medication_name stringlengths 6 170 | section_title stringclasses 42
values | text stringlengths 0 47.1k |
|---|---|---|
Gazyvaro 1,000 mg concentrate for solution for infusion | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
No studies have been performed to establish the carcinogenic potential of obinutuzumab.
No specific studies in animals have been performed to evaluate the effect of obinutuzumab on fertility. In repeat-dose toxicity studies in cynomolgus monkeys obinutuzumab had no adverse effects on male and fe... |
Gazyvaro 1,000 mg concentrate for solution for infusion | Pharmaceutical particulars - List of excipients | List of excipients
Histidine
Histidine hydrochloride monohydrate
Trehalose dihydrate
Poloxamer 188
Water for injections
6.2 |
Gazyvaro 1,000 mg concentrate for solution for infusion | Pharmaceutical particulars - Incompatibilities | Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 |
Gazyvaro 1,000 mg concentrate for solution for infusion | Pharmaceutical particulars - Shelf life | Shelf life
Unopened vial
3 years.
After dilution
After dilution, chemical and physical stability have been demonstrated in sodium chloride 9 mg/mL (0.9%) solution for injection at concentrations of 0.4 mg/mL to 20 mg/mL for 24 hours at 2°C to 8°C followed by 48 hours (including infusion time) at ≤ 30°C.
From a ... |
Gazyvaro 1,000 mg concentrate for solution for infusion | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
6.5 |
Gazyvaro 1,000 mg concentrate for solution for infusion | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
40 mL concentrate in a 50 mL vial (clear Type I glass) with stopper (butyl rubber). Pack size of 1 vial.
6.6 |
Gazyvaro 1,000 mg concentrate for solution for infusion | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Instructions for dilution
Gazyvaro should be prepared by a healthcare professional using aseptic technique. Do not shake the vial. Use a sterile needle and syringe to prepare Gazyvaro.
For CLL cycles 2 – 6 and all FL cycles
Withdraw 40 mL of concentrate from the v... |
Gazyvaro 1,000 mg concentrate for solution for infusion | Marketing authorisation holder | Roche Products Limited
6 Falcon Way, Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
8. Marketing authorisation number(s)
PLGB 00031/0856
9. |
Gazyvaro 1,000 mg concentrate for solution for infusion | Date of first authorisation/renewal of the authorisation | Date of first authorisation: 01 January 2021
Date of latest renewal:
10. |
Gazyvaro 1,000 mg concentrate for solution for infusion | Date of revision of the text | 13 April 2023 |
Gefitinib 250 mg film-coated tablets | Name of the medicinal product | Gefitinib 250 mg film-coated tablets
2. |
Gefitinib 250 mg film-coated tablets | Qualitative and quantitative composition | Each film-coated tablet contains 250 mg of gefitinib.
Excipient(s) with known effect
Each film-coated tablet contains 163.50 mg of lactose (as monohydrate).
Each film-coated tablet contains 3.869 mg of sodium.
For the full list of excipients, see section 6.1.
3. |
Gefitinib 250 mg film-coated tablets | Pharmaceutical form | Film-coated tablet.
Tablets are round, biconvex, brown film coated tablets debossed with 'C' on one side and plain on the other side. Diameter: 11.00 mm ± 0.20 mm.
4. |
Gefitinib 250 mg film-coated tablets | Clinical particulars - Therapeutic indications | Therapeutic indications
Gefitinib is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4).
4.2 |
Gefitinib 250 mg film-coated tablets | Clinical particulars - Posology and method of administration | Posology and method of administration
Treatment with gefitinib should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Posology
The recommended posology of gefitinib is one 250 mg tablet once a day. If a dose is missed, it should be taken as soon as the patient remembers. If... |
Gefitinib 250 mg film-coated tablets | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Breast-feeding (see section 4.6).
4.4 |
Gefitinib 250 mg film-coated tablets | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
When considering the use of gefitinib as a treatment for locally advanced or metastatic NSCLC, it is important that EGFR mutation assessment of the tumour tissue is attempted for all patients. If a tumour sample is not evaluable, then circulating tumour DNA (ctDNA) obtained from... |
Gefitinib 250 mg film-coated tablets | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
The metabolism of gefitinib is via the cytochrome P450 isoenzyme CYP3A4 (predominantly) and via CYP2D6.
