Instructions Fervex set for adults powder for oral solution in sachets No. 8 + Multigrip rapid nasal combi-test for the detection of coronavirus antigens and influenza A and B viruses No. 1
Composition
active ingredients: paracetamol, ascorbic acid (vitamin C), pheniramine maleate;
1 sachet contains paracetamol 500 mg, ascorbic acid (vitamin C) 200 mg, pheniramine maleate 25 mg;
excipients: sucrose, anhydrous citric acid, acacia, sodium saccharin, Antillean flavoring, which includes maltodextrin, acacia, α-pinene, β-pinene, limonene,
γ-terpinene, linalool, neral, α-terpineol, geranial.
Dosage form
Powder for oral solution.
Main physicochemical properties: light beige granular powder.
Pharmacotherapeutic group
Other combination medicines used for colds.
ATX code N02B E51.
Pharmacological properties
Pharmacodynamics.
Pharmacological effects caused by the components of the drug:
- pheniramine maleate – a blocker of H1-histamine receptors, provides a desensitizing effect, which is manifested by a decrease in the inflammatory reaction of the mucous membranes of the upper respiratory tract (nasal breathing improves, rhinitis, sneezing and lacrimation decrease);
- Paracetamol has an antipyretic and analgesic effect, which relieves pain and fever (headache, myalgia);
- Ascorbic acid compensates for the body's needs for vitamin C.
Pharmacokinetics.
Paracetamol after oral administration is rapidly and almost completely absorbed in the digestive tract. The maximum concentration of paracetamol in the blood plasma is reached 30-60 minutes after administration. Paracetamol is rapidly distributed in all tissues. Concentrations in blood, saliva and plasma are similar. Binding to plasma proteins is weak. Paracetamol is metabolized mainly in the liver with the formation of compounds with glucuronic acid and sulfates. A secondary metabolic pathway, catalyzed by cytochrome P 450, leads to the formation of an intermediate reagent (N-acetylbenzoquinoneimine), which under normal conditions of use is rapidly neutralized by reduced glutathione and excreted in the urine after conjugation with cysteine and mercapturic acid. However, in severe poisoning, the amount of this toxic metabolite increases.
Excreted in the urine, mainly as metabolites. 90% of the dose taken is excreted by the kidneys within 24 hours, mainly in the form of glucuronide conjugates (60-80%), sulfate conjugates (20-30%).
Approximately 5% of the dose is excreted unchanged. The half-life is approximately 2 hours.
Pheniramine maleate is well absorbed from the gastrointestinal tract. It is excreted mainly by the kidneys. The half-life in blood plasma is 60-90 minutes.
Ascorbic acid is well absorbed in the digestive tract. It is excreted mainly in the urine.
Indication
Symptomatic treatment of colds, rhinitis, rhinopharyngitis, flu-like conditions manifested by runny nose, lacrimation, sneezing, fever and/or headache.
Contraindication
Hypersensitivity to the components of the drug or to other antihistamines, severe liver and/or kidney dysfunction, congenital hyperbilirubinemia, glucose-
6-phosphate dehydrogenase, alcoholism, blood diseases, severe anemia, leukopenia, severe arterial hypertension, unstable angina; severe cardiac conduction disorders, acute period of myocardial infarction, severe atherosclerosis, uncompensated heart failure, hyperthyroidism, acute urinary retention in prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction, gastric and duodenal ulcer in the acute stage, angle-closure glaucoma, thrombosis, thrombophlebitis, severe forms of diabetes mellitus, epilepsy, old age; fructose intolerance, glucose/galactose malabsorption syndrome or sucrose-isomaltose insufficiency, due to sucrose content, phenylketonuria.
Do not use with MAO inhibitors and within two weeks after stopping MAO inhibitors. Fervex for adults is contraindicated in patients taking tricyclic antidepressants or β-blockers for urolithiasis - provided that ascorbic acid enters the body in a dose of more than 1 g per day.
