Baten may be available in the countries listed below.
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Treating minor pain or irritation of the mouth or throat.
Dyclonine Lozenges are an oral anesthetic. It works by numbing the affected area.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Dyclonine Lozenges. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Dyclonine Lozenges. Because little, if any, of Dyclonine Lozenges are absorbed into the blood, the risk of it interacting with another medicine is low.
Ask your health care provider if Dyclonine Lozenges may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Dyclonine Lozenges as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Dyclonine Lozenges.
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Dyclonine Lozenges. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Dyclonine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Dyclonine Lozenges at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dyclonine Lozenges out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Dyclonine Lozenges. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Ellenal may be available in the countries listed below.
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Daptacel® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday).
Daptacel vaccine is to be administered as a 5 dose series at 2, 4 and 6 months of age (at intervals of 6-8 weeks), at 15-20 months of age and at 4-6 years of age. The first dose may be given as early as 6 weeks of age. Four doses of Daptacel vaccine constitute a primary immunization course for pertussis. The fifth dose is a booster for pertussis immunization. Three doses of Daptacel vaccine constitute a primary immunization course for diphtheria and tetanus. The fourth and fifth doses are boosters for diphtheria and tetanus immunization. [See Clinical Studies (14.1, 14.2, 14.3).]
Data are not available on the safety and immunogenicity of using mixed sequences of Daptacel vaccine and DTaP vaccines from different manufacturers for successive doses of the DTaP vaccination series. Daptacel vaccine may be used to complete the immunization series in infants who have received 1 or more doses of whole-cell pertussis DTP. However, the safety and efficacy of Daptacel vaccine in such infants have not been fully demonstrated.
If a decision is made to withhold any recommended dose of pertussis vaccine, [see Contraindications (4.2), (4.3) and Warnings and Precautions (5.2)], Diphtheria and Tetanus Toxoids Adsorbed For Pediatric Use (DT) should be administered.
Just before use, shake the vial well, until a uniform, white, cloudy suspension results. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, the product should not be administered.
When withdrawing a dose from a rubber-stoppered vial, do not remove either the rubber stopper or the metal seal holding it in place.
Each 0.5 mL dose of Daptacel vaccine is to be administered intramuscularly. In infants younger than 1 year, the anterolateral aspect of the thigh provides the largest muscle and is the preferred site of injection. In older children, the deltoid muscle is usually large enough for injection. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Do not administer this product intravenously or subcutaneously.
Daptacel vaccine should not be combined through reconstitution or mixed with any other vaccine.
Daptacel vaccine is a suspension for injection in 0.5 mL single dose vials. See Description (11) for a complete listing of ingredients.
A severe allergic reaction (eg, anaphylaxis) after a previous dose of Daptacel vaccine or any other tetanus toxoid, diphtheria toxoid, or pertussis-containing vaccine, or any other component of this vaccine is a contraindication to administration of Daptacel vaccine. [See Description (11).] Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.
Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine (1), including Daptacel vaccine.
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine (1) including Daptacel vaccine. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized. (1)
Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.
If any of the following events occur within the specified period after administration of a whole-cell pertussis vaccine or a vaccine containing an acellular pertussis component, the decision to administer Daptacel vaccine should be based on careful consideration of potential benefits and possible risks. (1) [See Dosage and Administration (2.1).]
A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. (2) If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give Daptacel vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. (1)
For infants or children with a history of previous seizures, an appropriate antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with a vaccine containing an acellular pertussis component (including Daptacel vaccine) and for the following 24 hours, to reduce the possibility of post-vaccination fever. (1)
Vaccination with Daptacel vaccine may not protect all individuals.
If Daptacel vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See Immunosuppressive Treatments (7.2).]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.
A total of 17,577 doses of Daptacel vaccine have been administered to infants and children in 8 clinical studies. In all, 4,998 children received 3 doses of Daptacel vaccine, 1,725 of these children received 4 doses of Daptacel vaccine, and 485 of these children received 5 doses of Daptacel vaccine.
In a randomized, double-blinded pertussis vaccine efficacy trial, the Sweden I Efficacy Trial, conducted in Sweden during 1992-1995, the safety of Daptacel vaccine was compared with DT and a whole-cell pertussis DTP vaccine. A standard diary card was kept for 14 days after each dose and follow-up telephone calls were made 1 and 14 days after each injection. Telephone calls were made monthly to monitor the occurrence of severe events and/or hospitalizations for the 2 months after the last injection. There were fewer of the solicited common local and systemic reactions following Daptacel vaccine than following the whole-cell pertussis DTP vaccine. As shown in Table 1, the 2,587 infants who received Daptacel vaccine at 2, 4 and 6 months of age had similar rates of reactions within 24 hours as recipients of DT and significantly lower rates than infants receiving whole-cell pertussis DTP.