Active substances that may increase gefitinib plasma concentrations
In vitro studies have shown that gefitinib is a substrate of p-glycoprot... |
Gefitinib 250 mg film-coated tablets | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential must be advised not to get pregnant during therapy.
Pregnancy
There are no data from the use of gefitinib in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk fo... |
Gefitinib 250 mg film-coated tablets | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
During treatment with gefitinib, asthenia has been reported. Therefore, patients who experience this symptom should be cautious when driving or using machines.
4.8 |
Gefitinib 250 mg film-coated tablets | Clinical particulars - Undesirable effects | Undesirable effects
Summary of the safety profile
In the pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 gefitinib-treated patients), the most frequently reported adverse drug reactions (ADRs), occurring in more than 20 % of the patients, are diarrhoea and skin reactions (including ra... |
Gefitinib 250 mg film-coated tablets | Clinical particulars - Overdose | Overdose
There is no specific treatment in the event of overdose of gefitinib. However, in phase I clinical trials, a limited number of patients were treated with daily doses of up to 1000 mg. An increase of frequency and severity of some adverse reactions was observed, mainly diarrhoea and skin rash. Adverse reactions... |
Gefitinib 250 mg film-coated tablets | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Absorption
Following oral administration of gefitinib, absorption is moderately slow and peak plasma concentrations of gefitinib typically occur at 3 to 7 hours after administration. Mean absolute bioavailability is 59 % in cancer patients. Exposure to gefitinib is not significantly altered... |
Gefitinib 250 mg film-coated tablets | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows:
- Corneal epithelia atrophy and corneal translucencies
- Renal papillary necrosis
- Hepatocellular necro... |
Gefitinib 250 mg film-coated tablets | Pharmaceutical particulars - List of excipients | List of excipients
Tablet core
Lactose monohydrate,
Croscarmellose sodium,
Microcrystalline cellulose,
Povidone (E1201),
Sodium lauryl sulfate,
Magnesium stearate (E572).
Tablet coating
Polyvinyl alcohol-part hydrolysed (E1203),
Macrogol (E1521),
Talc,
Titanium dioxide (E171),
Red iron oxide (E172),
Yellow iron oxi... |
Gefitinib 250 mg film-coated tablets | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gefitinib 250 mg film-coated tablets | Pharmaceutical particulars - Shelf life | Shelf life
2 years.
6.4 |
Gefitinib 250 mg film-coated tablets | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
This medicinal product does not require any special storage condition.
6.5 |
Gefitinib 250 mg film-coated tablets | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
PVC/Aluminium in perforated unidose blister containing 10 tablets or PVC/Aluminium non-perforated blister containing 10 tablets.
Three blisters are combined with an aluminium foil laminate over-wrap in a carton.
Pack size of 30 film-coated tablets. Not all pack sizes may be marketed.
6.... |
Gefitinib 250 mg film-coated tablets | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. |
Gefitinib 250 mg film-coated tablets | Marketing authorisation holder | Cipla (EU) Limited
Dixcart House,Addlestone Road,
Bourne Business Park Addlestone
KT15 2LE
United Kingdom.
8. Marketing authorisation number(s)
PL 36390/0244
9. |
Gefitinib 250 mg film-coated tablets | Date of first authorisation/renewal of the authorisation | 20/03/2019
10. |
Gefitinib 250 mg film-coated tablets | Date of revision of the text | 26/05/2022 |
Gefitinib 250 mg Film-Coated Tablets | Name of the medicinal product | Gefitinib 250 mg film-coated tablets
2. |
Gefitinib 250 mg Film-Coated Tablets | Qualitative and quantitative composition | Each tablet contains 250 mg of gefitinib.
Excipient with known effect:
Each tablet contains 163.5 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. |
Gefitinib 250 mg Film-Coated Tablets | Pharmaceutical form | Film-coated tablet.
Brown coloured, round biconvex coated tablets (with a diameter of approximately 11 mm), debossed with G9FB 250 on one side.
4. |
Gefitinib 250 mg Film-Coated Tablets | Clinical particulars - Therapeutic indications | Therapeutic indications
Gefitinib is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4).