Interaction with other medicinal products and other types of interactions
Undesirable combinations.
Due to the presence of pheniramine, ethanol increases the sedative effect of H1-blockers, so you should refrain from driving vehicles or working with other mechanisms. During treatment, you should avoid drinking alcoholic beverages and using medications containing ethyl alcohol.
Due to the presence of pheniramine, other sedatives may cause central nervous system depression, including: morphine derivatives (analgesics, cough suppressants, and substitution therapy), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (e.g. meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative H1-blockers, centrally acting antihypertensives, baclofen, and thalidomide.
Due to the presence of pheniramine, drugs that have atropine-like effects, such as: imipramine antidepressants, most atropine H1-blockers, anticholinergics, antiparkinsonian drugs, atropine antispasmodics, disopramide, phenothiazine neuroleptics and clozapine, may add undesirable atropine-like effects, such as urinary retention, constipation and dry mouth.
When taken simultaneously with oral anticoagulants, there is a risk of their enhanced effect and an increased risk of bleeding when taking paracetamol in maximum doses (4 g/day) for at least 4 days. INR (international normalized ratio) should be checked regularly. If necessary, the dose of the oral anticoagulant can be adjusted during paracetamol administration and after discontinuation of paracetamol treatment.
Taking paracetamol may affect the results of blood glucose determination using the glucose oxidase-peroxidase method with abnormally high concentrations, and the results of blood urea determination using the phosphotungstic acid method.
The rate of absorption of paracetamol may be increased by concomitant use with metoclopramide and domperidone and decreased by co-administration with cholestyramine. Barbiturates reduce the antipyretic effect of paracetamol.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of liver microsomal enzymes, may enhance the toxic effect of paracetamol on the liver due to an increase in the degree of conversion of the drug to hepatotoxic metabolites. With simultaneous use of paracetamol with isoniazid, the risk of developing hepatotoxic syndrome increases. Paracetamol reduces the effectiveness of diuretics.
Ascorbic acid increases the absorption of iron in the intestine, increases the level of ethinyl estradiol, penicillins, tetracyclines; reduces the level of antipsychotics, phenothiazine derivatives in the blood. Glucocorticosteroids reduce the reserves of ascorbic acid. Simultaneous administration of ascorbic acid and deferoxamine increases the tissue toxicity of iron, especially in the heart muscle, which can lead to decompensation of the circulatory system. It can be used only 2 hours after the injection of deferoxamine. Large doses of ascorbic acid reduce the effectiveness of tricyclic antidepressants. Absorption of ascorbic acid is reduced with simultaneous use of oral contraceptives, consumption of fruit or vegetable juices, alkaline drinks.
Caution should be exercised when using paracetamol and flucloxacillin simultaneously, as concomitant administration is associated with metabolic acidosis with a high anion gap, especially in patients at risk ("Special warnings and precautions for use").
Application features
In case of high body temperature or prolonged fever that persists for 5 days while using the drug, or if signs of superinfection appear, you should consult a doctor to determine the appropriateness of further use of the drug.
Use with caution in patients with diabetes.
Alcohol enhances the sedative effect of pheniramine maleate and the hepatotoxicity of paracetamol.
Ascorbic acid may alter the results of laboratory tests (glucose, blood bilirubin, transaminase activity).
The risk of mainly psychological dependence appears when recommended doses are exceeded and with long-term treatment.
To prevent overdose, all medications containing paracetamol should be checked and excluded.
For adults weighing more than 50 kg, the total dose of paracetamol should not exceed 4 g per day.
Caution is advised when paracetamol and flucloxacillin are used concomitantly due to the increased risk of developing metabolic acidosis with a high anion gap, especially in patients with severe renal insufficiency, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those taking maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.
Precautions.
Drinking alcoholic beverages or using sedatives (especially barbiturates) increases the sedative effect of pheniramine maleate, therefore, the use of these substances should be avoided during treatment.