| Dose 1 (2 MONTHS) | Dose 2 (4 MONTHS) | Dose 3 (6 MONTHS) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| EVENT | Daptacel vaccine N = 2,587 | DT N = 2,574 | DTP N = 2,102 | Daptacel vaccine N = 2,563 | DT N = 2,555 | DTP N = 2,040 | Daptacel vaccine N = 2,549 | DT N = 2,538 | DTP N = 2,001 |
| DT: Swedish National Biologics Laboratories DTP: whole-cell pertussis DTP, Sanofi Pasteur Inc. N = Number of evaluable subjects | |||||||||
| |||||||||
| Local | |||||||||
| Tenderness (Any) | 8.0* | 8.4 | 59.5 | 10.1* | 10.3 | 60.2 | 10.8* | 10.0 | 50.0 |
| Redness ≥2 cm | 0.3* | 0.3 | 6.0 | 1.0* | 0.8 | 5.1 | 3.7* | 2.4 | 6.4 |
| Swelling ≥2 cm | 0.9* | 0.7 | 10.6 | 1.6* | 2.0 | 10.0 | 6.3*† | 3.9 | 10.5 |
| Systemic | |||||||||
| Fever‡ ≥38°C (100.4°F) | 7.8* | 7.6 | 72.3 | 19.1* | 18.4 | 74.3 | 23.6* | 22.1 | 65.1 |
| Fretfulness§ | 32.3 | 33.0 | 82.1 | 39.6 | 39.8 | 85.4 | 35.9 | 37.7 | 73.0 |
| Anorexia | 11.2* | 10.3 | 39.2 | 9.1* | 8.1 | 25.6 | 8.4* | 7.7 | 17.5 |
| Drowsiness | 32.7* | 32.0 | 56.9 | 25.9* | 25.6 | 50.6 | 18.9* | 20.6 | 37.6 |
| Crying ≥1 hour | 1.7* | 1.6 | 11.8 | 2.5* | 2.7 | 9.3 | 1.2* | 1.0 | 3.3 |
| Vomiting | 6.9* | 6.3 | 9.5 | 5.2¶ | 5.8 | 7.4 | 4.3 | 5.2 | 5.5 |
The incidence of serious and less common selected systemic events in the Sweden I Efficacy Trial is summarized in Table 2.
| EVENT | Dose 1 (2 MONTHS) | Dose 2 (4 MONTHS) | Dose 3 (6 MONTHS) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Daptacel vaccine N = 2,587 | DT N = 2,574 | DTP N = 2,102 | Daptacel vaccine N = 2,565 | DT N = 2,556 | DTP N = 2,040 | Daptacel vaccine N = 2,551 | DT N = 2,539 | DTP N = 2,002 | |
| DT: Swedish National Biologics Laboratories DTP: whole-cell pertussis DTP, Sanofi Pasteur Inc. N = Number of evaluable subjects | |||||||||
| Rectal temperature ≥40°C (104°F) within 48 hours of vaccination | 0.39 | 0.78 | 3.33 | 0 | 0.78 | 3.43 | 0.39 | 1.18 | 6.99 |
| Hypotonic-hypo-responsive episode within 24 hours of vaccination | 0 | 0 | 1.9 | 0 | 0 | 0.49 | 0.39 | 0 | 0 |
| Persistent crying ≥3 hours within 24 hours of vaccination | 1.16 | 0 | 8.09 | 0.39 | 0.39 | 1.96 | 0 | 0 | 1.0 |
| Seizures within 72 hours of vaccination | 0 | 0.39 | 0 | 0 | 0.39 | 0.49 | 0 | 0.39 | 0 |
In the Sweden I Efficacy Trial, one case of whole limb swelling and generalized symptoms, with resolution within 24 hours, was observed following dose 2 of Daptacel vaccine. No episodes of anaphylaxis or encephalopathy were observed. No seizures were reported within 3 days of vaccination with Daptacel vaccine. Over the entire study period, 6 seizures were reported in the Daptacel vaccine group, 9 in the DT group and 3 in the whole-cell pertussis DTP group, for overall rates of 2.3, 3.5 and 1.4 per 1,000 vaccinees, respectively. One case of infantile spasms was reported in the Daptacel vaccine group. There were no instances of invasive bacterial infection or death.
