medication_name stringlengths 6 170 | section_title stringclasses 42
values | text stringlengths 0 47.1k |
|---|---|---|
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in cartridge | Pharmaceutical particulars - Shelf life | Shelf life
Unused cartridge
3 years.
After cartridge insertion
28 days.
6.4 |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in cartridge | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Unused cartridge
Store in a refrigerator (2°C – 8°C). Do not freeze. Do not expose to excessive heat or direct sunlight.
After cartridge insertion
Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the needle attached.
6.5 |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in cartridge | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
3 ml suspension in a cartridge (type I glass) with a plunger head at the bottom (rubber) and disc seal at the top (rubber). Pack size of 5 or 10. Not all pack sizes may be marketed.
6.6 |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in cartridge | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Do not reuse needles. Dispose of the needle in a responsible manner. Needles and pens must not be shared. Cartridges can be used until empty, then properly discard. Any unused medicinal product or waste material should be disposed of in accordance with local requireme... |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in cartridge | Marketing authorisation holder | Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
8. Marketing authorisation number(s)
PL 14895/0299
9. |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in cartridge | Date of first authorisation/renewal of the authorisation | 30 July 2019
10. |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in cartridge | Date of revision of the text | 25 January 2021
LEGAL CATEGORY
POM
HU127M |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Name of the medicinal product | Humulin® M3 (Mixture 3) 100 IU/ml suspension for injection in vial
2. |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Qualitative and quantitative composition | 1 ml contains 100 IU insulin human (produced in E. coli by recombinant DNA technology).
One vial contains 10 ml equivalent to 1000 IU of biphasic isophane insulin – 30 % soluble insulin / 70 % isophane insulin.
For a full list of excipients, see section 6.1.
3. |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Pharmaceutical form | A suspension for injection in a vial.
Humulin M3 is a sterile suspension of human insulin in the proportion of 30 % soluble insulin to 70 % isophane insulin.
4. |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Clinical particulars - Therapeutic indications | Therapeutic indications
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.
4.2 |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
The dosage should be determined by the physician, according to the requirement of the patient.
Paediatric population
No data are available
Method of administration
Humulin M3 should be given by subcutaneous injection but may, although not recommended, also be give... |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Clinical particulars - Contraindications | Contraindications
Hypoglycaemia.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, unless used as part of a desensitisation programme.
Under no circumstances should any Humulin formulation other than Humulin S (Soluble) be given intravenously.
4.4 |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (soluble, isophane, mixture), species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DN... |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
A number of medicinal products are known to interact with glucose metabolism and therefore the physician should be consulted when using other medications in addition to human insulin (see section 4.4). The physician must therefore take possible in... |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
It is essential to maintain good control of the insulin treated (insulin-dependent or gestational diabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester and increase during the second and third trimesters. Patients with diabetes should be ... |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Patients should be advised to take precautions t... |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Clinical particulars - Undesirable effects | Undesirable effects
Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the ins... |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Clinical particulars - Overdose | Overdose
Insulin has no specific overdose definitions, because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes. Hypoglycaemia may occur as a result of an excess of insulin relative to food intake and energy expenditure.
Hypogly... |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
The pharmacokinetics of insulin do not reflect the metabolic action of that hormone. Therefore, it is more appropriate to examine glucose utilisation curves (as discussed above) when considering the activity of insulin.
5.3 |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Humulin is human insulin produced by recombinant technology. No serious events have been reported in subchronic toxicology studies. Human insulin was not mutagenic in a series of in vitro and in vivo genetic toxicity assays.
6. |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Pharmaceutical particulars - List of excipients | List of excipients
m-cresol
glycerol
phenol
protamine sulfate
dibasic sodium phosphate 7H2O
zinc oxide
water for injections.
The following may be used to adjust pH; hydrochloric acid and/or sodium hydroxide.
6.2 |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Humulin preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.
6.3 |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Pharmaceutical particulars - Shelf life | Shelf life
Unopened vials
3 years.
