Lyophilisate solution - 3 years. Suspensions - 3 years. The shelf life of the vaccine at room temperature is 130-150 minutes. Shelf life when stored in the refrigerator is 1 year. After the expiration date indicated on the packaging, the drug cannot be used. Administration of an expired drug may cause contamination of the body and systemic infection.
Why is this happening? To answer this question, you need to remember what a vaccine is - it is also an infection, the cells of the cortex are previously weakened by chemicals. When they enter the body, the immune system easily fights them, as a result of which it acquires immunity and produces antibodies. If you introduce an expired infection, the virus cells will be dead, the immune system will allow non-living organisms into the body, and they, in turn, will decompose and poison the body.
If there are 3-7 days left before the expiration date, then the drug can only be used if it was in ideal temperature conditions. In all other cases, use is highly not recommended; most likely, the active substance has already begun to decompose.
How to store Pentaxim vaccine at home
It is recommended to store in the refrigerator in the temperature range from +2 to +8 degrees , that is, do not freeze.
The packaging should be in a bag to eliminate the chance of food particles and dirt getting into the solution.
The drug can be left outside the refrigerator
for no more than 130 minutes . During this time, it warms up to room temperature and the active substance reacts with the solvent (this process should occur in the child’s body, and not in the ampoule).
Vaccine Pentaxim
SanofiAventis Pasteur, France
Release form: 1 syringe containing 1 dose of vaccine against diphtheria, tetanus and whooping cough, polio, hemophilus influenzae type B.
Vaccination schedule: according to the National Vaccination Calendar at 3, 4, 5, 6 months. life. Revaccination after 18 months.
INSTRUCTIONS FOR USE of the vaccine Pentaxim\Pentaxim.
Vaccine for the prevention of diphtheria and tetanus, adsorbed, acellular pertussis, inactivated poliomyelitis, infection caused by Haemophilus influenzae type b, conjugated.
Registration certificate No. LSR-005121/08-010708 dated July 1, 2008
DOSAGE FORM
Lyophilisate for preparing a suspension for intramuscular administration 1 dose, complete with a suspension for intramuscular administration 0.5 ml.
COMPOUND
1. Vaccine for the prevention of diphtheria and tetanus, adsorbed; acellular whooping cough; inactivated poliomyelitis (suspension for intramuscular administration).
One dose of vaccine (0.5 ml) contains:
Active substances:
Diphtheria toxoid… ≥ 30 IU;
Tetanus toxoid… ≥ 40 IU;
Pertussis toxoid… 25 mcg;
Hemagglutinin filamentous... 25 mcg;
Poliomyelitis virus type 1 inactivated……….40 units of D antigen;
Poliomyelitis virus type 2 inactivated... 8 units of D antigen;
Poliovirus type 3 inactivated... 32 units of D antigen;
Excipients: aluminum hydroxide 0.3 mg; Hanks medium 199* 0.05 ml; formaldehyde 12.5 mcg; phenoxyethanol 2.5 µl; water for injections up to 0.5 ml; acetic acid or sodium hydroxide - to pH 6.8 - 7.3.
*: does not contain phenol red
2. Vaccine for the prevention of infection caused by Haemophilus influenzae type b, conjugated (lyophilisate for the preparation of a suspension for intramuscular administration)
One dose of lyophilisate contains:
Active substance: Haemophilus influenzae type b polysaccharide conjugated with tetanus toxoid... 10 mcg.
Excipients: sucrose 42.5 mg; trometamol 0.6 mg;
DESCRIPTION
Vaccine for the prevention of diphtheria and tetanus, adsorbed; acellular whooping cough; polio inactivated (suspension for intramuscular administration):
Whitish cloudy suspension.
Vaccine for the prevention of infection caused by Haemophilus influenzae type b, conjugated (lyophilisate for preparing a suspension for intramuscular administration):
White homogeneous lyophilisate.
PURPOSE
Prevention of diphtheria, tetanus, whooping cough, polio and invasive infection caused by Haemophilus influenzae type b (meningitis, septicemia, etc.) in children starting from 3 months of age.