4.2 |
Gefitinib 250 mg Film-Coated Tablets | Clinical particulars - Posology and method of administration | Posology and method of administration
Treatment with Gefitinib should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Posology
The recommended posology of Gefitinib is one 250 mg tablet once a day. If a dose is missed, it should be taken as soon as the patient remembers. If ... |
Gefitinib 250 mg Film-Coated Tablets | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Breast-feeding (see section 4.6).
4.4 |
Gefitinib 250 mg Film-Coated Tablets | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
When considering the use of gefitinib as a treatment for locally advanced or metastatic NSCLC, it is important that EGFR mutation assessment of the tumour tissue is attempted for all patients. If a tumour sample is not evaluable, then circulating tumour DNA (ctDNA) obtained from... |
Gefitinib 250 mg Film-Coated Tablets | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
The metabolism of gefitinib is via the cytochrome P450 isoenzyme CYP3A4 (predominantly) and via CYP2D6.
Active substances that may increase gefitinib plasma concentrations
In vitro studies have shown that gefitinib is a substrate of p-glycoprot... |
Gefitinib 250 mg Film-Coated Tablets | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential must be advised not to get pregnant during therapy.
Pregnancy
There are no data from the use of gefitinib in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk fo... |
Gefitinib 250 mg Film-Coated Tablets | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
During treatment with gefitinib, asthenia has been reported. Therefore, patients who experience this symptom should be cautious when driving or using machines.
4.8 |
Gefitinib 250 mg Film-Coated Tablets | Clinical particulars - Undesirable effects | Undesirable effects
Summary of the safety profile
In the pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 gefitinib-treated patients), the most frequently reported adverse drug reactions (ADRs), occurring in more than 20 % of the patients, are diarrhoea and skin reactions (including ra... |
Gefitinib 250 mg Film-Coated Tablets | Clinical particulars - Overdose | Overdose
There is no specific treatment in the event of overdose of gefitinib. However, in phase I clinical trials, a limited number of patients were treated with daily doses of up to 1 000 mg. An increase of frequency and severity of some adverse reactions was observed, mainly diarrhoea and skin rash. Adverse reac... |
Gefitinib 250 mg Film-Coated Tablets | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Absorption
Following oral administration of gefitinib, absorption is moderately slow and peak plasma concentrations of gefitinib typically occur at 3 to 7 hours after administration. Mean absolute bioavailability is 59 % in cancer patients. Exposure to gefitinib is not significantly altered... |
Gefitinib 250 mg Film-Coated Tablets | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows:
• Corneal epithelia atrophy and corneal translucencies
• Renal papillary necrosis
• Hepat... |
Gefitinib 250 mg Film-Coated Tablets | Pharmaceutical particulars - List of excipients | List of excipients
Tablet core
Sodium laurilsulfate
Lactose monohydrate
Cellulose microcrystalline
Povidone
Croscarmellose sodium
Magnesium stearate
Tablet coating
Polyvinyl alcohol
Macrogol
Talc
Iron oxide red (E172)
Iron oxide yellow (E172)
Iron oxide black (E172)
6.2 |
Gefitinib 250 mg Film-Coated Tablets | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gefitinib 250 mg Film-Coated Tablets | Pharmaceutical particulars - Shelf life | Shelf life
3 years
6.4 |
Gefitinib 250 mg Film-Coated Tablets | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 |
Gefitinib 250 mg Film-Coated Tablets | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
oPA/Al/PVC-Al perforated or non-perforated blister.
Boxes containing 30 tablets or 30 x 1 tablet. Not all pack sizes may be marketed.
6.6 |
Gefitinib 250 mg Film-Coated Tablets | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. |
Gefitinib 250 mg Film-Coated Tablets | Marketing authorisation holder | Genus Pharmaceuticals Ltd. (trading as 'STADA'),
Linthwaite, Huddersfield, HD7 5QH, UK
8. Marketing authorisation number(s)
PL 06831/0314
9. |
Gefitinib 250 mg Film-Coated Tablets | Date of first authorisation/renewal of the authorisation | 10/08/2018
10. |
Gefitinib 250 mg Film-Coated Tablets | Date of revision of the text | 22/02/2023 |
Gefitinib Glenmark 250 mg film-coated tablets | Name of the medicinal product | Gefitinib Glenmark 250 mg film-coated tablets
2. |
Gefitinib Glenmark 250 mg film-coated tablets | Qualitative and quantitative composition | Each film-coated tablet contains 250 mg of gefitinib.