Each sachet contains 11.5 g of sucrose, which should be taken into account by patients with diabetes and patients on a low-sugar diet.
Use during pregnancy or breastfeeding
Since the effect of the drug on the course of pregnancy or breastfeeding has not been sufficiently studied, it should not be prescribed during such periods.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug may cause drowsiness, so while taking the drug you should refrain from driving vehicles or operating other mechanisms.
Method of administration and doses
Internally, adults and children over 15 years of age should take 1 sachet 2-3 times a day. Dissolve the contents of the sachet in a sufficient amount of cold or warm water. Take the solution immediately after preparation. Patients with symptoms of a cold should take a warm solution of the drug in the evening. The interval between doses should be at least 4 hours.
The maximum duration of treatment is 5 days.
For patients with impaired renal function (creatinine clearance less than 10 ml/min), the interval between doses should be at least 8 hours.
If the symptoms of the disease do not disappear or worsen, a doctor's consultation is required.
Children.
Do not use in children under 15 years of age.
Overdose
Related to pheniramine.
Overdose with pheniramine can cause convulsions (especially in children), impaired consciousness, and coma.
Related to paracetamol.
There is a risk of intoxication in the elderly and especially in young children (cases of therapeutic overdose and accidental poisoning occur quite frequently).
An overdose of paracetamol can be fatal.
Symptoms
Nausea, vomiting, anorexia, pallor, increased sweating, abdominal pain, which usually appear within the first 24 hours.
Overdose of more than 10 g of paracetamol per 1 dose in adults and 150 mg/kg of body weight in
1 dose in children causes hepatic cytolysis, which can lead to complete and irreversible necrosis and hepatocellular failure, metabolic acidosis, encephalopathy, which, in turn, can lead to coma and death.
At the same time, elevated levels of hepatic transaminases, lactate dehydrogenase, and bilirubin are observed against the background of elevated prothrombin levels, which may appear 12-48 hours after administration.
Urgent measures:
- immediate hospitalization;
- determination of the initial level of paracetamol in blood plasma;
- immediate removal of the used drug by gastric lavage;
- The usual treatment for overdose includes the administration of the antidote N-acetylcysteine, either intravenously or orally. The antidote should be administered as soon as possible, preferably within 10 hours of the overdose;
- methionine as symptomatic therapy.
Side effects
From the hematopoietic and lymphatic system: anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia; thrombosis, hyperprothrombinemia, erythrocytopenia, thrombocytopenia, agranulocytosis, neutrophilic leukocytosis, purpura, leukopenia, neutropenia.
On the part of the immune system: anaphylaxis, anaphylactic shock, skin hypersensitivity reactions, including itching, rash on the skin and mucous membranes (usually erythematous, urticaria), angioedema, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).
Respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.
On the part of the digestive tract: dry mouth, nausea, heartburn, vomiting, constipation, epigastric pain, diarrhea, impaired liver function, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).
From the endocrine system: hypoglycemia up to hypoglycemic coma.
From the nervous system: rarely - headache, dizziness, sleep disturbances, insomnia, drowsiness, confusion, hallucinations, nervousness, tremor; in some cases - coma, convulsions, dyskinesia, behavioral changes, increased excitability; impaired balance and memory, inattention, especially in elderly patients.
Cardiovascular system: in rare cases - tachycardia, myocardial dystrophy (dose-dependent effect with prolonged use), orthostatic hypotension.
Metabolic disorders: zinc and copper metabolism disorders.
On the part of the urinary system: urinary retention and difficulty urinating, aseptic pyuria, renal colic.
Skin: eczema.
From the organs of vision: dry eyes, mydriasis, accommodation disorders.
