suppository (250 mg of paracetamol) for children of 4-6 years and 1 APIRETAL SUPOSITORIOS ADULTOS suppository (500 mg of paracetamol) for children over 10 years old.
The administration of the product is recommended at the onset of symptoms of pain or fever. When these symptoms disappear, treatment should be discontinued.
IF YOU EXCEED THE STATED DOSE OF APIRETAL SUPOSITORIOS NINOS, consult your doctor or pharmacist immediately. Overdoses of paracetamol cause hepatoxicity (sickness, nausea, vomiting, anorexia, jaundice, abdominal pain). In adults, an overdose is considered to be a single dose of more than 6g, and in children a dose of more than 100mg/kg of weight. The hepatoxic dose may be less in the case of chronic alcoholism, in patients with liver disorders and if the patient is undergoing concomitant treatment with barbiturates.
The treatment consists of aspiration and gastric lavage, activated charcoal orally, intravenous administration of an adequate dose of N-acetylcysteine, and if necessary haemodialysis.
The period in which the treatment offers most guarantee of success is during the 12 hours after the ingestion of the overdose.
IF YOU FORGET TO USE APIRETAL SUPOSITORIOS NINOS:
Don’t take a double dose to compensate.
POSSIBLE ADVERSE EFFECTS
Like all medicines APIRETAL SUPOSITORIOS NINOS can have adverse effects.
It may produce hepatoxicity in high doses or with prolonged treatment.
Occasionally cutaneous eruptions and haematological alterations, such as leucopenia and neutropenia, may occur.
If you observe any reaction not described in this prospectus, please consult your doctor or pharmacist.
STORAGE OF APIRETAL SUPOSITORIES
Maintain APIRETAL SUPOSITORIOS NINOS out of the sight and reach of children.
No special conditions are needed for their storage or preservation.
Expiry Date: Don’t use APIRETAL SUPOSITORIES NINOS after the expiry date indicated on the packaging.
This prospectus has been approved in
APIRETAL PARACETAMOL
Chosen infantile antipyretic
NAME OF MEDICINE: Apiretal Solution Drops.
QUALITATIVE AND QUANTITATIVE COMPOSITION: Formula per ml: Paracetamol (I.C.D.)100 mg.
PHARMACEUTICAL FORM: Solution drops.
CLINICAL DATA: Therapeutic indications: Apiretal Solution Drops are indicated for the symptomatic treatment for fever and slight or moderate pain. Dosage and form of use: The dosage of Apiretal Solution Drops can be realized in drops (4 mg/drop) or in ml (100 mg/ml), by means of the dropper-dosimeter or the external 5 ml. dosimeter. Children: 0 to 3 months: 0.6 ml (60 mg), equal to 15 drops; 4 to 11 months:1.2 ml (120 mg), equal to 30 drops; 12 to 23 months:1.6 ml (160 mg); 2 to 3 years: 2.0 ml (200 mg); 4 to 5 years: 2.8 ml (280 mg); 6 to 8 years: 3.6 ml (360 mg); 9 to 10 years: 4.8 ml (480 mg). These doses may be repeated every 6 hours. A dosage plan of 15mg/kg per intake, every 6 hours, can also be established with a total dose of 60 mg/kg/day, especially for children under the age of 1. If the desired effects have not been achieved 34 hours after use, the dose can be taken every 4 hours, in which case 10 mg/kg will be taken. The use of this preparation is subject to the appearance of symptoms of pain or fever. As they disappear, this medication should be suspended.