Excipient with known effect:
Each film-coated tablet contains 161 mg of lactose (as monohydrate)
Each tablet contains 0.1 mg sodium
For the full list of excipients, see section 6.1.
3. |
Gefitinib Glenmark 250 mg film-coated tablets | Pharmaceutical form | Film-coated tablet (tablet).
The film-coated tablets are brown, round and biconvex, marked with “250” on one side and plain on the other.
The film-coated tablets have a diameter of approx. 11.1 mm and a thickness of approx. 5.6 mm.
4. |
Gefitinib Glenmark 250 mg film-coated tablets | Clinical particulars - Therapeutic indications | Therapeutic indications
Gefitinib Glenmark is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4).
4.2 |
Gefitinib Glenmark 250 mg film-coated tablets | Clinical particulars - Posology and method of administration | Posology and method of administration
Treatment with Gefitinib Glenmark should be initiated and supervised by a physician experienced in the use of anti-cancer therapies.
Posology
The recommended posology of Gefitinib Glenmark is one 250 mg tablet once a day. If a dose is missed, it should be taken as soon as the pat... |
Gefitinib Glenmark 250 mg film-coated tablets | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding (see section 4.6).
4.4 |
Gefitinib Glenmark 250 mg film-coated tablets | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
When considering the use of Gefitinib Glenmark as a treatment for locally advanced or metastatic NSCLC, it is important that EGFR mutation assessment of the tumour tissue is attempted for all patients. If a tumour sample is not evaluable, then circulating tumour DNA (ctDNA) obta... |
Gefitinib Glenmark 250 mg film-coated tablets | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
The metabolism of gefitinib is via the cytochrome P450 isoenzyme CYP3A4 (predominantly) and via CYP2D6.
Active substances that may increase gefitinib plasma concentrations
In vitro studies have shown that gefitinib is a substrate of p-glycoprot... |
Gefitinib Glenmark 250 mg film-coated tablets | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential must be advised not to get pregnant during therapy.
Pregnancy
There are no data from the use of gefitinib in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk fo... |
Gefitinib Glenmark 250 mg film-coated tablets | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
During treatment with gefitinib, asthenia has been reported. Therefore, patients who experience this symptom should be cautious when driving or using machines.
4.8 |
Gefitinib Glenmark 250 mg film-coated tablets | Clinical particulars - Undesirable effects | Undesirable effects
Summary of the safety profile
In the pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 gefitinib-treated patients), the most frequently reported adverse drug reactions (ADRs), occurring in more than 20% of the patients, are diarrhoea and skin reactions (including rash,... |
Gefitinib Glenmark 250 mg film-coated tablets | Clinical particulars - Overdose | Overdose
There is no specific treatment in the event of overdose of gefitinib. However, in phase I clinical trials, a limited number of patients were treated with daily doses of up to 1000 mg. An increase of frequency and severity of some adverse reactions was observed, mainly diarrhoea and skin rash. Adverse reactions... |
Gefitinib Glenmark 250 mg film-coated tablets | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Absorption
Following oral administration of gefitinib, absorption is moderately slow and peak plasma concentrations of gefitinib typically occur at 3 to 7 hours after administration. Mean absolute bioavailability is 59% in cancer patients. Exposure to gefitinib is not significantly altered ... |
Gefitinib Glenmark 250 mg film-coated tablets | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows:
- Corneal epithelia atrophy and corneal translucencies
- Renal papillary necrosis
- Hepatocellular necro... |
Gefitinib Glenmark 250 mg film-coated tablets | Pharmaceutical particulars - List of excipients | List of excipients
Tablet core
Lactose monohydrate
Microcrystalline cellulose
Crospovidone
Povidone
Sodium laurilsulfate
Magnesium stearate
Tablet coating
Polyvinyl alcohol
Macrogol
Talc
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)
6.2 |
Gefitinib Glenmark 250 mg film-coated tablets | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Gefitinib Glenmark 250 mg film-coated tablets | Pharmaceutical particulars - Shelf life | Shelf life
24 months.