Contraindications
Progressive encephalopathy, accompanied by or without seizures. Encephalopathy that develops within 7 days after administration of any vaccine containing Bordetella pertussis antigens.
A severe reaction that developed within 48 hours after a previous vaccination with a vaccine containing a pertussis component: an increase in body temperature to 40 ° C or higher,
prolonged unusual crying syndrome, febrile or afebrile convulsions, hypotonic-hyporesponsive syndrome.
An allergic reaction following previous administration of a vaccine to prevent diphtheria, tetanus, whooping cough, polio and a vaccine to prevent infection caused by Haemophilus influenzae type b.
Confirmed systemic hypersensitivity reaction to any vaccine ingredient, as well as glutaraldehyde, neomycin, streptomycin and polymyxin B.
Diseases accompanied by an increase in body temperature, acute manifestations of an infectious disease or exacerbation of a chronic disease. In these cases, vaccination should be postponed until recovery.
USE WITH CAUTION
If a child has a history of febrile seizures that are not associated with previous vaccination, the vaccinated person’s body temperature should be monitored for 48 hours after vaccination and, if it increases, antipyretic (antipyretic) drugs should be regularly used throughout this period.
METHOD OF APPLICATION AND DOSES
The vaccine is administered intramuscularly in a dose of 0.5 ml, the recommended injection site is the middle third of the anterolateral thigh. Do not administer intradermally or intravenously. Before insertion, you must ensure that the needle does not penetrate a blood vessel. For the packaging option with two separate needles, before preparing the vaccine, the needle should be tightly secured by rotating it a quarter turn relative to the syringe.
To prepare the vaccine, having previously removed the plastic colored cap from the bottle, completely introduce the suspension for intramuscular administration (vaccine for the prevention of diphtheria, tetanus, whooping cough and polio) through a needle from a syringe into the bottle with lyophilisate (vaccine for the prevention of infection caused by Haemophilus influenzae type b) .
Shake the bottle without removing the syringe from it and wait until the lyophilisate is completely dissolved (no more than 3 minutes). The resulting suspension should be cloudy and have a whitish tint. The vaccine should not be used if there is a change in color or presence of foreign particles. The vaccine prepared in this way should be completely drawn into the same syringe. The finished vaccine should be administered immediately.
The PENTAXIM vaccination course consists of 3 injections of one dose of vaccine (0.5 ml) with an interval of 1-2 months, starting from 3 months of age. Revaccination is carried out by administering 1 dose of PENTAXIM at the age of 18 months. life.
In accordance with the National Calendar of Preventive Vaccinations of the Russian Federation, the course of vaccination for the prevention of diphtheria, tetanus, whooping cough and polio consists of 3 injections of the drug with an interval of 1.5 months, at the age of 3, 4.5 and 6 months, respectively; revaccination is carried out once at the age of 18 months.
If the vaccination schedule is violated, subsequent intervals between the next dose of the vaccine do not change, including the interval before the 4th (revaccination) dose - 12 months.
If the first dose of Pentaxim was administered at the age of 6-12 months, then the second dose is administered after 1.5 months. after the first, and as the 3rd dose, administered after 1.5 months. after the second, a vaccine should be used to prevent diphtheria, tetanus; whooping cough and poliomyelitis, initially presented in a syringe (i.e. without diluting the lyophilisate in the vial (HIb)). The usual dose of Pentaxim (with dilution of lyophilisate (HIb)) is used as a booster (4th dose).