In a US study, children received 4 doses of Daptacel vaccine at 2, 4, 6 and 15-17 months of age. A total of 1,454 children received Daptacel vaccine and were included in the safety analyses. Of these, 51.7% were female, 77.2% Caucasian, 6.3% Black, 6.5% Hispanic, 0.9% Asian and 9.1% other races. In a subsequent study, a non-random subset of 485 of these children received a fifth dose of Daptacel vaccine at 4-6 years of age. The children included in the fifth dose study were representative of all children who received four doses of Daptacel vaccine in the earlier study with regard to frequencies of solicited local and systemic adverse events following the fourth dose. At 2, 4 and 6 months of age, Daptacel vaccine was administered concomitantly with Haemophilus influenzae type b (Hib) conjugate vaccine (tetanus toxoid conjugate) (Sanofi Pasteur SA), inactivated poliovirus vaccine (IPV) (Sanofi Pasteur SA), and 7-valent pneumococcal conjugate vaccine (Wyeth Pharmaceuticals Inc.). Infants had received the first dose of hepatitis B vaccine at 0 months of age. At 2 and 6 months of age, hepatitis B vaccine (recombinant) (Merck & Co., Inc.) was also administered concomitantly with Daptacel vaccine. Based on random assignment, the fourth dose of Daptacel vaccine was administered either alone; concomitantly with Hib conjugate (tetanus toxoid conjugate) vaccine; or concomitantly with Hib conjugate (tetanus toxoid conjugate) vaccine, 7-valent pneumococcal conjugate vaccine, measles, mumps, rubella (MMR) vaccine (Merck & Co., Inc.), and varicella vaccine (Merck & Co., Inc.). The fifth dose of Daptacel vaccine was administered concomitantly with IPV and MMR vaccine.
In the US studies, the occurrence of solicited local and systemic adverse events listed in Table 3 was recorded daily by parents or guardians for Days 0-7 following vaccination. For Days 0 and 1 following the first three doses of Daptacel vaccine, signs and symptoms of HHE also were solicited. Periodic telephone calls were made to inquire about adverse events. Serious adverse events were monitored during the two studies, through 6 months following the fourth and fifth doses of Daptacel vaccine, respectively.
The incidence and severity of selected solicited local and systemic adverse events that occurred within 3 days following each dose of Daptacel vaccine are shown in Table 3. The incidence of redness, tenderness and swelling at the Daptacel injection site increased with the fourth and fifth doses, with the highest rates reported after the fifth dose.
| Dose 1* | Dose 2* | Dose 3* | Dose 4* | Dose 5* | |
|---|---|---|---|---|---|
| N = 1390-1406 % | N = 1346-1360 % | N = 1301-1312 % | N = 1118-1144 % | N = 473-481 % | |
| |||||
| Injection Site Reactions (Daptacel vaccine injection site) | |||||
| Redness | |||||
| >5 mm | 6.2 | 7.1 | 9.6 | 17.3 | 35.8 |
| 25 - 50 mm | 0.6 | 0.5 | 1.9 | 6.3 | 10.4 |
| >50 mm | 0.4 | 0.1 | 0.0 | 3.1 | 15.8 |
| Swelling | |||||
| >5 mm | 4.0 | 4.0 | 6.5 | 11.7 | 23.9 |
| 25 - 50 mm | 1.2 | 0.6 | 1.0 | 3.2 | 5.8 |
| >50 mm | 0.4 | 0.1 | 0.1 | 1.6 | 7.7 |
| Tenderness† | |||||
| Any | 48.8 | 38.2 | 40.9 | 49.5 | 61.5 |
| Moderate | 16.5 | 9.9 | 10.6 | 12.3 | 11.2 |
| Severe | 4.1 | 2.3 | 1.7 | 2.2 | 1.7 |
| Increase in Arm Circumference‡ | |||||
| >5 mm | - | - | - | 30.1 | 38.3 |
| 20 - 40 mm | 7.0 | 14.0 | |||
| >40 mm | 0.4 | 1.5 | |||
| Interference with Normal Activity of the Arm§ | |||||
| Any | - | - | - | - | 20.4 |
| Moderate | 5.6 | ||||
| Severe | 0.4 | ||||
| Systemic Reactions | |||||
| Fever¶ | |||||
| ≥38.0°C | 9.3 | 16.1 | 15.8 | 10.5 | 6.1 |
| >38.5-39.5°C | 1.5 | 3.9 | 4.8 | 2.7 | 2.1 |
| >39.5°C | 0.1 | 0.4 | 0.3 | 0.7 | 0.2 |
| Decreased Activity/Lethargy# | |||||
| Any | 51.1 | 37.4 | 33.2 | 25.3 | 21.0 |
| Moderate | 23.0 | 14.4 | 12.1 | 8.2 | 5.8 |
| Severe | 1.2 | 1.4 | 0.6 | 1.0 | 0.8 |
| Inconsolable CryingÞ | |||||
| Any | 58.5 | 51.4 | 47.9 | 37.1 | 14.1 |
| Moderate | 14.2 | 12.6 | 10.8 | 7.7 | 3.5 |
| Severe | 2.2 | 3.4 | 1.4 | 1.5 | 0.4 |
| Fussiness/Irritabilityß | |||||
| Any | 75.8 | 70.7 | 67.1 | 54.4 | 34.9 |
| Moderate | 27.7 | 25.0 | 22.0 | 16.3 | 7.5 |
| Severe | 5.6 | 5.5 | 4.3 | 3.9 | 0.4 |
In the US study in which children received 4 doses of Daptacel vaccine, of 1,454 subjects who received Daptacel vaccine, 5 (0.3%) subjects experienced a seizure within 60 days following any dose of Daptacel vaccine. One seizure occurred within 7 days post-vaccination: an infant who experienced an afebrile seizure with apnea on the day of the first vaccination. Three other cases of seizures occurred between 8 and 30 days post-vaccination. Of the seizures that occurred within 60 days post-vaccination, 3 were associated with fever. In this study, there were no reported cases of HHE following Daptacel vaccine. There was one death due to aspiration 222 days post-vaccination in a subject with ependymoma. Within 30 days following any dose of Daptacel vaccine, 57 (3.9%) subjects reported at least one serious adverse event. During this period, the most frequently reported serious adverse event was bronchiolitis, reported in 28 (1.9%) subjects. Other serious adverse events that occurred within 30 days following Daptacel vaccine include three cases of pneumonia, two cases of meningitis and one case each of sepsis, pertussis (post-dose 1), irritability and unresponsiveness.