With prolonged use in large doses: damage to the glomerular apparatus of the kidneys, crystalluria, formation of urate, cystine and/or oxalate stones in the kidneys and urinary tract; damage to the insular apparatus of the pancreas (hyperglycemia, glucosuria) and impaired glycogen synthesis up to the development of diabetes mellitus.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
8 sachets in a cardboard box.
Vacation category
Without a prescription.
Producer
UPSA SAS, France.
Address
304, avenue du Docteur Jean Bru, 47000 Agen, France;
979, avenue des Pyrenees, 47520 Le Passage, France.
2. Multigrip rapid nasal combi-test for the detection of coronavirus antigens, influenza A and B virus No. 1
The product is intended for self-testing. In vitro diagnostic medical device.
Indications for use
MULTIFLU rapid nasal combi-test for the detection of coronavirus antigens, influenza A and B viruses is a single-use test kit intended for the detection of SARS-CoV-2, influenza A and influenza B viruses, which cause COVID-19 and/or influenza, in a self-collected nasal swab specimen. The test is intended for use in symptomatic/asymptomatic individuals with suspected COVID-19 and/or influenza A+B infection. The results are intended for the detection of SARS-CoV-2 nucleocapsid protein, influenza A and influenza B nucleoprotein antigens. The antigen can usually be detected in upper respiratory tract specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with medical history and other diagnostic data is necessary to determine the infectious status. Positive results indicate the presence of SARS-CoV-2 and/or influenza A+B. Individuals who test positive should self-isolate and seek further medical attention from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not rule out SARS-CoV-2 and/or influenza A+B. Individuals who test negative and continue to experience COVID- or influenza-like symptoms should contact their healthcare provider for further follow-up.
Please read all information in this manual before performing the test.
Method of application
Wash your hands with soap and water for at least 20 seconds before and after the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.
STEP 1
Remove the cap from the extraction buffer tube and place the tube in the tube holder in the box.
STEP 2. Collect nasal swab samples
- Remove the sterile specimen swab from the package without touching the soft tip of the swab.
- Insert the swab into your nostril until you feel a slight resistance (about 2 cm up your nose). Slowly twist the swab, rub it along the inside of your nostril against the nasal wall 5-10 times, and carefully remove the swab.
Note:
This may cause discomfort. Do not insert the swab deeper if you feel strong resistance or pain. If the nasal mucosa is damaged or bleeding, it is not recommended to take nasal swabs. When collecting a sample from other people, please wear a mask. When collecting a sample from children, it is not necessary to insert the swab so deep into the nostril. For very young children, another person may be needed to hold the child’s head while taking the swab.
3. Repeat step 2 in the other nostril using the same swab.
STEP 3. Sample preparation
- Place the swab in the tube with the buffer solution, make sure it touches the bottom, and mix (rotate the swab for 10-15 seconds in the tube).
- Remove the swab by pressing the swab head against the inside of the tube to obtain the maximum amount of sample from the swab. Place the swab in a plastic bag for used materials.
- Close the cap or put the tip on the tube.
STEP 4. Testing
- Remove the test cassette from the packaging and use it within one hour. For best results, perform the test immediately after opening. Place the test cassette on a flat surface.
- Shake the sample tube, open the cap, holding it vertically, and add 3 drops of extracted sample to each well (S) of the test cassette and start the timer. Do not move the test cassette during the test development.
- Read the result after 10 minutes. Do not read the result after 20 minutes.
Note:
After completing the test, place all components in a plastic bag for used materials and seal it tightly, then dispose of as medical waste.
STEP 5. Reading the results
Please share your test results with your doctor and carefully follow local COVID guidelines/requirements.
POSITIVE RESULT SARS-CoV-2:*
Two colored lines appear in the COVID-19 result window.
One colored line should be in the control region (C) and the other colored line should be in the test region (T).
POSITIVE FLU A RESULT:*
Two colored lines appear in the FLU A+B result window. One colored line should be in the control region (C) and the other colored line should be in the flu A region (A).