If the first dose of Pentaxim is administered after 1 year of age, then for the 2nd, 3rd and 4th (booster) doses, a vaccine should be used to prevent diphtheria, tetanus; whooping cough and poliomyelitis, initially presented in a syringe, without diluting the lyophilisate in a vial (HIb).
| First vaccination, child’s age (the full drug Pentaxim is administered) | The second vaccination (after 1.5 months) is administered: | Third vaccination (after 1.5 months), entered: | Revaccination (after 12 months), entered: |
| Up to 6 months | full drug Pentaxim | full drug Pentaxim | full drug Pentaxim |
| 6 - 12 months | full drug Pentaxim | Pentaxim without dilution of lyophilisate HIb in a bottle | full drug Pentaxim |
| After 12 months | Pentaxim without dilution of lyophilisate HIb in a bottle | Pentaxim without dilution of lyophilisate HIb in a bottle | Pentaxim without dilution of lyophilisate HIb in a bottle |
In all cases of violation of the vaccination schedule, the doctor must be guided by the National Calendar of Preventive Vaccinations of the Russian Federation. Adverse Reactions
1) Local: soreness (usually expressed by short crying at rest or with gentle pressure in the injection area); redness and thickening at the injection site (in 0.1%-1% of cases - ≥5 cm in diameter). These reactions may develop within 48 hours after vaccination.
2) General. Increased body temperature: ≥38 °C - with a frequency of 1%-10%; ≥39 °C - with a frequency of 0.1%-1%; rarely (0.01%-0.1%) - over 40 °C. (Rectal temperature was assessed; as a rule, it is higher than axillary (axillary) by 0.6-1.1 ° C.)
Irritability, drowsiness, sleep disturbances, anorexia, diarrhea, vomiting, and, less commonly, prolonged crying were also noted.
In very rare (<0.01%) cases, rash, urticaria, febrile and afebrile convulsions, hypotension and hypotonic-hyporeactive syndrome, anaphylactic reactions (facial edema, Quincke's edema, shock) were observed.
Rarely, after administration of vaccines containing the HIb component, cases of edema of one or both lower extremities (with a predominance of edema in the extremity where the vaccine was administered) have been reported. Swelling was mainly observed during the first few hours after primary vaccination. These reactions were sometimes accompanied by increased body temperature, soreness, prolonged crying, cyanosis or change in skin color, less often - redness, petechiae or transient purpura, increased body temperature, and rash. These reactions resolved spontaneously within 24 hours without any residual effects and were not associated with any adverse cardiac or respiratory events.
Very rarely, after the administration of vaccines containing acellular pertussis component, there have been cases of severe reactions (more than 5 cm in diameter) at the site of vaccine administration, including swelling extending to one or both joints. These reactions appeared 24-72 hours after vaccine administration and may be accompanied by redness, increased skin temperature at the injection site, sensitivity or pain at the injection site. These symptoms disappeared on their own within 3-5 days without any additional treatment. It is believed that the likelihood of developing such reactions increases depending on the number of administrations of the acellular pertussis component; this likelihood is greater after the 4th and 5th doses of such a vaccine.
The Company has evidence that Guillain-Barré syndrome and brachial neuritis have occurred following administration of other vaccines containing tetanus toxoid.
SPECIAL INSTRUCTIONS
Pentaxim does not form immunity against infections caused by other serotypes of Haemophilus influenzae, as well as against meningitis of other etiologies.
The doctor should be informed of all cases of adverse reactions, including those not listed in this instruction. Before each vaccination, in order to prevent possible allergic and other reactions, the doctor must clarify the state of health, immunization history, medical history of the patient and immediate family (in particular, allergic), and cases of side effects from previous vaccinations. The doctor should have the medications and instruments necessary for the development of a hypersensitivity reaction.
Immunosuppressive therapy or an immunodeficiency condition may cause a poor immune response to the vaccine. In these cases, it is recommended to postpone vaccination until the end of such therapy or remission of the disease. However, in persons with chronic immunodeficiency (eg, HIV infection), vaccination is recommended, even though the immune response may be weakened.
In case of thrombocytopenia and other bleeding disorders, the vaccine should be administered with caution due to the risk of bleeding during intramuscular injection.
If there is a history of Guillain-Barré syndrome or brachial neuritis in response to any vaccine containing tetanus toxoid, the decision to vaccinate with Pentaxim should be carefully justified. In such cases, it is generally appropriate to complete the primary immunization (if less than 3 doses have been given).
INTERACTIONS WITH OTHER MEDICINES
With the exception of immunosuppressive therapy (see section “Special Instructions”), there is no reliable data on the possible mutual influence when used with other drugs, including other vaccines.