After first use
28 days.
6.4 |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not freeze. Do not expose to excessive heat or direct sunlight.
Unopened vials
Store in a refrigerator (2°C - 8°C).
After first use
Store below 30°C.
6.5 |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
10 ml of suspension in a vial (type I glass) with a stopper (rubber) sealed with a seal (aluminium) combined with a flip top (plastic). Pack size 1 or 2 or 5 (5 x 1). Not all pack sizes may be marketed.
6.6 |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Do not reuse needles. Dispose of the needle in a responsible manner. Needles must not be shared. Vials can be used until empty, then properly discard. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Instruct... |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Marketing authorisation holder | Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
8. Marketing authorisation number(s)
PL 14895/0298
9. |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Date of first authorisation/renewal of the authorisation | 30 July 2019
10. |
HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial | Date of revision of the text | 25 January 2021
LEGAL CATEGORY
POM
HU124M |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Name of the medicinal product | Humulin M3 KwikPen (Mixture 3) 100 IU/ml suspension for injection
2. |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Qualitative and quantitative composition | 1 ml contains 100 IU insulin human (produced in E. coli by recombinant DNA technology).
One pre-filled pen contains 3 ml equivalent to 300 IU of biphasic isophane insulin – 30 % soluble insulin / 70 % isophane insulin.
For a full list of excipients, see section 6.1.
3. |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Pharmaceutical form | A suspension for injection in a pre-filled pen.
Humulin M3 is a sterile suspension of human insulin in the proportion of 30 % soluble insulin to 70 % isophane insulin.
4. |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Clinical particulars - Therapeutic indications | Therapeutic indications
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.
4.2 |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
The dosage should be determined by the physician, according to the requirement of the patient.
Paediatric population
No data are available.
Method of administration
Humulin M3 in pre-filled pen is only suitable for subcutaneous injections. This formulation should not... |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Clinical particulars - Contraindications | Contraindications
Hypoglycaemia.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, unless used as part of a desensitisation programme.
Under no circumstances should any Humulin formulation other than Humulin S (Soluble) be given intravenously.
4.4 |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (soluble, isophane, mixture), species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DN... |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
A number of medicinal products are known to interact with glucose metabolism and therefore the physician should be consulted when using other medications in addition to human insulin (see section 4.4). The physician must therefore take possible in... |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
It is essential to maintain good control of the insulin treated (insulin-dependent or gestational diabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester and increase during the second and third trimesters. Patients with diabetes should be ... |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Patients should be advised to take precautions t... |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Clinical particulars - Undesirable effects | Undesirable effects
Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the ins... |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Clinical particulars - Overdose | Overdose
Insulin has no specific overdose definitions, because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes. Hypoglycaemia may occur as a result of an excess of insulin relative to food intake and energy expenditure.
Hypogly... |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
The pharmacokinetics of insulin do not reflect the metabolic action of that hormone. Therefore, it is more appropriate to examine glucose utilisation curves (as discussed above) when considering the activity of insulin.
5.3 |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Humulin is human insulin produced by recombinant technology. No serious events have been reported in subchronic toxicology studies. Human insulin was not mutagenic in a series of in vitro and in vivo genetic toxicity assays.
6. |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Pharmaceutical particulars - List of excipients | List of excipients
m-cresol
glycerol
phenol
protamine sulfate
dibasic sodium phosphate 7H2O
zinc oxide
water for injections.
The following may be used to adjust pH; hydrochloric acid and/or sodium hydroxide.
6.2 |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Humulin preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.
6.3 |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Pharmaceutical particulars - Shelf life | Shelf life
Unused pre-filled pens
3 years.
After first use
28 days.
6.4 |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Unused pre-filled pens
Store in a refrigerator (2°C– 8°C). Do not freeze. Do not expose to excessive heat or direct sunlight.
After first use
Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached.