In the 5th dose study of Daptacel vaccine in the US, within 30 days following the 5th consecutive dose of Daptacel vaccine, 1 (0.2%) subject reported 2 serious adverse events (bronchospasm and hypoxia).
In another study (Sweden II Efficacy Trial), 3 DTaP vaccines and a whole-cell pertussis DTP vaccine, none of which are licensed in the US, were evaluated to assess relative safety and efficacy. This study included HCPDT, a vaccine made of the same components as Daptacel vaccine but containing twice the amount of detoxified PT and four times the amount of FHA (20 μg detoxified PT and 20 μg FHA). HHE was observed following 29 (0.047%) of 61,220 doses of HCPDT; 16 (0.026%) of 61,219 doses of an acellular pertussis vaccine made by another manufacturer; and 34 (0.056%) of 60,792 doses of a whole-cell pertussis DTP vaccine. There were 4 additional cases of HHE in other studies using HCPDT vaccine for an overall rate of 33 (0.047%) in 69,525 doses.
The following adverse events have been spontaneously reported during the post-marketing use of Daptacel vaccine in the US and other countries. Because these events are reported voluntarily from a population of uncertain size, it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
The following adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Daptacel vaccine.
In clinical trials, Daptacel vaccine was administered concomitantly with one or more of the following US licensed vaccines: Hib conjugate vaccine, IPV, hepatitis B vaccine, pneumococcal conjugate vaccine, MMR vaccine, and varicella vaccine. [See Adverse Reactions (6.1) and Clinical Studies (14).] When Daptacel vaccine is given at the same time as another injectable vaccine(s), the vaccine should be administered with different syringes.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to Daptacel vaccine.
Pregnancy Category C
Animal reproduction studies have not been conducted with Daptacel vaccine. It is also not known whether Daptacel vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Daptacel vaccine is not indicated for infants below 6 weeks of age or children 7 years of age or older. Safety and effectiveness of Daptacel vaccine in these age groups have not been established.
Daptacel vaccine is a sterile isotonic suspension of pertussis antigens and diphtheria and tetanus toxoids adsorbed on aluminum phosphate, for intramuscular injection.
Each 0.5 mL dose contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid and acellular pertussis antigens [10 µg detoxified pertussis toxin (PT), 5 µg filamentous hemagglutinin (FHA), 3 µg pertactin (PRN), and 5 µg fimbriae types 2 and 3 (FIM)].
Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg of aluminum) as the adjuvant, ≤5 µg residual formaldehyde, <50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative).
The acellular pertussis vaccine components are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (3) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. The FIM components are extracted and co-purified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate.
Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (4) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (5) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.
The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection.
Both diphtheria and tetanus toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test. The potency of the acellular pertussis vaccine components is determined by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA).
Diphtheria
Diphtheria is an acute toxin-mediated disease caused by toxigenic strains of C diphtheriae. Protection against disease is due to the development of neutralizing antibodies to diphtheria toxin. A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection. Antitoxin levels of at least 0.1 IU/mL are generally regarded as protective. (6) Levels of 1.0 IU/mL have been associated with long-term protection. (7)
Tetanus
Tetanus is an acute disease caused by an extremely potent neurotoxin produced by C tetani. Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assay is considered the minimum protective level. (6) (8) A tetanus antitoxin level ≥0.1 IU/mL as measured by the ELISA u
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