The doctor should be informed about the recent or concurrent administration of any other drug to the child (including over-the-counter drugs).
RELEASE FORM
Vaccine for the prevention of diphtheria and tetanus, adsorbed, acellular pertussis, inactivated poliomyelitis - suspension for intramuscular administration 0.5 ml; complete with a vaccine for the prevention of infection caused by Haemophilus influenzae type b, conjugated - lyophilisate for the preparation of a suspension for intramuscular administration, 1 dose.
One dose of lyophilisate in a glass bottle and 0.5 ml (1 dose) of suspension in a glass syringe (with or without a fixed needle) with a capacity of 1 ml, with a chlorobromobutyl piston; 1 bottle and 1 syringe in a closed cell packaging
(PET/PVC). If the syringe does not have a needle attached, then 2 separate sterile needles are placed in the package. 1 cell packaging in an individual cardboard box with instructions for use.
SHELF LIFE 3 years. Do not use after the expiration date stated on the packaging.
STORAGE CONDITIONS Store in the refrigerator (at a temperature of 2 to 8 ° C). Do not freeze. Keep out of the reach of children.
Conditions for dispensing from pharmacies By doctor's prescription.
About all cases of unusual vaccination reactions, please inform the Federal State Budgetary Institution GISK named after. L.A. Tarasevich Rospotrebnadzor (119002, Moscow, Sivtsev-Vrazhek lane, 41, tel.: (495) 241-39-22) and Sanofi Pasteur Representative Office in Moscow (115035, Moscow, Sadovnicheskaya st., 82, bldg. 2, tel. 935-86-90).
MANUFACTURER:
SANOFI PASTER S.A., 2, Avenue Pont Pasteur, 69007 Lyon - France General Director of the Representative Office of Sanofi Pasteur in the CIS Normunds Zemvaldis
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Conditions for storing the drug in pharmacies and clinics
In pharmacies, all medications are stored according to their pharmacological group and storage conditions. Such data is always indicated in the annotation to the drug or on the package.
- The bulk of drugs are stored at a temperature not exceeding +25, that is, at room temperature.
- There should be two refrigeration chambers in the sales area, one containing drugs that should be stored at temperatures from +2 to +8, in the other - from +8 to +15.
The pharmacy constantly keeps temperature logs both in the sales area and in each of the storage rooms.
Quality control
How does the quality control department work at ? The laboratories are equipped with a computer system to which all the equipment used to test products is connected. The results of all tests immediately go there and this “primary data” can no longer be deleted. If suddenly during the release control process it turns out that something is wrong with a batch of vaccine, it will be impossible to hide it. In addition, samples from each series are archived. They will be needed for investigation if the vaccine is suddenly suspected of causing harm. And they are stored for the entire shelf life of the vaccine!
Transportation
Medicines are transported in refrigerators or freezers to eliminate the chance of spoilage. Tablets, ampoules, powders, etc. are transported separately from each other, in sealed packages, without access to oxygen and light. The transportation vehicle is equipped with sensors to monitor microclimatic conditions.
Video: Portable medical thermal container for transporting medicines, vaccines, immunobiological preparations
Pentaxim storage conditions
A qualified pharmacist with ten years of experience in pharmaceutical organizations.
In 2007, she graduated from Engel Medical College with honors in the specialty “Pharmacy”, then in 2013 she graduated from the Samara Medical Institute, receiving the qualification “Pharmacist”, in 2014 she completed an internship in the specialty “Management and Economics of Pharmacy”.
Regular participant of specialized conferences. Currently she works as the head of a pharmacy.
She will help you navigate the variety of modern medicines, medical products and medical (dietary) products, answer any questions regarding the use and interaction of medications, help you understand doctors’ recommendations, and also help you decide on the choice of medicinal and children’s cosmetics.
In 2007, she graduated from Engel Medical College with honors in the specialty “Pharmacy”, then in 2013 she graduated from the Samara Medical Institute, receiving the qualification “Pharmacist”, in 2014 she completed an internship in the specialty “Management and Economics of Pharmacy”.