6.5 |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
3 ml suspension in a cartridge (type I glass) with a plunger head at the bottom (rubber) and disc seal at the top (rubber) in a pre-filled pen. Pack size of 5, 6 or 10 (2 x 5). Not all pack sizes may be marketed.
6.6 |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Do not reuse needles. Dispose of the needle in a responsible manner. Needles and pens must not be shared. Humulin M3 KwikPen can be used until empty, then properly discard. Any unused medicinal product or waste material should be disposed of in accordance with local ... |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Marketing authorisation holder | Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
8. Marketing authorisation number(s)
PL 14895/0300
9. |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Date of first authorisation/renewal of the authorisation | 30 July 2019
10. |
HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection | Date of revision of the text | 25 January 2021
LEGAL CATEGORY
POM
HU129M |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Name of the medicinal product | Humulin® S (Soluble) 100 IU/ml solution for injection in cartridge.
2. |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Qualitative and quantitative composition | 1 ml contains 100 IU insulin human (produced in E. coli by recombinant DNA technology).
One cartridge contains 3 ml equivalent to 300 IU of soluble insulin.
For a full list of excipients, see section 6.1.
3. |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Pharmaceutical form | A solution for injection in a cartridge.
Humulin S is a sterile, clear, colourless, aqueous solution of human insulin.
4. |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Clinical particulars - Therapeutic indications | Therapeutic indications
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.
4.2 |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
The dosage should be determined by the physician, according to the requirement of the patient.
Paediatric population
No data are available
Method of administration
Humulin S in cartridges is only suitable for subcutaneous injections from a reusable pen. If administra... |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Clinical particulars - Contraindications | Contraindications
Hypoglycaemia.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, unless used as part of a desensitisation programme.
Under no circumstances should any Humulin formulation other than Humulin S (Soluble) be given intravenously.
4.4 |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (soluble, isophane, mixture), species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DN... |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
A number of medicinal products are known to interact with glucose metabolism and therefore the physician should be consulted when using other medications in addition to human insulin (see section 4.4). The physician must therefore take possible in... |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
It is essential to maintain good control of the insulin treated (insulin-dependent or gestational diabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester and increase during the second and third trimesters. Patients with diabetes should be ... |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Patients should be advised to take precautions t... |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Clinical particulars - Undesirable effects | Undesirable effects
Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the ins... |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Clinical particulars - Overdose | Overdose
Insulin has no specific overdose definitions, because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes. Hypoglycaemia may occur as a result of an excess of insulin relative to food intake and energy expenditure.
Hypogly... |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
The pharmacokinetics of insulin do not reflect the metabolic action of that hormone. Therefore, it is more appropriate to examine glucose utilisation curves (as discussed above) when considering the activity of insulin.
5.3 |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Humulin is human insulin produced by recombinant technology. No serious events have been reported in subchronic toxicology studies. Human insulin was not mutagenic in a series of in vitro and in vivo genetic toxicity assays.
6. |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Pharmaceutical particulars - List of excipients | List of excipients
m-cresol
glycerol
water for injections
The following may be used to adjust pH; hydrochloric acid and/or sodium hydroxide.
6.2 |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Humulin preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.
6.3 |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Pharmaceutical particulars - Shelf life | Shelf life
Unused cartridge
2 years.
After cartridge insertion
28 days.
6.4 |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Unused cartridge
Store in a refrigerator (2°C – 8°C). Do not freeze. Do not expose to excessive heat or direct sunlight.
After cartridge insertion
Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the needle attached.
6.5 |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
3 ml solution in a cartridge (type I glass) with a plunger head at the bottom (rubber) and disc seal at the top (rubber). Pack size of 5 or 10. Not all pack sizes may be marketed.