POSITIVE FLU B RESULT:*
Two colored lines appear in the FLU A+B result window. One colored line should be in the control region (C) and the other colored line should be in the influenza B region (B).
POSITIVE RESULT FLU A and FLU B:*
*NOTE: The intensity of the color in the test line region (T/B/A) will vary depending on the amount of SARS-CoV-2 antigen and/or influenza A+B antigen present in the specimen. Therefore, any shade of color in the test region (T/B/A) should be considered positive. A positive result means that there is a high probability that you have COVID-19 and/or influenza A/influenza B, but laboratory confirmation is required. Immediately self-isolate according to local guidelines and contact your GP/physician or local health department immediately according to the instructions of your local authority. Your test result will be verified by PCR confirmation and you will be advised of the next steps.
NEGATIVE RESULT:
One colored line appears in the control line region (C). No visible colored line appears in the test line region (T/B/A). It is unlikely that you have COVID-19 and/or influenza A/influenza B. However, in some people with COVID-19 and/or influenza A/influenza B, this test may give a false negative result (false negative). This means that you may have COVID-19 and/or influenza A/influenza B even if the test is negative.
You can repeat the test with a new test kit. In case of suspicion, repeat the test after 1-2 days, as the coronavirus/flu virus cannot be accurately detected at all stages of infection. Even if the test result is negative, it is necessary to follow the rules of distance and hygiene, migration/travel, attending events, etc. according to local recommendations/requirements regarding COVID/flu.
INVALID RESULT:
Control line does not appear. Insufficient specimen volume or incorrect test technique are the most likely reasons for the absence of a control line.
Review the procedure and repeat the test with a new test or contact a COVID-19 and/or flu testing center.
Reservation
The product is intended for self-testing. In vitro diagnostic medical device. Do not eat, drink or smoke in the area where specimens or kits are handled. Do not drink the buffer solution. Handle the buffer solution with care and avoid contact with skin or eyes, in case of contact, rinse immediately with plenty of running water. Do not use if the packaging is damaged. This test kit is for preliminary testing only, and repeated invalid results should be discussed with a doctor. Strictly follow the specified test time. Do not reuse. Do not disassemble or touch the test wells of the test cassette. The kit cannot be frozen or used after the expiration date stated on the package. Children should perform the test under adult supervision. Wash hands thoroughly before and after handling the kit. Please ensure that sufficient specimen is used for testing. Too much or too little specimen may result in invalid results.
Storage conditions
Store in the original packaging at a temperature of 2°C to 30°C in a dry place and out of reach of children. The test cassette should remain in the sealed pouch until use.
Packaging
Test cassette packed in a sealed package with a desiccant, buffer solution in a tube with a dispenser cap, a disposable swab for sample collection, a plastic bag for used materials, and instructions for use.
Test Cassette Components: Well pad contains chemicals and detergents, as well as SARS-CoV-2 antibody conjugate particles, influenza A antibody conjugate particles, influenza B antibody conjugate particles, and mouse IgG conjugate particles. Result window (nitrocellulose membrane): Control line contains IgG antibodies. Test line: contains SARS-CoV2 antibodies, mouse influenza A antibodies, and mouse influenza B antibodies. Absorbent pad is made of highly absorbent paper.
Additional required materials for the test that are not provided: timer.
Producer
Delta Medical Promotions AG, 26 Oetenbachgasse, Zurich, CH-8001, Switzerland/Delta Medical Promotions AG, Oetenbachgasse 26, Zurich, CH-8001, Switzerland. At the production site at: 550#, Yinhai Street, Hangzhou Economic and Technological Development Area, Hangzhou – 310018, PR China/№550, Yinhai Street, Hangzhou Economic and Technological Development Area, Hangzhou – 310018, PR China.
Authorized representative in Ukraine:
Representative office of Delta Medical Promotions AG, 08132, Vyshneve, Chornovola St., 43.
Expiration date
2 years.