Directions for use and dosage
The drug "Pentaxim" is a vaccine that can be administered to children three months of age. The standard dose is 0.5 ml. It consists of two components: antihemophilic (in a dry state in a special bottle) and pertussis-diphtheria-tetanus in a separate dispenser syringe (in a liquid state). Before use, the dry part must be dissolved in the liquid. The latter is adapted for ease of storage and transportation and is packaged in an aseptic blister. The dispenser syringe has a special needle that minimizes pain during injection. Its use eliminates overdose. Reuse of this syringe is strictly prohibited. The vaccine is administered intramuscularly into the middle third of the thigh. For older children, injections are given into the deltoid muscle. Injections in the buttocks are not practiced. Subcutaneous administration is allowed, but intravenous administration is strictly prohibited!
Analogs
Level 4 ATX code matches:
The same pharmacological group with the Pentaxim vaccine includes the drugs Bubo-Kok, Bubo-M, DPT vaccine, DPT-M vaccine, DPT-Hep-B vaccine, Infanrix, Infanrix Hexa, Tetraxim, Infanrix Penta.
DTP or Pentaxim - which is better?
The drug Pentaxim contains antigens of tetanus and diphtheria toxoids, components of the cell walls of Bordetella pertussis (the causative agent of whooping cough), inactivated polio virus types 1-3 and capsular polysaccharides HIB (Haemophilus influenzae serotype b).
The main difference between Pentaxim and the whole-cell DTP vaccine is the method of its preparation, due to which the vaccine is characterized by lower reactogenicity in comparison with its analogue.
Which is better - DTP or Pentaxim?
To this question, doctor Komarovsky E.O. answers that the acellular pertussis component of the Pentaxim vaccine allows the baby to more easily endure the post-vaccination period, while the child suffers much less often from pain at the injection site and fever.
Another “advantage” of Pentaxim is that this vaccine makes it possible to immunize a child against 5 diseases in 4 injections.
Pentaxim or Infanrix - which is better?
Which is better - Pentaxim or Infanrix? Which is better Pentaxim or Infanrix Hexa? Such questions worry almost all young parents who are faced with vaccination for the first time.
Most often, doctors suggest vaccinating a child with DTP, or Pentaxim, or Infanrix. These preparations differ from each other in the number of components and the degree of their purification.
The DPT vaccine allows a child to develop immunity to whooping cough, tetanus and diphtheria (it contains a suspension of dead microbes Bordetella pertussis, as well as purified tetanus and pertussis toxoids adsorbed on Al hydroxide).
The Infanrix vaccine comes in three-, four-, five- and six-component versions: the three-component Infanrix suspension is used to prevent diphtheria, whooping cough and tetanus; the four-component suspension Infanrix IPV allows the child to additionally develop immunity to polio; five-component Infanrix Penta is used to prevent 3 of these diseases, polio and hepatitis B;
Unlike the whole-cell vaccine DPT, Pentaxim and Infanrix are acellular preparations that contain only fragments of disease antigens. Comparing reviews of parents whose children were immunized with DTP and acellular vaccines, we can conclude that the latter are much better tolerated and cause fewer side effects.
To the question “Which is better - Pentaxim or Infanrix?”, Komarovsky E.O. answers that both vaccines are high-quality products with highly purified components.
If we compare the tolerability indicators of both drugs, then Infanrix wins here, since the pertussis component is present in it in the most split form. This has an impact on the effectiveness of vaccination, but it can significantly reduce not only the severity, but also the likelihood of adverse reactions.
Pentaxim or Tetraxim?
The drugs Tetraxim and Pentaxim are produced by the same manufacturer. The only difference between the Tetraxim vaccine and Pentaxim is the absence of the HIB component.
In cases where parents, in accordance with the individual vaccination schedule, do not need to vaccinate their child against hemophilus influenzae, the use of the Tetraxim vaccine allows them not to overpay for the unused hemophilus influenzae component.