6.6 |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Do not reuse needles. Dispose of the needle in a responsible manner. Needles and pens must not be shared. Cartridges can be used until empty, then properly discard. Any unused medicinal product or waste material should be disposed of in accordance with local requireme... |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Marketing authorisation holder | Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
8. Marketing authorisation number(s)
PL 14895/0314
9. |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Date of first authorisation/renewal of the authorisation | 30 July 2019
10. |
HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge | Date of revision of the text | 24 March 2021
LEGAL CATEGORY
POM
HU125 |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Name of the medicinal product | Humulin® S (Soluble) 100 IU/ml solution for injection in vial
2. |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Qualitative and quantitative composition | 1 ml contains 100 IU insulin human (produced in E.coli by recombinant DNA technology).
One vial contains 10 ml equivalent to 1000 IU of soluble insulin.
For a full list of excipients, see section 6.1.
3. |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Pharmaceutical form | A solution for injection in a vial.
Humulin S is a sterile, clear, colourless, aqueous solution of human insulin.
4. |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Clinical particulars - Therapeutic indications | Therapeutic indications
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.
4.2 |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
The dosage should be determined by the physician, according to the requirement of the patient.
Paediatric population
No data are available
Method of administration
Humulin S should be given by subcutaneous injection but may, although not recommended, also be given by... |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Clinical particulars - Contraindications | Contraindications
Hypoglycaemia.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, unless used as part of a desensitisation programme.
Under no circumstances should any Humulin formulation other than Humulin S (Soluble) be given intravenously.
4.4 |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (soluble, isophane, mixture), species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DN... |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
A number of medicinal products are known to interact with glucose metabolism and therefore the physician should be consulted when using other medications in addition to human insulin (see section 4.4). The physician must therefore take possible in... |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
It is essential to maintain good control of the insulin treated (insulin-dependent or gestational diabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester and increase during the second and third trimesters. Patients with diabetes should be ... |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Patients should be advised to take precautions t... |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Clinical particulars - Undesirable effects | Undesirable effects
Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the ins... |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Clinical particulars - Overdose | Overdose
Insulin has no specific overdose definitions, because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes. Hypoglycaemia may occur as a result of an excess of insulin relative to food intake and energy expenditure.
Hypogly... |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
The pharmacokinetics of insulin do not reflect the metabolic action of that hormone. Therefore, it is more appropriate to examine glucose utilisation curves (as discussed above) when considering the activity of insulin.
5.3 |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Humulin is human insulin produced by recombinant technology. No serious events have been reported in subchronic toxicology studies. Human insulin was not mutagenic in a series of in vitro and in vivo genetic toxicity assays.
6. |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Pharmaceutical particulars - List of excipients | List of excipients
m-cresol
glycerol
water for injections.
The following may be used to adjust pH; hydrochloric acid and/or sodium hydroxide.
6.2 |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Humulin preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.
6.3 |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Pharmaceutical particulars - Shelf life | Shelf life
Unopened vials
3 years.
After first use
28 days.
6.4 |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not freeze. Do not expose to excessive heat or direct sunlight.
Unopened vials
Store in a refrigerator (2°C– 8°C).
After first use
Store below 30°C.
6.5 |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
10 ml of solution in a vial (type I glass) with a stopper (rubber) sealed with a seal (aluminium) combined with a flip top (plastic). Pack size 1 or 2 or 5 (5 x 1). Not all pack sizes may be marketed.
6.6 |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Do not reuse needles. Dispose of the needle in a responsible manner. Needles must not be shared. Vials can be used until empty, then properly discard. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Instruct... |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Marketing authorisation holder | Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
8. Marketing authorisation number(s)
PL 14895/0313
9. |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Date of first authorisation/renewal of the authorisation | 30 July 2019
10. |
HUMULIN S (Soluble) 100IU/ml solution for injection in vial | Date of revision of the text | 24 March 2021
LEGAL CATEGORY
POM
HU122 |
Hyalase 1500 I.U. Powder for Solution for Injection/Infusion or Hyaluronidase 1500 I.U. Powder for Solution for Injection/Infusion | Name of the medicinal product | Hyalase® 1500 I.U. Powder for Solution for Injection / Infusion or Hyaluronidase 1500 I.U. Powder for Solution for Injection / Infusion
2. |
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