6.4 |
Gefitinib Glenmark 250 mg film-coated tablets | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not store above 30 °C
6.5 |
Gefitinib Glenmark 250 mg film-coated tablets | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
PVC/PVDC-Aluminium perforated blister containing 10 tablets or PVC/PVDC-Aluminium non-perforated blister containing 10 tablets.
Additionally, the blisters may be packed into aluminium pouches.
Pack size of 30 film-coated tablets. Not all pack sizes may be marketed.
6.6 |
Gefitinib Glenmark 250 mg film-coated tablets | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. |
Gefitinib Glenmark 250 mg film-coated tablets | Marketing authorisation holder | Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue
Kenton, Middlesex
HA3 0BU
United Kingdom
8. Marketing authorisation number(s)
PL 25258/0277
9. |
Gefitinib Glenmark 250 mg film-coated tablets | Date of first authorisation/renewal of the authorisation | 05/09/2018
10. |
Gefitinib Glenmark 250 mg film-coated tablets | Date of revision of the text | 13/12/2021 |
Glycerin Suppositories BP 1g Infants' Size | Name of the medicinal product | Glycerin Suppositories BP 1g Infants' Size
2. |
Glycerin Suppositories BP 1g Infants' Size | Qualitative and quantitative composition | Glycerol BP 70% w/w
3. |
Glycerin Suppositories BP 1g Infants' Size | Pharmaceutical form | Suppositories.
4. |
Glycerin Suppositories BP 1g Infants' Size | Clinical particulars - Therapeutic indications | Therapeutic indications
For the relief of occasional constipation.
4.2 |
Glycerin Suppositories BP 1g Infants' Size | Clinical particulars - Posology and method of administration | Posology and method of administration
Route of administration:
Rectal.
Dose:
One suppository.
Dosage schedule:
As required.
The suppository should be dipped in water before insertion.The suppositories are defined as infants' size, therefore there is no adults' or c... |
Glycerin Suppositories BP 1g Infants' Size | Clinical particulars - Contraindications | Contraindications
Contraindicated in patients with known hypersensitivity to glycerol.
4.4 |
Glycerin Suppositories BP 1g Infants' Size | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Keep all medicines away from children.Not to be swallowed. Suppositories must not be taken by mouth. Consult your doctor before use.
4.5 |
Glycerin Suppositories BP 1g Infants' Size | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
None known.
4.6. |
Glycerin Suppositories BP 1g Infants' Size | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Not applicable.
4.7 |
Glycerin Suppositories BP 1g Infants' Size | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
None.
4.8 |
Glycerin Suppositories BP 1g Infants' Size | Clinical particulars - Undesirable effects | Undesirable effects
Gastrointestinal Disorders: May cause irritation and occasionally abdominal cramps.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal ... |
Glycerin Suppositories BP 1g Infants' Size | Clinical particulars - Overdose | Overdose
Glycerol has a mildly laxative action, however, if the product is accidentally swallowed it is unlikely to cause such effects and it is unlikely that active measures will be required. Accidental ingestion of a large number of suppositories may cause headache, nausea and vomiting; less frequently diarrhoea, th... |
Glycerin Suppositories BP 1g Infants' Size | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
No information available.
5.3 |
Glycerin Suppositories BP 1g Infants' Size | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
None.
6. |
Glycerin Suppositories BP 1g Infants' Size | Pharmaceutical particulars - List of excipients | List of excipients
Gelatin Purified Water
6.2 |
Glycerin Suppositories BP 1g Infants' Size | Pharmaceutical particulars - Incompatibilities | Incompatibilities
None known.
6.3 |
Glycerin Suppositories BP 1g Infants' Size | Pharmaceutical particulars - Shelf life | Shelf life
18 months unopened.
6.4 |
Glycerin Suppositories BP 1g Infants' Size | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store below 25°C in a dry place.
6.5 |
Glycerin Suppositories BP 1g Infants' Size | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
12's: Sealed, PVC/PE laminate inside a cardboard carton.
6.6 |
Glycerin Suppositories BP 1g Infants' Size | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
None.
7. |
Glycerin Suppositories BP 1g Infants' Size | Marketing authorisation holder | Thornton & Ross Ltd.Linthwaite LaboratoriesHuddersfieldHD7 5QH.
8. Marketing authorisation number(s)
PL 00240/6100R
9. |
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